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Document No.:CE-ZJZM-01 Version :A/0

CE Technical Files

hdeTable of contents

No. Document name Page No. Page number

1 Introduction of Manufacturer 2 1

2 Introduction of Product 3-7 5

3 Process Chart 8 1

4 Instruction for User 9-10 2

5 Applicable Standards 11 1

6 Label and Language 12-18 7

7 EC Declaration of Conformity 19 1

8 Essential Requirement Checklist 20 1

9 Risk Analysis Report 21 1

10 Test Report 22 1

11 The Evaluation from the user in the Market 23 1

12 Attachment List and Attachments 24 1

http://dict.baidu.com/s?wd=table%20of%20contents

http://dict.baidu.com/s?wd=process%20chart


CE Technical Files

1. Introduction of Manufacturer

1.1 Introduction of the Manufacturer

ZHEJIANG WHARNEY DAILY CHEMICAL CO.,LTD was founded in 1993, is one of the

earliest sanitary manufacture companies.Our company insisted with high beginning and

requirement since foundation,and fetched in many advanced production pipe linings from

Italy and Japan .Nursing products include: disposable masks, disposable baby diaper ,

baby wipes ,baby bibs ,nursing under pad,disposable pet diaper ,pet pad , sanitary

napkins ,etc.The products sell far to Southeast Asia ,UK,North America,South Africa and

other area and countries,and welcomed by our customers.

ZHEJIANG WHARNEY DAILY CHEMICAL CO.,LTD takes the manage principle of“Unity

and Cooperation,Service and Innovation,Credit and FIRST continuous

Management”.With high development since foundation,it adjusted construction product

with change of markets and fetched advanced abroad technique and equipment.In order

to ensure the high quality of product ,it built a strict quality supervise system and

acquired the certificate of ISO9001--2000 quality management system.

Rooting on the culture corporation of “Wharney ,Share and Innovation ,Aspiring of the

serving the society ,Wharney will endeavor to enhance the quality of customers ' life

continuously


CE Technical Files

1.2 Basic information of the Manufacturer

Applicant:ZHEJIANG WHARNEY DAILY CHEMICAL CO.,LTD

Address:NO.1648 Jingang RD,Jinsanjiao Economic Zone of Jinhua City

TEL: +86-0579-83707666

FAX:+86-0579-83707566

Email:[email protected]


CE Technical Files

2. Introduction of Product

2.1 Classification

Products do not belong to the instruction of implantable medical device. According to the

Rule 1, Annex XI (Rule 1: All non-invasive devices are in class I, unless one of the rules

set out hereinafter applies.) of EU medical devices directive MDD（Medical Devices

Directive, 93/42/EEC including Directive 2007/47/EC）, it shall be considered as Class I.

The certification will be conducted against Annex VII of 93/42/EEC


CE Technical Files2.2 Product Information

Name Description Material Picture

DisposableMask

This product is suitable for all ages andcan be used in cases of poor air qualityand epidemic severity. It is convenientfor people to isolate the abuse of airpollutants and germs.

Non- woven fabric,melt-blownnonwovens


CE Technical Files

2.3 Quality control systemQuality control system of ZHEJIANG WHARNEY DAILY CHEMICAL CO.,LTD

1 Management Responsibility1.1 Quality PolicyThe quality policy shall be relevant to the ZHEJIANG WHARNEY DAILY CHEMICALCO.,LTD’s organizational goals and the expectations and needs of itscustomers.ZHEJIANG WHARNEY DAILY CHEMICAL CO.,LTD shall ensure that thispolicy is understood, implement, and maintained at all levels of the organization.1.2 Management ReviewZHEJIANG WHARNEY DAILY CHEMICAL CO.,LTD’s management with executiveresponsibility shall responsibility shall review the quality system at defined intervalssufficient to ensure its continuing suitability and effectiveness in satisfying therequirements of these requirements.2 Quality SystemZHEJIANG WHARNEY DAILY CHEMICAL CO.,LTD shall establish, document andmaintain a quality system as and maintain a quality system as a means of ensuring thatproduct and maintain a quality system as a means of ensuring that product conforms thespecified requirements.3 Contract ReviewBefore submission of a tender, or the acceptance of a contract or order, the tender,contract, or order shall be reviewed by the ZHEJIANG WHARNEY DAILY CHEMICALCO.,LTD4 Design ControlNot applicable.5 Document and data controlZHEJIANG WHARNEY DAILY CHEMICAL CO.,LTD shall establish and maintaindocumented procedure to control all documents and data that relate to the requirementsof this requirements including to the extent applicable, documents of external origin suchas standard and customer drawing. The TCF for CE marking is one of the controlleddocuments.ZHEJIANG WHARNEY DAILY CHEMICAL CO.,LTD shall establish and maintaindocumented procedures to ensure that purchased product conforms to specifiedrequirements.6 Control of SupplierZHEJIANG WHARNEY DAILY CHEMICAL CO.,LTD shall establish and maintaindocumented procedures for the control of supplier provided raw and auxiliary material fortheZHEJIANG WHARNEY DAILY CHEMICAL CO.,LTD7 Product Identification and TractabilityWhere appropriate,ZHEJIANG WHARNEY DAILY CHEMICAL CO.,LTD shall establishand maintain documented procedures for identifying the product by suitable means fromreceipt and during all stages of production, delivery, and installation.8 Process Control


CE Technical FilesZHEJIANG WHARNEY DAILY CHEMICAL CO.,LTD shall identify and plan the production,installation and servicing processes which directly affect quality and shall ensure thatthese processed are carried out under controlled condition.9 Inspection and TestingZHEJIANG WHARNEY DAILY CHEMICAL CO.,LTD shall establish and maintaindocumented procedures for inspection and testing activities in order to verify that thespecified requirements for the product are met.10 Control of Inspection,Measuring, and Test Equipment shall establish and maintain documented procedures tocontrol, calibrate and maintain inspection, measuring, and test equipment usedbyZHEJIANG WHARNEY DAILY CHEMICAL CO.,LTD to demonstrate the conformance ofproduct to the specified requirements. Inspection, measuring and test requirement shallbe used in manners which ensure that the measurement uncertainty is known and isconsistence with the required measurement capability.11 Inspection and Test StatusThe inspection and test status of product shall be identified by suitable means, whichindicate the conformance or nonconformance of product with regard to inspection andtests performed.12 Control of Nonconforming ProductZHEJIANG WHARNEY DAILY CHEMICAL CO.,LTD shall establish and maintaindocumented procedures to ensure that product that does not conform to specifiedrequirements is prevented from unintended use or installation.13 Corrective and Preventive ActionZHEJIANG WHARNEY DAILY CHEMICAL CO.,LTD shall establish and maintaindocumented procedure for implementing corrective and preventive action.14 Handling, Storage, Packaging, Preservation and DeliveryZHEJIANG WHARNEY DAILY CHEMICAL CO.,LTD shall establish and maintaindocumented procedures for handling, storage, packaging, preservation and delivery ofproduct.15 Control of Quality RecordsZHEJIANG WHARNEY DAILY CHEMICAL CO.,LTD shall establish and maintaindocumented procedures for identification, collection, indexing, access, fitting, storage,maintenance, and disposition of quality records.16 Internal Quality AuditsZHEJIANG WHARNEY DAILY CHEMICAL CO.,LTD shall establish and maintaindocumented procedures for planning and implementing internal quality audits to verifywhether quality activity and related results comply with planned arrangements and todetermine the effectiveness of the quality system.17 TrainingZHEJIANG WHARNEY DAILY CHEMICAL CO.,LTD shall establish and maintaindocumented Procedures for identifying training needs and provide for the training needsand provide for the training of all personnel performing activities affecting quality.18 ServicingWhere servicing is specified requirements,ZHEJIANG WHARNEY DAILY CHEMICAL


