practical application guide of the machinery directive 2006/42/ec

|

Practical Application guide of the

Machinery Directive 2006/42/EC By Stephan Pochon

[email protected]

TÜV Rheinland of North America. Business Field Commercial 10/22/2012 1

| 10/22/2012 2

2006/42/EC – The Machinery Directive.

USA Safety Regulations

TÜV Rheinland of North America. Business Field Commercial

1. In the USA you have to comply with OSHA (occupational safety and health

administration) requirements which are the US law. OSHA does not enforce any

machinery standard.

2. In order to put a machinery into service in USA you will need to get a

permit/approval from the local AHJ (Authority having jurisdiction [law

enforcement agency, it’s a government agency]) – no self declaration accepted

3. The AHJ will usually look at the electrical/fire safety and may ask for a listing

mark or a labeling from a NRTL (Nationally Recognized Testing laboratory)

(varies by inspector and location).

4. Use of compliance of safety standards may not be sufficient at the courts even if

followed (since not enforced by law).

| 10/22/2012 3


European Safety Regulations


1. European parliament adopt the different safety directives developed by

committees (commission + member states) and working group (committees +

European stakeholders)

2. These directives become national laws in the member state without any

alteration same law in every state/country

3. Local authorities (country where the equipment is put in service) have the right

and duty to enforce the law.

4. The directives only stipulate the essential health and safety requirement.

5. The European standardization bodies (CEN, CENELEC, ETSI) are mandated to

create harmonized standards, which are essential tools for applying the

Machinery Directive. Their application is not mandatory. However, their

application confers a presumption of conformity with the essential health and

safety requirements they cover.

6. If you want to place your equipment in the EU and if it falls under the machinery

directive. It must be CE-marked a DoC must be drafted and you must also

comply to all other applicable directives. .

| 10/22/2012 4


Structure of the machinery directive


1. The recitals (30), they have no legal force but they explain/clarify the meaning of

the directive.

2. The articles (29) cover general item: the scope and definitions, specific

directives, market surveillance, placing products on the market and putting them

into service, freedom of movement, harmonized standards, partly completed

machinery, notified bodies, CE marking, non conformity of marking, etc…

3. Annex I details the Essential Health and Safety Requirements.

Annex II lists the exact contents of the EC Declaration of Conformity.

Annex III describes how the CE Mark is to be placed on Machinery

Annex IV identifies the machinery which require EC type examinations by

approved Notified Bodies.

Annex V defines safety component listed under annex IV.

Annex VI defines assembly instruction for partly completed machinery.

Annex VII, VIII describe the procedure to follow to compile the Technical File.

Annex, IX, X and XI are related to equipment falling into Annex IV.

.

| 10/22/2012 5


Scope and definition


1. Is the machinery directive applicable?

2. Scope: Machinery, interchangeable equipment, safety components, lifting

accessories, partly completed machinery, etc.. (art. 1)

3. Definition: To be a machinery is shall meet the following definition (art. 2) :

An assembly, fitted with or intended to be fitted with a drive system other than

directly applied human or animal effort, consisting of linked parts or components,

at least one of which moves, and which are joined together for a specific

application.

4. The following equipment are not covered by this directive:

• Household appliances, audio and video equipment,

IT, office machinery, switchgears, electric motors

• Weapons, machinery for military/nuclear, means of

transport, etc..

| 10/22/2012 6


Practical Application [directive + standards]


1. Find the applicable directives [free + guide available] • http://www.newapproach.org/Directives/DirectiveList.asp

2. Find the applicable harmonised standard [official journal,

copyrighted] • http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/

Type A standards: Fundamental safety standards,

giving basic principles for design and general aspects

for all machinery.

Type B standards: Grouping more specific safety

standards that may be applied across a range

of machines and industries.

Type C standards: Machinery safety standards

for specific types of machines or industrial applications. Type C harmonised

standard under the directive proves full compliance!

http://www.newapproach.org/Directives/DirectiveList.asp

http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/





| 10/22/2012 7


Practical Application [harmonized standards]


Type A standards Type B standards

Type C standards:

| 10/22/2012 8


Practical Application [About the Standards]


• It may be difficult to find, chose and apply the right standard(s)

• For European compliance, European standards must be used (if available).

• If European standard(s) are not available, national standards of the member states

may be used.

• A third option is to use international / industrial standards.(Most European standards

are based on (and identical with) international standards (IEC, ISO)).

• Since the standards are difficult to read,

understand and apply, many test and certification

agencies support customers in the process.

• TUV Rheinland is one of the many, providing

expertise and consulting, testing and, if required,

certification services for a wide variety of customers.

• USA / Canadian standards cannot be used (they are not international).

• It is dangerous to assume that a machine is safe (European safety) based on prior

safety record, compliance with USA or Canadian safety specs.

| 10/22/2012 9


Some important requirements to follow


1. Low Voltage Directive vs Machinery directive

2. 'Authorized representative' is defined as 'any natural or legal person

established in the community who has received a written mandate from the

manufacturer to perform on his behalf all or part of the obligations and

formalities connected with the Directive.(Need to be on the DoC, see Annex II)

3. Name and address of the person authorized to compile the technical file,

who must be established in the Community (need to be in the DoC, see

Annex II);

4. A risk assessment (per EN ISO 12100) must be carried out and must be

documented in the Technical file, it must be updated if the machine is modified.

5. “Misuses” must be avoided – if they can cause a risk – should be either

addressed in design or covered in documentation (as a practical advise)

6. The CE mark must be affixed using the same technique as the name plate and

must be affixed in its immediate vicinity.

| 10/22/2012 10




7. The safety of the design shall include the different phases of the

'foreseeable lifetime' which includes: phases of transport, assembly,

dismantling, disabling and scrapping.

