Machinery Safety Directive
Which standards should I cite on my Declaration of Conformity? Open
You should cite the standards which are most specific for your machine and which you have applied. Generally, these should be what are called "Type C' standards.
'Type C standards' is a term defined in more depth in EN ISO 12100:2010. To quote from the introduction to the standard:
"⎯ type-A standards (basic safety standards) giving basic concepts, principles for design and general aspects that can be applied to machinery;
⎯ type-B standards (generic safety standards) dealing with one safety aspect or one type of safeguard that can be used across a wide range of machinery:
⎯ type-B1 standards on particular safety aspects (for example, safety distances, surface temperature, noise);
⎯ type-B2 standards on safeguards (for example, two-hand controls, interlocking devices, pressure sensitive devices, guards);
⎯ type-C standards (machine safety standards) dealing with detailed safety requirements for a particular machine or group of machines."
An example of a type A standard is EN 12100 "Safety of machinery - General principles for design - Risk assessment and risk reduction"
An example of a type B1 standard is EN ISO 13857 "Safety of machinery. Safety distances to prevent hazard zones being reached by upper and lower limbs"
An example of a type B2 standard is EN ISO 14119 "Safety of machinery. Interlocking devices associated with guards. Principles for design and selection"
An example of a type C standard is EN ISO 23125 "Machine tools. Safety. Turning machines"
A type C standard will include a list of "normative references" which are standards which it is assumed you comply with in order for you to be able to legitimately comply with the main standard. Most of these standards will be type A or type B standards, so the inclusion of the type C standard on your declaration is an implicit statement that you have complied with the type A and B standards which it references. You only need to be explicit about the type B standards where you have used a different approach to that defined in the normative references.
For example, if the type C standard cross references EN ISO 13849-1 as the basis of the control reliability requirements but instead you use EN 62061 then you would include both the type C standard and EN 62061 on your Declaration.
Updates: 2021-10-12 16:50
Under CE regulations do O & M manuals have to show the CE mark and if so where? Open
There is no obligation to put the CE logo on OEM manuals.
Updates: 2021-10-12 16:48
Under CE regulations is there a standard labelling for wiring diagrams? Open
There are standards for wiring diagrams. Please refer to the EN 60417 and the EN 61082 series of standards. These documents are normative references to EN 60204-1.
Updated: 2021-10-12 16:47
Goods hoists below 0.15 m/sec do not fall within the Lifts Directive but carry CE marking. Why, and why are they not in the Lifts Directive? Open
The new Machinery Directive 2006/42/EC moved a number of items which were previously covered by the Lift Safety Directive into the scope of the Machinery Directive. The section of the new Machinery Directive (2006/42/EC) which deals with this is article 24. Full text of the new Directive is available here:
https://www.conformance.co.uk/images/directives-documents/Machinery-full-text-directive.pdf
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Updated: 2021-10-12 16:46
Do all components (electrical components: push buttons, power supplies, motors, motor starters, terminal blocks, etc.)?used on a machine have to have the CE mark? Open
What matters is whether the completed machine complies with the requirements of the Machinery Directive. Using CE marked components helps because it means the machine manufacturer can rely on the component manufacturers rather than doing their own analysis of component performance, but it is not a requirement that all components must be CE marked before a valid CE mark can be put on the completed machine.
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Updated: 2021-10-12 16:27
Is there a regulation that would appoint the final responsibility to either the manufacturer or his representative when it comes to creating the Translation of the Original Instructions? We both export and import standard machinery within member states of EU and 2006/42/EC only speaks of shared responsibility for making translations of user manuals. Open
The Directive does not seek to regulate the division of responsibility for the translation of the instructions between the manufacturer and their authorised representative, it simply requires that when the machinery is delivered to the end user is must be accompanied by instructions in the language of the country in which they are located.
The Commission Guide to the Directive states (para. 257):
"Paragraphs (a) and (b) of section 1.7.4.1 explain in more detail how the language requirements set out in section 1.7.4 must be fulfilled.
Paragraph (a) of section 1.7.4.1 explains that the original instructions are the language versions of the instructions that have been verified by the manufacturer or his authorised representative. These language versions must bear the words 'Original instructions' (in the language of each version). The manufacturer may provide "Original Instructions" in one or more languages. Paragraph (b) of section 1.7.4.1 deals with the situation where machinery is placed on the market in a Member State for which the manufacturer or his authorised representative has not prepared original instructions. This may occur, for example, if an importer, a distributor or a user takes the initiative to place the machinery on the market or put it into service in a Member State not initially foreseen by the manufacturer. In such cases, a translation of the instructions into the official Community language(s) of the Member State concerned must be provided by the manufacturer or his authorised representative or by the person bringing the machinery into the language area in question.
