European standards compliance with

Of the 5,(KK) EN standards issued, over 600 have been published in the OJEC as of this writing, with many more to come. Since most ENs are based on lEC standards, compliance with the EN standards also ensures conformity with equivalent lEC standards. The world is following Europe s lead, and most countries have, or eventually will have, accepted the European standards or the lEC equivalents. Therefore, meeting the European standards will also help manufacturers to comply with the technical standards worldwide. 

Electrical components and devices shall be suitable for their intended use, e.g., industrial (heavy, light), commercial, leisure, domestic, and shall comply with the relevant European Standards [EN] where such exist. In absence of European Standards, compliance shall be to available International Standards [lEC]. (4.2)... 

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 With the adoption of these EN standards, BS 5304 has had to be withdrawn as a British Standard and declared obsolete.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. 

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. 

All cable references contained in this text are based upon cable specifications in Germany as required by DIN (Deutsche Industrie Normen). We are aware that these specifications may or may not be applicable to the reader s specific requirements, and we therefore recommend the reader consult local standards and codes to ensure compliance with the necessary local codes. Some of the cables are defined in a list of American and European electrical cable sizes located in the front of this book. 

Member States shall take all measures necessary to ensure that the laboratories referred to in Article 7 of Directive 89/397/EEC1 comply with the general criteria for the operation of testing laboratories laid down in European standard EN 450013 supplemented by Standard Operating Procedures and the random audit of their compliance by quality assurance personnel, in accordance with the OECD principles Nos. 2 and 7 of good laboratory practice as set out in Section II of Annex 2 of the Decision of the Council of the OECD of 12 Mar 1981 concerning the mutual acceptance of data in the assessment of chemicals.4... 

Beyond perfonnance optimization, issues relative to packaging and the need for compliance with certain safety and electronics regulatory codes are cited as reasons for a customized solution. In the latter case, a systems approach is required, especially when attempting to meet the code or performance requirements for compliance with European Certification (CE) mark or electrical and fire safety codes such as National Eire Prevention Association (NFPA) and CENELEC (European Committee for Electrotechiucal Standardization). Off-the-shelf electronics may provide the necessary performance characteristics for generic applications, and their use eliminates large expenses related to product development, plus the associated time delays. Photonics-related components are solely addressed in this section because they are used to customize instruments for application-specific systems. 

Injection-molded specimen 4 mm, barrier values 100 pm blown films [3] Measured using standard test method ASTM D 3985 Compliance with European Commission Directive 2002/72/EC Compliance with European Standard EN 13432... 

The international standard ISO 9003 1994 was established by Technical Committee ISO/TC 178, and is based on British standard 5750 1987 series, European standard EN 29000 1987 series, and international standards ISO 9000 1987 series. The standard was adopted by the company to provide objective evidence that the company s operations of final product inspection and testing are in compliance with the requirement of this standard. However, this third edition canceled and replaced the second edition (ISO 9003 1994). The quality manual QM-4 is revised in accordance with the corresponding changes specified in the third edition of ISO 9001 2000 to specify quality system requirements for use where a contract between the company and customer requires the demonstration of capability of final product inspection and testing with customer satisfaction. The permissible exclusions are made to ... 

European countries have to take note of The European Committee for Standardisation (CEN) which was founded in 1961 and comprises the national standards bodies of EC and EFTA plus some eastern European countries. CENELEC is the equivalent body in the electrical field. To many people, the concept of European standards, or any other national grouping, is an unnecessary complication, it being argued that there is no need for any activity in between ISO and the national bodies. However, the work of CEN assumes great commercial importance because EC countries are bound to adopt them to replace national standards and they can be used to demonstrate compliance with EC Directives. The CEN web site can be found at www.cenorm.be. 