CE Technical FilesCO.,LTD shall establish and maintain documented procedure for performing, verifying andreporting that the servicing meets the specified requirements.19 Statistical TechniquesZHEJIANG WHARNEY DAILY CHEMICAL CO.,LTD shall identify the need for statisticaltechniques required for establishing, controlling and verifying process capability andproduct characteristics.20 Provisions for the change of designAny change of the products described in this TCF must be checked in detail and writtendown again in the TCF by the designer of ZHEJIANG WHARNEY DAILY CHEMICALCO.,LTD if the change may effects the related electrical or mechanical characteristics.


CE Technical Files

3. Process Chart

http://dict.baidu.com/s?wd=process%20chart


CE Technical Files

4. Instruction for User

[Product Name] Disposable Mask

[Application] This product is suitable for all ages and can be used in cases of poor air

quality and epidemic severity. It is convenient for people to isolate the abuse of air

pollutants and germs.

[Methods] 1.It is recommended to buy masks made by regular enterprises, choose the

model that suits you, and ensure sealing.

2.Note that disposable masks have inside and outside, light- colored surface has moisture

absorption function, should be attached to the mouth and nose, dark side outward.

3.Please timely change masks to maintain the isolation of the mask and avoid wearing it

for long periods of time.

4.When removing the mask, try not to touch the outside, remove the mask and remember

to wash your hands immediately.

5.Do not throw away the mask at will, you should wrap and throw into the trash can.

[Storage] Avoid high temperature & moisture.

[ Shelf-life] Three years

Warning 1.The mask should not be worn for long periods of time, if the mask

smells or can not be wrapped in the mouth and nose, replace it immediately.

2.Do not reuse.

3.Wash hands before wearing.

ZHEJIANG WHARNEY DAILY CHEMICAL CO.,LTDAddress:NO.1648 Jingang RD,Jinsanjiao Economic Zone of Jinhua City


CE Technical Files

Date: March 11, 2020 Version: A/0

5. Applicable Standards

No. File No. Version File Title

1

MDD 93/42/EECincluding

Directive2007/47/EC

2007 Medical Device Directive

2 EN ISO 14971 2012 Medical Device -Application of RiskManagement in Medical Device

3 EN ISO 15223-1 2016Medical devices. Symbols to be used withmedical device labels, labelling and informationto be supplied General requirements.

4 EN 1041 2013Terminology, Symbols and Information Relatedto Medical Devices –Information Provided byManufacturers of Medical Devices

5 EN ISO 10993-1 2010Biological evaluation of medical devices - Part1: Evaluation and testing within a riskmanagement process (ISO 10993-1:2009)

6 EN ISO 10993-5 2009Biological evaluation of medical devices - Part5: Tests for in vitro cytotoxicity (ISO10993-5:2009)

7 EN ISO 10993-10 2013 Biological Evaluation of Medical Device –Part10: Irritation and Sensitization Test


CE Technical Files

6. Label and Language

6.1 General

This Clause contains symbols that are already in use, and are deemed to be

suitable without need for further explanation.

NOTE Symbols used with medical devices for use by other than healthcare

professionals can require additional explanations.

6.2 Symbol for "DO NOT REUSE"

NOTE 1 Synonyms for "Do not reuse" are "single use”, "Use only once"

6.3 Symbol for “BATCH CODE”

This symbol shall be accompanied by the manufacturer's batch code. The

batch code shall be adjacent to the symbol

NOTE 1 The relative size of the symbol and the size of the batch code are

not specified.

NOTE 2 Synonyms for "batch code" are "lot number", "batch number".


CE Technical Files

6.4 Symbol for "CONSULT INSTRUCTIONS FOR USE"

NOTE 1 Synonym for "Consult instructions for use" is "Consult operating

instructions".

NOTE 2 This symbol corresponds to that given in ISO 7000-1641 and to

symbol number 5.3 in ISO 15223-1:2007.

6.5 Symbol for "DATE OF MANUFACTURE"

This symbol shall be accompanied by a date to indicate the date of

manufacture, expressed as given in ISO 8601, as four digits for the year, and

where appropriate, two digits for the month and

two digits for the day. The date could be a year, year and month, or year,

month, and day, as required by the relevant Directive. The date shall be

located adjacent to the symbol (see A.4).

NOTE 1 The relative sizes of the symbol and the date are not specified.


CE Technical Files

6.6 Symbol for "CATALOGUE NUMBER"

The manufacturer's catalogue number shall be after or below the symbol

adjacent to it (See A.5).

NOTE 1 The relative size of the symbol and the size of the catalogue

number are not specified.

NOTE 2 Synonyms for "catalogue number" are "reference number",

"re-order number".

6.7 Symbol for "CAUTION"

NOTE 1 This symbol is essentially a safety symbol and should be used to

highlight the fact that there are specific warnings or precautions associated

with the device, which are not otherwise found on the label. The symbol

“Caution” is still sometimes used to have the meaning of “Attention, see

instructions for use” (see 5.18).


CE Technical Files

6.8 Symbol for "MANUFACTURER"

This symbol shall be accompanied by the name and the address of the

manufacturer (the person placing the device on the market), adjacent to the

symbol (see A.6).

NOTE 1 The relative size of the symbol and the size of the name and

address are not specified.

NOTE 2 The full definition of ‘manufacturer’ is given in Council Directives

90/385/EEC, 93/42/EEC including Directive 2007/47/EC and 98/79/EC.

NOTE 3 The date of manufacture as well as the name and address of the

manufacturer can be combined in one symbol (see A.7).

6.9 Symbol for "AUTHORISED REPRESENTATIVE IN THE EUROPEAN

COMMUNITY"

This symbol shall be accompanied by the name and the address of the

authorised representative in the European Community, adjacent to the symbol

(see A.8).

NOTE The relative size of the symbol and the size of the name and address

are not specified.

b) Diameter of the pattern shall not be less than 5mm.

c) CE marking shall be distinct, visible, durable and in clear writing.


CE Technical Files

6.10 After passing CE certification, mark of CE needs to be printed on labels;

a) Pattern

b) Diameter of the pattern shall not be less than 5mm.

c) CE marking shall be distinct, visible durable and in clear writing.

