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【CODEX】YYT0497-2018 Sterile insulin syringe for single use
Date:2021-11-05
¥1859.25
Download

【CODEX】YYT0497-2018一次性使用无菌胰岛素注射器



一次性使用无菌胰岛素注射器

Sterile insulin syringe for single use

 

1    范围

1    Scope

 

      本标准规定了一次性使用无菌胰岛素注射器(以下简称注射器)的要求和测试方法,该注射器仅一次性使用,用于抽吸胰岛素后立即进行人体注射。


This standard specifies the requirements and test methods for the sterile insulin syringe for single use (hereinafter referred to as syringe). The syringe is single-use only, and is used for insulin injection soon after filling.

 

      本标准适用于注射40单位每毫升(U-40)和100单位每毫升(U-100)胰岛素的注射器。


This standard covers syringes for use with 40 units of insulin/ml (U-40) and 100 units of insulin/ml (U-100).

 

      本标准不适用于长期储存胰岛素的注射器。


This standard does not apply to syringes containing insulin over extended periods of time.

 

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 documents are indispensable for the application of this document. For dated references, only the dated edition applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

 

GB/T 1962.1 注射器、注射针及其他医疗器械6%(鲁尔)圆锥接头 1部分:通用要求(ISO 594-1:1986IDT

GB/T 1962.1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirement (ISO 594-1: 1986, IDT)

 

GB/T 6682—2008 分析实验室用水规格和试验方法(ISO 3696:1987MOD

GB/T 6682-2008 Water for analytical laboratory use - Specification and test methods (ISO 3696:1987, MOD)

 

GB/T 14233.1—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/T 14233.2 医用输液输血、注射器具检验方法 2部分:生物学试验方法

GB/T 14233.2 Test methods for infusion, transfusion, injection equipments for medical use - Part 2: Biological test methods

 

GB 15810—2001 一次性使用无菌注射器(ISO 7886-1: 1993EQV

GB 15810-2001 Sterile Hypodermic Syringes for Single Use (ISO 7886-1: 1993, EQV)

 

GB 15811 一次性使用无菌注射针(ISO 7864:1993MOD

GB 15811 Sterile hypodermic needles for single use (ISO 7864:1993, MOD)

 

GB/T 16886.1 医疗器械生物学评价:第1部分:风险管理过程中的评价与试验(ISO 10993-1:2009IDT

GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009, IDT)

 

GB 18278.1—2015 医疗保健产品灭菌 湿热 1部分:医疗器械灭菌过程的开发、确认和常规控制要求(ISO 17665-1: 2006IDT

GB 18278.1-2015 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1: 2006, IDT)

 

GB 18279.1—2015 医疗保健产品灭菌 环氧乙烷 1部分:医疗器械灭菌过程的开发、确认和常规控制的要求(ISO 11135-1 :2007IDT

GB 18279.1-2015 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007, IDT)

 

GB 18280.1—2015 医疗保健产品灭菌 辐射 1部分:医疗器械灭菌过程的开发、确认和常规控制要求(ISO 11137-1:2006IDT

GB 18280.1-2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, IDT)

 

GB/T 18457 制造医疗器械用不锈钢针管(ISO 9626:1991:2001MOD

GB/T 18457 Stainless steel needle tubes for medical instruments manufacture (ISO 9626:1991:2001, MOD)

 

GB/T 19633.1 最终灭菌医疗器械包装 1部分:材料、无菌屏障系统和包装系统的要求(ISO 11607-1 :2006IDT

GB/T 19633.1 Packaging for terminally sterilized medical device - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1: 2006, IDT)

 

ISO 7000:2014 设备用图形标志——已注册的符号

ISO 7000:2014 Graphical symbols for use on equipment - Registered symbols

 

ISO 81714-1:2010 图形符号的设计用于产品的技术文档——1部分:基本规则

ISO 81714-1:2010 Design of graphical symbols for use in the technical documentation of products - Part 1: Basic rules

 

YY/T 0466.1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(ISO 15233-1:2012IDT

YY/T 0466.1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15233-1: 2012, IDT)




      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】YYT0497-2018 Sterile insulin syringe for single use
Date:2021-11-05
¥1859.25
Download

【CODEX】YYT0497-2018一次性使用无菌胰岛素注射器



一次性使用无菌胰岛素注射器

Sterile insulin syringe for single use

 

1    范围

1    Scope

 

      本标准规定了一次性使用无菌胰岛素注射器(以下简称注射器)的要求和测试方法,该注射器仅一次性使用,用于抽吸胰岛素后立即进行人体注射。


This standard specifies the requirements and test methods for the sterile insulin syringe for single use (hereinafter referred to as syringe). The syringe is single-use only, and is used for insulin injection soon after filling.

