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    【CODEX翻譯】YYT 1794-2021 口腔膠原膜通用技術要求-英文版PDF
    發布日期:2022-06-08
    ¥1719.90
    立即購買

    【CODEX翻譯】YYT 1794-2021 口腔膠原膜通用技術要求-英文版PDF


    YYT 1794-2021 口腔膠原膜通用技術要求

    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北京科譯翻譯有限公司是一家專業提供生命科學翻譯和本地化服務的公司,作為中國專業的生命科學翻譯公司之一以及國內為數不多的通過國際ISO17100: 2015認證的醫學翻譯提供商,CODEX科譯擁有更多的醫學資深語言專家,能實現40多種語言對的互譯,接受更高難度的醫學領域的項目挑戰,并在最短時間內適應以給出最合理的解決方案。保證最高質量,100%按時交付,高效、完善的售后保障是CODEX科譯給客戶的用心承諾。


    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.


          以上是免費內容,查看更多可立即購買

    【CODEX翻譯】YYT 1794-2021 口腔膠原膜通用技術要求-英文版PDF


    YYT 1794-2021 口腔膠原膜通用技術要求

    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北京科譯翻譯有限公司是一家專業提供生命科學翻譯和本地化服務的公司,作為中國專業的生命科學翻譯公司之一以及國內為數不多的通過國際ISO17100: 2015認證的醫學翻譯提供商,CODEX科譯擁有更多的醫學資深語言專家,能實現40多種語言對的互譯,接受更高難度的醫學領域的項目挑戰,并在最短時間內適應以給出最合理的解決方案。保證最高質量,100%按時交付,高效、完善的售后保障是CODEX科譯給客戶的用心承諾。


    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.


          以上是免費內容,查看更多可立即購買
    發布日期:2022-06-08
    ¥1719.90
    立即購買
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