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61/5926/CC

COMPILATION OF COMMENTS ON COMMITTEE DRAFT (CC)

PROJECT NUMBER:

IEC 60335-2-115 ED1

DATE OF CIRCULATION:

2019-09-06

REFERENCE NUMBER OF THE CD:

61/5881/CD

IEC TC 61 : SAFETY OF HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES

SECRETARIAT: SECRETARY: CHAIR:

United States of America Ms Randi Myers Mr Fabio Gargantini

OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:

TC 87

FUNCTIONS CONCERNED:

EMC ENVIRONMENT QUALITY ASSURANCE SAFETY

The chair(in cooperation with the secretariat and the project leader) has taken the following course of action:

A A REVISED DRAFT WILL BE DISTRIBUTED AS A COMMITTEE DRAFT FOR VOTE (CDV) BY

B A REVISED DRAFT WILL BE DISTRIBUTED AS A COMMITTEE DRAFT (CD) FOR COMMENT BY

C THE COMMITTEE DRAFT AND COMMENTS WILL BE DISCUSSED AT THE NEXT MEETING ON 2019-10-25

In the case of a proposal A or B made by the chair, P-members objecting to such a proposal shall inform the Central Office with copy to the secretary in writing within 2 months of the circulation of this compilation(see ISO/IEC Directives, Part 1, 2.5.3).

TITLE:

Household and Similar Electrical Appliances – Safety – Part 2-115: Particular requirements for beauty care appliances

NOTE FROM TC/SC OFFICERS:

This compilation includes comments from IEC TC 87, Ultrasonics.

This document will be discussed during the TC 61 Plenary meeting in Shanghai, China, 21-25 October 2019. After the meeting, a revised CC document will be circulated with Observations of the Secretariat included.

Annexes: Report of Comments, Comments received

61(Shanghai/PT60335-2-115)56

October 2019

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Report of Comments on 61/5881/CDCirculation Date: 2019-07-05 Closing Date: 2019-08-30IEC 60335-2-115 ED1: Household and Similar Electrical Appliances – Safety – Part 2-115: Particular requirements for beauty care appliancesCountry Status Comments ReceivedAlbania PArgentina OAustralia P Y 2019-08-16Austria P N 2019-08-12Belarus O N 2019-08-30Belgium P N 2019-08-30Brazil O N 2019-08-30Bulgaria OCanada P Y 2019-08-13China P N 2019-08-19Czech Republic P N 2019-08-29Denmark P Y 2019-08-30Egypt P Y 2019-08-29Finland P Y 2019-08-28France P N 2019-08-05Germany P Y 2019-08-28Greece P N 2019-08-29Hungary P N 2019-08-30India P N 2019-08-30Indonesia P N 2019-08-26Iran P N 2019-08-28Ireland P N 2019-07-10Israel P N 2019-08-28Italy P N 2019-08-06Japan P Y 2019-08-26Korea, Republic of P N 2019-08-30Kuwait OMalaysia P N 2019-08-30Mexico P N 2019-08-29Netherlands P Y 2019-08-27New Zealand P Y 2019-08-13Norway P N 2019-08-13Pakistan P N 2019-08-26Philippines, Rep. of the P N 2019-08-29Poland P N 2019-08-29Portugal P N 2019-08-30Qatar ORomania ORussian Federation O N 2019-08-29Saudi Arabia OSerbia PSingapore OSlovakia OSlovenia P N 2019-07-12South Africa P N 2019-08-30Spain P N 2019-07-10Sweden PSwitzerland PThailand P N 2019-07-25Turkey P N 2019-08-26Ukraine P N 2019-08-29United Arab Emirates - N 2019-08-25United Kingdom P Y 2019-08-29United States of America P Y 2019-08-08Vietnam P N 2019-08-14

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P-members O-members Non-members TotalY : comments 11 0 0 11

N : no comments 28 3 1 32- : no response 4 8 0 12

NotesP-members with no response: Albania; Serbia; Sweden; Switzerland

*Comments rejected because they were not submitted in the IEC Comment form.

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Date Document Project Nr.2019-08-30 61/5881/CD 60335-2-115

MB/NC Line number(e.g. 17)

Clause/ Subclause(e.g. 3.1)

Paragraph/ Figure/ Table/

(e.g. Table 1)

Type of comment

Comments Proposed change Observations of PT60335-2-115

1 GB01 ge The British National Committee supports progression of the draft with the following comment:

noted

2 FI01 ge The Finnish NC wishes to submit following comments on doc. 61/5881/CD.

noted

3 NL01 64, 180 Title of standard

te A clear distinction is needed between the scope of part 2-23 (appliances for skin care) and this new part 2-115 (appliances for beauty care).Care for skin and care for beauty are very closely related in many applications !E.g.: is an appliance applying a cream to the skin and brushing it out on the skin under part 2-23 or under part 2-115?

Change title of the standard to:Household and Similar Electrical Appliances – Safety – Part 2-115: Particular requirements for beauty care appliances for application on the skin.(last time NLNC uses “application through”)

Accepted in principle.

Change the title to “Household and Similar Electrical Appliances – Safety – Part 2-115: Particular requirements for skin beauty care appliances”.

4 AU01 GE te We recommend referring to “a detachable power supply part” rather than a power supply

Replace power supply with “a detachable power supply part” throughout the document

Accepted in principle .Refer to other comments.

5 EG01 183 15 te Clause 15 of IEC 60317-0-2:2019 applies, where the minimum temperature index shall be200.

You mentioned in row 171 that shock temp be 220

Not understood

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(e.g. Table 1)

Type of comment


6 NL02 185-187 1 Scope te Reading the scope it should be clear which products are covered by the standard. A clear distinction is needed between the scope of part 2-23 (appliances for skin care) and this new part 2-115 (appliances for beauty care).Care for skin and care for beauty are very closely related in many applications !E.g.: is an appliance applying a cream to the skin and brushing it out on the skin under part 2-23 or under part 2-115?

Change scope to:This part of IEC 60335 deals with the safety of electric appliances for beauty care for application on the skin and intended for household, commercial and similar purposes, their rated voltage being not more than 250 V.

See 3.

7 US01 185 1 te The term “beauty care” is not defined and as such it is not clear what products would be covered under this product standard versus those in 2-23. 2-23 deals with the safety of electric appliances for the care of skin or hair of persons or animals and intended for household and similar purposes, their rated voltagebeing not more than 250 V.

Either define beauty care or more clearly specify in the scope of both 2-115 and -2-23 the products that would be covered. Perhaps 2-23 should deal with hair and 2-115 should deal with skin type devices other than those covered by 2-113

Change “beauty care appliances” to “skin care appliances” or “skin care and muscle stimulation appliances” in the title and throughout the proposal

Initiate proposal to modify -2-23 to remove skin care appliances so they are all covered under one Part 2 standard

See 4

Add at the end of the line 227: hand dryers and foot care appliances,

8 NL03 189-190 1 NOTE101 te The second sentence of the note is already addressed by (new) annex B of part 1.

Delete the second sentence of NOTE 101. Not accepted at the time, Ed 6of part 1 is not yet approved for publication.

9 NL04 201-203 1 NOTE102 te Appliances for:- Beauty care appliances for melting

wax;- Appliances intended to produce

surface cooling effect on the skin;- Facial cleaning appliances for

commercial use; Are skin care appliances

Delete lines 201-203Add these products to IEC 60335-2-23.

Not accepted. Refer to US02

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(e.g. Table 1)

Type of comment


10 US02 203 1 te Line 203 indicates that standard covers commercial facial cleaning appliances but does not indicate that it covers household type. Both should be included to avoid confusion

-Facial cleaning appliances for household and commercial use.

Not accepted.Household types are covered by Part 2-23.Refer to 6.101 for distinction between household use and commercial use.

11 DK01 206 1 te There is no a clear determination between appliances in the scope of this standard and 60335-2-23. For example in IEC60335-2-23, cl.1, ‘NOTE 102 Appliances covered by this standard may incorporate steam-producing or spray-producing devices ‘. And in

IEC 60335-2-115, cl 1, ‘NOTE 103 Appliances covered by this standard may incorporate steam-producing or spray-producing devices

How shall the main function be distinguished from another function provided by the appliance?Without this being clearly explained, the distinction cannot be made

Examples of these requirements are:-line 257-line 628-line 632-line 648-line 842

Provide a clearly described way to distinguish between the main function and another function of appliances in the scope of this standard

or

remove requirements associated with appliances incorporating steam producing or spray producing devices from this standard and instead indicate that 60335-2-23 is the applicable standard for these functions.

(this is similar to the approach taken in other part-2’s under 60335)

Not accepted.Leave it as is.This comment applies equally to the note in part 2-23.

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(e.g. Table 1)

Type of comment


12 JP01 233 2 te A beauty care appliance that carries Galvanic current is an appliance that is intended for cleansing and moisturizing skin generally. The flowing current is a positive or negative DC (direct current of electricity) or pulse current.The current output from the radio frequency appliances is AC (alternating current) in general.

The word of "galvanic" seems to have the meaning of "having an electric effect" and "producing a direct current of electricity". To prevent confusion, the wording should be modified.

Replace “galvanic” by “electric” as follows.

– radio frequency appliances without galvanicelectric contact to the skin.

To make it general.Delete the word “galvanic”, and this follows Part 2-113.

13 FI02 241-242 2 ge IEC 63009:2019 was published on 11th July 2019 and covers ultrasonic physiotherapy systems operating in the frequency range 20 kHz to 500 kHz.