A.2 Example of use of symbol for "BATCH CODE"

A.4 Examples of use of symbol for "DATE OF MANUFACTURE"

A.5 Examples of use of symbol for "CATALOGUE NUMBER"

A.6Example of use of symbol for "MANUFACTURER"

A.7Example of use of symbol for “MANUFACTURER” combined with “DATE

OFMANUFACTURE”

A.8Example of use of symbol for " AUTHORISED REPRESENTATIVE IN THE

EUROPEAN COMMUNITY"


CE Technical FilesLanguage

Country

Denish

Dutch

English

Finnish

French

Germ

an

Greek

Icelandic

ItalianNorw

egi

Portugue

se

Spanish

Swedish

Czech

Estonian

Russian

Hungaria

Latvian

Lithuania

Polish

Slovak

Slovesn

Austria ★

Belgium ★ ★ ★

Denmark ★

Finland ★ ★

France ★

Germany ★

Greek ★

Holland ★

Iceland ★

Ireland ★

Italy ★

Luxembour

g★ ★

Norway ★

Portugal ★

Spain ★

Sweden ★

Switzerland ★ ★

UK ★

Cyprus ★

Czech ★

Estonia ★ ★ ★

Latvia ★ ★ ★

Lithuania ★

Malta ★

Poland ★

Slovakia ★

Slovenia ★

Hungary ★

dict://key.0895DFE8DB67F9409DB285590D870EDD/Slovene

dict://key.0895DFE8DB67F9409DB285590D870EDD/Slovene


CE Technical Files

Disposable MaskSIZE/MODEL: XXXXX

YYYY-MM-DD YYYYMMDD

YYYYMMDD

ZHEJIANG WHARNEY DAILY CHEMICAL CO.,LTDAddress:NO.1648 Jingang RD,Jinsanjiao Economic Zone of Jinhua City

1.Do not reuse.2.Wash hands before wearing.


CE Technical Files

7. EC Declaration of Conformity

See Declaration of Conformity

(File No: CE-TCF-001)


CE Technical Files

8. Essential Requirement Checklist

See Checklist of Essential Requirements



CE Technical Files

9. Risk Analysis Report

See Risk Analysis Report



CE Technical Files

10. Test Report

See Test Report



CE Technical Files

11. The Evaluation from the user in the Market

See The Evaluation from the user in the Market



CE Technical Files

12. Attachment List and Attachments

No. File No. File Title

1 CE-TCF-001 EC Declaration of Conformity

2 CE-TCF-002 Essential Requirements Report

3 CE-TCF-003 Risk Analysis Report

4 CE-TCF-004 Test Report

5 CE-TCF-005 The Evaluation from the user in the Market

扫描全能王创建

File NO: CE-TCF-002

Checklist of Essential Requirement

The requirement of Medical Device Directive93/42/EEC amended by 2007/47/EC

Applicable StandardEvidence ofConformity

I. GENERAL REQUIREMENTS1. The devices must be designed and manufacturedin such a way that, when used under the conditionsand for the purposes intended, they will notcompromise the clinical condition or the safety ofpatients, or the safety and health of users or, whereapplicable, other persons, provided that any riskswhich may be associated with their intended useconstitute acceptable risks when weighed againstthe benefits to the patient and are compatible with ahigh level of protection of health and safety.This shall include:— reducing, as far as possible, the risk of use errordue to the ergonomic features of the device and theenvironment in which the device is intended to beused (design for patient safety), and—consideration of the technical knowledge,experience, education and training and whereapplicable the medical and physical conditions ofintended users (design for lay, professional,disabled or other users).

A

EN ISO 15223-1EN ISO 14971EN ISO 10993-1EN ISO 10993-5EN ISO 10993-10

LabelRisk analysisreportTest report

2. The solutions adopted by the manufacturer forthe design and construction of the devices mustconform to safety principles, taking account of thegenerally acknowledged state of the art.In selecting the most appropriate solutions, themanufacturer must apply the following principles inthe following order:

eliminate or reduce risks as far as possible(inherently safe design and construction),where appropriate take adequate protectionmeasures including alarms if necessary, inrelation to risks that cannot be eliminated,inform users of the residual risks due to any

shortcomings of the protection measures adopted.

A EN ISO 14971Risk analysisreport

3.The devices must achieve the performancesintended by the manufacturer and be designed,manufactured and packaged in such a way that they

AEN ISO 10993-1EN ISO 10993-5EN ISO 10993-10

Test report

File NO: CE-TCF-002

are suitable for one or more of the functions referredto in Article 1 (2) (a), as specified by themanufacturer.

EN ISO 15223-1 Label

4. The characteristics and performances referred toin Sections 1, 2 and 3 must not be adverselyaffected to such a degree that the clinical conditionsand safety of the patients and, where applicable, ofother persons are compromised during the lifetimeof the device as indicated by the manufacturer,when the device is subjected to the stresses whichcan occur during normal conditions of use.

A EN ISO 15223-1 Label

5. The devices must be designed, manufacturedand packed in such a way that their characteristicsand performances during their intended use will notbe adversely affected during transport and storagetaking account of the instructions and informationprovided by the manufacturer.

AEN ISO 15223-1EN ISO 14971

LabelRisk analysisreport

6. Any undesirable side-effect must constitute anacceptable risk when weighed against theperformances intended.6a. Demonstration of conformity with the essentialrequirements must include a clinical evaluation inaccordance with Annex X.


7.1. The devices must be designed andmanufactured in such a way as to guarantee thecharacteristics and performances referred to inSection I on the ‘General requirements’. Particularattention must be paid to:— the choice of materials used, particularly asregards toxicity and, where appropriate,flammability,— the compatibility between the materials used andbiological tissues, cells and body fluids, takingaccount of the intended purpose of the device,— where appropriate, the results of biophysical ormodeling research whose validity has beendemonstrated beforehand.

A

EN ISO 10993-1EN ISO 10993-5EN ISO 10993-10

Test report

7.2 The devices must be designed, manufacturedand packed in such a way as to minimize the riskposed by contaminants and residues to the personsinvolved in the transport, storage and use of thedevices and to the patients, taking account of theintended purpose of the product. Particular attention


File NO: CE-TCF-002

must be paid to the tissues exposed and to theduration and frequency of exposure.

7.3 The devices must be designed andmanufactured in such a way that they can be usedsafely with the materials, substances and gaseswith which they enter into contact during theirnormal use or during routine procedures; if thedevices are intended to administer medicinalproducts they must be designed and manufacturedin such a way as to be compatible with the medicinalproducts concerned according to the provisions andrestrictions governing these products and that theirperformance is maintained in accordance with theintended use.

