SINUMERIK 840D sl

CE Conformity
Sinumerik 840D sl

Edition 2019.03
Training Manual

This document was produced for training purposes.

Siemens assumes no responsibility for its contents.
SINUMERIK 840D sl

CE Conformity

Valid for:

Sinumerik 840D sl Software 4.8

 A005 CE Conformity
Sinumerik
Operate

Module Description:

This module explains the requirements for an OEM to conform to CE

Module Objective:

To give a basic understanding of the requirements to Conform to CE

Content:
Sinumerik

Introduction
How to show Conformity to
 Machinery Directive
 Low Voltage Directive
 EMC Directive
 Ecodesign Directive
Risk Assessment
Technical File
Documentation
CE marking

840D sl SINUMERIK Operate v4.8 Page 1 This document was produced for training purposes. A005
Siemens assumes no responsibility for its contents.
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 CE Conformity A005

CE
CE Conformity Marking
START

CE Conformity
Introduction END

Supplier
CE
Requirements

Risk
Assessment

Technical
File

Documentation

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Introduction: CE Marking of Machinery

The CE mark is a symbol that when affixed to a product indi-
cates that it complies with the relevant EU legislation, which
enables the free movement of products within the European
market. The CE mark is affixed by a manufacturer, importer or
authorised representative, who are required to ensure and
make a declaration that the product complies.
Machines that are being placed on the market in Europe are
required to be CE Marked under the Machinery Directive be-
fore they are put into service. The Directive applies to ma-
chines that are new, but also applies to machines that have
been built for own use, or where they have been modified or
rebranded.

CE Marking is compulsory and must be affixed before a prod-
uct is placed (for sale or own use) on the market within the 28
member states of the European Economic Area. Not all prod-
ucts are required to be CE marked, only products that fall with-
in the scope of a European Directive that has requirements for
a product to be CE marked. Where a product is required to be
CE marked, there is a simple process to follow
Machinery for the European market has been required to be
CE marked since 1995, and the current Directive (2006/42/
EC, which came into force on the 29th December 2009) sets
out 7 categories of equipment which are within its scope. A
Machine Tool falls into one of these categories.

Conformity Requirements
The majority of machinery will fall under the ‘Internal Checks’
route; which requires the manufacturer to undertake 5 key
CE Marking Machine Tools under the Directive is relatively tasks:
straightforward when it comes to establishing the route to con-
•Undertake a risk assessment
formity for equipment within the scope. The majority of equip-
•Demonstrate conformity to the Essential Health and Safety
ment will fall under a self-declaration route, however there are
Requirements of Annex I, or against the requirements of
separate routes for ‘high-risk’ equipment (which are items that
applicable harmonised standards.
are listed within Annex IV of the Directive) and for partly com-
•Compile technical documentation
pleted machinery, as shown below:
•Complete an EC Declaration of Conformity
•Affix the CE mark
MACHINERY
Once a manufacturer has completed these tasks and found

Not Annex Partly that the machine fulfils all of those requirements, then the
IV or partly High Risk Completed
Equipment machine can be deemed to be CE marked and is now ready
Completed Machinery
(Annex IV) to be placed on the market.
Choice

Internal Internal Full Quality Declaration

Checks Checks EC Type Procedure of Incorpo-
(Annex VIII) (if using a Examina- (Annex X) ration
harmonised tion(Annex (Article 13)
standard) IX)

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2) How to Show Conformity to the Directives