Consider adding IEC 63009:2019 as a normative reference.

Accepted.Also 107

14 DE01 2 + 11.3

Should be 11.3

te Addition according to the recommendation of the MT4. The CD includes temperature rise limits for applied parts, but not for other parts that may be touched. (see document 61/5864/DC)

Addition:Insert the proposal of document 61/5864/DC) into the standard:Add after line 249 for §2,add after line 507 § 11.3,Replace 1st paragraph of 11.8,add table 103 and figure 102 after line 543

Ok, if the content of the DC of MT4 is approved.

15 NL05 281-282 3.5.103 ed The electrical phenomena should all be indicated in singular form.And sentence is editorially not fully correct.

Change as follows:appliance intended to produce radiofrequency current, electric field, magnetic field, or electromagnetic field for application to the human body

Accepted.EG1 will reorder it.

16 NL06 285 3.5.104 ed Appliances should be in singular form.And sentence is editorially not fully correct.

Change as follows:appliance intended to produce ultrasound for application to the human body

accepted.

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(e.g. Table 1)

Type of comment


17 NL07 312-314 5.102 te We do not understand the meaning of this paragraph when the artificial skin to be used is already defined in the second paragraph (315-316).Furthermore if artificial skin for other applications is so important the standard should not omit to indicate the specifications of this artificial to be used with regards to softness, specific heat capacity, electrical resistivity or ultrasound properties. See also NL08

Delete the first paragraph (312-314) of 5.102 accepted

18 NL08 315-316 5.102 te Agar is not a defined substance. Different agar may lead to different test results.

Further it seems highly unlikely that agar possesses all relevant properties similar to natural skin (e.g. regarding resistivity, softness, heat capacity, sound propagation etc.).

It is likely that, depending on the test, different materials serving as artificial skin may be required.

In part 2-113 the following artificial skin is specified:NOTE Suitable material for the artificial skin is silicone rubber with a thickness of 10 mm [e.g., (Wacker Chemie AG Elastosil RT 604, A/B) mix ratio = 9:1 with 0,6 % colour (Max Factor Creme Puff Compact Powder – 41 Medium Beige) and 6 % scattering material (Sigma Aldrich Chemical Co. AL203)]1.

1 This information is given for the convenience of users of this document and does not constitute an endorsement by IEC of these products.

Add details of agar composition.Ensure all relevant properties of natural skin are sufficiently covered by agar or specify different materials for different tests.Or replace the reference to agar by:NOTE Suitable material for the artificial skin is silicone rubber with a thickness of 10 mm [e.g., (Wacker Chemie AG Elastosil RT 604, A/B) mix ratio = 9:1 with 0,6 % colour (Max Factor Creme Puff Compact Powder – 41 Medium Beige) and 6 % scattering material (Sigma Aldrich Chemical Co. AL203)]1.

1 This information is given for the convenience of users of this document and does not constitute an endorsement by IEC of these products.

The artificial skin in Part 2-113 is exactly what is required for appliances in Part 2-113.

Add in line 316, “food grade agar”

6 gm agar is mixed with 100cc of water to prepare the agar.

Refer to EG1 for the text.

19 NZ01 316 5.102 te More details of the agar to be used is needed since it can be sold in powder form.

Add ‘solidified’ before “agar” See 18

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(e.g. Table 1)

Type of comment


20 NL09 323-325 6.2 te The IP classification for a PS in flexible cords is missing.

Furthermore we would like to extent the IP requirement for PS provided with pins for insertion into socket outlets.

Change the 1st and 2nd sentence by the following:

Appliances that are washable according to the instructions shall be at least IPX7. except that parts that are intended to be fixed, and power supplies fitted in flexible cords or provided with pins for insertion into socket-outlets, shall be at least IPX4.

Accepted in principle. Also refer to comment 4.

But change the first sentence to：The hand-held parts of an appliance which can be cleaned under water according to the instructions shall be IPX7.

21 DK02 327-330 6.101 te The purpose of the classification either for household use or for use in beauty parlours is not understood.

In particular line 330 (note 1) seem to make the distinction irrelevant

Clarify the purpose of this additional classification

and

Delete line 330

No need to clarify, it aligns with Part 2-27 and Part 2-113.

Not accepted to delete line 330.

22 DK03 327-331 6.101 te How shall this classification be given? Shall this be stated in the instructions?

With reference to line 331, how can compliance with this requirement be determined by tests?

Explain how this classification shall be given.

and

Delete the part of line 331 that reads “and by the relevant tests”

Not accepted. It aligns with Part 2-27 and Part 2-113.

Refer to lines 346-348 and 370-372.

23 NL10 337-338 7.1 te Based on NL04 Wax melting appliances are skin care products

Delete lines 337-338. Not accepted. See comment 9.

24 NL11 339-340 7.1 te A warning in text should be allowed as an alternative to symbol ISO 7010-P026 (similar to part 2-23)

Add at the end of the sentence:

or with the substance of the following:

WARNING: Do not use this appliance near water.

Accepted. The manufacturer is free to use the mark or the text, as long as 7.13 is followed.

25 NL12 344-345 7.1 ed Add the word ‘For’. Add the word ‘For’ as follows:

For Ultrasound appliances that have non-replaceable ultrasound probes, the BNR shall be marked on the appliance.

Not needed.

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(e.g. Table 1)

Type of comment


26 DK04 352 7.6 te The sign for “not for household use” is not clear and cannot be expected to be generally understood by the general public and might lead to confusion.It is also not a standardized sign covered by IEC 60417 or ISO 7000

As such the sign shall not be used in this standard.

The sign shall be proposed for and accepted in IEC 60417 or in ISO 7000 before it can be used in this standard.

Not accepted. It follows Part 2-27.This is prohibition sigh.

IEC 60417 and ISO 7000 covers symbols they do not cover signs.

27 NL13 352 7.6 te Symbols ISO 7000-0790 (2004-01) and ISO 7000-0434A (2004-01) are missing.

Add symbols ISO 7000-0790 (2004-01) and ISO 7000-0434A (2004-01).

Not accepted. Those symbols are detailed in Part 1.

28 NL14 352 7.6 te The symbol is a crossed-out version of the symbol for appliances intended for indoor use only.This proposed symbol therefore may suggest that the appliance may not be used indoor but only outdoor.

1) Delete the symbol ‘not for household use’ and as a result change the following text in penultimate paragraph (346-348) of 7.1:

If the appliance is intended to be only used in beauty parlours and similar premises, it shall be marked with the substance of the following:

2) In 7.12 delete lines 370-372.

3) In lines 373 – 385 add the following new dashed item:

-this appliance is not for household use

Not accepted. See comment 26.

29 JP02 353-357 7.10 te This requirement should not be applicable for appliances where the user cannot regulate the duration of operation.For example, there are many home-use appliances whose operation time is predetermined according to the operation mode. Since the power is automatically turned off after a predetermined time has passed, the user can know the end of the operation.

Add underlined sentence as follows.

For appliances delivering current to the human body, timing controls used to regulate the duration of operation shall be clearly and indelibly marked at regular intervals over the complete timing range to indicate time settings. Time settings may also be indicated using digital displays. This is not applicable for appliances for home use that users cannot regulate the duration of operation.

It is not necessary. It is obvious that the requirement is not applicable if the duration of operation cannot be set.

30 JP03 367-369 7.12 ed This sentence is unnecessary because the warning sign ISO 7010-W005 has already been deleted in 7.6.

Delete lines 367-369

If Warning sign ISO 7010-W005 (2011-05) is used its meaning shall be explained using the substance of the following:

Accepted.

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(e.g. Table 1)

Type of comment


31 NL15 367-369 7.12 te Warning symbol ISO 7010-W005 is nowhere required in this proposal.

Delete lines 367-369 and 458. See comment 30

32 NL16 393 7.12 ed Delete comma.

Delete dot after the word ‘number’.

Delete comma.

Delete dot after the word ‘number’.

Accepted.

33 NL17 399-401 7.12 te/ed As the sentences ‘It shall not be used more than once’ and ‘The depth of penetration…’ are isolated sentences it may be unclear if these sentences concern general requirements or requirements for the instructions.

Replace 399 – 401 by the following:

The instructions for micro-needling appliances shall include the following:- the needle cartridge shall be replaced after use. It shall not be used more than once.-The depth of penetration on the face shall not exceed 0.5 mm.

Accepted in principle.Add at the end of the second item: (/if necessary)

34 JP04 403-405 7.12 te Even if the power is not turned off, there is no matter as long as no output is made (such as a standby state).

Replace “de-energize“ by “stop the output of ” as follows.

– de-energizestop the output of the appliance before placing or removing the electrodes to or from the skin (not applicable, if in normal use the appliance is moved continuously over the surface of the skin);

Accepted in principle. Replace “de-energize” by “Deactivate the output of the appliance”

35 NL18 404 7.12 ed Delete comma. Delete comma. Accepted36 NL19 409 7.12 te As the eyes are crucial organs of the human

and there appears to be no need to apply electrical stimulators close to the eyes, the exclusion for appliances having an output current not exceeding 50 uA is of no use.

Change as follows:

-do not use the electrical stimulator near the eyes;

Not accepted.

37 NL20 414 7.12 te In line with line 418 the word ‘type’ should be used instead of ‘size’.

Change as follows:

– information on the type of the applied part to be used

Accepted to change to type, for example, shape, and size are relevant.