8. From each control position the operator must be able to ensure that no-

one is in the danger zones.

9. “Fixing systems must remain attached to the guards of machinery when

the guards are removed.” Fixings can not be loose

10. The instruction accompanying the machinery

must be either ‘Original instructions’ or a ‘Translation of the original

instructions’, in which case the translation must be accompanied

by the original instructions.

11. A copy of DoC must be included in the instruction

12. Sound power level over 80dB(A) must be stated in the instruction

| 10/22/2012 11




13. Principle of safety integration: in selecting the most appropriate methods,

the manufacturer must apply the following principle in the order given:

• Eliminating or minimizing the hazards

(by design and construction).

• Provision of protective measure against

hazards which can not be eliminated.

• Informing the users about residual hazards which can not be avoided due

to the incomplete effectiveness of safeguarding; reference to possibly

required special training and personal protective equipment.

| 10/22/2012 12


Penalties, what not to do


• Absence of CE marking and/or absence of the EC declaration of conformity (DoC)

for machinery.

• Reference to wrong harmonized standard or to withdrawn version

of standard or to wrong directive.

• Non conformity of CE marking (Annex III)

• Declaring compliance but it is not.

• Missing or incomplete technical file.

• Missing or incomplete instructions.

Penalties apply. Need to make the product conform, if not, member state will

restrict or prohibit the placing on the market of the product or ensure it is

withdrawn from the market.

| 10/22/2012 13


The Risk Assessment per EN ISO 12100


• As required by Annex I of the machinery

directive a risk assessment must be

performed and provided in the technical

file.

• The method is not defined but follow the

following flow chart [EN ISO 12100].

• Iterative process to be done for each

hazards

| 10/22/2012 14


The Risk Assessment [Risk Analysis]


• 5.3 Limit of the machinery

Use limits: environment, operation mode, training

Space limits: range of movement, operator machine

interaction

Time limits: life time of the machinery, service intervals.

| 10/22/2012 15


The Risk Assessment [5.4 Hazard Identification, Annex B]


| 10/22/2012 16


The Risk Assessment [5.5 Risk Estimation]


5.5 Risk Estimation for each hazardous situation depends on the following elements:

- Slight, serious, death.

- One person, several person

Need for access, frequency of

access, time spent in hazard zone

Accident history, statistical data,

comparison of similar machine

- How quick the hazardous situation could

lead to harm (suddenly, quickly, slowly)

- Skilled vs unskilled

| 17


The Risk Assessment [Risk Evaluation and Risk Reduction]

5.6 Risk Evaluation/ Risk Reduction:

after risk estimation has been

completed, risk evaluation shall be

carried out to determine if risk

reduction is required. If risk reduction

is required, then appropriate

protective measures shall be selected

and applied.

| 10/22/2012 18


Evaluation of safety circuit using EN ISO 13849-1


• If you use a safety control system as a protective measure to reduce the risk, it

must be designed per EN ISO 13849-1. EN 954 is no longer a valid standard

since January 2012 and is no longer referenced in harmonized standards.

• EN ISO 13840-1 is using quantitative approach to assess the reliability of the

safety control system/safety function. Takes into account: architecture (sof/hard),

diagnostic (fault detection), reliability of component (MTTFd),

• It can be applied to any system performing a safety function: Hydraulic,

pneumatic, electro-mechanical (relay), solid state, programmable solution and

their combinations.

• The safety categories B, 1, 2, 3, 4 are replaced by Performance Level (PL): a, b,

c, d, e.

| 10/22/2012 19




• If risk reduction is required and selected

method uses the control system. The part of

the control system performing this safety

function is evaluated by this standard

PLr

| 10/22/2012 20


EN ISO 13849-1 (PL: Category, MTTFd, DC, CCF)


1. Performance Level (PL): ability of a SRP (Safety Related Part) /CS (Control

System) to perform a safety function

.

|

Safe

ty R

elia

bility

incre

ase

10/22/2012 21




2. Dangerous Failure: failure which has the potential to put the SRP/CS in a

hazardous or fail to function state

.

| 10/22/2012 22




3. Safety Category (a, 1, 2, 3, 4) of the SRP/CS depends on the structural

arrangement, fault detection and/or their reliability.

Same classification than in EN 954.

4. Mean Time To dangerous Failure (MTTFd): expectation of the mean time to

dangerous failure.

To be applied to each channel (when redundancy is used).

A) Use manufacturer’s data

B) Use values given in Annexes C and D.

C) Worst case apply 10 years.

.

| 10/22/2012 23




5.Diagnostic Coverage (DC) measure of the effectiveness of diagnostics, which

may be determined as the ratio between the failure rate of detected dangerous

failures and the failure rate of total dangerous failure. reliability of the monitoring

function. from the manufacturer or from annex E

.

| 10/22/2012 24


EN ISO 13849-1 (PL: Category, MTTFd, DCavg, CCF)


No, start again!!

Ok you are fine!

|

• You can use SISTEMA its free and pretty easy to use. The IFA is an institute for

research and testing of the German Social Accident Insurance in Germany. http://www.dguv.de/ifa/en/pra/softwa/sistema/index.jsp

10/22/2012 25




http://www.dguv.de/ifa/en/pra/softwa/sistema/index.jsp

| 10/22/2012 26



TÜV Rheinland of North America

Stephan Pochon

[email protected]

practical application guide of the machinery directive 2006/42/ec

Documents