IEC/TR 62685 Test requirements and EMC

IEC/TR 62685:2010 is NOT harmonized. The full title is Industrial communication networks – Profiles – Assessment guideline for safety devices using IEC 61784-3 functional safety communication profiles  (FSCPs).

IEC/TR 62685 was produced from the test requirements of the German BGIA document GS-ET-26 and covers the requirements of safety components within a safety function. It covers the issue of labeling and  EMC as well as mechanical and climatic tests. This closes some of the gaps left by EN ISO 13849-1 and EN 61784-3. Overall the document is more relevant to safety component manufacturers than plant and  machine builders. However, as the document contains a good comparison of EMC requirements, it may also  be of interest to machine builders.

Engineering Safety Standards

There is no intention at this point to provide a complete list of the European engineering safety standards. Over 600 standards are listed as harmonized under the Machinery Directive alone. The following section  addresses a selection of the general safety standards. They are explained in various degrees of detail,  depending on the significance of the individual standard.

Machinery Directive

98 /37/EC and its successor 2006/42/EC have special significance in terms of the functional safety of machinery. This directive, generally known as the “Machinery Directive”, is concerned with the standardization of European safety requirements on machinery.

Content:
The Machinery Directive covers the key aspects of machine safety. The contents of the Machinery Directive are as follows:

• Scope, placing on the market, freedom of movement
• Conformity assessment procedures
• CE marking
• Essential health and safety requirements
• Categories of machinery and the applicable conformity assessment procedures
• EC declaration of conformity and type-examination
• Requirements of notifi ed bodies

Validity:
The Machinery Directive 2006/42/EC replaced the previous version 98/37/EC with effect from 29.12.2009. There is no transition period.

Standards relating to the Machinery Directive:
At this point, it makes no sense to name all the standards that are listed under the Machinery Directive and are therefore considered as harmonized. As of Spring 2011, there were more than 700 standards listed directly. To then add all the standards that are relevant indirectly via the standards that are listed directly, would go far beyond the scope of this compendium. The following chapters will therefore concentrate on those standards for the Machinery Directive which are of general significance.

Standards, Directives and Laws: Directives

Of the almost 30 active directives now available, only a small selection is relevant to the typical machine builder. Some directives may have a very long or bureaucratic title in addition to the directive number (e.g. 2006/42/EC). Variations can be seen in the last part of the directive number. This will contain EC, EU, EG, EWG or some other abbreviation, depending on the language area and issue date. As a result it is generally very difficult to name the directive. These long titles are often abbreviated separately, even though this can  also lead to misunderstandings. Here is a list of some of the key directives with both their official title and  their usual, though unofficial, abbreviated title:

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The aim of the directives is to guarantee freedom of movement within the EU. The full texts of the directives http://eur-lex.europa.eu/de/legis/index.htm are available from the EU. Of all these directives, only the  Machinery Directive will be examined here in any further detail. However, the list of relevant standards will naturally refer to standards that relate to other directives.

Seven Steps to a CE Mark: Step 7, Affix the CE Marking

The CE mark may be affixed once the EC declaration of conformity has been issued.

It’s important that CE marking for the complete machine is clearly  distinguishable from any other CE markings, e.g. on components. To  avoid confusion with any other  markings, it is advisable to affix the CE marking for the complete machine to the machine type plate, which should also contain the name and address of the manufacturer.

Seven Steps to a CE Mark: Part Six, Issue the Declaration of Conformity

By issuing the EC declaration of conformity, the manufacturer declares that they have considered all the  directives that apply to the product. The person signing an EC declaration of conformity must be authorized to represent his company. This means that the signatory is legally entitled to execute a legal transaction, such as signing the EC declaration of conformity, on account of their job function.

When an authorized employee of the company adds their valid signature to an EC declaration of conformity, they trigger the liability of the natural responsible person and, if applicable, the company as a legal entity.

The declaration may also be signed by an authorized representative, who is established in the EU.