Supplier CE Requirements :
2.1 Machinery Directive
1) Introduction
Provide a Certificate and Test report from a recognised, prod-
uct assessment organisation (e.g. TUV) for an assessment
Machine Tools can only be sold in Europe if: against the Machinery Directive or the relevant Harmonised
standard if it exists:
1. They conform to the following Directives:
a. Machining Centres: EN 12417:2001+A2:2009
a. Machinery Directive: 2006/42/EC b. Turning Centres/Lathes: ISO 23125:2015
b. Low Voltage Directive: 2014/35/EU c. Milling Machines: EN 13128:2001+A2:2009
c. EMC Directive: 2014/30/EU
d. Ecodesign Directive 2009/125/EC 2.2 Low Voltage Directive
Provide a Certificate and Test report from a recognised, prod-
2. A Technical File is available for the machine uct assessment organisation (e.g. TUV) for an assessment
against EN 60204-1:2006+A1:2009
3. Machines are supplied with the necessary documentation:
2.3 EMC Directive:
a. Instruction Manual(s)
Provide a Certificate and Test report from a recognised, prod-
b. EC Declaration of Conformity uct assessment organisation (e.g. TUV) for an assessment
against:
4. Machines are CE marked a. EN 61000-6-4:2007 or EN 50370-1:2005 (Emissions)
b. EN 61000-6-2:2005 or EN 50370-2:2003 (Immunity)

Nominal minimum efficiencies (n) for IE2 efficiency level (50 Hz)
2.4 Ecodesign Directive
Rated Power Number of poles
This applies to general purpose induction motors fitted to the Output
machine which are 0.75kW or larger. (kW) 2 4 6
It does NOT apply to motors specifically designed to be driv-
en by an inverter nor those fitted with an electromagnetic 0,75 77,4 79,6 75,9
brake inside the motor. 1,1 79,6 81,4 78,1

If motors are fitted to the machine which achieve the following 1,5 81,3 82,8 79,8
efficiency ratings, then the OEM will comply:
2,2 83,2 84,3 81,8
Before January 2017: 3 84,6 85,5 83,3
 IE2 if <7.5Kw or inverter driven
4 85,8 86,6 84,6
 IE3 if >7.5Kw
5,5 87,0 87,7 86,0
After January 2017: 7,5 88,1 88,7 87,2
 IE2 if inverter driven, else
11 89,4 89,8 88,7
 IE3
15 90,3 90,6 89,7
The efficiency rating must be marked on the motor plate.
18,5 90,9 91,2 90,4
Efficiency ratings are: 22 91,3 91,6 90,9

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Nominal minimum efficiencies (n) for IE3 efficiency level (50 Hz)

Rated Power Number of poles

Output
(kW) 2 4 6
0,75 80,7 82,5 78,9
1,1 82,7 84,1 81,0
1,5 84,2 85,3 82,5

2,2 85,9 86,7 84,3

3 87,1 87,7 85,6
4 88,1 88,6 86,8
5,5 89,2 89,6 88,0
7,5 90,1 90,4 89,1
11 91,2 91,4 90,3
15 91,9 92,1 91,2
18,5 92,4 92,6 91,7
22 92,7 93,0 92,2

For more information see EC Regulation 640/2009:

Example of a Certificate from a recognised, product assess-

ment organisation (e.g. TUV) for an assessment against the
Machinery Directive 2006/42/EC and the relevant Harmonised
standards applied:

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Example of a Certificate from a recognised, product assess-

ment organisation (e.g. TUV) for an assessment against the
Low Voltage Directive 2014/35/EU and the relevant Harmo-
nised standards applied:

Example of a Certificate from a recognised, product assess-

ment organisation (e.g. TUV) for an assessment against the
EMC Directive 2014/30/EU and the relevant Harmonised
standards applied:

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Example of a Test Report from a recognised, product assess-

ment organisation (e.g. TUV) for an assessment against the
Low Voltage Directive 2014/35/EU and the relevant Harmo-
nised standards applied:

Example of a Test Report from a recognised, product assess-

ment organisation (e.g. TUV) for an assessment against the
Low Voltage Directive 2014/35/EU:

This shows the documents submitted for the test e.g. Electri-
cal circuit diagrams, parts list, component conformity docu-
ments, block diagram, manuals etc

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Risk Assessment :  provide information about any residual risks and

Manufacturers should:
Carry out a detailed risk assessment by:
 Identifying the health and safety hazards (trapping,
crushing, electrical shock, dust or fumes, noise, vibra-
tion, etc) that are likely to be present when the ma-
chinery is used. The essential health and safety re-
quirements listed in the Directives should be used by
manufacturers as a guide to ensure all possible haz-
ards have been considered, and that they have identi-
fied those relevant to the machine;
place signs on the machinery to warn of risks that
cannot be reduced in other ways (eg ‘noisy machine’
signs)
Following risk assessment, a decision as to whether risk
reduction measures have to be initiated, must be made.
Such risk reduction comprises:
 Design measures
 Technical protective equipment as well as training
measures for users

