This page is intended to provide a background explanation of the way in which standards are developed and used under the New Approach Directives. It does not contain lists of standards harmonised under specific directives - these may be found on the European Commission's DGIII web site.

The European Telecommunications Standardisation Institute (ETSI) do have a web site from which standards may be freely downloaded. Otherwise, harmonised standards are only available in printed form at present, although the British Standards Institute (BSI) do offer a downloadable electronic service for people prepared to subscribe to 'modules' of standards. Each module contains about a hundred standards and the basic price is around £1000 (US$1500) per module.

Somes standards are available on-line from the ISO and IEC. These web sites will take credit card payment and standards can be downloaded individually as required. However, note that the IEC and ISO implementations are often different from the harmonised standards issued by CEN and CENELEC. If you need a standard to give you the definitive requirements for CE Marking, there is currently no alternative to buying the hard copy from one of the national members of CEN and CENELEC. Links to these can be found on our links page.
If you need English language versions of the documents the best place to get them from is BSI who will take credit card orders for hard copy standards over the phone. Their sales partner, Technical Indexes also have an on-line catalogue where you can search for and order standards.

Introduction

Increasing Europe-wide integration of the markets for many types of product has led to a drive by all participating states in the European trading block to remove actual and perceived trade barriers wherever possible. Many types of electrical, mechanical, medical and other products may now be manufactured in one country within the European Union and sold without modification in any other. Product safety legislation has been harmonised throughout the EU to ensure that less stringent requirements in one part of the community cannot provide a back door for unsafe products to reach another, and that over-stringent requirements in some countries cannot be used to prevent the sale of perfectly safe products in others. Products which comply with the new legislation are marked with the CE logo to indicate to enforcement authorities that the manufacturer claims compliance with the local and international laws, and in many cases it is now illegal to sell products which are not CE marked whether for sale at home or abroad.

The following discussion describes the situation with electrical products but is broadly applicable to all other product areas affected by the CE marking directives. Electrical/electronic goods represent the market sector most comprehensively covered by current legislation and standards and so provide a good model for the shape of things to come in the field of mechanical goods, medical appliances, personal protective equipment, gas appliances and all the other market sectors affected by CE marking. Principal differences are that the directives covering some market sectors (personal protective equipment and gas appliances, for instance) do require mandatory independent assessment of product safety whereas this is not generally required for electrical products.

Product safety legislation

There are three aspects to the acceptance of a product as being safe in any particular market. The first of these are the legal obligations of a manufacturer or supplier not to supply a product which could cause damage or injury. In the UK these are embodied in the Low Voltage Electrical Equipment (Safety) Regulations 1994 and it is a criminal offence to supply any equipment which contravenes these Regulations. The Regulations enforce both domestic requirements for product safety and also European Directives - in this case the main one being the Low Voltage Directive. Similar legislation exists in all other countries within the EU.

Product standards

Clearly it is not the job of legislators to lay down detailed requirements for the design of every type of product on the market so a wide range of standards have been developed to support the Directives which enforce the CE mark requirements. These are the second aspect of product safety. It is these standards which contain the details of safe product design and they may include specifications for insulation strength, material compatibility, limits of rise in temperature and many other safety related specifications.

New standards are developed on a Europe-wide basis under the control of CENELEC (which deals with all electrical related standards) or CEN (which deals with everything else). For some specialist areas, actual production of the standards is delegated to other bodies with appropriate European membership: standards for telecommunications are developed by the European Telecommunications Standards Institute (ETSI) and standards for iron and steel products are handled by the European Committee for Iron and Steel Standardisation (ECISS).

The procedure starts with the establishment of a Europe wide with representatives from each country. A draft standard is produced, often based on an existing standard from one of the participating countries. The work is done is one of the three main languages of the Community (English, French and German). As various stages of the process are completed, translations are made into the other two languages so that the draft standard may be published for public comment or for technical consultation. When the standard is completed and agreed (under a weighted majority voting system) its number and title are published in the Official Journal of the European Community (the ‘OJ’) and only then can it be used officially. Such harmonized standards are known as Euronorms or Common Technical Regulations (in the case of telecommunication standards from ETSI).

