Harmonised standards

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. 

Two main types of harmonised standards can be distinguished the product standards and the horizontal standards. The latter, as their denomination indicates, contain issues of a horizontal nature, e.g. for materials or provisions relating to welding or welder approvals. These standards should be formulated in such a way as to be self-sufficient. That means it should be possible to apply them without having to use individual product standards. 

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. 

Finally, under the heading Specific pressure equipment requirements specific requirements are set out for equipment with a risk of overheating, for piping and, last but not least, specific quantitative requirements which set out a series of safety factors for certain pressure equipment. These latter provisions apply as a general rule which means that a manufacturer or a harmonised standard may deviate from these factors if it can be demonstrated that appropriate measures have been taken to achieve an equivalent level of safety. 

Although the directives allow flexibility in the methods and solutions that a manufacturer may employ to fulfil the essential requirements, they promote the use of standards as the preferred method to establish conformity. Specifically, the directives stipulate that Member States shall presume compliance with the essential requirements in respect of devices that are in conformity with relevant harmonised standards. 

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. 

The results of the risk analysis and a list of harmonised standards applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the harmonised standards have not been applied... 

Product QA is the process whereby the manufacturer applies to a Notified Body to have his/her quality system for final inspection audited and certified. EN 46003 may be used as the harmonised standard for this model. 

Table 10.3 Harmonised standards for labelling of medical devices.

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 ... 

Section 2 above implies that a manufacturer must carry out a risk analysis. A harmonised standard is available on this topic, EN 14 971, which amplifies the methodology for risk analysis, elimination or reduction required by section 2. 

Where appropriate, this information should take the form of s)nnbols. Any symbol or identification colour used must conform to the harmonised standards. In areas for which no standards exist, the s)nnbols and colours must be described in the documentation supplied with the device. 

Although much work needs to be done in developing organic regulatory structures at an international level that are truly sensitive to the needs of producers and the local realities that they face, a harmonised standards architecture based on general baseline standards upon which local or regional standards can be fleshed out, along with an allowance for justified variations, offer useful models and tools that can be built upon. 

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 )... 

It is always important to remember that these harmonised standards remain standards they are not compulsory. Only because they support the PED, they give useful guidelines to comply with the PED. 

In 1992 IFOAM established the IFOAM Accreditation Programme to provide a means of harmonising standards and certification worldwide. The programme offered independent evaluation of inspection bodies against the Basic Standards and the developed IFOAM criteria of organic certification programmes. In 1997 they licensed the International Organic Accreditation Service to perform this function. 

EC Commission Decision 2005/34/EC of 11 January 2005 laying down harmonised standards for the testing for certain residues in products of animal origin imported from third countries, Ojf. J. Eur. Commun. 2005 L16 61-63. 

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. 

Currently, attempts are being made to harmonise standards, with the constmction industry farthest along the route to finalise such procedures. Examples of standards are shown in Table 2.1. 

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 ... 

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