European Standardization Organization

Test procedures for building materials covering the FLEC are also developed within the European standardization organization (CEN, 1999). 

The International Standards Organization 9000 (ISO 9000) standard, developed by the European Economic Community (EEC), also impacts manufacturers implementation of LIMS systems. ISO 9000 is a set of standards which are required for manufacturers selling products to the EEC. The 9000 standards are credited with playing an important part in the impetus to greater computerization of laboratory information management (9). 

In relation to the European Standard EN 71/3 concerning toy safely 2661. Girneno Adelantado et al. [267] have proposed a simultaneous multi-elemental preconcentration approach to increase the sensitivity of the technique for the elements of interest (Sb(III), Ba, Cd, Cr(III), Hg, Pb and As(HI)). As the organic matrix of the... 

Where there is a dosing device provided with the product, the dose reproducibility and accuracy should be demonstrated. Examples include dropper devices, dose-measuring devices, and pen injectors. The instructions for use should also be discussed for such devices and may be particularly important for devices such as two-chamber cartridges and the like containing suspension products. It might be necessary to discuss how dosing devices meet the relevant Essential Requirements of the Medical Device Directives with reference to appropriate and relevant harmonized and other European (EN) and International Standards Organization (ISO) standards. 

In the European Union, organic farming is implemented, labelled, controlled and marketed according to EC Reg. 2092/91 and its updates. Within the European Union, IFOAM Basic Standards are replaced by EC Reg. 2092/91. Thus, EC Reg. 2092/91 provides a framework for organic farming within the EU based on subsidiary principle and its implementation. It is to a certain extent flexible with respect to adaptation, supplementation, and precision of technical details in respect to national conditions. 

The International ISO 9000 1994 series of standards has been established and is based on the British Standard 5750 1987 series, European Standard EN 29000 1987 series, and International Standard ISO 9000 1987 series. The third edition of ISO 9001 cancels and replaces the second edition (ISO 9000 1994) together with ISO 9002 1994 and ISO 9003 1994. It constitutes a revision of these documents. Those organizations that have used ISO 9002 1994 and ISO 9003 1994 in the past may use this revised international standard by excluding certain requirements in accordance with Clause 1.2 of ISO 9001 2000. It should be noted that where the exclusives in sub-clause 1.2 of ISO/EDIS 9001 2000 are exceeded, conformity to ISO/EDIS 9001 2000 shall not be cleared. All requirements of the revised standard are generic and are applicable to all organizations, regardless of type, size, and products offered. If any requirements of this international standard cannot be applied due to the nature of an organization, its products can be considered for exclusion. 

DIN, EN 1484, European standard (1997). Water analysis—guidelines for the determination of total organic carbon (TOC) and dissolved organic carbon (DOC). In Deutsche Einheits-verfahren, John Wiley Sons, Lieferung, 1998, p. 40. 

For the majority of the methods, the necessary quality assurance is provided by a combination of simple and robust sampling techniques with well-described sampling equipment, and the use of synthetic control samples for the chemical analyses. The methods defined in EMEP4 are harmonized whenever possible with recommendations in other networks such as WMO/GAW5 and standardization organizations such as the European Committee for Standardization (CEN). 

The hierarchy established among the different methods and materials suggests an easy organization (Tietz, 1979). However, serious practical problems have hampered fast progress. In the United States and in Europe, the National Committee for Clinical Laboratory Standards (NCCLS) and the European Committee for Clinical Laboratory Standards (ECCLS) have been founded. These standardization organizations promote the development and the ultimate use of reference materials and methods. The National Bureau of Standards (NBS) and the Centers for Disease Control (CDC) in the United States (Bayse, 1982), and the European Community Bureau of Beference (BCR) in Europe, undertake projects oriented more toward the preparation of certified reference materials (BCR, 1982). 

WHO. 1970. World Health Organization. European standards for drinking water, 2nd ed. Geneva WHO, 33. 

European and International Standards, European Standards (CEN, Brussels) and International Standards Organization, Geneva, various dates ... 

In addition, the lack of local certification bodies imposes significant constraints and risks to organic agriculture in Africa. They increase the costs of certified organic production, as certifiers have to be flown in. So far, only Tunisia has its own European-standard certification bodies (Parrot and van Elzakker, op. cit.). The costs of certification have to be seen as investment costs and hence risks, for if the investment costs are not amortised by the revenues, e.g. in the case of harvest failures or a sudden shortfall of market outlets, investments in certification are lost and hence the respective farmers are prone to a significant investment risk. 

In the course of the integration of European states and the removal of trade barriers, national standardization loses importance considerably. The majority of electrical standards comes into existence by international cooperation with IEC, International Electrotechnical Commission, Geneva/Switzerland. On the basis of IEC Standards many European Standards have been developed in the past. This work has been done by CENELEC, Comite Europeen de Normalisation Electrotechnique, Brussels/Belgium. European Standards or Norms (EN) often deviate from their IEC origins in their technical content. To avoid double action and to ensure a more effective standardization procedure, IEC and CENELEC are now working in closer cooperation. CENELEC is a private organization and does not act as an institution of the European Union at all. This fact indicates that European Standards need a legal act to come into force. Members of CENELEC are the national committees for standardization of the member states (not identical with the European Union). 

Guidance on the preparation of SDS s under the requirements of the GHS can be found in Annex 4. It has been developed by the GHS Sub-Committee after consideration of the main internationally-recognized standards which provided guidance in the preparation of an SDS, including the ILO Standard under the Recommendation 177 on Safety in the Use of Chemicals at Work, the International Standard 11014 of the International Standard Organization (ISO), the European Union Safety Data Sheet Directive 91/155/EEC and the American National Standard Institute (ANSI) standard Z 400.1. 

The International Organization for Standardization (ISO) coordinates the publication of international standards. The European countries used to maintain their own national standards, but these are now being superseded by common European standards. 

The Blue Guide is the only one of the pivotal regulatory documents that is particular to sterile products ( Sterile Medical Devices and Surgical Products ). In its 1990 revision, it has adopted the principles, style, and content of International (ISO 9000 to 9004), European (EN 29000 to 29004), and British Standards Organizations (BS S750) requirements for integrated quality assurance systems. Additional requirements specific to sterile products are included. 

At present, several approved Hsts of air sampHng and analytical methods exist on a national basis within and outside Europe, these having been developed more or less independently by standardization organizations or regulatory authorities. European organizations have developed and edited a remarkable number of approved methods for air sampHng at the workplace. These include the British Health and Safety Executive (HSE), which has the so-called MDHS series [6-88], and the French INRS Institut National de Recherche et de Securite , which offers... 

International standards from the International Standards Organization (ISO) and Emopean standards (EN) from the European Standardisation Organization (CEN) can remove trade barriers and promote business across national frontiers. Standardization is based on consensus, on scientific findings and on technical progress, and one has to bear in mind the economic consequences (DIN, 1998). 

The CEN deals with European Standards, which are then issued by national standards organizations. The equivalent of the CEN for electrical products is the CENELEC. 

During development of the European standard, an interlaboratory trial was organized involving six laboratories within Europe to follow a defined protocol to assess aerosol output and size from two fundamentally different nebulizer systems. Results demonstrated that the methods were repeatable within +/- 10% of mean return for both aerosol output and aerosol size (unpublished data). Results of preliminary research investigating the correlation between in vivo response and in vitro estimate of aerosol output and size show a promising correlation (33), though further work is needed in this area. 

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