Standard No.:	YY/T 0639-2019
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
ICS Classification:	11.040.55 11.040.55    Diagnostic equipment 11.040.55
Source Content Issued by:	National Medical Products Adminstration
Issued on:	2019-07-24
Implemented on:	2020-8-1
Status:	valid
Superseding:	YY/T 0639-2008 In Vitro Diagnostic Medical Devices-Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Staining in Biology
Target Language:	English
File Format:	PDF
Word Count:	9500 words
Translation Price(USD):	280.0
Delivery:	via email in 1~3 business day

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、显色试剂和其他用于组织学和细胞学染色(微生物学，血液学、组织化学)的生产者、供应商和零售商。这些试剂用于医学实验室进行常规染色，以及微生物学研究的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。本标准代替YY/T 0639-2008《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》。