European Harmonised Standard

The manufacturer may self-certify that the product complies with an appropriate European harmonised standard. There is a significant number of standards that can be used the main generic ones are ... 

Having carried out an area classification exercise, the electrical equipment to be installed in the area must then be selected for its explosion protection properties. There is a range of options to choose from, with a variety of protection techniques employed. Each of the techniques, bar one, is described in detail in a European harmonised standard and is allocated a designation letter, mainly for ease of labelling. The following text summarises each of the techniques, and identifies its letter designation and appropriate construction standard. 

Harmonised standards are technical specifications adopted by one of the European standards organisations following a mandate issued by the European Commission on which Member States were consulted. When published by the Commission in the Official Journal of the European Communities, the hamionised standards give presumption of confomiity to the essential requirements they specify. This means that manufacturers applying these standards do not have to demonstrate the compliance of the manufactured products with the relevant requirements of the directive. 

A section related to materials sets out, apart from general requirements, that compliance with the material specifications of the directive can be achieved in one of the following forms by using materials which comply to harmonised standards, by using materials covered by a European approval of materials, a subject which will be explained further on, and by a particular material appraisal carried out by the notified body. 

The European Commission has mandated CEN/CENELEC to develop many standards to support manufacturers in the realisation of the essential requirements of the Directives. If the Commission determines that an adopted standard is fit for this purpose, then a reference is published in the Official Journal of the EU, which elevates the status of the standard to that of a harmonised standard for European regulatory purposes. 

European Communities are presumed by Member States to comply with those aspects of the essential requirements that are covered by the standard. Harmonised standards are those adopted by the EC standards bodies pursuant to a mandate issued by the Commission, in this case the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (CENELEC). A large number of standards are contemplated but may take time to be written and adopted. Standards may be horizontal (covering aspects common to all or a number of product types) or vertical (dealing only with a specific aspect or specific product type). Important harmonised standards exist on the following ... 

To support the PED, many European (EN) standards are now harmonised with the PED. The PED has been introduced as the pressure vessel code in each and every country of the European Union. Likewise, the new EN standards have been introduced and they replace all the local standards. For example, the standard for safety valves, EN 4126, is now the German standard DIN EN 4126, or the French standard NF EN 4126, etc... This harmonised standard has an annex (called Annex ZA ) that lists the paragraphs which address the requirements of the PED. By following these harmonised standards, one is sure therefore to comply with the PED clauses supported by the paragraphs listed in the Annex ZA. (However, we may need to follow several harmonised standards to cover all the possibilities )... 

European harmonisation of the environmental exhaust emission legislation is a basic demand from industry - to improve the general quality standard, through less complexity and thus fewer line disturbances, and to avoid distortion of competition and trade between the European countries and to create - through excellence and economy of scale - the best possible product for the best possible price. 

European Commission. Commission Decision 2005/34/EC of 11 January 2005 laying down harmonised standards... 

At this point it is worth mentioning how the ALARP approach to risk acceptability changes markedly when it comes to medical devices. For example. International Standard ISO 14971 [10] affords manufacturers the ability to justify risks on an ALARP basis. The European Commission Medical Device Directive (MDD) [11] cites ISO 14971 as a Harmonised Standard however the directive contains a number of Essential Requirements on risk acceptability which appear to conflict with ISO 14971. 

ISO 14971 has been adopted by the European Committee for Standardization as EN ISO 14971 2012 [6]. Importantly it is one of the harmonised standards which manufacturers are obliged to comply with if they wish to certify their product as a CE Marked medical device (including in vitro diagnostic devices). Similarly in the US, the 21 code of federal regulations requires risk management to be undertaken as part of design validation (820.30 (g)). ISO 14971 is a Recognised Consensus Standard which the FDA expects manufacturers to comply with to meet this requirement. 

European Harmonisation document HD 22.9, from CENELEC, is specified in British Standard BS7211 and calls for low smoke, zero halogen materials that maintain the levels of flame retardancy, cost and processing speed experienced with PVC, while reducing the potential risk of combustion products. 

A harmonised standard is a standard adopted by one of the European standardisation bodies listed in Annex 1 to Directive 98/34/EC (EC 1998), as follows ... 

