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【CODEX】YYT 1794-2021 General technical requirements for dental collagen materials
Date:2022-06-08
¥1719.90
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【CODEX】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】YYT 1794-2021 General technical requirements for dental collagen materials
Date:2022-06-08
¥1719.90
Download

【CODEX】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
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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 has been deeply engaged in medical translation. Quality translation and services are the driving force for our sustainable development.
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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.
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Authoritative Quality Certification
We provide services for many world-renowned pharmaceutical companies with ISO9001:2015 and ISO17100:2015 Quality Management System Certification.
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Strict Control Process
Codex 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”.
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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.
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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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