Delete lines 420-422. See 9

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(e.g. Table 1)

Type of comment


39 JP05 428-429 7.12 te The safety of the temperature of the vapour is ensured by the test on lines 540-541 of Clause 11.

This requirement fails to perform its intended function for home use appliances intended for use around the eye under safe conditions where the producing rate of vapour is slow.

Add the underlined sentence after line 429 as follows.

– do not apply vapour to the eyes unless the eyes are cover by towelling or similar material. The appliances for home use that the producing rate of vapour is slow and are intended use around the eye is not applied.

Not accepted.Vapor may not just include water maybe include other substance.

40 FI03 432-439 7.12 te The requirements do not cover RF appliances which produce a non-continuous pulse train (burst of pulses).

Add the following text after the first sentence on row 438:“For appliances producing a burst of pulses, the combined maximum total output energy (J) or maximum total output energy density (J/cm2 or J/cm3) per a single burst pulse shall be specified.”

Accepted but we need to clarify what is a single pulse or a single burst of pulse, and continuous pulse trains.(maybe put into secretary’s note when CDV is prepared)More information will be needed

41 FI04 442-443 7.12 ed Ultrasound appliances covered by the proposed standard may utilize frequencies from tens of kHz up to the GHz range. It is impractical to require the frequency to specified in MHz in all cases.

Replace the sentence with:“The instructions for ultrasound appliances shall state the operating frequency (in kHz or MHz) or frequency range and intensity (in W/cm²).”

Accepted in principle, but do not need to specify the unit.

42 NL22 444-445 7.12 ed This is a general instruction for all type of beauty care appliances and shall therefore be part of the list of general instructions in lines 373 - 385

Move the sentence to a new dashed item in the list of general instructions in lines 373 – 385.

Accepted.See comment 110 in 61/5724A/CC

43 JP06 458 7.12 ed This sentence is unnecessary because the warning sign ISO 7010-W005 has already been deleted in 7.6.

Delete line 458.

The height of the triangle in Warning sign ISO 7010-W005 (2011-05) shall be at least 10 mm.

accepted

44 DK05 461 8 te The proposed addition belong to cl. 8.1.4 and not to cl. 8 as proposed

Specify the proposed text as an addition to cl. 8.1.4

Not accepted.It is a general requirement for Clause 8.

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(e.g. Table 1)

Type of comment


45 DK06 461 8 te The proposed addition exclude electrical stimulator from the limits of cl. 8.1.4 but does not otherwise contain any requirements, limitations or condition to ensure that electrical stimulators are safe and does not pose a risk of electric shock.

Appropriate limitations of the output values will be necessary to ensure the safety of these parts.The text and requirements proposed as cl. 22.105 would be more correctly placed in cl. 8.1.4 as the relevant limits for applied parts of electrical stimulators.

Move the text of the proposed cl. 22.105 to be included as part of the addition to cl. 8.1.4

Not accepted.Refer to comment 43 in 19-PT60335-2-115 observations on 61/5834/CC

46 CA01 462-463 8 - te It is understood that based on clauses such as 22.104, 22.105 and 22.106 the applied parts of an electrical stimulator are safe to touch. However, there is no need to specify that in clause 8. The part 1 should simply apply.

Delete the proposed addition in lines 462 and 463.

Not accepted.Refer to comment 44.

47 JP07 462-463 8 te Comments on the material “Annex to JPNC comments of 61_5834e_CD(20190513).pptx” are not even reflected.See Attachment.

Add the underlined text in line 462 as follows.

For electrical stimulators and radio frequency appliances, the applied parts are not considered to be live parts.

Accepted.

48 NL23 468-481 10.101 te This is rather an addition to clauses 10.1 and 10.2 than a new requirement.

Replace 10.101 as a whole by the following text:

10.1 Addition:Electrical stimulators are operated at rated voltage with a load resistance applied to the output that maximizes the power input.

The appliance is operated for the maximum period specified in the instructions or maximum setting of an incorporated timer whichever is shorter.

The maximum value of power input, averaged over any 5 s period is obtained. Themaximum of the average values so obtained is taken as the maximum value of the power input.

If the appliance cannot operate as intended when applying a load resistance, the manufacturer may specify a different method to achieve the required

Not accepted. The requirement and test specification are different to those in 10.1 and 10.2.

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(e.g. Table 1)

Type of comment


input power and that method shall be applied.

10.2 Addition:Electrical stimulators are operated at rated voltage with a load resistance applied to the output that maximizes the input current.


The maximum value of current, averaged over any 5 s period is obtained. Themaximum of the average values so obtained is taken as the maximum value of the input current.

If the appliance cannot operate as intended when applying a load resistance, the manufacturer may specify a different method to achieve the required input current and that method shall be applied.

49 NL24 482-497 10.102 te This is rather an addition to clauses 10.1 and 10.2 than a new requirement.

Replace 10.102 as a whole by the following text:

10.1 Addition:Radio frequency appliances are operated at rated voltage with a load resistance applied to the output that maximizes the power input.


The maximum value of power input, averaged over any 5 s period is obtained. The maximum of the average values so obtained is taken as the maximum value of the power input.

To carry out the test, a specially prepared sample may be needed with the load resistorattached across the output applicator.

If the appliance cannot operate as intended when applying a load resistance, themanufacturer may specify a different method to achieve the required input power and that method shall be applied.

10.2 Addition:

See 48

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(e.g. Table 1)

Type of comment


Radio frequency appliances are operated at rated voltage with a load resistance applied to the output that maximizes the input current.


The maximum value of power input or current, averaged over any 5 s period is obtained. The maximum of the average values so obtained is taken as the maximum value of the input current.

To carry out the test, a specially prepared sample may be needed with the load resistorattached across the output applicator.

If the appliance cannot operate as intended when applying a load resistance, themanufacturer may specify a different method to achieve the required input current and that method shall be applied.

50 DK07 518-541 11.8 te The proposal to apply temperature limits based on the contact time is not acceptable.

It cannot be expected that users are respecting the contact times stated in the instructions and so with the proposed limits there may be a risk of burns.In particular this may be critical for appliances that are used by an operator and applied against another person and so the operator cannot feel if a burn is starting to set in and so does not remove the applied part in such cases.

Provide specific limiting values that ensures that there is not risk of burns even if the recommended contact times with the skin are exceeded.

Noted. DK NC is invited to make a proposal for the specific limiting values.

50a PT 519-520 11.8 te For the last sentence, the test should be carried out with the applied part in air or in contact with the artificial skin whichever is more unfavourable.

Replace the last sentence by:For other appliances the test is carried out with the applied part in air or in contact with the artificial skin whichever is more unfavourable.

Accepted.

51 NL25 541 11.8 te Replace ‘tested’ by ‘measured’. Replace ‘tested’ by ‘measured’. Accepted.

52 NL26 542 11.8 te Based on NL04 Wax melting appliances are skin care products

Delete line 542 See 9

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(e.g. Table 1)

Type of comment


52a GB02 557-559 13.1 te 60335-2-115 has its roots in prEN 50415 2003, which was based on the philosophy of 60601-1.

The leakage current tests of 60335 are not logical for products with electrical connection direct to the human body; in particular in Class III and battery operated appliances the insulation may be over stressed by mains voltage when the working voltage in the appliance is ELV, and leakage currents between different parts of the appliance are not measured.

Also the scenario of operating a rechargeable battery device whilst charging is not addressed.

Also dc currents of >0.01mA are known to cause skin burn.

Also 60335 fault condition compliance criteria (19.13) do not include leakage currents! Also removal of protective impedance and radio interference filters seems to be illogical.

Replace the addition with the following MODIFICATION:Delete the last sentence: ‘Protective impedance and radio interference filters are disconnected before carrying out the tests.’

Not accepted.

IEC 60335-2-115 had its roots in AS/NZS 3130:1995 “Beauty Therapy Equipment”Leakage current from Class III appliances is specified in 13.2 in IEC 60335-1Charging a battery in a battery operated appliance while the appliance is operating is covered by Annex B in IEC 60335-1.

The required performance of insulation under conditions of abnormal operation are covered by insulation requirements in other parts of the standard such as the application of 16.3 and BP test temperature requirements.PI and RIF are removed because we are checking the performance at operating temperature of the insulation alone. The affects of PI and RIF are covered by 16.2 of IEC 60335-1

52b GB03 560-567 13.101 te See GB02 Delete 13.101 and introduce the following. Not accepted.Excluding applied

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(e.g. Table 1)

Type of comment


13.2 REPLACEMENT The leakage current is measured as in Fig 104. Metal foil 20cm x 10cm is used on non- protectively earthed accessible parts.Appliances that can be operated whilst connected to the mains via an adapter are tested as such. For battery only operated products, the mains connection is not applied. The outputs of circuits intended to be connected to the human body are loaded with the maximum resistance that allows normal operation (R in Fig 104). Worst case leakage currents regarding operation mode are measured. The leakage current from the body of the appliance to earth, and from the output circuits, one at a time and also all connected together, to 1) earth, and, 2) the body of the appliance, shall be measured under each of the following conditions in turn:

a. With all supply conductors connected in the correct polarity.

b. With each supply conductor open.c. With the phase and neutral supply

conductors transposed. d. With any supply earthing conductor

open circuited.

