GB/T 6387-1986
Replaced
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
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
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
Related Standards
YY 0270-2003
Replaced
YY 0270-2003 Dentistry—Denture base polymers
YY 0462-2003
Replaced
YY 0462-2003 Dental gypsum products
YY 0463-2003
Replaced
YY 0463-2003 Dental phosphate-bonded casting investments
YY 1042-2003
Replaced
YY 1042-2003 Dentistry—Polymer-based filling,restorative and luting materials
YY 0493-2004
Replaced