注册
CN
【CODEX翻译】YYT 1794-2021 口腔胶原膜通用技术要求-英文版PDF
发布日期:2022-06-08
¥1719.90
立即购买

【CODEX翻译】YYT 1794-2021 口腔胶原膜通用技术要求-英文版PDF


YYT 1794-2021 口腔胶原膜通用技术要求

General technical requirements for dental collagen materials


1 Scope

This standard specifies terms and definitions, classification, requirements and test methods of dental collagen materials.

This standard is applicable to membrane materials with collagen as the main ingredient for the purpose of guidance, isolation, repair, fixation, decompression and replacement by repairing oral soft and hard tissue defects caused by various causes.


2 Normative references

The following documents are indispensable for the application of this document. For dated references, only the edition cited is applicable to this document. For undated references, the latest edition (all revision lists included) is applicable to this document.

GB/T 528-2009 Rubber, vulcanized or thermoplastic - Determination of tensile stress-strain properties

GB/T 1040.3-2006 Plastics – Determination of tensile properties – Part 3: test conditions for films and sheets

GB 5009.6-2016 National standard for food safety – Determination of fat in food

GB/T 6682-2008 Water for analytical laboratory use – Specification and test methods

GB/T 14233.1-2008 Test methods for infusion, transfusion, injection equipments for medical use – Part 1: Chemical analysis methods

GB/T 14233.2-2005 Test methods for infusion, transfusion, injection equipment for medical use – Part 2: Biological test methods

GB/T 16886.1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process

GB/T 16886.3 Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

GB/T 16886.4 Biological evaluation of medical devices – Part 4: Selection of tests for ineractions with blood

GB/T 16886.5 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity

GB/T 16886.6 Biological evaluation of medical devices – Part 6: Test for locol effects after implantation

GB/T 16886.7 Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals

GB/T 16886.10 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization

GB/T 16886.11 Biological evaluation of medical devices – Part 11: Tests for systemic toxicity

GB/T 16886.12 Biological evaluation of medical devices – Part 12: Sample preparation and reference materials

GB/T 16886.20 Biological evaluation of medical devices – Part 20: Principles and methods for immunotoxicology testing of medical devices

YY/T 0127.2 Biologycal evaluation of medical devices used in detistry – Part 2: Test method – Acute systemic toxicity: intravenous path

YY/T 0127.4 Biologycal evaluation of medical devices used in detistry – Part 2: Test method – Bone implant test

YY/T 0127.8 Biologycal evaluation of dental materials – Part 2: Biological evaluation test method of dental materials – Subcutaneous implant test

YY/T 0127.10 Biologycal evaluation of medical devices used in detistry – Part 2: Test method – Salmonella typhimurium reverse mutation assay (Ames mutagenicity test)

YY/T 0268 Dentistry – Biological evaluation of medical devices used in dentistry – Part 1: Evaluaiton and test

YY/T 0606.25-2014 Tissue engineered medical product – Part 25: Quantification of remnant DNA in biological materials utilizing animal tissues and their derivatives: Fluorescence method

YY 0954-2015 Nonactive surgical implants – Type I collagen implants

YY/T 15112017 Collagen sponge

Pharmacopoeia of the People’s Republic of China (2020 Edition)



      


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翻译】YYT 1794-2021 口腔胶原膜通用技术要求-英文版PDF


YYT 1794-2021 口腔胶原膜通用技术要求

General technical requirements for dental collagen materials


1 Scope

This standard specifies terms and definitions, classification, requirements and test methods of dental collagen materials.

This standard is applicable to membrane materials with collagen as the main ingredient for the purpose of guidance, isolation, repair, fixation, decompression and replacement by repairing oral soft and hard tissue defects caused by various causes.


2 Normative references

The following documents are indispensable for the application of this document. For dated references, only the edition cited is applicable to this document. For undated references, the latest edition (all revision lists included) is applicable to this document.