 Assessing the likely level of risks involved;

 Eliminate significant risks or, if that is not possible;

 Provide safeguards (eg guarding dangerous parts of

the machinery, providing noise enclosures, etc) or, if
that is not possible;

Risk Reduction

Residual Risk Acceptable Risk EUC Risk

(Equipment Under Control)

Necessary risk reduction

Actual risk reduction

Partial risk covered by E/E/PE Partial risk covered by
Safety related systems Other technology Safe-
ty related systems.
Programmable Electrical Guards, Machine
Electronic Safety systems design...etc
Partial risk covered
by external risk
reduction facilities
Training,
Signage...etc

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Risk Reduction Process in accordance with EN 1050

Start

Determine the machine limits

Identify the hazard Risk analysis Risk assessment

Estimate the risk

Evaluate the risk

Yes
End
No
Reduce the risk

Risk reduction and the selection of appropriate safety measures are not part of the risk assessment
process. For further information, refer to EN ISO 12100-1/-2.

Application of the Safety Standards EN ISO 13849 and EN 62061

Conformity with the machinery directive, and thus exportability and security against liability, can be achieved, by machine manu-
facturers, through application of the EN ISO 13849 and EN 62061 standards. These have introduced not only qualitative observa-
tions but also quantitative aspects, whereby “functional safety” and the “safety function” play an important part. Risk-reducing pro-
tective measures described by way of safety functions can be derived from the risk evaluation process. The safety function solu-
tion is then checked and evaluated with hardware and possibly software components until the level of safety integrity specified in
the risk assessment has been attained.

Once the risk assessment is completed, the OEM will then choose an appropriate standard for his machine

EN 62061-Based on SIL (Safety Integrity level) assignment

Or
EN ISO 13849-1-Based on PL (Performance Level) by risk graph

The risk elements (S, F, O and P) serve as input variables for both EN 62061 and EN ISO 13849-1. the risk elements are evaluat-
ed in different ways, according to EN 62061, a required safety integrity level (SIL) is determined.
According to EN ISO 13849-1, a performance level (PL) is determined.

Frequency and duration of exposure F

Risk
Related to the considered danger Severity of danger S Occurrence probability O

Prevention Possibilities P

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Determination of required SIL (Safety Integrity Level) for EN 62061 (SIL 1, 2 or 3)

Frequency and/or dura- Occurrence Probability Prevention Possibili-

tion of stay of ties
Hazardous situation
F O P
=< 1 hour 5 Frequently 5
> 1 hour to =< 1 day 5 Probable 4
> 1 day to =< 2 weeks 4 Possible 3 Impossible 5

> 2 weeks to =< 1 year 3 Rarely 2 Possible 3

> 1 year 2 Negligible 1 Probable 1

Effects Severity Class

Cl =F + O + P

S 3-4 5-7 8-10 11-13 14-15

Death, loss of eye or arm 4 SIL 2 SIL 2 SIL 2 SIL 3 SIL 3

Permanent, loss of fingers 3 SIL 1 SIL 2 SIL 3

Reversible, medical treatment 2 SIL 1 SIL 2

Other Measures
Reversible, first aid 1 SIL 1

Example Hazard S F O P Cl Safety Measures Safe

+ + =
Rotating Spindle 3 5 4 3 12 Monitor protective cover with SIL 2 Yes

Determination of required Performance Level (PL) for EN ISO 13849-1 (PL a - e)

Risk Parameters

S = Severity of injury
S1 = slight (usually reversible) injury
S2 = severe (usually irreversible) injury
Including death

F = Frequency and/or duration of exposure to Start

hazard
F1 = rare to often and/or short
exposure to hazard
F2 = frequent to continuous and/or
long exposure to hazard

P = Possibility of avoiding or limiting harm

P1 = possible under certain circumstances
P2 = hardly possible

High Risk

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Evaluation of safety Related Devices:

Once the ‘SIL’ or ‘PL’ has been determined for the machine, the OEM must then choose the various safety related devices that
will make up the different ‘Safe Systems’ on the machine i.e. Emergency Stop, Operator Door ….etc

It is the responsibility of the OEM to prove and document that the combination and integration of the different safety related devic-
es achieve the ‘SIL’ or ‘PL’ required

The Siemens Safety Evaluation Tool for the EN 62061 and EN ISO 13849-1 standards takes you to your goal directly.

