Europe norms

For it to be applied more extensively at the clinical level, one needs to develop standardized commercial instrumentation and its utility has to be demonstrated in more controlled and rigorous pre-clinical and clinical studies in terms of the accepted surgical norms in North America and Western Europe. 

France Norme experimentale—Odour standard, 1st draft (1982). Pollution atmospheric, methode de mesurage de l odeur d un effluent gazeux, determination du facteur de dilution au seuil de perception—X 43-101. AFNOR, Tour Europe Cedex 7, 92080 Paris. 

It is widely accepted that two placebo-controlled pivotal studies are necessary, although it is not clear whether this is a mandatory regulation in the FDA or EMEA regulations. There is, however, a certain insurance in this approach as studies, even of drugs that are effective, can occasionally fail to show a statistically positive result if the treated population somehow deviates from the norm or if the placebo response is unexpectedly increased. In Europe the use of an active comparator in a pivotal study is more common. 

Today in Europe, the term safety valve is used to describe Safety Valves, Safety/ Relief-Valves and Relief Valves. This term is now used in European Norms (EN) and ISO 4126 descriptions. Safety Valves are included as Safety Accessories in the PED (Article 1, paragraph 2.1.3) and are classified in risk category IV (the highest). As with ASME, the legislation texts are complex and possibly open to interpretation. In this book, we have distilled all parts direcdy related to Safety (Relief) Valves and tried to make them comprehensive and practically usable. 

When the EU Regulation was first published, it set very few guidelines on the qualifications of certification bodies (both within and outside of Europe) and the procedures for their approval. Regulation 1935/95 added the requirement for all inspection bodies to comply with the guidelines set down in European Norm 45011, which is the EN version of IS065. 

Compliance with the Norm is required, not necessarily accreditation. Some inspection bodies within Europe have opted or been required by their national authority to gain accreditation at considerable expense. In other countries, competent authorities have conducted compliance inspections themselves. 

The ChemLeg program, in turn, focused on closer cooperation between policy makers, industry experts and national federations to facilitate the implementation of these standards. The main indicators of achievement were the enlargement of CEFIC with new full and associate CEFIC members representing nine of the ten Central and Eastern Europe states that subsequently joined the European Union the creation of an influential regional network of chemical industry and active involvement in European advocacy on the part of federations from Central and Eastern Europe (Doktor 2002). The political dynamics of trans-European industry mobilisation, organisation at the domestic and European level, and alliances with supranational and domestic policy elites and experts developed in full swing and in support of the horizontal diffusion of EU chemical safety policies and norms. 

The role of environmental advocacy organisations in the diffusion of chemical safety and environmental policies from the EU to the Central and Eastern Europe states has been surprisingly limited. The vacuum of societal activism on the issue illustrates once again the critical meditating role of actor associations in linking domestic and EU regulatory and normative arenas. 

Historically, the major players in the industry have been jacks-of-all-trades. Integrated businesses in which a single company controlled the entire process - from the supply of raw materials to the outlets for its products - were the norm. Because of the development of individual national markets and the lack of a significant pipeline infrastructure, Europe became even more integrated than North America. 

Various regulatory authorities in Europe (e.g. European Standard or Norm, EN British Standards, BS Germany, DGHM France, AFNOR) and North America (e.g. Food and Drug Administration, FDA Environmental Protection Authority, EPA Association of Official Analytical Chemists, AO AC) have been associated with attempts to pro-... 

There are a few other minor issues that need to be borne in mind about studies in China. For example, adverse events are not dealt with in the same way as in Europe. Complaints are often made by the patient direct to the company (an obvious breach of GCP regulations regarding anonymity of data), and staff feel honor bound to offer some compensation to the complainant, to save face for the company, even if there is limited merit in the complaint. The recompense offered is usually a small amount of money (for inconvenience caused), medicine (to speed recovery) and some food (to facilitate healing). This presents a nightmare of assumed liability, but is very much the norm in China. 

As mentioned at the beginning of this chapter, uniform testing procedures provide the methods used to control the quality of down and feather products. By using standardized terms to reflect the quality of down and feather products on the product label, the consumer can be confident that a pillow labeled 100% goose down, is what it is claimed to be. In Europe, for instance, the Emopean Norm (EN) is standard. In reference to product labeling, the following norms are applied ... 

The movement of the Blue Guide toward the ISO 9000 series of standards is an unusual example of convergence between quality assurance of medical and pharmaceutical products and quality assurance in other industries. The ISO 9000 series of standards is becoming the accepted norm for progressive customer-oriented companies in both western and eastern Europe. It rests on three important themes, which if addressed properly will provide a systematic basis to quality assurance ... 

Feed and foodstuffs in Europe contain bromine concentrations which exceed the normative requirement of animals and man. The normative requirement of goats was calculated to be > 1000 to 1500 pg kg feed DM. The bromine requirement of animals and man is met by feed, foodstuff and water (Anke etal. 2001) hence, bromine-deficiency experiments with rats, mice and chicks were generally unsuccessful (Winnek and Smith 1937, Huff etal. 1956, Bosshardt et al. 1956). 

The iron, zinc, iodine and selenium concentrations of the food dry matter consumed is only slightly higher than the normative requirements of these elements (see Table 4.8). The findings show that the intakes of iron, zinc, iodine and selenium in Germany and Europe do not always meet the normative requirements. 

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