An example of an evaluation undertaken according to this protocol is for the measurement of benzene in ambient air by tube type samplers subject to thermal desorption (EN, 2005b) and samplers subject to solvent desorption (EN, 2005a). These standards were developed specifically to provide measurement methods meeting requirements for checking compliance with the air quality standard for benzene set by the European Ambient Air Quality Directive (Directive 96/62/EC, 1996). Evaluation of published data concerning the samplers under the test conditions enabled an evaluation of the expanded relative uncertainty of measurement at a limit value (5 pgnT3) for benzene in air and for solvent and thermally desorbed samplers a value of 13.4% was obtained. 

It is interesting that regulations such as these are not effective in isolation. For example ER 3 of the CPD, requiring that chemical emissions from products used indoors must not adversely impact the indoor environment, became European law in 1989. However, it has not yet been effectively implemented. This is partly because there has not, hitherto, been a validated and broadly applicable (horizontal) standard test method available to carry out emissions measurement in compliance with the regulation. 

Continuing with the above example of ER3 of the European Construction Products Directive horizontal emissions test methods (i.e., applicable to multiple product types) have been developed by CEN and ISO for compliance with the CPD and are now available as parts 6, 9,10 and 11 of EN/ISO standard 16000 (see Table 6.1). Furthermore, a program of work led by CEN TC351 has now been instigated under European Council Mandate M/366 to amalgamate and validate these standards. Once this work is completed (estimated 2010) it is understood that chemical emissions testing will become a mandatory part of CE marking for construction products. 

The difference between decision making on the basis of a standard alone and on the basis of a standard plus other information can be described as one aspect of the direct versus the indirect model. In the direct model, action is defined exactly as that needed to secure compliance with the standard, for example, as permit conditions for discharges to water that are calculated to meet an environmental standard in a river. The classic cases here are substances like ammonia or cadmium in rivers and other mandatory standards in various European directives. 

In the case of Cd in drinking water the performance criteria are clearly speci-bed as 10 percent for both trueness and precision. Therefore, it is rather surprising to see PT providers stating assigned standard deviations of 5, 7, 10, or even 14 percent for Cd in water, in compliance with the WFD. This is because some PT providers only consider trueness, others, in turn, combine trueness and precision. Some consider precision properly, others take it as a direct estimate of the normalization factor. To improve such situations, the European Union initiated the CoEPT project to study the differences and similarities in the operation of PT schemes and the evaluation of PT results in view of implementing a harmonized approach to provide a basis for the comparability of the PT schemes operated on the market [70]. 

Palacios, M., Pampillon, J.F. and Rodriguez, M.E. (2000) Organohalogenated compounds levels in chlorinated drinking water and current compliance with quality standards throughout the European Union. Water Res. 34, 1002-1016. 

If an apparatus has been designed, constructed and successfully type tested according to established standards (e.g. according to European Standards EN. .. drawn up by CENELEC), the compliance with the ESRs is assumed generally (the so-called assumption of conformity - to be completed - with the ESRs ). 

Hence, the standards for conducting clinical trials must be known before they can be applied. Standards are either international (e.g. ICH GCP), European (e.g. European Union Clinical Trials Directive (2001) and GCP Directive (2005)), national (i.e. national drug laws and GCP regulations) or even more local, such as State laws in the United States (Isidor and Kaltmann, 1999). Apart from the regulations, the clinical trial protocol, SOPs and other internal or external instructions document procedures how the trial should be carried out from start to finish. Compliance with these standards is expected. 

Directive 2001/20 required that compliance with GMP guidelines was introduced into the national laws of all MS and (see European Commission Directive 2003/94/EC). GMP inspections have long been standard for all companies at the time of a MA application, but there had previously been no such requirement for IMPs. This gap has now been closed. 

In sum, the zealous over-compliance with international acidification norms by the Czech Republic was driven by strong domestic concern and policies that mandated strict emission standards and neutralized the opposition of industry through policy concessions and subsidies. International norms provided a commitment mechanism for domestic reformers and a model for regulations. Beyond these facilitating factors, the close correspondence between domestic preferences and international commitments was the single most important factor that explains the high compliance with European acid rain standards in the Czech Republic. The significant acidi-... 

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