The new Machinery Directive requires the declaration to name the person authorized to compile the technical documentation. This person must be established in the EU.

The Seven Steps to a CE Mark: Step 5, Compile the Technical Documentation

In accordance with the Machinery Directive, technical documentation specifically comprises:

• An overall drawing of the machinery and drawings of the control circuits
• Full, detailed drawings (accompanied by any calculation notes, test results, etc.) required to check the conformity of the machinery with the essential health and safety requirements
• A list of the essential requirements of this directive, standards and other technical specifications used in the design of the machinery, a description of the protective measures implemented to eliminate hazards presented by the machinery (generally covered by the risk analysis)
• Technical reports or certificates; reports or test results showing conformity
• The machine’s operating instructions
• A general machine description
• Declaration of conformity or declaration of incorporation plus the assembly instructions
• Declarations of conformity for the machines or devices incorporated into the machinery

This documentation does not have to be permanently available in material form. However, it must be possible to assemble it and make it available within a period of time commensurate with its importance. It must be retained for at least ten years following the date of manufacture and be available to present to the relevant national authorities. In the case of series manufacture, that period shall start on the date that the last machine is produced.

The Seven Steps to a CE Mark: Step 4, Performing the Risk Assessment

The manufacturer is obliged to carry out a risk analysis to determine all the hazards associated with his machine. The result of this analysis must then be considered in the design and construction of that machine. The contents and scope of a hazard analysis are not specified in any directive, but EN ISO 12100 describes the general procedure.

All relevant hazards must be identified, based on the intended use – taking into consideration all the lifecycles once the machine is first made available on the market. All the various groups who come into contact with the machine, such as operating, cleaning or maintenance staff for example, are also considered.

The risk is assessed and evaluated for each hazard. Risk-reducing measures are established in accordance with the state of the art and in compliance with the standards. The residual risk is assessed at the same time: If it is too high, additional measures are required. This iterative process is continued until the necessary safety is achieved.

Seven Steps to a CE Mark: Step Three, Ensure That Safety Regulations Are Met

It is the responsibility of the machine manufacturer to comply with the essential health and safety requirements in accordance with Annex I of the Machinery Directive. The formulation of these requirements is relatively abstract, but specifics are provided through the EU standards.

The EU publishes lists of directives and the related harmonized standards. Application of these standards is voluntary, but compliance does provide presumption of conformity with the regulations. This can substantially reduce the amount of evidence required, and a lot less work is needed to incorporate the risk assessment.

Seven Steps to a CE Mark: Step Two, Check the Appplication of Additional Directives

Where machinery is also subject to other EU directives, which cover different aspects but also provide for the affixing of the CE mark, the provisions of these directives must be met before the CE mark is applied. If the machine contains electrical equipment, for example, it will often be subject to the Low Voltage Directive and, possibly, the EMC Directive too.

Seven Steps to a CE Mark: Step 1, Categorize the Product

Step 1: Categorize the product
The CE marking process starts by categorizing the product.

The following questions need to be answered:
• Is the product subject to the Machinery Directive?

Here it’s important to note that with the new Machinery Directive coming into force, some new products have been introduced (e.g. pressure vessels, steam boilers and funicular railways), while others have been omitted (e.g. electrical household and office equipment).

• Is the product listed in Annex IV of the Machinery Directive?

Annex IV of the Machinery Directive lists machinery that is  considered “particularly hazardous”, such as presses,  woodworking machinery, service lifts, etc. In this case, CE marking and the declaration of conformity must meet special requirements.

• Is the machine a subsystem or partly completed machinery?

Manufacturers issue an EC declaration of conformity for functional machines that meet the full scope of Annex I of the Machinery Directive. For subsystems, e.g. robots, which cannot yet meet the full scope of
Annex I, the manufacturer issues a manufacturer’s declaration in accordance with Annex II B.

