YY/T 0639-2019 Active Industry standards-Medicine

YY/T 0639-2019 In vitro diagnostic medical devices—Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

YY/T 0639-2019 In vitro diagnostic medical devices—Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

Publish Date: 2019-07-24 Implement Date: 2020-08-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0639-2019

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Diagnostic equipment

Publish Date: 2019-07-24

Implement Date: 2020-08-01

Publisher: 国家药品监督管理局

Technical Committee: 全国医用临床检验实验室和体外诊断系统标准化技术委员会(SAC/TC 136)

Pages: 16 pages

Scope

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。

Development Information

Drafting Units:

北京市医疗器械检验所

Drafting Persons:

杜海鸥、杨忠、代蕾颖

Word Count: 28 Thousand words Pages: 16 pages

Replace the following standards

YY/T 0639-2008 In vitro diagnostic medical devices—Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

Referenced Standards

GB/T 29791.1-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer(labelling)—Part 1:Terms,definitions and general requirements GB/T 29791.2-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 2:In vitro diagnostic reagents for professional use ISO 80000-1 ISO 80000-9 GB/T 19001-2000 Quality management systems—Requirements GB/T 19001-2008 Quality management systems—Requirements GB/T 19001-2016 Quality management systems—Requirements YY/T 0287-2003 Medical devices—Quality management systems—Requirements for regulatory purposes YY/T 0287-2017 Medical devices—Quality management systems—Requirements for regulatory purposes

Adopt standards

ISO 19001:2013

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