Standard No.:	YY/T 0639-2008
English Name:	In Vitro Diagnostic Medical Devices-Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Staining in Biology
Chinese Name:	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
Chinese Classification:	C30    Medical apparatus and devices in general
Professional Classification:	YY    Professional Standard - Pharmaceutics
Source Content Issued by:	China Food and Drug Administration
Issued on:	2008-04-25
Implemented on:	2009-6-1
Status:	superseded
Superseded by:	YY/T 0506.8-2019 Surgical drapes,gowns and clean air suits for patients, clinical staff and equipment—Part 8:Special requirements for products YY/T 0639-2019 In vitro diagnostic medical devices-Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
Superseded on:	2020-8-1
Target Language:	English
File Format:	PDF
Word Count:	7000 words
Translation Price(USD):	190.0
Delivery:	via email in 1~3 business day

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。