A

EN ISO 15223-1EN ISO 14971

EN ISO 10993-1EN ISO 10993-5EN ISO 10993-10

LabelRisk AnalysisReportTest Report

7.4. Where a device incorporates, as an integralpart, a substance which, if used separately, may beconsidered to be a medicinal product as defined inArticle 1 of Directive 2001/83/EC and which is liableto act upon the body with action ancillary to that ofthe device, the quality, safety and usefulness of thesubstance must be verified by analogy with themethods specified in Annex I to Directive 2001/83/EC.For the substances referred to in the first paragraph,the notified body shall, having verified theusefulness of the substance as part of the medicaldevice and taking account of the intended purposeof the device, seek a scientific opinion from one ofthe competent authorities designated by theMember States or the European Medicines Agency(EMEA) acting particularly through its committee inaccordance with Regulation (EC) No 726/2004 (1)on the quality and safety of the substance includingthe clinical benefit/risk profile of the incorporation ofthe substance into the device. When issuing itsopinion, the competent authority or the EMEA shalltake into account the manufacturing process andthe data related to the usefulness of incorporation ofthe substance into the device as determined by thenotified body.

Where a device incorporates, as an integral part, ahuman blood derivative, the notified body shall,having verified the usefulness of the substance as

NA

File NO: CE-TCF-002

part of the medical device and taking into accountthe intended purpose of the device, seek a scientificopinion from the EMEA, acting particularly throughits committee, on the quality and safety of thesubstance including the clinical benefit/risk profile ofthe incorporation of the human blood derivative intothe device. When issuing its opinion, the EMEAshall take into account the manufacturing processand the data related to the usefulness ofincorporation of the substance into the device asdetermined by the notified body.

Where changes are made to an ancillary substanceincorporated in a device, in particular related to itsmanufacturing process, the notified body shall beinformed of the changes and shall consult therelevant medicines competent authority (i.e. the oneinvolved in the initial consultation), in order toconfirm that the quality and safety of the ancillarysubstance are maintained. The competent authorityshall take into account the data related to theusefulness of incorporation of the substance into thedevice as determined by the notified body, in orderto ensure that the changes have no negative impacton the established benefit/risk profile of the additionof the substance in the medical device.

When the relevant medicines competent authority(i.e. the one involved in the initial consultation) hasobtained information on the ancillary substance,which could have an impact on the establishedbenefit/risk profile of the addition of the substance inthe medical device, it shall provide the notified bodywith advice, whether this information has an impacton the established benefit/risk profile of the additionof the substance in the medical device or not. Thenotified body shall take the updated scientificopinion into account in reconsidering its assessmentof the conformity assessment procedure.

7.5 The devices must be designed andmanufactured in such a way as to reduce to aminimum the risks posed by substances leakingfrom the device.

NA

File NO: CE-TCF-002

Special attention shall be given to substances whichare carcinogenic, mutagenic or toxic toreproduction, in accordance with Annex I to CouncilDirective 67/548/EEC of 27 June 1967 on theapproximation of laws, regulations andadministrative provisions relating to theclassification, packaging and labeling of dangeroussubstances.If parts of a device (or a device itself) intended toadminister and/or remove medicines, body liquids orother substances to or from the body, or devicesintended for transport and storage of such bodyfluids or substances, contain phthalates which areclassified as carcinogenic, mutagenic or toxic toreproduction, of category 1 or 2, in accordance withAnnex I to Directive 67/548/EEC, these devicesmust be labeled on the device itself and/or on thepackaging for each unit or, where appropriate, onthe sales packaging as a device containingphthalates.If the intended use of such devices includestreatment of children or treatment of pregnant ornursing women, the manufacturer must provide aspecific justification for the use of these substanceswith regard to compliance with the essentialrequirements, in particular of this paragraph, withinthe technical documentation and, within theinstructions for use, information on residual risks forthese patient groups and, if applicable, onappropriate precautionary measures.

7.6 Devices must be designed and manufactured insuch a way as to reduce, as much as possible, risksposed by the unintentional ingress of substancesinto the device taking into account the device andthe nature of the environment in which it is intendedto be used.

NA

8.1 The devices and manufacturing processes mustbe designed in such as way as to eliminate orreduce as far as possible the risk of infection to thepatient, user and third parties. The design mustallow easy handling and, where necessary,minimize contamination of the device by the patientor vice versa during use.


File NO: CE-TCF-002

8.2 Tissues of animal origin must originate fromanimals that have been subjected to veterinarycontrols and surveillance adapted to the intendeduse of the tissues.Notified bodies shall retain information on thegeographical origin of the animals.Processing, preservation, testing and handling oftissues, cells and substances of animal origin mustbe carried out so as to provide optimal security. Inparticular safety with regard to viruses and othertransferable agents must be addressed byimplementation of validated methods of eliminationor viral inactivation in the course of themanufacturing process.

NA

8.3 Devices delivered in a sterile state must bedesigned, manufactured and packed in anon-reusable pack and/or according to appropriateprocedures to ensure that they are sterile whenplaced on the market and remain sterile, under thestorage and transport conditions laid down, until theprotective packaging is damaged or opened.

NA

8.4 Devices delivered in a sterile state must havebeen manufactured and sterilized by an appropriate,validated method.

NA

8.5 Devices intended to be sterilized must bemanufactured in appropriately controlled (e.g.environmental) conditions.

NA

8.6 Packaging systems for non-sterile devices mustkeep the product without deterioration at the level ofcleanliness stipulated and, if the devices are to besterilized prior to use, minimize the risk of microbialcontamination; the packaging system must besuitable taking account of the method of sterilizationindicated by the manufacturer.

NA

8.7 The packaging and/or label of the device mustdistinguish between identical or similar productssold in both sterile and non-sterile condition.

AEN 1041EN ISO 15223-1

Instruction ofuseLabel

9.1 If the device is intended for use in combinationwith other devices or equipment, the wholecombination, including the connection system mustbe safe and must not impair the specifiedperformances of the devices. Any restrictions onuse must be indicated on the label or in the

NA

File NO: CE-TCF-002

instructions for use.

9.2 Devices must be designed and manufactured insuch a way as to remove or minimize as far as ispossible:

the risk of injury, in connection with theirphysical features, including the volume/pressureration, dimensional and where appropriateergonomic features,risks connected with reasonably foreseeableenvironmental conditions, such as magneticfields, external electrical influences, electrostaticdischarge, pressure, temperature or variationsin pressure and acceleration,the risks of reciprocal interference with otherdevices normally used in the investigations offor the treatment given,Risks arising when maintenance or calibration

are not possible (as with implants), from ageing ofmaterials used or loss of accuracy of any measuringor control mechanism.

NA

9.3．Devices must be designed and manufacturedin such a way as to minimize the risks of fire orexplosion during normal use and single faultcondition. Particular attention must be paid todevices whose intended use includes exposure toflammable substances or to substances which couldcause combustion

NA

10 Devices with a measuring function10.1 Devices with a measuring function must bedesigned and manufactured in such a way as toprovide sufficient accuracy and stability withinappropriate limits of accuracy and taking account ofthe intended purpose of the device. The limits ofaccuracy must be indicated by the manufacturer.10.2 The measurement, monitoring and displayscale must be designed in line with ergonomicprinciples, taking account of the intended purpose ofthe device.10.3 The measurements made by devices with ameasuring function must be expressed in legal unitsconforming to the provisions of Council Directive80/181/EEC.

