YY 0167-2020 Active Industry standards-Medicine

YY 0167-2020 Non-absorbable surgical suture

YY 0167-2020 Non-absorbable surgical suture

Publish Date: 2020-02-26 Implement Date: 2021-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0167-2020
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Generally, it refers to microsurgical instruments
ICS Name: Surgical instruments and materials
Publish Date: 2020-02-26
Implement Date: 2021-03-01
Publisher: 国家药品监督管理局
Technical Committee: 全国外科器械标准化技术委员会(SAC/TC 94)
Pages: 13 pages

Scope

本标准规定了非吸收性外科缝线的分类、要求、试验方法、型式检验、标签、说明书、包装、运输、贮存和有效期。
本标准适用于人体组织缝合、结扎的非吸收性外科缝线(以下简称缝线)。
本标准不适用于特殊设计的非吸收性外科缝线。

Development Information

Drafting Units:

强生(中国)医疗器材有限公司、上海市医疗器械检测所、上海浦东金环医疗用品股份有限公司和淮阴医疗器械有限公司

Drafting Persons:

马文忠、黄书泽、张延青、陆广恒、夏爱红、王凤才

Word Count: 26 Thousand words Pages: 13 pages

Replace the following standards

Referenced Standards

GB/T 16886.17-2025 Biological evaluation of medical devices—Part 17:Toxicological risk assessment of medical device constituents GB/T 16886.18-2011 Biological evaluation of medical devices—Part 18:Chemical characterization of materials GB/T 16886.18-2022 Biological evaluation of medical devices—Part 18:Chemical characterization of medical device materials within a risk management process GB/T 16886.19-2011 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials GB/T 16886.19-2022 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials GB/T 16886.20-2015 Biological evaluation of medical devices—Part 20:Principles and methods for immunotoxicology testing of medical devices GB/Z 16886.22-2022 Biological evaluation of medical devices—Part 22:Guidance on nanomaterials GB/T 16886.23-2023 Biological evaluation of medical devices—Part 23:Tests for irritation YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements YY/T 0816-2010 Implants for surgery—Malleable wires for use as sutures and other surgical applications 中华人民共和国药典(2015年版)四部

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