The new Machinery Directive refers to subsystems as “partly completed machinery”. From the moment the new Machinery Directive becomes valid, all partly completed machinery must be accompanied by a declaration of incorporation in accordance with Annex II. At the same time, the manufacturer must perform a risk assessment and provide assembly instructions in accordance with Annex VI. Effectively the  manufacturer’s declaration or declaration of incorporation bans the subsystem from being put into service, as the machine is incomplete and as such may not be used on its own.

• Is it a safety component?

Under the old Machinery Directive, safety components are treated separately and are not awarded a CE mark, although it is necessary to produce a declaration of conformity. Under the new Directive they will be treated as machinery and will therefore be given a CE mark.

Potential assessment procedures in accordance with the new Machinery Directive.

Machinery for own use

CE certification for individual machines and the overall plant.

The Machinery Directive also obliges users who manufacture machinery for their own use to comply with the Directive. Although there are no problems in terms of free trade - after all, the machine is not to be traded - the Machinery Directive is applied to guarantee that the safety level of the new machine matches that of other machines available on the market.

Importing a machine from a country outside the EU

When a machine is imported from a third country for use within the EU, that machine must comply with the Machinery Directive when it is made available on the EU market.Anyone who places a machine on the market for the first time within the European Economic Area must have the necessary documentation to establish conformity, or have access to such documentation. This applies whether you are dealing with an  “old machine” or new machinery.

CE Marking of Plant and Machinery

According to the Machinery Directive, a machine manufacturer is anyone who assembles machines or  machine parts of various origins and places them on the market.

A manufacturer may be the actual machine builder or – where a machine is modified – the operator. In the case of assembled machinery, it may be the manufacturer, an assembler, the project manager, an engineering company or the operator himself, who assembles a new installation from various machines, so that the different machine parts constitute a new machine.

However, according to the Machinery Directive, only one manufacturer is responsible for the design and manufacture of the machine. This manufacturer or his authorized representative takes responsibility for implementing the administrative procedures for the entire plant. The manufacturer may appoint an authorized representative, who must be established in the EU, to assume responsibility for the necessary procedures for placing the product on the market:

• Compiling the plant’s technical documentation
• Complying with the technical annex
• Providing operating instructions for the plant
• Affixing the CE mark in a suitable position on the plant and drawing up a declaration of conformity for the  entire plant

It’s important that the manufacturer considers the safety aspect early, as the contracts are being formulated or in the components’ requirement manual. The documentation shall not be compiled solely from the point of view of machine performance. The manufacturer is responsible for the whole of the technical documentation and must determine the part that each of his suppliers is to undertake in this process.

Use of machinery in the European Economic Area
Irrespective of the place and date of manufacture, all machinery used in the European Economic Area for the fi rst time from 01.01.1995 is subject to the EU Machinery Directive and as such must be CE certified.

Assembled machinery
On large production lines a machine may often consist of several individual machines assembled together. Even if each of these bears its own CE mark, the overall plant must still undergo a CE certification process.

CE Marking of Machinery: What is a machine?

For the purposes of the Directive, one definition of a machine is:

An assembly of linked parts or components, at least one of which moves, and which are joined together for a specific application. (see Article 2 of the Machinery Directive)

Example of a machine for the purposes of the Directive.

 

The following are also considered as machines for the purposes of the Machinery Directive:

• An assembly of machines or complex plants (complex plants include production lines and special purpose machinery made up of several machines)
• Safety components (The issue of which components to classify as safety components is very controversial. As yet there is no discernible, uniform trend.)
• Interchangeable equipment that can modify the basic functions of a machine.

There is also a list of exceptions where machinery falls under the scope of the Directive by definition, but for which other statutory provisions generally apply.

Legal Principles of the CE Mark and the Machinery Directive

The obligation to affix CE marking extends to all products which fall under the scope of directives providing for such marking and which are destined for the single market. CE marking should therefore be affixed to the following products that fall under the scope of a directive:

• All new products, irrespective of whether they were manufactured in member states or third-party  countries
• Used products imported from third-party countries and second hand products
• Products that have been substantially modified and fall under the scope of the directives as new products.

