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 1511—2017 Collagen sponge

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