NA

File NO: CE-TCF-002

11.1 General11.1.1 Devices shall be designed and manufacturedin such a way that exposure of patients, users andother persons to radiation shall be reduced as far aspossible compatible with the intended purpose,whilst not restricting the application of appropriatespecified levels for therapeutic and diagnosticpurposes.

NA

11.2 Intended radiation11.2.1 Where devices are designed to emithazardous levels of radiation necessary for aspecific medical purpose the benefit of which isconsidered to outweigh the risks inherent in theemission, it must be possible for the user to controlthe emissions. Such devices shall be designed andmanufactured to ensure reproducibility andtolerance of relevant variable parameters.11.2.2 Where devices are intended to emitpotentially hazardous, visible and/or invisibleradiation, they must be fitted, where practicable,with visual displays and/or audible warnings of suchemissions.

NA

11.3 Unintended radiation11.3.1 Devices shall be designed and manufacturedin such a way that exposure of patients, users andother persons to the emission of unintended, strayor scattered radiation is reduced as far as possible.

NA

11.4 Instructions11.4.1 The operating instructions for devicesemitting radiation must give detailed information asto the nature of the emitted radiation, means ofprotecting the patient and the user and on ways ofavoiding misuse of eliminating the risks inherent ininstallation.

NA

11.5 Ionizing radiation11.5.1 Devices intended to emit ionizing radiationmust be designed and manufactured in such a wayas to ensure that, where practicable, the quantity,geometry and quality of radiation emitted can bevaried and controlled taking into account theintended use.

NA

11.5.2 Devices emitting ionizing radiation intendedfor diagnostic radiology shall be designed and

NA

File NO: CE-TCF-002

manufactured in such a way as to achieveappropriate image and/or output quality for theintended medical purpose whilst minimizingradiation exposure of the patient and user.11.5.3 Devices emitting ionizing radiation, intendedfor therapeutic radiology shall be designed andmanufactured in such a way as to enable reliablemonitoring and control of the delivered dose, thebeam type and energy and where appropriate thequality of radiation.

NA

12.1. Devices incorporating electronicprogrammable systems must be designed to ensurethe repeatability, reliability and performance of thesesystems according to the intended use. In the eventof a single fault condition (in the system) appropriatemeans should be adopted to eliminate or reduce asfar as possible consequent risks.12.1a For devices which incorporate software orwhich are medical software in themselves, thesoftware must be validated according to the state ofthe art taking into account the principles ofdevelopment lifecycle, risk management, validationand verification.

NA

12.2 Devices where the safety of the patientsdepends on an internal power supply must beequipped with a means of determining the state ofthe power supply.

NA

12.3 Devices where the safety of the patientsdepends on an external power supply must includean alarm system to signal any power failure.

NA

12.4 Devices intended to monitor one or moreclinical parameters of a patient must be equippedwith appropriate alarm systems to alert the user ofsituations which could lead to death or severedeterioration of the patient's state of health.

NA

12.5 Devices must be designed and manufacturedin such a way as to minimize the risks of creatingelectromagnetic fields, which could impair theoperation of other devices or equipment in the usualenvironment.

NA

12.6 Protection against electrical risksDevices must be designed and manufactured insuch a way as to avoid, as far as possible, the risk

NA

File NO: CE-TCF-002

of accidental electric shocks during normal use andin single fault condition, provided the devices areinstalled correctly.12.7 Protection against mechanical and thermalrisks12.7.1 Devices must be designed and manufacturedin such a way as to protect the patient and useragainst mechanical risk connected with, forexample, resistance, stability and moving parts.

NA

12.7.2 Devices must be designed and manufacturedin such a way as to reduce to the lowest possiblelevel the risks arising from vibration generated bythe devices, taking account of technical progressand of the means available for limiting vibrations,particularly at source, unless the vibrations are partof the specified performance.

NA

12.7.3 Devices must be designed and manufacturedin such a way as to reduce to the lowest possiblelevel the risks arising from the noise emitted, takingaccount of technical progress and of the meansavailable to reduce noise, particularly at source,unless the noise emitted is part of the specifiedperformance.

NA

12.7.4 Terminals and connectors to the electricity,gas or hydraulic and pneumatic energy supplieswhich the user has to handle must be designed andconstructed in such a way as to minimize allpossible risks.

NA

12.7.5 Accessible parts of the devices (excludingthe parts or areas intended to supply heat or reachgiven temperatures) and their surroundings mustnot attain potentially dangerous temperatures undernormal use.

NA

12.8 Protection against the risks posed to thepatient by energy supplies or substances12.8.1 Devices for supplying the patient with energyor substances must be designed and constructed insuch a way that the flow-rate can be set andmaintained accurately enough to guarantee thesafety of the patient and of the user.

NA

12.8.2 Devices must be fitted with the means ofpreventing and/or indicating any inadequacies in theflow-rate, which could pose a danger.

NA

File NO: CE-TCF-002

Devices must incorporate suitable means toprevent, as far as possible, the accidental release ofdangerous levels of energy from an energy and/orsubstance source.12.9 The function of the controls and indicatorsmust be clearly specified on the devices.Where a device bears instructions required for itsoperation or indicates operating or adjustmentparameters by means of a visual system, suchinformation must be understandable to the userand, as appropriate, the patient.

NA

13.1. Each device must be accompanied by theinformation needed to use it safely and properly,taking account of the training and knowledge of thepotential users, and to identify the manufacturer.This information comprises the details on the labeland the data in the instructions for use.As far as practicable and appropriate, theinformation needed to use the device safely must beset out on the device itself and/or on the packagingfor each unit or, where appropriate, on the salespackaging. If individual packaging of each unit is notpracticable, the information must be set out in theleaflet supplied with one or more devices.Instructions for use must be included in thepackaging for every device. By way of exception, nosuch instructions for use are needed for devices inClass I or IIa if they can be used safely without anysuch instructions.

AEN 1041EN ISO 15223-1

Instruction ofuseLabel

13.2 Where appropriate, this information shouldtake the form of symbols. Any symbol oridentification colour used must conform to theharmonized standards. In areas for which nostandards exist, the symbols and colours must bedescribed in the documentation supplied with thedevice.