 

      本标准适用于注射40单位每毫升(U-40)和100单位每毫升(U-100)胰岛素的注射器。


This standard covers syringes for use with 40 units of insulin/ml (U-40) and 100 units of insulin/ml (U-100).

 

      本标准不适用于长期储存胰岛素的注射器。


This standard does not apply to syringes containing insulin over extended periods of time.

 

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 documents are indispensable for the application of this document. For dated references, only the dated edition applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

 

GB/T 1962.1 注射器、注射针及其他医疗器械6%(鲁尔)圆锥接头 1部分:通用要求(ISO 594-1:1986IDT

GB/T 1962.1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirement (ISO 594-1: 1986, IDT)

 

GB/T 6682—2008 分析实验室用水规格和试验方法(ISO 3696:1987MOD

GB/T 6682-2008 Water for analytical laboratory use - Specification and test methods (ISO 3696:1987, MOD)

 

GB/T 14233.1—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/T 14233.2 医用输液输血、注射器具检验方法 2部分:生物学试验方法

GB/T 14233.2 Test methods for infusion, transfusion, injection equipments for medical use - Part 2: Biological test methods

 

GB 15810—2001 一次性使用无菌注射器(ISO 7886-1: 1993EQV

GB 15810-2001 Sterile Hypodermic Syringes for Single Use (ISO 7886-1: 1993, EQV)

 

GB 15811 一次性使用无菌注射针(ISO 7864:1993MOD

GB 15811 Sterile hypodermic needles for single use (ISO 7864:1993, MOD)

 

GB/T 16886.1 医疗器械生物学评价:第1部分:风险管理过程中的评价与试验(ISO 10993-1:2009IDT

GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009, IDT)

 

GB 18278.1—2015 医疗保健产品灭菌 湿热 1部分:医疗器械灭菌过程的开发、确认和常规控制要求(ISO 17665-1: 2006IDT

GB 18278.1-2015 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1: 2006, IDT)

 

GB 18279.1—2015 医疗保健产品灭菌 环氧乙烷 1部分:医疗器械灭菌过程的开发、确认和常规控制的要求(ISO 11135-1 :2007IDT

GB 18279.1-2015 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007, IDT)

 

GB 18280.1—2015 医疗保健产品灭菌 辐射 1部分:医疗器械灭菌过程的开发、确认和常规控制要求(ISO 11137-1:2006IDT

GB 18280.1-2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, IDT)

 

GB/T 18457 制造医疗器械用不锈钢针管(ISO 9626:1991:2001MOD

GB/T 18457 Stainless steel needle tubes for medical instruments manufacture (ISO 9626:1991:2001, MOD)

 

GB/T 19633.1 最终灭菌医疗器械包装 1部分:材料、无菌屏障系统和包装系统的要求(ISO 11607-1 :2006IDT

GB/T 19633.1 Packaging for terminally sterilized medical device - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1: 2006, IDT)

 

ISO 7000:2014 设备用图形标志——已注册的符号

ISO 7000:2014 Graphical symbols for use on equipment - Registered symbols

 

ISO 81714-1:2010 图形符号的设计用于产品的技术文档——1部分:基本规则

ISO 81714-1:2010 Design of graphical symbols for use in the technical documentation of products - Part 1: Basic rules

 

YY/T 0466.1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(ISO 15233-1:2012IDT

YY/T 0466.1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15233-1: 2012, IDT)




      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



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Since the establishment, CODEX Translation has been deeply engaged in medical translation. Quality translation and services are the driving force for our sustainable development.
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