The leakage current measured using the circuit of Figure 101 shall not exceed 0.35mA ac (175mV measured) for all parts except circuits intended to make electrical connection to the human body and 0.1mA ac (50mV ac measured) and 0.01mA dc (5mV dc measured) for circuits intended to make electrical connection to the human body.In a single fault condition, as 19.1, the allowed level for all parts except circuits intended to make electrical connection to the human body is 0.7mA ac and for circuits

part leakage current, the leakage current from appliance enclosure is covered in 13.2 of IEC 60335-1.The leakage current from applied parts is covered in 13.101 in the CD.

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intended to make electrical connection to the human body the levels are 5x higher.

For 3 phase appliances, the leakage current is measured with the switches a, b and c inthe closed position. The measurements are then repeated with each of the switches a, b and c open in turn, the other two switches remaining closed. For three-phase without neutral (3~) connected appliances, the measuring circuit in IEC 60335-1 Figure 3 or Figure 4 shall be used as applicable, but the neutral is not connected to the appliance.

53 JP08 560-561 13.101 te In the case of an electrical stimulator intended to supply current or pulse energy to the human body, when measuring the leakage current, the current output from the applied part is included in leakage current, due to stray capacitance and the like.

Add the underlined text as follows.

13.101 The leakage current from output circuits intended to make electrical connection to the human body shall be measured without the output under each of the following conditions in turn:

Replace line 560-561 by: 13.101 The leakage current is measured between the applied part and the poles of the supply under each of the following conditions in turn.

54 NL27 560-567 13.101 te The leakage current measurement in part 1 is performed between the relevant accessible part and each pole of the supply (leakage current is measured to both L and N). As measuring to both poles of the supply has the same effect as transposing the phase and neutral conductor at the supply, there is no need to repeat the measurements with phase and neutral transposed.

The leakage current measurement in the existing standard is performed with any earth connection open (not connected, see fig 1 and 2 from part 1).

Therefore conditions a) to c) are already fulfilled in part 1.

Further we see no relevance for items d) and e). For item e) in particular, we cannot imagine beauty care appliances with

Delete 13.101.

And delete figure 104.

And delete as a consequence the addition to 13.1

Not accepted. The applied parts must be of Class III construction – see 22.104.The analogy with the shaver is not relevant because the shaver does not have parts that make an electrical connection to the body.

The limit aligns with that used in the IEC 60601 series.Replace item d) by the following:

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multiple output circuits. Even if there are, we do not see how connecting multiple output circuits together could reasonably result in higher leakage current measurements.

The example constructions shown in fig 104 are class II constructions. We see no reason why to deviate from the leakage current limit in part 1 (0,35 mA pk / 0,5 mA rms for sinusoidal waveforms) for class II constructions. Why should an appliance in part 2-115 have a lower leakage current than e.g. a shaver which has also a part applied to the human body (shaver head)?

From the individual outputs of each output circuit one at a time.

55 NL28 576 16.2 te We cannot imagine beauty care appliances with multiple output circuits. Even if there are, we do not see how connecting multiple output circuits together could reasonably result in higher leakage current measurements.

We see no reason why to deviate from the leakage current limit in part 1 (0,25 mA rms) for class II constructions. Why should an appliance in part 2-115 have a lower leakage current than e.g. a shaver which has also has a part applied to the human body (shaver head)?

Delete 16.2 in the proposal. See 54.


Delete “or wax” from line 584. See 9

57 NL30 590-591 19.7 te The requirement that the appliance shall not emit flames is already covered by 19.13 from part 1.

Delete the addition in lines 590-591. Not accepted.Part 1 states “During the tests, the appliance shall not emit flames”Here we are aligning with Part 2-23 Clause 19.7

58 NL31 594 19.10 ed Editorial improvement. Replace ‘the’ by ‘any’ Not accepted. Here we are aligning with Part 2-23 Clause 19.10

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59 NL32 600 21.1 ed Reference to 21.102 for power supplies is missing.

Add the following after line 600:

Appliances with power supplies in a flexible cord shall also comply with 21.102.

Not accepted.21.102 has it own requirement.

60 AU02 601 21,101 te This requirement is not adequate as the usage of Beauty care appliances may result in a much higher number of drops i.e 500

Modify the proposal to The enclosure of power supplies used in a flexible cord shall have adequate mechanical strength against dropping. The power supply is dropped 500 times from a height of 900mm

Not accepted.21.101 only applies to the hand-held part. It does not apply to the power supply part.

61 NL33 601-608 21.101 te Adapt the test method to the one from the latest publication of part 2-23 (using a sling instead of pulling the cord)

Replace 21.101 by the following (text taken from part 2-23 A1:2019):The hand-held part of the appliance is placed in a sling that is constructed by tying togetherthe four corners of a single layer of cheesecloth. The lowest point of the sling is suspended at a height of 900 mm above a concrete or similar hard surface.

The hand-held part of the appliance in the sling is dropped from a stationary position. The test is carried out a total of five times with the hand-held part of the appliance being positioned so that it falls onto the concrete surface in five different orientations.

The appliance shall not be damaged to such an extent that compliance with 8.1 and Clause 29 is impaired.

Accepted.

62 JP09 21.102 ge We do not make any proposal to 21.102 and instead we propose modifying the 1st dash in clause 24.2 of Part 1 to clarify that “power supplies in flexible cords” do not include detachable power supply units.

1, History to add “power supplies” to clause 24.2.(1) China 2 in 61(Kista/Chairman)02a (Report from the Chairman of TC 61)

The concerned hairdryer has a power supply for an ion generator and obviously it was not a detachable power supply unit.

We propose to add underlined text, in 1st dash of clause 24.2 of Part 1 (FDIS of Edition 6.0), as follows.

– switches, automatic controls, power supplies except detachable power supply units, and the like in flexible cords;

Additionally, issue Interpretation Sheet for Edition 5.2 of Part 1 in order to clarify that detachable power supply units are not included in “power supplies in flexible cords”.

Accepted that“power supplies in flexible cords” do not include detachable power supply units.”See comment 4.

To be discussed by TC61.

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Item 28a in 61(Kista/Secretariat)11 said:China 2: Confirmed. Clarified the power supply is for a hair dryer. Prepare DC to modify first dashed item of 24.2 to indicate “switches, automatic controls, power supplies, and the like”(2) 61/4813A/INF for 61/4765A/DCProposed change of CA-2 (No.19) – switches, automatic controls, powersupplies (except detachable power supplyunits) and the like in flexible cords;

Decision: Noted. Editorial.

JP NC understood:CA-2 was just an editorial comment and TC61 interpreted that detachable power supply units are not included in “power supplies in flexible cords”.

(3) 61/4936A/RVC for 61/4859/CDVProposed change of DE-7 and JP5 (No.39 and NO.40) to repeatedly ask the addition based on on CA-2. – switches, automatic controls, powersupplies (except detachable power supply units) and the like in flexible cords;

Decision: For DE-7, “The decision for CA-2 was Noted- Editorial.”For JP5, “Not necessary so not accepted.”

JP NC understood that:The interpretation that detachable power supply units are not included in “power supplies in flexible cords” is too obvious to add the proposed exception. (This interpretation was clear enough and an

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additional clarification was not necessary.)

2, Our proposalIn 1st dash of clause 24.2 of Part 1 (FDIS of Edition 6.0), add the clarification to exclude detachable power supply units, as above-mentioned.

Additionally, for the same purpose, issue Interpretation Sheet for Edition 5.2 of Part 1 because the clarification is necessary from Ed. 5.2.

63 NL34 609-618 21.102 te We are of the following opinion:

-The force of 450 N shall be raised to 1000 N

-The steady force test shall be repeated with the power supply placed in all possible orientations, not only in a single orientation.

-The mechanical strength test for PS enclosures should be extended with a drop test similar to the NLNC proposals for part 2-2, 2-8, 2-23, 2-52 and 2-85.(See also 61/5866/DC, 61/5868/DC, 61/5871/DC, 61/5872/DC, 61/5874/DC)

Replace 21.102 by the following and add new clause 21.103 (text taken from NLNC proposals for part 2-2, 2-8, etc):21.102 The enclosure of power supplies used in a flexible cord shall have adequate mechanical strength against stepping-on.

Compliance is checked by the following test.

The power supply is operated under the conditions of Clause 11 when placed on the floor of the test corner.After steady conditions are established, a force of 1000 N is applied to the power supplyenclosure. The force is applied using a flat surface of 100 mm × 250 mm and repeated with the power supply placed in all possible different orientations.

The power supply shall not be damaged to such an extent that compliance with this standard is impaired. In particular, it shall not emit flames or molten material and the requirements ofClauses 8 and 29 shall be fulfilled.21.103 The enclosure of power supplies used in a flexible cord shall have adequate mechanical strength against dropping.

The power supply is placed in a sling that is constructed by tying together the four corners of a single layer of cheesecloth. The lowest point of the sling is suspended at a height of 900mm above a concrete or similar hard surface.The power supply in the sling is dropped from a stationary position. The test is carried out a total

21.102 accepted in principle.Refer to comment 4 and comment 64.

The force shall align with 22.109 for foot –operated control device, which is 1350N.

But not applicable for detachable power supply part with pins for insertion into a socket-outlet.

21.103 accepted in principle.

But not applicable for detachable power supply part with pins for insertion into a socket-outlet.

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of five times with the power supply being positioned so that it falls onto the concrete surface in five different orientations.

The appliance shall not be damaged to such an extent that compliance with 8.1 and Clause 29is impaired.