Harmonised standards, known as European Norms (EN), provide solutions that enable compliance with the essential requirements of New Approach, or other relevant, Directives. They provide a presumption of conformity but for this to apply the standard must have been published in the Official Journal of the European Union (OJEU). Standards are produced by the European Standards Organisation for a technical sector, e.g. electrical and machinery, and published by national standards bodies, e.g. British Standards Institute (BSI), DIN in Germany, NF in France. 

From time-to time the European Commission publishes in the OJEU the titles and references of harmonised standards issued. Generally, the publication provides ... 

A list of harmonised standards and/or other relevant technical specifications, the references of which have been published in the Official Journal of the European Union, applied in full or in part, and the descriptions of the solutions adopted to meet the essential requirements of the legislative instruments where those harmonised standards have not been apphed. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied... 

In the UK, standards are developed by tire British Standards Institution which remains the national standards making body but, witir membership of the EU, procedures for making standards changed. In 1983 the Commission reached agreement witir the two European standards making bodies that conformity with harmonised standards would be accepted as evidence of conformity with the directives. These two bodies, CEN and CENELEC, are sponsored by the Commission but act independently. 

Subjects for an EN standard are determined from a perceived need or by a proposal from a Member State that is considered to be of benefit to the EU as a whole. Where a Member State has a standard which they consider could beneficially apply across tire EU they can submit it as the basis for an EN standard. BS 5304 Safety of machinery was put forward and accepted on this basis. In the event, rather than keeping it as a comprehensive standard on the guarding of machinery, it has been split into component subjects each of which has become a separate harmonised standard. With the adoption of these EN standards, BS 5304 has had to be withdrawn as a British Standard and declared obsolete. However, because it is so comprehensive, well imderstood and widely used, it has been reissued in a revised form - as a Tublished Document PD 5304. This document does not have the status of a standard but does offer advice on basic principles of safeguarding for machinery. It contains an extensive cross-reference to European Standards, conformity with which is necessary for compliance with PUWER 98. 

The Machinery Directive was drawn up using the new approach to legislative harmonisation whereby the main body of the directive itself lays down broad objectives to be achieved, lists in annexes the areas to which safety attention should be directed and relies on European harmonised (EN) standards to specify the conditions to give conformity. 

The general principles of guarding are contained in BS EN ISO 14120 and a number of harmonised European (EN) standards. Other publications are available that give advice on the safety and care of site plant and equipment. 

The basic requirements of the directive are concretised by harmonised European standards. A list of the valid harmonised standards is regularly updated and published by the European Commission in the official journal of the EU. The relevant standards for non-electrical equipment (e.g. vacuum pumps) which define the requirements of the directive are, for example the EN 1127-1 [23], the series EN 13 463 [6-24] and ENISO 16852 [21]. 

Unfortunately the extruders at that time experienced difficulties in meeting the mixing requirements of the applicable standards. Those standards have since been incorporated into current European harmonised versions [2-4] in which the carbon black dispersion requirements are essentially the same. 

Complying with national and European conformity standards in existence at the particular time. (This requirement does not apply to PPE obtained before the harmonising Regulations came into force, which can continue to be used v/ithout European Conformity marks, but the employer must ensure that the equipment he/she provides remains suitable for the purpose to which it is put)... 

The EU Machinery directives define goal-oriented safety requirements to machinery (European Council, 1989/98). Machinery manufacturers have to carry out risk assessments to document that they meet these requirements. Documentation on risk assessments has to be available before the manufacturer can issue a Declaration of Conformity and mark the machinery with the CE sign. The harmonised standards EN 292 and EN 1050 describe the basic requirements for the risk assessments (CEN, 1991 CEN, 1996),... 

Medical Device Directive 98/79/EC (1998) In vitro diagnostic medical devices. http //ec. europa.eu/growth/single-markel/european-standards/harmonised-standards/iv-diagnostic-medi cal-devices/index en.htm... 

From 1985 three major changes have been introduced to do away with the disadvantages encountered with the old approach . In 1985 the European Council adopted a New Approach to technical harmonisation and standards , in 1989 it adopted the Global Approach to conformity assessment which was amended in 1993 and in 1987 the legal basis for... 

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