YY/T 1794-2021 Active Industry standards-Medicine

YY/T 1794-2021 General technical requirements for dental collagen membrane

YY/T 1794-2021 General technical requirements for dental collagen membrane

Publish Date: 2021-03-10 Implement Date: 2022-04-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1794-2021
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Dental instruments, equipment, and materials
ICS Name: Dental materials
Publish Date: 2021-03-10
Implement Date: 2022-04-01
Pages: 10 pages

Scope

This standard specifies the terms and definitions, classification, requirements, and test methods for oral collagen membrane materials.
This standard applies to membrane materials primarily composed of collagen protein, which are used to repair soft and hard oral tissue defects caused by various factors, and play the roles of guidance, isolation, repair, fixation, tension reduction, and substitution.

Development Information

Word Count: 16 Thousand words Pages: 10 pages

Referenced Standards

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 The National Standard of Food Safety: Determination of Fat in Foods 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 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/T 0954-2015 Nonactive surgical implants—Type Ⅰ collagen implants—Specific requirements YY/T 1511-2017 Collagen sponge 中华人民共和国药典(2020年版) GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity GB/T 16886.3-2008 Biological evaluation of medical devices—Part 3:Tests for genotoxicity,carcinogenicity and reproductive toxicity GB/T 16886.3-2019 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity GB/T 16886.4-2003 Biological evaluation of medical devices—Part 4:Selection of tests for interactions with blood GB/T 16886.4-2022 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood GB/T 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.6-2015 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals GB/T 16886.10-2000 Biological evaluation of medical devices—Part 10:Tests for irritation and sensitization GB/T 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.11-2011 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.12-2000 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2005 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.20-2015 Biological evaluation of medical devices—Part 20:Principles and methods for immunotoxicology testing of medical devices YY/T 0127.2-2009 Biological evaluation of medical devices used in dentistry—Part 2:Test method—Acute systemic toxicity:intravenous path YY/T 0127.4-1998 Biological evaluation of dental materials—Unit 2:Biological evaluation method of dental materials—Bone implant test YY/T 0127.4-2023 Biological evaluation of medical devices used in dentistry—Part 4:Bone implant test YY/T 0127.8-2001 Biological evaluation of dental materials—Part 2:Biological evaluation test method of dental materials—Subcutaneous implant test YY/T 0127.10-2001 Biological evaluation of dental materials—Part 2:Biological evaluation test method of dental materials—Salmonella typhimurium reverse mutation assay(Ames mutagenicity test) YY/T 0127.10-2009 Biological evaluation of medical devices used in dentistry—Part 2:Test method—Salmonella typhimurium reverse mutation assay(Ames mutagenicity test) YY/T 0268-2001 Dentistry—Preclinical evaluation of biocompatibility of medical devices used in dentistry—Part 1:Evaluation and test methods selection YY/T 0268-2008 Dentistry—Biological evaluation of medical devices used in dentistry—Part 1:Evaluation and test YY/T 0127.4-2009 Oral medical device biocontamination evaluation. The second unit: test methods, Bone implant test YY/T 0127.2-1993 Oral Material Biological Test Methods: Venous Injection Acute Systemic Toxicity Test

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