【CODEX翻译】YY 1116-2020 可吸收性外科缝线-英文版PDF
发布日期：2022-04-07
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【CODEX翻译】YY 1116-2020 可吸收性外科缝线-英文版PDF
YY 1116-2020 可吸收性外科缝线
Absorbablesurgicalsuture
1 范围
1 Scope
本标准规定了可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。
This standard specifies the classification, requirements, test methods, type test, labels, instructions for use, packaging, transportation, storage and validity period of absorbable surgical sutures.
本标准适用于人体组织缝合、结扎的可吸收性外科缝线（以下简称缝线）。
This standard is applicable to absorbable surgical sutures (hereinafter referred to as sutures) for suture and ligation of human tissues.
本标准不适用于特殊设计的可吸收性外科缝线。
This standard is not applicable to specially designed absorbable surgical sutures.
2 规范性引用文件
2 Normative References
下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件，仅注日期的版本适用于本文 件。凡是不注日期的引用文件，其最新版本（包括所有的修改单）适用于本文件。
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition (including any amendments) applies.
GB/T191 包装储运图示标志
GB/T 191 Packaging-Pictorial Marking for Handling of Goods
GB/T6682-2008 分析实验室用水规格和试验方法
GB/T 6682-2008 Water for analytical laboratory use - Specification and test methods
GB/T9737-2008 化学试剂 易碳化物质测定通则
GB/T 9737-2008 Chemical reagent-General rules for the determination of readily carbonizable substances
GB/T9969 工业产品使用说明书 总则
GB/T 9969 General principles for preparation of instructions for use of industrial products
GB/T14233.1-2008 医用输液、输血、注射器具检验方法 第1部分：化学分析方法
GB/T 14233.1-2008 Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
GB/T16886（所有部分） 医疗器械生物学评价
GB/T 16886 (All parts) Biological evaluation of medical devices
YY/T0466.1 医疗器械 用于医疗器械标签、标记和提供信息的符号 第1部分：通用要求
YY/T 0466.1 Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements
中华人民共和国药典（2015年版·四部）
Pharmacopoeia of the People’s Republic of China (2015 Edition, Volume IV)
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is a leading provider of cross-border communications based in Beijing.
With our exclusive database in life science, and ISO 17100:2015
certified, CODEX has the required expertise and experience in
localization, documentation, and medical literature to deliver a full
range of end-to-end content and consulting services in many languages.
We closely work with clients to deliver solutions to the challenges of
engaging markets, consumers, and regulatory and patent environments
worldwide.
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