The directives may exclude certain products from CE marking.

The manufacturer uses the declaration of conformity to confirm that his product meets the requirements of the relevant directive(s).

The information that follows is intended to explain CE marking in terms of the Machinery Directive.

The Basis of Machine Safety: Machinery Directive and CE mark

When the Machinery Directive (MD) was ratified in 1993, the aim was to remove trade barriers and enable a free internal market within Europe. After a two-year transition period, the Machinery Directive has been binding in Europe since 01.01.1995. It describes standardized health and safety requirements for interaction between man and machine and replaces the host of individual state regulations that existed on machinery safety. The new Machinery Directive 2006/42/EC has applied since 29.12.2009.

The CE mark stands for “Communauté Européenne”. A manufacturer uses this mark to document the fact that he has considered all the European internal market directives that are relevant to his product and applied all the appropriate conformity assessment procedures. Products that carry the CE mark may be imported and sold without considering national regulations. That’s why the CE mark is also referred to as the “Passport to Europe”.

Generally speaking, all directives in accordance with the new concept (“new approach”) provide for CE marking. Where a product falls under the scope of several directives which provide for CE marking, the marking indicates that the product is assumed to conform with the provisions of all these directives.

Standards, directives and laws in the European Union (EU)

Relationship between harmonized standards and laws in the EU.

 The European Union is increasingly merging. Machine builders will recognize this in the increasing  harmonization of laws, regulations and provisions. Not that long ago, each country published its own guidelines on the different areas of daily life and the economy, but today you’ll find more and more standardized regulations within Europe.

How are European laws, directives and standards connected?

Initially, the EU formulates general safety objectives via directives. These safety objectives need to be specified more precisely; the actual provision is made via standards.

EU directives generally deal with specific issues. The directives themselves have no direct impact on individual citizens or companies. They only come into effect through the agreements of individual countries within the EU, who incorporate these directives into their domestic law. In each EU country, a law or provision refers to the relevant EU directive and thus elevates it to the status of domestic law. Between the time a directive is adopted and the point at which it is incorporated into domestic law there is inevitably a transition period, during which time the directive awaits incorporation into domestic law in the individual  countries. However, for users this is generally unimportant because the directives themselves provide clear indication on the respective validity date. So although the titles of these documents describe them almost harmlessly as directives, in practice they have legal status within the EU.

This explains how laws and directives are connected, but doesn’t deal with the issue of the standards.

Although the standards themselves make interesting reading, on their own they have no direct legal relevance until they are published in the Official Journal of the EU or are referenced in domestic laws and provisions. These are the publications by which a standard can acquire “presumption of conformity”. Presumption of conformity means that a manufacturer can assume he has met the requirements of the corresponding directive provided he has complied with the specifications in the standard. So presumption of conformity confirms proper conduct, as it were. In a formal, legal context this is called a reversal of the burden of proof. Where the manufacturer applies a harmonized standard, if there is any doubt, misconduct will need to be proven. Where the manufacturer has not applied a harmonized standard, he will need to prove that he has acted in compliance with the directives.

If a manufacturer does not comply with a standard, it does not necessarily mean that he has acted incorrectly. Particularly in innovative industries, relevant standards either may not exist or may be inadequate. The manufacturer must then demonstrate independently that he has taken the necessary care to comply with the safety objectives of the relevant directives. Such a route is usually more complex but, in an innovative industry, it is often unavoidable.

It’s important to stress that the EU does not publish every standard in the Official Journal, so many are still not harmonized. Even if such a standard is deemed to have considerable technical relevance, it will still not have presumption of conformity. However, sometimes a standard that has not been listed in the EU Official Journal does achieve a status that’s comparable with harmonization. This is the case, for example, when a harmonized standard makes reference to the respective standard. The standard that is not listed in the EU Official Journal is then harmonized “through the back door”, as it were.