64 NZ02 609 21.102 ed It is necessary to align with Part 1 where the appliance is supplied in two parts – the detachable power supply part and the part of class III construction. (see 6.1 and 22.56 for example).It is also has to be compatible with the proposal from WG 31 in the rewrite of Annex B for the Ed 6 of Part 1.

The part of class III construction (generally considered to be the functional part of the appliance) is likely to be hand-held as in the case of this Part 2. Consequentially the detachable power supply part is likely to be on the floor.

Replace “The enclosure of power supplies used in a flexible cord”ByFor appliances with a detachable power supply part and a hand-held part of class III construction, the enclosure of the detachable power supply part”

Accepted.See comment 4 and comment 100.But not applicable for detachable power supply part with pins for insertion into a socket outlets.

65 NZ03 612-613 21.102 ed See NZ1 Replace lines 612-613ByThe appliance is operated under the conditions of Clause 11 with the detachable power supply part placed on the floor of the test corner.

AcceptedSee 64

66 NZ04 614-615 21.102 te See NZ1.The force applied should align with the force agreed for 22.109 and an application time should be specified.

Replace “450 N is applied to the power supply enclosure.”By“1 350 N is applied to the detachable power supply part enclosure for a period of 1 min.”

Accepted.

67 NZ05 616 21.102 ed See NZ2 Replace “power supply”By“detachable power supply part”

Accepted.See comment 4

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68 CA02 626-627 22.40 - te The content of clause 22.40 in the part 1 may not apply to certain products in this standard. Hence, the use of the wording “the switch” is confusing.

In order to avoid confusion, the proposed addition in the part 2 should be written independently from the other switch requirements in this clause of the part 1.

It is the CANC’s understanding that the intent was to cover all switches with an off position.

Modify the proposed text as follows:

If compliance with Clause 19 depends on the operation of a self-resetting thermal cut-out, thea switch in the off-position shall disconnect the electronic circuits.

Accepted

69 DK08 625-627 22.40 te The proposed addition is not understood. There does not seem to be any relation between dependence on a non-self-resetting thermal cut for compliance with cl. 19 and the need to disconnect electronic circuits with a switch.

Additionally according to cl 22.40 not all appliances are required to have a switch, so those for which a switch is not required would not necessarily be affected by the proposed addition.

Delete line 625-627 Not accepted. These appliances are tested as motor-operated appliance (see 5.101) so must have a switch if required by the addition to 20.40 of part 1.

70 NL35 625-627 22.40 te We see no rational for this requirement. What is the relation between the operation of a thermal cut-out in clause 19 and a switch in 22.40?

Delete the addition to 22.40. See 69

71 NL36 628 22.101 ed Delete the word ‘also’. Delete the word ‘also’. Not acceptedSee 11

72 NL37 632 22.102 ed Delete the word ‘also’. Delete the word ‘also’. Not acceptedSee 11

73 NL38 644 22.102 ed Editorial mistake. Delete the words ‘and by inspection’ in line 644. Not acceptedBecause of the first sentence in line 634

74 NL39 648 22.103 ed Delete the word ‘also’. Delete the word ‘also’. Not accepted See 11

75 DK09 655 22.104 te Considering the text proposed in Modify the proposed text in line 655 to read the following:

Refer to comment 47, change to

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cl.8, ‘For electrical stimulators, the applied parts are not considered to be live parts’.

In IEC60335-1, cl.3.6.4live part is conductor or conductive part intended to be energized in normal use.

3.3.12 class III appliance is appliance in which protection against electric shock relies on supply at safety extra-low voltage.

SELV is an electrical system in which the voltage cannot exceed ELV (50v a.c. and 120v d.c.) under normal conditions.

IEC60335-2-23, cl.8 exclude applied part of electrical stimulators from compliance with requirements for SELV, these parts cannot be considered as cl. III constructions.

Therefor the proposed text effective exclude these appliances from being able to comply with the standard. Therefor a modified text is suggested.

“Applied parts of appliances, other than electrical stimulators, shall be of class III construction”

“Applied parts of appliances, other than electrical stimulators and RF appliances, shall be of class III construction.Adding the following:For electrical stimulators and RF appliances, they shall be isolated from the supply through the isolating transformer.

76 FI05 655-682 22.104 & 22.105

te RF appliancesIf the requirement on Clause 22.104 effectively limits the output voltage between the electrodes of an RF appliance to 42,4 V, should similar provisions to 22.105 be added for RF appliances as well? Typical devices on the market provide output voltages of at least 150-200 Vrms.Electrical stimulators

For electrical stimulators, it appears that Clause 22.104 cannot be fulfilled if the output is close to the limits specified for application to body parts below the neck in 22.105.

For RF appliances it should be determined what are acceptable levels for output voltage and current in the typical operating frequency range of these appliances.

For electrical stimulators, clarify which requirements are to be fulfilled.

See comment 75.

77 NL40 655-656 22.104 ed This requirement is similar to the requirement in the addition to 22.26, therefore it would be more logical to add this requirement to 22.26 in this proposal.

Move the requirement from 22.104 to 22.26 and delete 22.104 and renumber 22.105 – 22.117.

Accepted.Refer to EG1

78 DK10 657-671 22.105 te The limits provided for the output current is Provide a thorough and substantial rationale for The limits are based

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exceeding the limits in cl. 8.1.4. (0,7 mA peak for a.c. and 2 mA for d.c.) which are the limits for what is considered as safe.As such this addition is a critical breach of the safety principle in the standardAny deviation from this shall require a substantial and thorough rationale

In fact the limits of up to 60mA are very high and above the values that are known to cause significant physiological effects (electric shock).Currents around 35-40mA are known to be able to cause ventricular fibrillation at 50Hz although at higher frequencies the limits may be higher.

Considering the influence of the frequency upon the current-tolerance in the body and hence the safety, substantial requirements for the stability of the output frequency and the reliability of the associated circuits and components must be given

the safe and risk-free application of the proposed limits.

on the limits in IEC 60601-2-10

The PT agrees the limit is changed to be 50% of the IEC 60601 limits below the neck.

Also refer to JP’s additional “Annex to JPNC additional comments of 61_5926e_CC” in Page 13.

79 DK11 658-671 22.105 te Using different limiting values for the output depending on which part of the body they are intended to be used on is not acceptable.

It cannot be expected that users are applying the appliances correctly according to the instructions and so the safety of the appliance in terms of the risk of electric shock shall not depend on strictly following the instruction for use.

Provide limiting values that ensure the appliance is safe to use and does not pose a risk of electric shock without relying on user instructions.

See 78

80 DK12 658-671 22.105 te Limits for the output voltage and current are provided. However there are no requirements how these values shall be limited and otherwise separated from the mains voltage. Shall isolating transformers be used or impedances?

Adequate separation from the supply mains is critical for the safety of the appliance.

Provide specifications and requirements for the separation from the supply mains and the components used to obtain the specified limits

See 75

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81 NL41 657-671 22.105 teIt is unclear if the output must comply with the indicated output limits of all electrical quantities or just with one.

E.g, would a (no load) output voltage exceeding 20 V be allowed if the current does not exceed 2.5 mA?As it is stated that the output value is to be measured under a 500 Ohm load we think that the output must comply with either the current or the voltage value.(20 V across 500 Ohm gives 40 mA)(2.5 mA through 500 Ohm gives 1.25 V)

Change as follows:22.105 For electrical stimulators the maximum output shall be limited.

For application to human body parts from the neck and above the output shall comply with one of the following limits:

Maximum output current 2,5mA Maximum output current density 0,5 mA/cm2 Maximum output voltage 20 V (peak)

If the maximum output current exceeds 0,5 mA, the appliance shall incorporate a timer with a maximum setting as follows: Maximum output current (I) 0,5 mA <I≤1 mA Maximum timer setting 30 min Maximum output current (I) 1 mA <I≤ 2,5 mA Maximum timer setting 10 min

For application to human body parts below the neck the output shall comply with one of the following limits:

Output frequency (f) ≤ 400 Hz Maximum output current 30 mAOutput frequency (f) 400Hz < f ≤1500Hz Maximum output current 48mA Output frequency (f) > 1 500 Hz Maximum output current 60 mA Maximum output voltage 200 V (peak) Maximum energy/pulse 120 mJ

Compliance is checked by…………….

Change as follows:

For application to human body parts from the neck and above the output shall comply with the following limits:

Rewrite the output limits specification, according to the methodology used in IEC 60601-2-10.

Refer to attached text in Page 14 of IEC 60601-2-10.

82 JP10 659 22.105 te Since the load resistance used when measuring the maximum output current value of the electrical stimulator was changed from 1000 Ω to 500 Ω, the maximum output current value also needs to be doubled. (For constant voltage operation)

Replace 2,5 by 5,0 in line 659 as follows.

Maximum output current 2,55,0 mA

accepted

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83 JP11 662-665 22.105 te For the same reason as JP10, the maximum output current should be modified when using the timer.

Replace each value of lines 662-665 as follows.

If the maximum output current exceeds 0,51,0 mA, the appliance shall incorporate a timer with a maximum setting as follows:

Maximum output current (I) 0,51,0 mA < I ≤ 12 mA Maximum timer setting 30 minMaximum output current (I) 12 mA < I ≤ 2,55 mA Maximum timer setting 10 min

Accepted.