Type Tests

These standards are laid out with the intention of providing a format for type testing the appliances to which they apply. They may be used by manufacturers during the design of their products but are principally aimed at providing an independent third party with a benchmark against which products can be assessed comprehensively and fairly. In the UK the best known of such type tests are probably the ones which consumers would recognise as the BSi Kite mark and the BEAB approval mark. Examples from overseas are TÜV’s GS mark or the UL mark in the USA. There are, however, many other test houses who perform type tests and whose results are recognised both nationally and internationally.

The international application of standards

One of the effects of the drive to produce standards for the CE mark directives has been an almost total halt to national standards writing activities and all electrical products are nowadays tested to international standards which are technically equivalent in France, Germany, Scandinavia, Italy and the rest of Europe. In order to make this system work, the participating countries have also had to devise schemes of accreditation to ensure that test house results obtained in one country are acceptable in another, and so a Europe wide system of accreditation for such test authorities has been developed. Test houses recognised by the national scheme for their respective country are ‘notified’ to the European Commission and all governments within the EU are bound to accept their test results.

Because the test criteria are identical in each country, there are several schemes which allow test results to be transferred from one country to another. Thus a series of test results obtained by BSi may be presented to VDE who will, on payment of the appropriate fee, permit their own type approval mark to be placed on the product without actually performing any testing themselves. Apart from the ‘CB’ and ‘CCA’ test schemes which are used by many of the ‘national’ testing bodies, other test houses may enter into agreements with counterparts in other countries so as to recognise each other’s test result. Examples are Rowland and AMTAC in the UK who have arrangements with branches of TÜV in Germany, and BSi Testing whose laboratory in Hemel Hempstead (England) is recognised by the Canadian Standards Authority (CSA) .

Beyond Europe there are wider ranging agreements falling into place. Australia and New Zealand recently entered into an agreement which will involve bringing their two standards writing bodies closer together, and an agreement between the UK’s test house accreditation service (UKAS) and their Australian equivalent (NATA) now allows products for sale in Australia (where type testing is mandatory on a much wider ranger of products than in Europe) to be tested in the UK.

Special national conditions

Not surprisingly, the actual implementation of this dream of uniformity across the European Union is not without a few problems. Common causes are the different languages in each state and technical differences such as different styles of house wiring and electrical sockets. Often these differences have the force of law behind them - the BS1362 style 13A plug is recognised in UK law as being the only one generally suitable for use in the UK and approved plugs of this type must be fitted to all appliances sold. However, this style of plug is unknown in mainland Europe so manufacturers must produce slightly different versions of their products for the different parts of the EU although each may carry a valid CE mark.

One way of coping with the national differences is to make them disappear by what amounts to legal sophistry. For instance, the UK domestic line voltage has for many years been 240VAC 50Hz +/- 6%. However, the rest of Europe has operated on 220 or 230V nominal line voltage. The way the UK has coped with this is to change our nominal limits to 230V +10%/-6% although there has been no actual change in the supply to peoples homes, nor is there currently a timetable for any such change.

The standards cope with these differences with what are known as special national conditions, which are areas of deviation from the harmonised standard which are necessary because of local regulations. It is important to realise, therefore, that a product type tested in one country may actually be slightly different from the type tested sample if it is sold in another country where different conditions apply even though the manufacturer fixes the CE mark to both versions and uses only one type test to justify so doing. This is perfectly legal. It is undeniable that morally manufacturers should make these differences clear to their customers but few actually do.

Legal status of the type test

It is important to understand that for most products independent testing to the standard(s) is not mandatory and, except in a few special circumstances, it is perfectly legal to place a product on the market without a third party approval. What the third party approval does is provide an independent assessment of the quality of a product, allowing potential purchasers to be confident that an impartial expert has examined the product and found it safe. For manufacturers and distributors selling products into large customers such as retail chains, third party approval is often a contractual condition of supply, and it is commonly also a requirement for product liability insurance to be valid. Thus while the type test is not a legal requirement, it is often a market requirement.