In practical terms, this requirement entails that the person bringing the machinery into the language area in question must either obtain a translation from the manufacturer or his authorised representative or, failing that, translate the instructions himself or have them translated.
The translations must bear the words 'Translation of the original instructions' (in the language of each version) and must be accompanied by original instructions."
More generally, therefore, it is clear that where the manufacturer of the machinery intends that a product of theirs is to be sold in a particular European country then they must take steps to ensure that the instructions are translated into the official languages for that country (there is a list of the official languages for each country in the Guide). They can either have the translation done themselves or they can agree with their Authorised Representative (if they have one) that they will do it.
However, if someone purchases a piece of machinery from a manufacturer for their own use, or to sell to someone else in a territory to which the manufacturer have not themselves already made a commitment, then this does not automatically give the manufacturer an obligation to provide a translation of the instructions. Instead, it will be the purchaser's responsibility to provide a translation of the instructions, and in this case the instructions will need to be identified as not being the originals by the use of the words 'translation of the original instructions' on the front cover.
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Updated: 2021-10-12 16:26
What is the meaning of the phrase 'original instructions' in the Machinery Directive? We are a machinery manufacturer based in China so our 'original' instructions are always in Chinese. Do we have to provide a copy of these alongside copies in English and other European languages? Open
EHSR 1.7.4.1(a) requires the instructions to be drawn up in a European language and then translated into the language of the end user where this is different. The Commission Guide to the Machinery Directive makes it clear that any instructions drawn up and verified as accurate by the manufacturer are to be treated as 'original' so if the manufacturer produces instructions in English (or another European language) as well as those in Chinese, then only the copy in the European language needs to be provided as the 'original' version. It is not necessary for end users in Europe to be given a copy of the instructions in Chinese.
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Updated: 2021-10-12 16:20
I note from your website the following assertion; - "The Machinery Directive is mutually exclusive with the Voltage Directive, so that either one or the other will apply but never both. Annex 1 of the Machinery Directive contains requirements for electrical safety which precisely mirror those of the LVD, so the safety requirements of the two directives are identical, but the Declaration of Conformity will cite the Machinery Directive and not the LVD." Could you please provide the basis for this Open
The wording which provides for this is in the new Directive, EHSR 1.5.1 of Annex 1 of which states:
"The safety objectives set out in Directive 73/23/EEC shall apply to machinery. However, the obligations concerning conformity assessment and the placing on the market and/or putting into service of machinery with regard to electrical hazards are governed solely by this Directive."
This is also covered in §222 of the Machinery Directive guidance document and clarifies “This means that the Declaration of conformity for machinery subject to the Machinery Directive shall not refer to the LVD.”
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Updated: 2021-10-21 16:19
Are gears, chains etc. mounted on a machine and used to open a large vertically moving door considered to be 'lifting equipment' within the meaning of the Machinery Directive and LOLER? Open
If the mechanism which raises and lowers the doors is an integral part of the machine, dedicated solely to that function and cannot lift separate loads, it is not 'lifting equipment' within the meaning of the Machinery Directive or LOLER so the requirement for a regular thorough examination does not apply.
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Updated: 2021-10-12 16:10
I am looking to start importing machinery manufactured in China into the UK. The machines have the CE mark and are being manufactured with my company logo on them in China. Am I able to sell the products in the UK or do I need to re-apply for the CE mark and put it on myself? I am a bit confused as in some places in seems to state that anybody who sells the products in the UK is the legal manufacturer and needs to put the CE mark on themselves whilst in other places it says if the CE mark is app Open
If the CE Marking has been properly completed in China then you do not need to repeat everything here, but you do need to be aware that you will be responsible for whether or not the CE marking has been done properly, and you must also be able to deliver the Technical File for the machines if an enforcement authority asks for it. I'd recommend that you issue the Declaration of Conformity in your own name as well.
Many Chinese manufacturers take the process very seriously but others do not, or have been misinformed about what they are required to do, so although it is perfectly possible to obtain machines which meet all of the requirements without needing extra work, it can also be a nightmare. I would certainly recommend trying to get a copy of the manufacturer's technical file in order to confirm the job has been done properly.
Updated: 2021-10-12 16:03
I have a question about requirements for emergency switches used in machinery placed on market in EU. The machine complies to? MD by compliance with amongst others EN 60204-1:2006 and has a fully compliant emergency switch installed for the USERS easy activation during normal use. Now my question is I have nowhere seen a requirement that another emergency switch should be available for SERVICE personnel on say the back side or other place of the machine, as he/she might not have easy access duri Open
You need to refer to EN ISO 13850. Clause 4.3.1 states "The emergency stop device shall be designed to be easily actuated by the operator and others who could need to actuate it." In this context "the emergency stop device" should be taken to mean the complete e-stop system, not just a particular actuator.
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Updated: 2021-10-12 16:01