84 DE02 667-669 22.105 te Discussion during the last committee meetings a reduction of the values given in 61/5788/CD was topic. It has been decided to have a vote after the last meeting for the values below the neck whether the values of. 60601-2-10 should be reduced to 50% or 25% for home use products.Line 667-669 show increased values vs. 61/5788/CD. This is not acceptable.

Change max output current values to 25% of 60601-2-10 or at least back to values of 61/5788/CD:Output frequency (f) <= 400 Hz: Maximum output current 20 mAOutput frequency (f) 400 Hz < f <= 1500 Hz: Maximum output current 32 mAOutput frequency (f) < 1500 Hz: Maximum output current 40 mA

See 78

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85 NL42 667-669 22.105 te Current values exceeding 5 mA are to be considered dangerous when e.g. flowing from hand to feet (IEC TS 60479-1). If we allow currents flowing through the human body in excess of 5 mA the distance / area between the electrodes must be limited so that the current can only flow very locally in the human body and cannot flow through the heart region !

However where the electrodes are wired electrodes the electrodes can be placed far from each other on the human body such that the current could flow through the heart region.

Therefore the current limits shall be reduced to a safe value of max 5 mA.

(The 5 mA limit applies for AC 15-100 Hz according IEC TS 60479-1. For higher frequencies higher limits may apply following IEC TS 60479-2)

Change as follows:

Output frequency (f) ≤ 400 Hz Maximum output current 5 mA

Output frequency (f) 400Hz < f ≤1500Hz Maximum output current 5 mA

Output frequency (f) > 1 500 Hz Maximum output current 5 mA

For the type of applied part shown, consideration should be given reviewing the current limits.But we need to take account of the voltage and frequency to get the correct impedance to be used in the measurement.

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86 JP12 670-671768-770

22.10522.116

te The maximum output current density of the electrical stimulator used below the neck, as defined in 22.116, should be specified in 22.105 as well as other electrical requirements.

In addition, when artificial skin is used to measure the maximum current output density, the value may be unstable, so the maximum output current density should be obtained by dividing the maximum output current value by the area of the applied part.

Add underlined sentences in 22.105 as follows and delete 22.116.

Maximum output current density 2,0 mA/cm 2 Maximum output voltage 200 V (peak)Maximum energy/pulse 120 mJThe maximum output current density can be obtained by dividing the maximum output current value by the area of the applied part.

22.116 For electrical stimulators to be applied below the neck and capable of delivering output values in excess of 10 mA or 10 V, the current density at any applied part in shall not exceeding 2 mA/cm2

Compliance is checked as follows:The output current is measured with the appliance is supplied at rated voltage with the applied part placed in contact with the artificial skin.The ratio of the output current to the contact area of the applied part shall not exceed 2 mA/cm2.

Accepted in principle.Refer to EG1

87 NL43 670 22.105 te Electrodes of electrical stimulator are applied parts. The output limit of 200 V is in contradiction to the requirement in 22.104 which states that applied parts shall be of class III construction.

From part 1:3.3.13class III constructionpart of an appliance for which protection against electric shock relies upon safety extra-low voltage and in which voltages higher than those of safety extra-low voltage are not generated

Reduce the limit value of 200 V to the max voltage allowed for SELV (= 42 V rms), as follows:

Maximum output voltage 42 V

See 75

88 NL44 674-675 22.105 te It is not fully clear if the requirements for electronic circuits apply in case such circuit is used for compliance with the electrical limits and/or the time limits (timer).

Change as follows:

If compliance with the output limits or time setting relies on the operation of an electronic circuit, the test is repeated under thefollowing conditions applied separately:

Not accepted.The timer requirement in lines 662-663 is checked by inspection.

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89 NL45 687-691 22.107 te There should be a clear boundary between medical devices used by specialist and home use appliances. For that reason the NLNC understands the factor 2,5 in the current / voltage and energy values with respect to those mentioned in the IEC 60601-2-10, however we do not understand why a different load of 1000 Ohms is chosen. The IEC 60601-2-10 uses a load of 500 Ohms.Furthermore in 22.105 the electrical output is also measured using a load of 500 Ohm.

Change 1000 Ohm to 500 Ohm

90 NL46 712 22.109 te It does not make sense to use a different force compared to the mechanical strength test from 21.101. Align the force with the force used to test the mechanical strength of PS enclosures, see NL33.

Replace 1350 N by 1000 N. Not accepted,See 63

91 FI06 722 22.111 te The proposed requirement is not useful as such. If the local SAR limit is not exceeded within a 6 min period, the device is safe to be applied indefinitely.If the local SAR is exceeded within a 6 min period, automatic shutdown at exactly 6 min is not going to prevent overexposure.It should be noticed that a timer does not prevent overexposure in all conditions.

Remove the requirement or replace it with:“Radio frequency appliances which are capable of producing local SAR exceeding the limits specified in Table 103 within a 6 min time period shall be provided with a timer preventing overexposure.”

See comment 92

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92 JP13 722 22.111 te It is not necessary to specify that the maximum setting time of the timer is 6 minutes for the following reasons.

- There is no requirement of the maximum time in the ICNIRP Guideline referring to SAR.

- In the summary of biological effects and epidemiological studies (100 kHz–300 GHz) of the ICNIRP Guideline, human safety for 30 minutes of exposure has been verified.

- The maximum timer setting need not be limited to 6 minutes. Because the operation time of appliances should have flexibility, and the timer setting should be set by the manufacturer as based on the usage.

- The equipment described in the document “Lappalainen.pdf” shared by Fl NC can be set for up to 10 minutes. (See page29 (PDF-page 39) Section 3.1)

Remove the line722.

Radio frequency appliances shall be provided with a timer with a maximum setting of 6 min.

accepted

93 FI07 723-729 22.111 ed Compliance should be checked as detailed in Annex AA. The test procedure is partially repeated here for no obvious reason and only for appliances producing continuous output.

Remove the repetition as necessary. Accepted.

94 FI08 735-736 22.111 te/ed The requirement has been presented incorrectly.

Replace the text by:The measured power output shall not exceed the stated value by more than 20 %. This applies to all power settings.

Refer to EG1

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95 NL47 737-738 22.111 te It is not fully clear if the requirements for electronic circuits apply in case such circuit is used for compliance with the electrical limits and/or the time limits (timer).

Change as follows:

If compliance with the output limits or time setting relies on the operation of an electronic circuit, the test is repeated under thefollowing conditions applied separately:

Not necessary, see comment 92 and 93

96 NL48 753 22.112 ed From the first sentence it is already made clear that a control is only required when the penetration depth exceeds 0.5 mm.

Delete the last sentence as follows:

If the depth of penetration can exceed 0.5 mm, then the appliance shall be provided with a control that allows the depth of penetration to be set. The control shall indicate the set depth of penetration.

accepted

97 NL49 768-775 22.116 ed As this is another clause related to electrical output of electrical stimulators similar to those in 22.105 – 22.107 we would suggest to put this clause after clause 22.107 for better readability and logical structure.

Renumber 22.116 into 22.108 and renumber existing 22.108 – 22.117 into 22.109 – 22.117.

Accepted.Also refer to EG1

98 GB02 776 to 778

22.117 ge In this clause for “Ultrasound appliances for direct application of an ultrasonic source to the human body…” it quotes a figure not to exceed 10MHz. However, in clause 32, the figure not to exceed is 5MHz, but there are limits of 3W/cm2 for commercial use and 1W/cm2 for home use.

Clarification for 10MHz even if there is a note in clause 32 about the use of 10MHz.

See 107

99 DK13 790 24.2 te The use of power supplies in flexible cords is generally prohibited in 60335. There does not appear to be any consideration or special use conditions with appliances covered by this standard that would necessitate constructions using power supplied in flexible cords.Without any such special consideration there is no option to deviate from the general prohibition of this type of construction

Delete line 790

As a consequence also line 609-618 shall be deleted

Not accepted. The proposal is fully in line with the current standard for an appliance that is supplied in two parts – the detachable power supply part and the part of class III construction. (see 6.1 and 22.56 for example).It is also compatible with the proposal from WG 31 in the rewrite of Annex B for the Ed 6 of Part 1.

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100 NZ06 790 24.2 te See NZ1. Replace “power supply”By“detachable power supply part”

Accepted. See also comment 4.Also add a note stating the substance of “ a detachable power supply part with pins for insertion into a socket outlet is not a power supply in a flexible cord.

101 JP14 791-792 24 te Same as JP9. Same as JP9. See 100

102 NZ07 791-792 24.2 ed Because of our comment on line 790, the note is no longer needed

Delete lines 791-792 Accepted.

103 NL50 798-799 25.7 ed Editorial improvement. Change as follows:

The temperature rise limit of 75 K is increased to 130 K provided that the temperature rise decreases to 75 K within 5 min after the appliance has been switched off.

Not accepted. The text in the draft is correct.

104 AU03 800 25.14 te The proposal does not address any requirement for the supply cord flex test

Add the following 25.14 Addition:The test is applicable to the fixed supply cords of detachable power supply parts.

Not accepted. The detachable power supply part is not moved while the handheld part is in operation.

105 AU04 811 25.15 te The Proposal does not address any requirements for a suitable cord anchorage test.

Add the following

25.15 Addition: detachable power supply parts fitted into the supply cord must comply to a 100N cord pull test on both input and output

Not accepted. The 100 N pull test is only applied to a fixed part according to Part 1. So if a part is fixed the 100 N test is applied. If it is not fixed the pull test is based on weight.