Requirement for manufacturing to applicable standards

The other side to this coin is that it is perfectly possible for a product to be safe (and therefore it is legal to sell it) without an independent approval. Indeed, there may be instances when a product actually contravenes aspects of a safety standard but is still safe and legal for sale. This may be due to innovations which were not taken into account when the standard was written, or it may be because the standard is couched only in general terms and the specifics of the design of the product make compliance in certain areas impossible.

In these cases it is important to realise the role which type test standards play in demonstrating what is considered to be good practice in the design of a product. Non compliance with a relevant standard will very likely be used as evidence that a product contravenes the legal obligation to make a product safe and if injury or damage results from the use of a product the fact of non-compliance will be used as evidence that the law was broken. Conversely, complete compliance with a standard offers a very good defence that the product was indeed safe, but as the British Standards Institute states in the preamble to all its type test standards “compliance with a British Standard does not of itself confer immunity from legal obligations”.

Manufacturers who do not comply fully with the appropriate standards for their products should be aware of the risk they are running. If they do find themselves in front of a court having to justify why it is that they did not comply fully, they will need to be able to demonstrate that the steps they took were at least as good as, if not better than, the requirements of the standard. Documentation, dating back to the time that the product design decisions were made, will be absolutely vital.

Quality management systems

The third aspect of safety assessment is the manufacturers’ quality assurance procedure. Clearly it is no use having a product type tested if the production versions vary significantly from the type tested sample, so most product safety directives lay down a general requirement for the manufacturer to take steps to control ‘series production’. Where safety is a critical factor, the means the manufacturer uses to control their production must also be independently assessed. This is the purpose of the well known quality management standards in the ISO9000 series (formerly known in the UK as BS5750).

In some cases, full accreditation to ISO9000 may not be required and 100% or sample batch testing may be used as an alternative, but in all cases the manufacturer must be in control of their process. The difficulty of proving this without adequate records and documents is obvious. In other cases, even though an approved quality management system is not legally required, it is a requirement of product approval by an independent test house. A case in point is the BSi Kite mark which not only requires full compliance with the type test standard but also requires ISO9000 compatible procedures to be followed by the manufacturer.

Deciding which standards to use

Strictly speaking, standards may only be used to support CE marking on a product if they are harmonised and their number and title has been published in the Official Journal of the European Communities. In practice, manufacturers often cannot afford to wait for standards to be published before they have to ship product so with assistance from companies like Conformance it is possible to create a set of criteria which closely match those which will eventually appear in the relevant standard(s) and which can be used to assess whether or not the product can be CE marked.

Finding out which standards have been published is not always straightforward, since sometimes the title of the standard does not make it obvious that it applies to a particular product. For instance, EN953 which is concerned with the safety of machine guards applies to almost all machinery, but if a search is done which looks for standards whose titles contain the name of a particular type of machinery this standard might not be found.

The British Standards Institute have an on-line catalogue of standards complete with prices. This is, in effect, a comprehensive list of all the English language versions of published Euronorms. Also very useful is the European Commission's list of harmonised standards which is categorised by the Directives under which they are harmonised.

Obtaining standards

People often ask where standards can be obtained - in particular they look for web-sites where standards can be downloaded off the internet or WWW. While there is some small amount of standards related information in the Web, unfortunately little is available for free. The process of writing standards is extremely expensive, and since few (if any) standards bodies are subsidised by their government to any great degree, it is necessary for them to recoup the costs of standards making in the prices of the standards they sell.

Buying a standard is one way in which a company or individual can contribute towards the making of new standards. All standards are copyright, and if you copy them illegally for free, you are not avoiding making a publisher or author richer, you are freeloading on the work of more responsible members of society who are prepared to face the real costs of their activities.

Some sites on the Web do allow standards to be downloaded with payment made by credit card. Unfortunately, few of the harmonized European standards are available in electronic format so it will normally be necessary to get these in conventional printed format. BSi are looking at delivery of standards by electronic means, but this is unlikely to be available to any great degree for some years.

Further information

For further information and details of the standards which affect your products, please contact us at Conformance and we will be pleased to assist you.

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