A EN 1041Instruction ofuse

13.3 The label must bear the following particulars:(a) The name or trade name and address of themanufacturer. For devices imported into theCommunity, in view of their distribution in theCommunity, the label, or the outer packaging, orinstructions for use, shall contain in addition thename and address of the authorized representative

AEN ISO 15223-1EN 1041

LabelInstruction ofuse

File NO: CE-TCF-002

where the manufacturer does not have a registeredplace of business in the Community;

b) the details strictly necessary for the user toidentify the device and the contents of thepackaging;

AEN 1041ENI SO 15223-1

Instruction ofuse,Label

c）where appropriate, the word 'STERILE'; NA

d）where appropriate, the batch code, preceded bythe work 'LOT', or the serial number; A

EN 1041EN ISO 15223-1


e）where appropriate, an indication of the date bywhich the device should be used, in safety,expressed as the year and the month;

AEN 1041EN ISO 15223-1


(f) where appropriate, an indication that the deviceis for single use. A manufacturer's indication ofsingle use must be consistent across theCommunity; A

EN 1041EN ISO 15223-1


G）if the device is custom-made, the words'custom-made device';

NA

H）if the device is intended for clinical investigations,the words 'exclusively for clinical investigations';

NA

I）any special storage and/or handling conditions;A

EN 1041EN ISO 15223-1


J）any special operating instructions; NA

K）any warnings and/or precautions to take; A EN ISO 15223-1 Label

L）year of manufacture for active devices other thanthose covered by (e). This indication may beincluded in the batch or serial number;

AEN 1041EN ISO 15223-1


M）where applicable, method of sterilization. NA

N） in the case of a device within the meaning ofArticle 1 (4a), an indication that the device containsa human blood derivative.

NA

13.4 If the intended purpose of the device is notobvious to the user, the manufacturer must clearlystate it on the label and in the instructions for use.


13.5 Wherever reasonable and practicable, thedevices and detachable components must beidentified, where appropriate in terms of batches, toallow all appropriate action to detect any potential

NA

File NO: CE-TCF-002

risk posed by the devices and detachablecomponents.13.6 Where appropriate, the instructions for usemust contain the following particulars:a) the details referred to in Section 13.3, with theexception of (d) and (e);


b) the performances referred to in Section 3 and anyundesirable side-effects;


c) if the device must be installed with orconnected to other medical devices or equipment inorder to operate as required for it intended purpose,sufficient details of its characteristics to identify thecorrect devices or equipment to use in order toobtain a safe combination;

NA

d) all the information needed to verify whether thedevice is properly installed and can operatecorrectly and safely, plus details of the nature andfrequency of the maintenance and calibrationneeded to ensure that the devices operate properlyand safely at all times;

NA

e) where appropriate, information to avoid certainrisks in connection with implantation of the device;

NA

f) information regarding the risks of reciprocalinterference posed by the presence of the deviceduring specific investigations or treatment

NA

g) the necessary instructions in the event of damageto the sterile packaging and, where appropriate,details of appropriate methods of resterilization;

NA

(h) if the device is reusable, information on theappropriate processes to allow reuse, includingcleaning, disinfection, packaging and, whereappropriate, the method of sterilization of the deviceto be resterilized, and any restriction on the numberof reuses.

NA

i) Details of any further treatment or handlingneeded before the device can be used (for example,sterilization, final assembly, etc.);

NA

j) in the case of devices emitting radiation formedical purposes, details of the nature, typeintensity and distribution of this radiation.The instructions for use must also include detailsallowing the medical staff to brief the patient on anycontra-indications and any precautions to be taken.

NA

File NO: CE-TCF-002

These details should cover in particular:

k) precautions to be taken in the event of changesin the performance of the device;


l) precautions to be taken as regards exposure, inreasonably foreseeable environmental conditions,to magnetic fields, external electrical influences,electrostatic discharge, pressure or variations inpressure, acceleration, thermal ignition sources,etc.;

NA

m) adequate information regarding the medicinalproduct or products which the device in question isdesigned to administer, including any limitations inthe choice of substances to be delivered;

NA

n) precautions to be taken against any special,unusual risks related to the disposal of the device;

NA

(o) medicinal substances, or human bloodderivatives incorporated into the device as anintegral part in accordance with Section 7.4;

NA

p) Degree of accuracy claimed for devices with ameasuring function.

NA

(q) Date of issue or the latest revision of theinstructions for use.

A EN 1041 IFU

File No: CE-TCF-003

Risk Analysis ReportIdentification of qualitative and quantitative characteristics (acc.to EN ISO14971:2012, cl.4.2)

Questions AnswerC.2.1 What is the intended use and how is the medical device to beused?

How to use ,see manual

C.2.2 Is the medical device intended to be implanted? NO.C.2.3 Is the medical device intended to be in contact with the patientor other persons?

Product contact with human skinintact.

C.2.4 What materials or components are utilized in the medicaldevice or are used with, or are in contact with, the medical device?

Non- woven fabric, melt-blownnonwovens

C.2.5 Is energy delivered to or extracted from the patient? NO.

C.2.6 Are substances delivered to or extracted from the patient? NO.C.2.7 Are biological materials processed by the medical device forsubsequent re-use, transfusion or transplantation?

NO.

C.2.8 Is the medical device supplied sterile or intended to besterilized by the user, or are other microbiological controlsapplicable?

NO.

C.2.9 Is the medical device intended to be routinely cleaned anddisinfected by the user?

NO.

C.2.10 Is the medical device intended to modify the patientenvironment?

NO.

C.2.11 Are measurements taken? NO.C.2.12 Is the medical device interpretative? NO.C.2.13 Is the medical device intended for use in conjunction withother medical devices, medicines or other medical technologies?

NO.

C.2.14 Are there unwanted outputs of energy or substances? NO.C.2.15 Is the medical device susceptible to environmentalinfluences?

See user manual

C.2.16 Does the medical device influence the environment? NO.C.2.17 Are there essential consumables or accessories associatedwith the medical device?

NO.

C.2.18 Is maintenance or calibration necessary? NO.C.2.19 Does the medical device contain software? NO.C.2.20 Does the medical device have a restricted shelf-life? Three yearsC.2.21 Are there any delayed or long-term use effects? NO.C.2.22 To what mechanical forces will the medical device besubjected?

NO.

C.2.23 What determines the lifetime of the medical device? Product materialC.2.24 Is the medical device intended for single use? Single use.

C.2.25 Is safe decommissioning or disposal of the medical devicenecessary?

NO.

File No: CE-TCF-003

C.2.26 Does installation or use of the medical device require specialtraining or special skills?

NO.

C.2.27 How will information for safe use be provided? Manual.C.2.28 Will new manufacturing processes need to be established orintroduced?

NO.

C.2.29 Is successful application of the medical device criticallydependent on human factors such as the user interface?C.2.29.1 Can the user interface design features contribute to useerror?

NO.

C.2.29.2 Is the medical device used in an environment wheredistractions can cause use error?

NO.

C.2.29.3 Does the medical device have connecting parts oraccessories?

NO.

C.2.29.4 Does the medical device have a control interface? NO.C.2.29.5 Does the medical device display information? NO.C.2.29.6 Is the medical device controlled by a menu? NO.C.2.29.7 Will the medical device be used by persons with specialneeds?

NO.

C.2.29.8 Can the user interface be used to initiate user actions? NO.C.2.30 Does the medical device use an alarm system? NO.C.2.31 In what way(s) might the medical device be deliberatelymisused?

NO.

C.2.32 Does the medical device hold data critical to patient care? NO.C.2.33 Is the medical device intended to be mobile or portable? YES, portableC.2.34 Does the use of the medical device depend on essentialperformance?

NO.

