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测试物理危害时的质量要求是什么?
Question (EN)
What are the quality requirements when testing for physical hazards?
中文内容由 Google Cloud Translation 自动生成,仅供参考;请以英文原文为准。问答资料来自欧盟化学品管理局(ECHA)官方网站。
答案(中文)
根据CLP法规第8(5)条,为本法规目的而进行的新物理危害测试,必须最迟于2014年1月1日起,按照相关公认质量体系或由符合相关公认标准的实验室进行。该条款的规定在《CLP标准应用指南》第2.0.5节“质量”中有进一步的详细说明。根据该指南,即使质量要求不会立即生效,也强烈建议在合理可行的情况下立即生效。一般而言,可以采取以下替代策略:1. 遵守良好实验室规范 (GLP) 原则(DSD先前要求)。2. 根据EN ISO/IEC 17025“检测和校准实验室能力的通用要求”(相关公认标准)进行认证。3. 其他具有同等范围的国际公认标准。因此,任何进行物理危害分类测试的测试机构都可以选择如何满足 CLP 的质量要求。
Answer (EN)
According to Article 8(5) of the CLP Regulation, where new tests for physical hazards are carried out for the purposes of this Regulation, they must be carried out, at the latest from 1 January 2014, in compliance with a relevant recognised quality system or by laboratories complying with a relevant recognised standard. The provisions of that Article are further detailed in section 2.0.5 "Quality" of the Guidance on the Application of the CLP criteria. According to the Guidance, even though the quality requirement does not become immediately effective, it is highly recommended to do so if reasonably possible. In general, the following alternative strategies can be pursued:
1. Compliance with the principles of good laboratory practice (GLP) (as formerly required by the DSD).
2. Accreditation according to EN ISO/IEC 17025 "General requirements for the competence of testing and calibration laboratories" (a relevant recognised standard).
3. Other internationally recognised standards of comparable scope.
Any testing organisation that carries out physical hazard tests for classification purposes can therefore choose how to fulfil the quality requirements of CLP.