106 FI09 852-880 32.101 te Review the suitability of IEC 63009:2019 regarding the measurement of ultrasound appliances operating in the frequency range below 500 kHz.

Refer to IEC 63009:2019 regarding the measurement and remove the proposed calorimetric measurement method unless it produces comparable results.

accepted

107 TC 87 860-861 32.101 NOS te The convenor of PT 60335-2-115 submitted the following to TC 87

I am the convenor of PT60335-2-115 of IEC TC61. We are developing the standard

TC 87 responded as follows:

1) Yes, IEC 61689 is restricted to 0,5 MHz to 5 MHz, partly because typical physiotherapy equipment uses that range. However, the

Replace lines 852 to 880 by the following:

32.101 Ultrasound

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(e.g. Table 1)

Type of comment


“Household and similar electrical appliances ‐ safety ‐ Part 2-115: Part 2-115: Particular requirements for beauty care appliances” , in which the ultrasound appliances are included and the limit for the effective intensity over the frequency range 0,016 MHz to 5 MHz is required. (It is currently at stage A3CD). But as we know, the frequency range in IEC 61689 is from 0,5 MHz to 5MHz. Currently we can’t find the proper measurement method for the frequency range from 5 MHz to 10 MHz. So we would like to ask if it is possible to use IEC61689 from 5 MHz to 10 MHz for our purpose.

determination of the effective intensity can be performed similarly for frequencies from 5 MHz to 10 MHz as well. The power measurement would be the same using a radiation force balance, and the effective emitting area can be determined by hydrophone scanning close to the transducer as well. The only implication will be that the hydrophone effective diameter needs to be smaller for the smaller wavelength at the higher frequencies and possibly the scanning step size would need to be smaller. These items are discussed in 61689 and the already referenced 62127-1 in general, e.g. that existing information can be used for the frequencies above 5 MHz.

2) Technical problems may occur using 61689 at frequencies below 0,5 MHz. Since there are physiotherapy systems on the market using lower frequencies, we have addressed this recently. Just very recently published in 2019-07 was: IEC 63009 Ed.1 - Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 20 kHz to 500 kHz. It would make a lot of sense to add this reference to your document for the low frequency side. This standard fills the lower frequency gap and dovetails with 61689. Some differences to 61689 are: The documents opens up for different ultrasonic power measurement using hydrophone scanning if the classical radiation force measurement is not applicable. Furthermore, the absolute maximum effective intensity recommendation is different (Annex A.3), allowing "less than or equal to 10 W/cm^2 at 20 kHz linearly decreasing to less than or equal to 3 W/cm^2 at 500 kHz. This is because lower frequency ultrasound is less absorbed and thus will produce lower heat inside the body.

appliances for direct application of an ultrasonic source to the human body shall be constructed so that the effective intensity over the frequency range 0,016 MHz to 10 MHz shall not exceed 3 W/cm2 for commercial use; and shall not exceed 1 W/cm2 for household use.With the appliance operated under normal operation at rated voltage compliance is checked by measurement in accordance with- Clause 8 of IEC 61689 for appliances with rated frequency 0,5 MHz < f ≤ 10 MHz; - Clause 7 of IEC 63009 for appliances with rated frequency 0,016 MHz ≤ f ≤ 0,5 MHz.

107a

GB05 931-939 te See GB02 Replace Figure 104 by the following (see Annex to GB05 comment)

Not accepted.

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(e.g. Table 1)

Type of comment


108 FI10 959-1022

Annex AA te Clarification of the estimation method is needed.

See separate attachment for a proposed new text. Accepted in principle. Change the first paragraph under ‘Estimation of the local specific absorption rate (local SAR)” to the following:Maximum output power shall be converted to local SAR by the following method for RF appliances.

109 FI11 973-975, 1007-1009 & 1035-1037

Annex AA & BB

te Conflicting instructions regarding the calculation of the volume in which most of the RF power is absorbed, are given.According to Annex AA it seems that the depth used in calculations should be equal to the distance between the electrodes. However, Annex BB states that the depth is the average of the length of the electrodes and the distance between the electrodes.

Clarify which method is to be applied in estimation of the tissue volume.Consider removing the instructions regarding the volume calculation from Annex AA as it already refers to Annex BB for guidance (unnecessary repetition).

See 108

110 JP15 976-977 Annex AA te Regarding the line 976-977, “If the volume is smaller than or equal to 10 cm3, assume that all power is absorbed in a mass of 10 g.”, the rational reason is unclear.Because the definition of SAR is described as followings in ICNIRP Guideline.

“All SAR values are to be averaged over any 6-min period.”Should the item of the time duration be included as if it were larger than 10cm3, as written in Line 983?

1) Propose that this method and equation should be confirmed based on the scientific articles.

and,

2) If the volume is fixed as 10cm3, confirm whether the equation of line978 is replaced by the following equation:

SARL＝100 Pm

SARL＝ 100 P m Tex / 360

See 108

111 FI13 976-989 Annex AA ed The local SAR calculation appears to be divided based on whether or not the tissue volume exceeds 10 cm3 and does not consider exposure durations less than 360 seconds for Vth ≤ 10 cm3.

The example needs clarification. See 108

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(e.g. Table 1)

Type of comment


112 FI12 981 Annex AA ed The equation seems to be missing the division sign.

Replace the equation with:Pd = 1000 Pm / Vth

See 108

113 JP16 981 Annex AA ed Regarding the equation of output power density, the unit should be [W/kg], however the equation of line 981 uses [W kg].

Pd = 1000 Pm Vth　[W][kg]

If the following equation is correct, modify the text as follows.

Pd = 1000 Pm Vth

Pd = 1000 Pm / Vth

* Pd [W/kg]* Pm / ( Vth/1000 ) [W/kg]

See 108

114 JP17 988 Annex AA te Vth is defined as “volume of the treatment head” in 988, but another term “tissue volume” is used in line 1035 of Annex BB.

It is better to standardize the expression if it has the same meaning as “tissue volume”.

Replace the words “ volume of the treatment” by “tissue volume”.

Vth =volume of the treatment headtissue volume

See 108

115 FI14 990-993 Annex AA ed/te An example should be provided on how to determine the local SAR when the treatment area and treatment duration are specified by the manufacturer.If the specification of the treatment area and treatment time is applied in order to reduce local SAR to safe levels, the instructions should state that during the procedure the treatment head must be kept in motion at all times.Additionally, if the local SAR limit for a treatment area is reached in less than 6 minutes, the instructions for the end-user should state that the same area shall not be exposed any further until 6 minutes from the start of the initial treatment has elapsed.Consideration should also be given whether the provided instructions can be feasibly applied. For example, the required movement speed for the treatment head shall not be excessively high.

This section should be expanded and the additional requirements regarding the instructions should be presented in Clause 7.12.

See 108

116 FI15 994 Annex AA ed The compliance criterion is already specified in Clause 22.111 and is not repeated for pulsed appliances.

Remove the sentence. See 108

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(e.g. Table 1)

Type of comment


117 FI16 999 Annex AA te The measurement can be carried out as presented for appliances providing continuous output power.

Consider restructuring the contents of the Annex. See 108

118 FI17 1003 Annex AA ed/te The expression “within a short period of time” is both ambiguous and undefined. Furthermore, there seems to be no need to consider the time in the evaluation.

Replace “within a short period of time” with “within 360 seconds”.

See 108

119 JP18 1029-1033

Annex BB te If the electrode is covered with an insulating material, it is an appliance without galvanic (electric) contact and is out of scope of this standard, so this requirement is not necessary.

Remove the following sentence in line 1031-1033.

The dimensions of the active part of the treatment head shall be applied when calculating the local SAR as presented in Annex AA. The figures below show the electrodes of some treatment head types. The arrows indicate the dimension of significance. If the treatment head is partially or fully covered by insulating material, the insulating material shall be ignored in the measurement.

Accepted

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(e.g. Table 1)

Type of comment


120 DE03 1034 Annex BB Figure BB, 5th figure

te 5th figure of Annex BB has been transferred from the comment resolution sheet 61/5834/CC incorrect to 61/5881/CD

Change figure BB as follows:Replace:

By:

See 124

121 FI18 1034 Annex BB Figure BB.1 te The diameter of the circular area is presented incorrectly in the lower image depicting the circular electrode. The diameter should be equal to the diameter of the inner electrode.

Replace the image.See previous version of the proposed standard for reference.

See 124

122 FI19 1034 Annex BB Figure BB.1 ed/te The figure could be clarified by adding + and – symbols to represent the polarity of the electrodes, especially for the multipolar electrode.

Modify the figure as needed. See 124

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(e.g. Table 1)

Type of comment


123 FI20 1035-1037

Annex BB ed It is confusing and generally bad practice to use the same variable for two different purposes. The variable “d” is used here to illustrate the distance between the electrodes OR the diameter of the circular area.

Use another letter or symbol for the diameter of the circular area.

See 124

124 JP19 1035-1037

Annex BB te Regarding the depth required for the calculation of the tissue volume, they are described as below in line 1035-1037.

Depth ={ (length of electrode) + (distance of electrode) } /2 or Depth = diameter of the circular area.

On the other hand, the calculation of the volume in line 973-975 is specified as below, and this means that the depth is considered as the smallest distance between the electrodes.“The volume where most of the power is absorbed is calculated by measuring the smallest distance in between the electrodes(d) and multiplying it with the area that covers the section of smallest distance between the electrodes”

Additionally, in the scientific article of “Radiofrequency: An Update on Latest Innovations”, the depth of penetration of the treated area is described as follows. “The main limitation of this device is that the treated area is limited to the volume between the two electrodes with the depth of penetration being approximately half the distance between the two electrodes.”