This TUV tested online tool supports the fast and reliable assessment of your machines safety functions.

As a result, you are provided with a standard-compliant report, which can be integrated in the documentation as proof of safety.

Safety System

Protective Subsystem 1: Subsystem 2: Subsystem 1: Motor

door Detecting Evaluating Reacting

or

Advantages of using the Safety Evaluation Tool

 Certainty regarding compliance with the standards : TUV tested tool

 Free use of the online tool
 Automatic calculation in accordance with current standards
 Rapid result : report compliant with the standards
 Time saving in terms of safety function assessment
 Fast access to current product data
 Comfortable archiving : Projects can be saved and called up again as required
 Fast and easy handling : Comprehensive, pre-defined example libraries
 Selection menus for determining the DC and CCF
 Input of different operating cycles and two-channel design
 Calculation of failure rate
 Selection assistant for drive components

Here is a link to the Safety Evaluation Tool

(http://www.industry.siemens.com/topics/global/en/safety-intrgrated/machine-safety/safety-evaluation-tool/Pages/Default.aspx)

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Online Safety Evaluation Tool (SET)

The Safety Evaluation Tool contains useful examples based on the Sinumerik 840D sl. These examples cover both IEC 62061
and ISO EN 13849-1

The tool can produce a multi-page report that confirms the safety integrity of the safety related components used in your project.
This report can form part of the technical file for the machine.

SET projects can be saved locally and loaded again in the future.

The tool provides online help and tutorials to help you get started

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Typically the OEM has to do the risk assessment for safety

critical issues, for example Emergency Stop and Operator
Safety Door. In order to use the SET tool the OEM also needs
the data sheets of the other non Siemens components which
maybe used in the safety circuits.

These could be for example , Emergency Stop pushbuttons,

Safety Door Interlock switches, Hold to Run pushbuttons, Pro-
duction/ Setup Keyswitch, Contactor for feed to Auxilliary de-
vices.

These safety component data sheets should also be included

in the Technical File

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Technical File :  A Declaration of Conformity Certificate from the manu-

facturer showing conformity with the Directives and
The technical file is a document which shows how the ma- which Standards were used.
chine complies with the EC Machinery, Low Voltage & EMC
Directives. In particular, it shows how the machine satisfies
 Certificate of Conformity with Low Voltage Directive
the Essential Health and Safety Requirements of the Machin-
2014/35/EU (e.g. from TUV)
ery Directive.

It is the evidence that the machine can carry the CE mark and
that it is safe and legal to sell in Europe. Agents/Distributors
must have a copy in case they need to show it to the relevant
Health and Safety Authorities.
Here are some notes to help when putting together a Tech-
nical File:
Separate Technical files are not required for each Directive.
All the information can be put together into one folder.
Similar machines can be covered by one technical file. The
technical file can be supplied in electronic format.
So inside the Technical file as a minimum requirement should
be:-
 Certificate of Conformity with Machinery Directive
2006/42/EC (e.g. from TUV)
 Certificate of Conformity with EMC Directive 2014/30/
EU (e.g. from TUV)
 A copy of the Test Report from TUV. This report
should cover the requirements to check the conformity
of the machinery with the essential health and safety
requirements.
 A Risk Assessment or a statement that the standards
EN12147 Machining Centres/ISO23125 Turning Cen-
tres/Lathes cover all of the risks associated with the
machine.

