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【CODEX翻译】YY 1116-2020 可吸收性外科缝线-英文版PDF

Date:2022-04-07
¥1621.20
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【CODEX】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            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  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)



      CODEX北京科译翻译有限公司是一家专业提供生命科学翻译和本地化服务的公司,作为中国专业的生命科学翻译公司之一以及国内为数不多的通过国际ISO17100: 2015认证的医学翻译提供商,CODEX科译拥有更多的医学资深语言专家,能实现40多种语言对的互译,接受更高难度的医学领域的项目挑战,并在最短时间内适应以给出最合理的解决方案。保证最高质量,100%按时交付,高效、完善的售后保障是CODEX科译给客户的用心承诺。

CODEX 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.


      以上是免费内容,查看更多可立即购买
【CODEX】YY 1116-2020 Absorbablesurgicalsuture
Date:2022-04-07
¥1621.20
Download

【CODEX】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            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  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)



      CODEX北京科译翻译有限公司是一家专业提供生命科学翻译和本地化服务的公司,作为中国专业的生命科学翻译公司之一以及国内为数不多的通过国际ISO17100: 2015认证的医学翻译提供商,CODEX科译拥有更多的医学资深语言专家,能实现40多种语言对的互译,接受更高难度的医学领域的项目挑战,并在最短时间内适应以给出最合理的解决方案。保证最高质量,100%按时交付,高效、完善的售后保障是CODEX科译给客户的用心承诺。

CODEX 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.


      以上是免费内容,查看更多可立即购买
Our Advantages
Sixteen years of translation experience in medical and intellectual property fields
Sixteen years of translation experience in medical and intellectual property fields
Since the establishment, CODEX Translation has been deeply engaged in medical translation. Quality translation and services are the driving force for our sustainable development.
Professional and Elite Team
Professional and Elite Team
The translation team consists of graduates returned from abroad, post-graduate students from the most prestigious universities, professional native-speaking translators and consultants in the medical industry.
Authoritative Quality Certification
Authoritative Quality Certification
We provide services for many world-renowned pharmaceutical companies with ISO17100:2015,ISO18587:2017, ISO9001:2015, ISO14001:2015, ISO 13485:2016 Quality Management System Certification.
Strict Control Process
Strict Control Process
Codex Translation has established a perfect translation quality assurance system and systematic operation process, strictly adopts the working procedure of  “firstly translation, secondly modification, thirdly proofreading and fourthly review”.
Excellent Staff Quality
Excellent Staff Quality
Being strictly examined and selected, every one of us is characterized with a strong sense of responsibility and proficiency in medical translation , and we strictly follow the confidential system.
Client Support
Client Support
“Pursue Excellence, Strive for Perfection”. Serve you with quality and confidentiality .
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400-136-8786

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Who We Are
As one of the few medical translation suppliers in China that have been certified by ISO17100: 2015, we have been providing life sciences translation services, localization services and intellectual property translation services since our founding 16 years ago.
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