Product Liability and Protective Laws

In addition to the broad text of the general clausein § 823 para. 1 of the German Civil Code (BGB), liability  to pay compensation may also arise in accordance with § 823 para. 2:

§ 823 para. 2 of the German Civil Code (BGB) “The same liability (meaning liability to pay compensation) is held by anyone who breaks a law that is intended to protect another person.”

In this case, the activity that violates the protected right violates a “protective law”: Protective law means that the respective legal provision is (also) intended to protect the individual through some other body of legislation and therefore, in the event of damage, violation of the law itself already establishes liability for compensation.

In terms of the liability risks from violating a protective law, special laws that determine safety requirements for certain product groups have a role to play. The most important of these is the law covering technical work equipment and consumer products (Equipment and Product Safety Act/GPSG), as it covers a wide range of products: Hair dryers, kettles and skid loaders fall under its scope just as much as respiratory equipment and complex machinery. As various EC CE marking directives have also been “reflected” nationally via the GPSG and its subordinate ordinances (incl. the low voltage, ATEX, machinery, toys, pressure equipment, recreational craft, lifts, gas appliances directives), failure to comply with the safety specifications contained in the CE regulations can lead to unexpected liability risks. Further CE directives
have been implemented via separate legislation, which can also be combined with § 823 para. 2 of the German Civil Code (BGB) in the event of damage (e.g. EMC Act/EMVG, Medical Product Act/ MPG, Radio and Telecommunications Terminal Equipment Act/FTEG).

So, if an unsafe product is put into circulation, liability may arise due to violation of this type of technical safety regulation – in addition to liability under the Product Liability Act and § 823 para. 1 of the German Civil Code (BGB).

 

Hazard prevention measure, warning, retrofit, recall

If after-sales product monitoring establishes that a product which has been put into circulation fails to meet safety expectations, the producer should check whether a hazard prevention measure is indicated with regard to the respective product, in order to avoid liability risks. In the context of this Safety Compendium, this includes any measures to prevent, remove or reduce hazards emanating from products that have already been put into circulation (e.g. warnings, new operating instructions, safety uploads, on-site retrofits or factory recalls).

Prerequisites for hazard prevention measure
There is no general answer to the question as to when such a hazard prevention measure must be implemented. It depends on the circumstances of the individual case, taking into consideration the extent of the threatened damage and the likelihood of its occurrence. Expressed in economic terminology, the “expected loss value” is decisive, i.e. the product resulting from the extent of loss and the probability of occurrence. The producer must therefore analyze:

1. How high is the probability of the damage occurring:
Are individual batches affected or does the defect apply to the whole series? Does the damage occur when the product is applied in accordance with its intended use or only in cases of foreseeable misuse? Does it need an accumulation of multiple random behavior modes? Does the damage only occur after an extended period of use? Do the operating instructions contain a warning against this behavior?

2. What is the threatened damage: 
 Assuming that the product defect results in damage, what is to be expected? Simply material damage or minor, even serious personal injury?

Purely economic reasons (i.e. high recall costs or loss of image) are not an argument for rejecting the implementation of a hazard prevention measure, particularly when significant protected rights are at stake.

Provided the damage occurred in conjunction with the use of the product, it is irrelevant whether it’s already been possible to establish the actual cause of the damage in detail. So it is not acceptable to wait until an established engineering process has been followed concerning the cause of the damage. However, the producer will of course have the opportunity to check whether a product defect is actually present before introducing any measures. So there is no need for any knee-jerk reactions.

If the producer receives notification of damage, during product monitoring for example, he can first of all initiate some checks to verify whether the reported damage (e.g. a fragile glass part) can actually be attributed to a product defect or is purely down to transport damage or damage resulting from improper use. If it is established that a product defect is responsible for the damage, the producer must launch countermeasures, even if it has not yet been established whether the defect occurred during the temperature setting, for example, or in some other area of the glass blowing process.

Internal company risk prevention
It makes sense to set up an internal recall management procedure which, in case of an emergency, will enable a fast, efficient reaction to any product hazards that arise. Taking out recall insurance is another factor to consider.