File No: CE-TCF-003

- 1 -

No Hazard Identify hazards Risk Evaluation Risk Reduction Measure Evidence NH ALORGeneral S O D RLD2. Energy Hazards1 Electricity N/A2 Heat N/A3 Mechanical force N/A4 Ionizing radiation N/A5 Non Ionizing

radiation N/A

6 Electromagneticfields

7 Moving parts N/A8 Suspended

masses N/A

9 Patient supportdevice failure N/A

10 Pressure(vesselrupture) N/A

11 Acoustic pressure N/A12 Vibration N/A13 Magnetic

fields(e.g. MRI) N/A

D3. Biological hazards1 Bio-contamination The product may be contaminated if

the package is damaged.2 3 1 6 Single use and package

controlInstruction Acc

2 Bio-incompatibility The product may cause the useruncomfortable if the material is not OK

2 4 1 8 Choose raw materials offabrics with qualifiedbiological properties

See test report Acc

3 Incorrectformulation(chemical composition)

The product may cause the useruncomfortable if the material is not OK

2 3 1 6 Choose safe chemical rawmaterial in recognize toensure that the ingredientsare accurate.

See test report Acc

File No: CE-TCF-003

- 2 -

No Hazard Identify hazards Risk Evaluation Risk ReductionMeasure Evidence NH ALO

RGeneral S O D RL4 Toxicity


2 4 1 8 Choose raw materialsof fabrics with cytotoxicity meeting therequirements

See test report Acc

5 Allergenicity N/A6 Mutagenicity N/A7 Oncogenicity N/A8 Teratogenicity N/A9 Carcinogenicity N/A10 Re-and/or

cross-infection The product is single use product andcould not be re used.

2 3 2 12 Ensure that theproducts are for singleuse shall be shown onthe instruction of useand labels.

Instruction of use andLabels Acc

11 Pyrogenicity


2 3 1 6 Ensure that microbcontent in theproductionenvironment meetsthe requirements.

Products operatinginstructions Acc

12 Inability to maintainhygienic safety The product may cause the user

uncomfortable if the material is not OK

2 3 2 12 Ensure that microbcontent in theproductionenvironment meetsthe requirements.

Products operatinginstructions Acc

13 Degradation N/A

File No: CE-TCF-003

- 3 -

No Hazard Identify hazards Risk Evaluation Risk ReductionMeasure Evidence NH ALORGeneral S O D RL

D4. Environmental hazards and contributory factors1. 1Electromagnetic

fields N/A

2. Inadequate supplyof power or coolant N/A

3. Susceptibility toelectromagneticinterference

N/A

4. Emissions ofelectromagneticinterference

N/A

5. 2Inadequate supplyof power or coolant N/A

6. Inadequate supplyof coolant N/A

7. 3Storage oroperation outsideprescribedenvironmentalconditions

N/A

8. 5Incompatibility withother devices N/A

9. 6Accidentalmechanicaldamage

N/A

10. 7Contamination dueto waste productsand /or devicedisposal

N/A

File No: CE-TCF-003

- 4 -


D5. Hazards resulting from incorrect output of energy and substances1. Electricity NA2. Radiation NA3. Volume NA4. Pressure NA5. supply of medical

gases NA

6. supply ofanaesthetic agents NA

D6. Hazards related to the use of the device and contributory factors1 Inadequate

labelingThe inadequate labeling may causemisuse 2 2 1 4 Strengthen amending

the label for warning Refer to label Acc

2 Inadequateoperatinginstructions

The inadequate operating instructionsmay cause misuse 2 2 1 4

Strengthen amendingthe operatinginstructions

See instruction of use Acc

2.1 Inadequatespecification ofaccessories

NA

2.2 Inadequatespecification ofpre-use checks

The device may be damaged 2 2 1 4 To strengthen pre-usechecks See instruction of use Acc

2.3 Over-complicatedoperatinginstructions

NA

2.4 Inadequatespecification ofservice andmaintenance

NA

3 Use byunskilled/untrainedpersonnel

The device may be damaged 2 3 1 6 To strengthen training See instruction of use Acc

File No: CE-TCF-003

- 5 -

No Hazard Identify hazards Risk Evaluation Risk Reduction Measure Evidence NH ALORGeneral S O D RL4 Reasonably

foreseeablemisuse

NA

5 Insufficientwarning of sideeffects

The device has no side effects

6 Inadequatewarning ofhazards likely withre-use of singleuse devices

NA

7 Incorrectmeasurement andother metrologicalaspects

NA

8 Incompatibilitywithconsumables/accessories/otherdevices

NA

9 Sharp side NAD7. Complicated operation1 Mistakes and

judgement errors NA

2 Lapses andcognitive recallerrors

NA

3 Slips andblunders (mentalor physical)

NA

File No: CE-TCF-003

- 6 -


4 Violation orabbreviation ofinstructions,procedures, etc.,

NA

5 Complex orconfusing controlsystem

NA

6 Ambiguous orunclear devicestate

NA

7 0Ambiguous orunclearpresentation ofsettings,measurements orother information

NA

8 Mispresentationof results NA

9 Insufficientvisibility, audibilityor tactility

NA

10 Poor mapping ofcontrols to action,or of displayedinformation toactual state

NA

11 Controversialmodes ormappings ascompared toexistingequipment

NA

File No: CE-TCF-003

- 7 -

No Hazard Identify hazards Risk Evaluation Risk Reduction Measure Evidence NH ALORGeneral S O D RLD8. Hazards arising from functional failure, maintenance and ageing1 Erroneous data transfer NA2 Lack of , or inadequate

specification formaintenance includinginadequate specificationof post maintenancefunctional checks

The device may not work well iflack of inadequate postmaintenance or functional checks

2 1 3 6 Strengthen postmaintenance andfunctional checks

See instruction of use ACC

3 Inadequatemaintenance

The lifetime of the device may bereduced

1 2 2 4 Strengthenmanagement

See instruction of use ACC

4 Lack of adequatedetermination of end ofdevice life

NA

5 Loss of mechanicalintegrity NA

6 Inadequatepackaging(contamination and /or deteriorationof the device )

The lifetime of the device may bereduced 3 2 1 6 Acc

7 Re-use and / orImproper re-use NA

8 Deterioration in function(e.g. gradual occlusionof fluid/gas path, orchange in resistance toflow, electricalconductivity) as a resultof repeated use.

NA

File No: CE-TCF-003

- 8 -

B2. Additional hazards to in vitro diagnostic medical devices1 Batch

inhomogeneity,batch-to-batchinconsistency

NA

2 Commoninterfering factors

NA

3 Carry-over effects NA4 Specimen

identification errorsNA

5 Stability problems(in storage, inshipping, in use,after first openingof the container)

NA

6 Problems relatedto taking,preparation andstability ofspeciments

NA

7 Inadequatespecification ofprerequisites

NA

8 Inadequate testcharacteristics

NA

File No: CE-TCF-003

9

Abbreviations used

RE Risk Evaluation

S Severity (9 –very severe, 0 –not severe)

O Occurrence (9 –often, 0 –never)

D Detection

(9 –impossible to detect before risk occurs,

0 –will be certainly detected before risk occurs)

RL Risk Level = Severity × Occurrence × Detection

1-9: Neglectable risk, no further actions;

9-24: Moderate: minimal risk, preventive action recommended;

25-48: Moderate risk, preventive action required;

>48: Risk is usually not acceptable

RRM Risk Reduction Measure

NH New hazard generated (no/ yes - if yes, then number of new

hazard indicated)

ALOR Acceptable Level of Risk

Conclusion:According to the analysis of the risk, all the risk has been identified and the risks which are

none accepted have been controlled by measure taken by the manufacturer. In one word,

the risk has been managed accordingly.