 Description of the machine, usually accompanied by

block diagram

 Copy of instructions (user, maintenance, installation)

 Wiring and circuit diagrams

 General layout drawing

 Parts list/Bill of materials

 Copies of any markings and labels (possibly already

covered in manuals)

 Quality control & commissioning procedures (Copy of

ISO9001 certificate to show that series manufacture
will continue to conform to CE)

 EC Declarations of Conformity for products used

in the machine (e.g. Sinumerik 840D sl, Sinumerik 828D,
motors etc)

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Machinery Directive Technical File Requirements
What the Machinery Directive asks for :
(a) a construction file including
A general description of the machinery,
The overall drawing of the machinery and
Drawings of the control circuits,
As well as the pertinent descriptions and explanations neces-
sary for understanding the operation of the machinery
Full detailed drawings, accompanied by any calculation notes,
test results, certificates, etc., required to check the conformity
of the machinery with the essential health and safety require-
ments
The documentation on risk assessment demonstrating the pro-
cedure followed, including :
(i) a list of the Machinery Directive essential health and safety
requirements which apply to the machinery
(ii) the description of the protective measures implemented to
eliminate identified hazards or to reduce risks and where appro-
priate, the indication of the residual risks associated with the ma-
chinery
Any technical report giving the results of the tests carried out by The TUV test report should cover this, plus any test reports
either the manufacturer or by a body chosen by the manufacturer that were given to TUV for them to do their conformity assess-
or his authorised representative ment
A copy of the instructions of the machinery
Where appropriate, copies of the EC declaration of conformity of
the machinery or other products incorporated into the machinery
A copy of the EC Declaration of Conformity
(b) for series manufacture, the internal measures that will be im-
plemented to ensure that the machinery remains in conformity
with the provisions of this Directive
The manufacturer must carry out necessary research and tests
on components, fittings or the completed machinery to determine
whether by its design or construction it is capable of being as-
sembled and put into service safely. The relevant reports and
results shall be included in the Technical file
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What the supplier could provide (as a minimum)
This could be covered in the manual(s)
An installation drawing
Electrical drawings
This could be covered in the manual(s)
The TUV test report.
And any calculations, test results or certificates that were given
to TUV for them to do their conformity assessment (e.g. for
strength of guards)
A Risk Assessment, or a statement that the Harmonised stand-
ard covers all risks associated with the machine
The TUV test report should cover this
The TUV test report should cover this, residual risks should be
covered in the documentation
A copy of all manuals for the machine
EC Declarations of Conformity for products used in the ma-
chinery (e.g. motors, major electrical components etc.)
A Declaration of Conformity
Copy of ISO9001 certificate, plus any other manufacturing
quality plans, documents or accreditations
Any relevant calculations or test results which TUV asked for
or which TUV made as a part of the conformity assessment of
the machine
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Low Voltage Directive Technical File Requirements

What the Low Voltage Directive asks for : What the supplier could provide (as a minimum)
A general description of the electrical equipment (of the ma- This can be covered in the manual(s)
chine);

Conceptual design and manufacturing drawings and schemes Electrical drawings

of components, sub-assemblies, circuits etc. (same as for Machinery Directive)

Descriptions and explanations necessary for the understanding This can be covered in the manual(s)
of those drawings and schemes and the operation of the elec-
trical equipment (of the machine)

A list of the Harmonised standards applied in full or part EN 60204-1 and any other standards used

Results of design calculations made, examinations carried out, The TUV test report should cover this, plus any relevant calcu-
etc. lations or test reports that were given to TUV for them to do their
conformity assessment

Test reports The TUV Test report

EMC Directive Technical File Requirements

What the EMC Directive asks for : What the supplier could provide (as a minimum)

A general description of the machine As for machinery directive

Conceptual design and manufacturing drawings and schemes Electrical drawings

of components, sub-assemblies, circuits, etc. (same as machinery directive)

Descriptions and explanations necessary for the understanding As for machinery directive
of those drawings and schemes and the operation of the ma-
chine

A list of the harmonised standards applied in full or part EN 61000-6-4:2007 or EN 50370-1:2005

EN 61000-6-2:2005 or EN 50370-2:2003
and any other standards used

Results of design calculations made, examinations carried out, The TUV test report should cover this, plus any relevant calcu-
etc. lations or test reports that were given to TUV for them to do
their conformity assessment