We propose to confirm this method based on the scientific articles on the depth required for the calculation of the tissue volume and the calculation of the tissue volume described in line 1035-1037.

The distance between the electrodes of Circular treatment head (d) is illustrated as the following, because this is bipolar treatment head.

Accepted for definition of the depth which is half of the distance between the electrodes.

See attached Annex to comment JP19: (Comment 124) (JP’s opinon is in the third column)

Also See JP’s submitted Paper.

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Annex of FI.doc

Annex to comment FI10:

Annex AA(normative)Estimation of the local specific absorption rate (local SAR)If a direct measurement of the local specific absorption rate (local SAR) of a radio frequency appliance emitting electromagnetic radiation above 100 kHz cannot be carried out, the local SAR can be estimated by the following method. The method is applicable only for appliances with electrodes in direct galvanic contact with the skin.

AA.1 Bipolar and multipolar treatment heads

NOTE 1 A bipolar treatment head has two electrodes with opposite polarities. A multipolar treatment head has more than two electrodes with opposite polarities.

Measure the maximum output RF power using non-inductive resistive load. The measurement shall be carried out with an adjustable load resistance from 100 Ω to 1000 Ω inserted between the opposite polarities yielding the maximum output. If the manufacturer states a certain load resistance for reference, that shall also be applied (even if outside the above mentioned range).

NOTE 2 To carry out the test, a specially prepared sample may be needed to allow the attachment of the load resistance across the output.

Measure the dimensions of the treatment head and calculate the tissue volume (Vt) in which most of the power is absorbed (see Annex BB for guidance). If the calculated tissue volume is less than 10 cm3, assume that all power is absorbed in a mass of 10 g and thus the calculated value shall be replaced with 10 cm3 for the estimation of the local SAR.

AA.1.1 Appliances providing continuous power or continuous pulse train

Measure the voltage across the load resistance over any 360 second period that produces the highest value and calculate the average power:

PAVG =U rms2

R

Where

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PAVG = average RF power in wattsUrms = measured root mean square voltage across the resistive load in voltsR = resistance value of the load in ohms

The local SAR for static exposure is estimated with:

SARcont = PAVG

0,001 kgcm3

∗V t

Where

SARcont = local SAR for continuous static exposure in W/kgPAVG = average RF power over 360 seconds in wattsVt = calculated tissue volume in which most of the power is absorbed in cm3 (min. 10 cm3)

NOTE 3 Treatment heads of appliances providing continuous power or continuous pulse train are typically intended to be constantly moved during the treatment procedure. See AA.3 for further estimation of the local SAR when specific treatment instructions are provided.

AA.1.2 Appliances providing single pulse or a single burst of pulses

Measure the voltage across the load resistance over any complete wave period (Tw) less than 360 seconds that produces the highest value and calculate the average power. Record the duration of the wave period:

PAVG,Tw =U rms2

R

Where

PAVG,Tw = average RF power over the wave period in wattsUrms = measured root mean square voltage across the resistive load in voltsR = resistance value of the load in ohms

NOTE 4 A wave period consists of the active pulse duration and the inactive time between the pulses.

The local SAR for static exposure of single application is estimated with:

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SARpulse =PAVG ,Tw

0,001 kgcm3

∗V t

∗T w

360 s

Where

SARpulse = local SAR for static exposure of single application in W/kgPAVG,Tw = average RF power over the wave period in wattsVt = calculated tissue volume in which most of the power is absorbed in cm3 (min. 10 cm3)Tw = measured duration of the wave period in seconds (max. 360 seconds)

NOTE 5 The maximum number of pulses applied to the same treatment area shall be limited. See AA.3 for the treatment instructions required to be provided with the appliance.

AA.2 Monopolar treatment heads

NOTE 6 Monopolar treatment head is equipped with a single electrode. If an electrode with opposite polarity is used, it is a separate unit (e.g. a metal plate). The requirements for monopolar treatment heads are not currently covered by this standard.

AA.3 Estimation of the local SAR when treatment instructions are provided

For appliances providing continuous power or continuous pulse train, the local SAR can be reduced by moving the treatment head inside a larger treatment area or by reducing the exposure by limiting the treatment duration. If the appliance is intended for this type of operation, treatment instructions specifying treatment area sizes and maximum exposure times shall be provided with the appliance.

The maximum exposure times shall be specified in either seconds or the maximum exposure time related to a treatment area shall be specified (e.g. the maximum safe treatment time for an area of 100 cm2 is 60 seconds). If the appliance has means for altering the output power setting, the maximum exposure time shall be specified for each setting separately. In calculation of the local SAR, the maximum exposure time shall be limited to 360 seconds even if longer treatment duration is specified in the instructions.

The instructions shall also clearly state that the treatment head is to be kept in constant motion during the treatment and that once the maximum exposure time has been reached, the area shall not be subjected to any further exposure until 6 minutes from the start of the initial treatment has elapsed. Consideration should also be given to whether the required movement speed of the treatment head is such that the treatment can be carried out safely.

NOTE 7 If the maximum exposure time exceeds 360 seconds, it is not required to be specified in the instructions.

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When the size of the treatment area, the maximum exposure time or both are specified, the average local SAR within the treatment area can be calculated with:

SARAVG = SARcont∗AapplAarea∗T ex

360 s

Where

SARAVG = average local SAR in the treatment area in W/kgSARcont = local SAR for continuous static exposure in W/kgAappl = active area of the treatment head in cm2 (see Annex BB)Aarea = treatment area in cm2

Tex = maximum exposure time for the treatment area in seconds (max. 360 seconds)

The resulting average local SAR (SARAVG) shall not exceed the relevant local SAR limits of Table 103.

For appliances providing single pulse or a single burst of pulses with treatment heads intended to remain static during the treatment procedure, the maximum allowed number of applications on the same treatment area within 6 minutes can be calculated by dividing the relevant local SAR limit of Table 103 with SARpulse and rounding down to the nearest integer.

For pulsed appliances with treatment heads intended to be constantly moved within the treatment area and with power output such that reasonably uniform energy distribution within the treatment area can be expected, the local SAR estimate may be calculated with:

SARAVG = SAR pulse∗AapplAarea∗nappl

Where

SARAVG = average local SAR in the treatment area in W/kgSARpulse = local SAR for static exposure of single application in W/kgAappl = active area of the treatment head in cm2 (see Annex BB)Aarea = treatment area in cm2

nappl = number of applications within 360 seconds

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The maximum number of applications to each treatment area shall be stated in the instructions provided with the appliance and the resulting average local SAR (SARAVG) shall not exceed the relevant local SAR limits of Table 103. If the appliance has means for altering the output power setting, the maximum number of applications shall be specified for each setting separately.

The instructions shall also clearly state that once the maximum number of applications have been administered to a treatment area, the area shall not be subjected to any further exposure until 6 minutes from the initial application has elapsed. Additionally, for pulsed appliances with treatment heads intended to be moved during the treatment, the instructions shall state that the treatment head is to be kept in constant motion throughout the procedure.

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Annex of JP.doc

Attachment of JP07

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Annex to comment JP19: (Comment 124)

Treatment head calculations

Tissue volume calculation Options (min value 10 cm3)Vt = z × Aappl

Head type Active area of

treatment head Aappl

Zaverage of the length of the

electrodes (L) and the distance between the electrodes (d)

Z (JP19)Half the distance

between the electrodes

Z (CD line973)Smallest distance

between the electrodes

Pasi (via email)

1

dL Z = (d + L)/2

Vt = dL(d + L)/2

Z = d/2

Vt = d2L/2

Z = d

Vt = d2L

Z = (d + L)/2

Vt = dL(d + L)/2

2

dL Z = (d + L)/2

Vt = dL(d + L)/2

Z = d/2

Vt = d2L/2

Z = d

Vt = d2L

Z = (d + L)/2

Vt = dL(d + L)/2

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3

3dL

If each value of d is different

L∑i=1

N

d i

Z = (d + L)/2

Vt = 3dL(d + L)/2

Z= 12N∑

i=1

N

(L+d i¿)¿

Vt = L2N∑

i=1

N

(L+d ¿)d i¿

Z = d/2

Vt = 3d2L/2

Z = d

Vt = 3d2L

Z = (d + L)/2

Vt = 3dL(d + L)/2

4

dL Z = (d + L)/2

Vt = dL(d + L)/2

Z = d/2

Vt = d2L/2

Z = d

Vt = d2L

Not supplied

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5

dL Z = (d + L)/2

Vt = dL(d + L)/2

Z = d/2

Vt = d2L/2

Z = d

Vt = d2L

Z = d

Vt = d3

6

πd(D+d) Z = (πD+d)/2

Vt = π2d/2[D2 + dD(1 + 1/π) + d2/π]

Z = d/2

Vt = πd2(D+d)/2

Z = d

Vt = πd2(D+d)

Z = d

Vt = d3

7

πd2/4 Z = (d + d)/2 = dVt =πd3/4

Z = d/2

Vt = πd3/8

Z = d

Vt = πd3/4

Z = d

Vt = d3

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For treatment heads of the type 7

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Attached: Text taken from IEC 60601-2-10

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ulstandards.ul.com€¦ · web viewthe example constructions shown in fig 104 are class ii...

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