YY/T 0639-2008 in English
SUPERSEDEDIn Vitro Diagnostic Medical Devices-Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Staining in Biology
- Issued on:2008-04-25
- Implemented on:2009-06-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$185.00
本标准等同采用ISO 19001:2002《体外诊断医疗器械 制造商为生物学染色用体外诊断试剂提供的信息》(英文版)
本标准等同翻译ISO 19001:2002。
本标准规定了制造商为生物学染色用试剂所提供信息的要求。
本标准适用于染料,染色剂、发光试剂和用于生物学染色的其他其他试剂的生产商、供应商和零售商。在生物染色所有领域中,本标准所规定的制造商提供信息的要求,是获得可参照和可复现结果的先决条件。
Scope
This standard specifies the requirements for information provided by manufacturers of reagents used for biological staining. This standard applies to manufacturers, suppliers and retailers of dyes, stains, luminescent reagents and other reagents used in biological staining. In all areas of biological staining, the requirements for information provided by the manufacturer specified in this standard are a prerequisite for obtaining referable and reproducible results.

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