Test reports The TUV Test report

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Documentation :
Each machine should be supplied with manual(s) which inclu-
de all of the necessary information. The TUV assessment
should include a check that the manuals are complete.
Each machine or series of machines should be supplied with
a Declaration of Conformity.
The Declaration of Conformity must show:
Like the CE logo, the Declaration of Conformity is one of the
common threads throughout all of the CE marking directives.
Basically it's a piece of paper which someone has to sign to
say that the product meets the requirements of the directive
(s) which apply to it. The idea is that making someone put
their signature on a piece of paper concentrates their mind on
whether or not the product really does comply. It also allows
an enforcement authority to identify who is responsible for a
product and what that person claims to have done to CE
mark it.
The Declaration of Conformity must show:
 Business name and full address of the manufacturer
 Name and address of the person authorised to compi-
le the technical file, who must be established in the
European Community.
 Description and identification of the machinery, inclu-
ding generic denomination, function, model, type, seri-
al number and commercial name
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A properly issued Declaration of Conformity is
always issued by the product's manufacturer (or by the per-
son responsible for selling the product in Europe) and never
by a test house or Notified Body.
The Declaration needs to be signed by someone who has the
power to make binding commitments on behalf of the manu-
facturer, but for the Declaration to be truly meaningful the
signatory should also be someone who has the authority to
commit the resources required to ensure that the CE marking
process is properly completed. The effect of the Declaration is
to identify an individual in the company who can be held re-
sponsible if the CE marking on a product turns out to be inva-
lid.
One particular requirement in the Machinery Directive is wor-
thy of special mention. This is that the Declaration must iden-
tify the name and address from where the technical documen-
tation for the product may be obtained and that this must be
an address within the European Community.
 A sentence expressly declaring that the machinery
fulfils all of the relevant provisions of the Machinery,
Low Voltage and EMC Directives
 A reference to the harmonised standards used
 If applicable, the reference to other technical stand-
ards and specifications used
 The place and date of the declaration
 The name, job function and signature of the person
signing the declaration.
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An example of a Declaration of Conformity from a Machine

Tool Manufacturer declaring that the machinery fulfils all of the
relevant provisions of the Machinery, Low Voltage and EMC
Directives

A reference is also shown to the harmonised standards used

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CE Marking
The CE Mark must be affixed to (in order of preference) the
product, its instruction manual or to its packaging. Recent
guidance from the European Commission indicates that the
mark must appear on the product itself unless there are good
technical reasons why it cannot. It must be at least 5 mm
high. It is not intended to be a mark of quality - rather it is
intended to indicate to the authorities responsible for enforc-
ing the Directives that the product's manufacturer claims com-
pliance with the directives which apply to the product.
The act of fixing the mark to the product, and signing the Dec-
laration of Conformity, constitutes a declaration by the manu-
facturer that the product meets the requirements of all the
Directives which apply to it. The onus is very much on the
manufacturer to take responsibility for this actually being true.
Marking a product which is not fully in accordance with the
requirements of the applicable directives is an offence in its
own right, and would also contravene related consumer safe-
ty and trades descriptions legislation.
The CE mark should be applied to all machines:
The CE marking must be at least 5 mm tall.
The CE marking must be affixed close to the name of the
manufacturer.
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Implications for manufacturers:
The purpose of the directives is not to ban any products from
the European Single Market, unless the product is very poorly
made or is unsafe. For most reputable manufacturers, com-
plying with the essential protection requirements of the direc-
tives is not particularly onerous and companies which have
always taken a responsible attitude to the performance and
design of their products will have few problems complying
with the directives.
Where a manufacturer is based outside the EU, it is the per-
son who is responsible for bringing the equipment across the
first EU border who has legal responsibility for CE marking it.
However, because of their intimate involvement in the safety
of the product, manufacturers almost always have some re-
sponsibilities under the CE mark directives even if they are
not directly responsible for importing the goods into the EU.
Where the manufacturer has a formally appointed distributor
or subsidiary ('authorised representative') the situation is rea-
sonably straightforward.
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