GB/T 528-2009 Rubber, vulcanized or thermoplastic - Determination of tensile stress-strain properties

GB/T 1040.3-2006 Plastics – Determination of tensile properties – Part 3: test conditions for films and sheets

GB 5009.6-2016 National standard for food safety – Determination of fat in food

GB/T 6682-2008 Water for analytical laboratory use – Specification and test methods

GB/T 14233.1-2008 Test methods for infusion, transfusion, injection equipments for medical use – Part 1: Chemical analysis methods

GB/T 14233.2-2005 Test methods for infusion, transfusion, injection equipment for medical use – Part 2: Biological test methods

GB/T 16886.1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process

GB/T 16886.3 Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

GB/T 16886.4 Biological evaluation of medical devices – Part 4: Selection of tests for ineractions with blood

GB/T 16886.5 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity

GB/T 16886.6 Biological evaluation of medical devices – Part 6: Test for locol effects after implantation

GB/T 16886.7 Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals

GB/T 16886.10 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization

GB/T 16886.11 Biological evaluation of medical devices – Part 11: Tests for systemic toxicity

GB/T 16886.12 Biological evaluation of medical devices – Part 12: Sample preparation and reference materials

GB/T 16886.20 Biological evaluation of medical devices – Part 20: Principles and methods for immunotoxicology testing of medical devices

YY/T 0127.2 Biologycal evaluation of medical devices used in detistry – Part 2: Test method – Acute systemic toxicity: intravenous path

YY/T 0127.4 Biologycal evaluation of medical devices used in detistry – Part 2: Test method – Bone implant test

YY/T 0127.8 Biologycal evaluation of dental materials – Part 2: Biological evaluation test method of dental materials – Subcutaneous implant test

YY/T 0127.10 Biologycal evaluation of medical devices used in detistry – Part 2: Test method – Salmonella typhimurium reverse mutation assay (Ames mutagenicity test)

YY/T 0268 Dentistry – Biological evaluation of medical devices used in dentistry – Part 1: Evaluaiton and test

YY/T 0606.25-2014 Tissue engineered medical product – Part 25: Quantification of remnant DNA in biological materials utilizing animal tissues and their derivatives: Fluorescence method

YY 0954-2015 Nonactive surgical implants – Type I collagen implants

YY/T 15112017 Collagen sponge

Pharmacopoeia of the People’s Republic of China (2020 Edition)



      


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
发布日期:2022-06-08
¥1719.90
立即购买
我们的优势
16年医疗、知识产权领域翻译经验
16年医疗、知识产权领域翻译经验
自成立以来,CODEX 一直深耕医疗、知识产权领域翻译,高品质的翻译和服务,是CODEX得以持续发展的源动力。
专业的精英团队
专业的精英团队
CODEX的团队是由留学归国人员、重点高校毕业的研究生、专业的母语籍译员以及医学行业的专家顾问组成。
权威的质量认证体系
权威的质量认证体系
通过ISO 17100:2015质量认证,以及ISO 9001:2015质量管理体系认证,服务多家国际著名的医药企业。
严格的管控流程
严格的管控流程
CODEX制定了完善的翻译质量保证体系和系统化的运作流程,严格采取一译、二改、三校、四审的工作程序。
绝佳的员工素质
绝佳的员工素质
我们中的每一位都经过严格的考核和挑选,精通医学翻译工作,形象佳责任心强,并严格遵循保密制度。
客户支持
客户支持
“精益求精,至善至美”科译质量和实力以及严格的保密制度倾心为您服务。
联系我们
CODEX科译在您身边

北京科译翻译有限公司

400-136-8786

我们将全天候为您服务
我们是谁
16年来,CODEX是一直致力于提供生命科学翻译和本地化服务的公司,是国内为数不多的通过国家ISO17100:2015认证的医学翻译提供商。
会员注册
发送验证码
注册
已有账号?点击登录
账号登录
短信登录
登录
没有账号?点击注册
发送验证码
登录
没有账号?点击注册
扫码二维码
CODEX微信公众号
添加微信
CODEX翻译客服
联系我们
400-136-8786
邮箱
Info@codex-trans.com