检验报告 TEST REPORT

扫一扫关注我们扫一扫查询真伪

*YJ202001950*

报告编号 R E P O R T N O .

国纺委字第 YJ202001950 号

产品名称 NAME OF SAMPLE

民用口罩

委托单位 C U S T O M E R

浙江中美日化有限公司

检验类别 TEST CATEGORY

委托检验

浙江省轻工业品质量检验研究院

（浙江省纺织测试研究院）

Zhejiang Light Industrial Products Inspection and Research Institute

国家纺织服装产品质量监督检验中心（浙江）

National Textiles and Garment Quality Supervision Inspection Center(Zhejiang)

浙江省轻工业品质量检验研究院

国家纺织服装产品质量监督检验中心（浙江）

检验报告国纺委字第 YJ202001950 号第 1页共 3页

委托单位名称

Name of Customer 浙江中美日化有限公司

地址

Address ---

生产单位

Manufacturer ---

地址

Address ---

样品信息

Sample

information

样品名称 Name of sample：民用口罩

样品特性 Characteristics：蓝色

商标 Trademark：---

规格/号型 Specification/model：---

等级 Level：---

安全技术类别 Category of safety specification：---

样品款号/货号 Art. No.：---

------------------------------------------------

以上为客供信息（Above-mentioned information by Customer-supplied）

来样方式

The sent way of

sample

快递样品数量

Sample quantity 1 包

送检日期

Receiving Date of

Sample

2020-03-08 检测类别

Test Category 委托检验

判定依据

RatingRequirements GB/T 32610-2016

检测结论/Test Summary：

实测结果详见附页。

[签章] (检验报告专用章)Test Seal

批准日期/ Date of Approval：2020-03-08

备注

Remarks

1、样品标识未标注防护效果级别，按最低标准要求 D 级判定。

2、样品未经预处理。

签发：

Approved by


序号检测项目检测方法单位标准要求

（D级）实测值单项评价结果备注

1 呼吸阻力

吸气阻力

GB/T 32610-2016

Pa ≤175 82.8

符合 ---

呼气阻力 Pa ≤145 39.1

2 过滤效率 GB/T 32610-2016 附

录 A % ≥90 99.6 符合 ---

3 防护效果 GB/T 32610-2016 附

录 B % ≥65 65.7 符合 ---


样品照片

—以下空白—

声明一、本机构保证检测的公正性、独立性和诚实性，对检测结果负责，对委托方所提供的检测样品保密和保护所有权。

二、本报告无签发人员签字或未加盖本机构红色检验检测专用章无效。

三、报告涂改无效。复印件未重新加盖本机构红色检验检测专用章无效。

四、本报告的检测数据和结果仅对送检样品负责。

五、本报告各页均为报告不可分割之部分，使用者单独抽出某些页导致误解或用于其它用途及由此造成的后果，本机

构不负相应的法律责任。

六、委托方若对本报告有异议，应及时向本机构提出。政府行政管理部门下达的指令性任务，被检方对检验结果有异

议时，应按政府行政管理部门文件规定及国家相关法律、法规规定进行。

DECLARATION 1. Our organization guarantees impartiality, independence and honesty of inspection, and is responsible for the results of

inspection, keeping the samples supplied by the entrusting party confidential and at the same time protecting the ownership o f

the samples supplied.

2. The test report will be deemed invalid without signatures of the inspector/reviewer and authorized personnel, and the red

special inspection stamp of our organization.

3. The test report will be invalid if it is altered. Copies of the report are invalid without the red special inspection stamp of our

organization.

4. The test results shown in this report is only valid for the tested sample.

5. All the pages of the report are integral parts of the report. Our organization will not be responsible for any

misunderstanding or other results caused by using separate page(s) of the report.

6. If there is any dissent of the report, the entrusting party shall notify our organization timely. For the mandatory inspec tion

given by governmental administration departments, and dissent about the sample being tested or test results on the report

should be dealt with in accordance with national regulations.

浙江省轻工业品质量检验研究院及附设的检验中心 The Affiliated Inspection Centers

浙江省轻工业品质量检验研究院 Zhejiang Light Industrial ProductsInspectionandResearchInstitute 国家纺织服装产品质量监督检验中心（浙江） National Textiles and Garment Quality Supervision Inspection Center(Zhejiang)

联系电话：0571-85122669 Telephone：0571-85122669 E-Mail：[email protected]

地址：浙江省杭州市江干区下沙路 300 号 6 号楼 Address：Building No.6, 300 XiaSha Road, Hangzhou, Zhejiang

国家家具产品质量监督检验中心（浙江） National Center for Quality Supervision Inspection of Furniture(Zhejiang) 浙江省室内安全及家具产品质量检验中心 Zhejiang Center of Quality Test for Indoor Safety and Furniture Products


地址：浙江省杭州市余杭区良渚街道经一路 1 号良渚大学科技园 4 号楼 Address：Building 4 LiangZhu University Science and Technology Park, No.1,

JingYi Rd, Yuhang District, Hangzhou, Zhejiang 浙江省轻工及五金产品质量检验中心 Zhejiang Center of Quality Test for Light Industry and Hardware Products 浙江省体育用品质量检验中心 Zhejiang Center of Quality Test for Sports Products


地址：浙江省杭州市西湖区天目山路 222 号 3 号楼浙江省杭州市余杭区良渚街道经一路 1 号良渚大学科技园 3 号楼

Address：No. 222 Tianmushan Rd., Hangzhou, Zhejiang Building 3 LiangZhu University Science and Technology Park, No.1, JingYi Rd., Hangzhou, Zhejiang

国家锁具产品质量监督检验中心（浙江） National Center for Quality Supervision Inspection of Lock(Zhejiang) 浙江省锁具产品质量检验中心 Zhejiang Center of Quality Test for Lock Products


地址：浙江省杭州市塘苗路 24 号 Address：No. 24 Tangmiao Rd., Hangzhou, Zhejiang

网上业务受理/报告查询：http://www.zjttj.cn:807 Online Business-Reception/Report Inquires: http:// www.zjttj.cn:807

投诉电话：0571-85023552 Complaint Tel：0571-85023552

File NO: CE-TCF-005

The evaluation from the user in the market

1. The product has been put into the market for several years and the customer

satisfactory was investigated each year. And at the same time, the client could

report the accident and the problems of the product to the department of the

government.

2. Form the result of the investigation and the feedback from the customer, the

product is safe to be used.

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