YY/T 1794-2021General technical requirements for dental collagen membrane (English PDF)

1 Scope

This standard specifies the terms and definitions, classification, requirements and test methods of oral collagen membrane materials.

This standard is applicable to the repair of oral soft and hard tissue defects caused by various reasons, which can guide, isolate, repair, fix, reduce tension, replace, etc.

It is a membrane material with collagen as the main component.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article

Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document.

GB/T 528-2009 Determination of tensile stress and strain properties of vulcanized rubber or thermoplastic rubber

GB/T 1040.3-2006 Determination of tensile properties of plastics Part 3.Test conditions for films and sheets

GB 5009.6-2016 National Food Safety Standard Determination of Fat in Food

GB/T 6682-2008 Analytical laboratory water specifications and test methods

GB/T 14233.1-2008 Medical transfusion, blood transfusion, injection equipment inspection methods Part 1.Chemical analysis methods

GB/T 14233.2-2005 Medical transfusion, blood transfusion, injection equipment inspection methods Part 2.Biological test methods

GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in the Process of Risk Management

GB/T 16886.3 Biological Evaluation of Medical Devices Part 3.Genetic Toxicity, Carcinogenicity and Reproductive Toxicity Test

GB/T 16886.4 Biological Evaluation of Medical Devices Part 4.Test Selection for Interaction with Blood

GB/T 16886.5 Biological Evaluation of Medical Devices Part 5.In Vitro Cytotoxicity Test

GB/T 16886.6 Biological evaluation of medical devices Part 6.Local reaction test after implantation

GB/T 16886.7 Biological Evaluation of Medical Devices Part 7.Residues of Ethylene Oxide Sterilization

GB/T 16886.10 Biological Evaluation of Medical Devices Part 10.Irritation and Skin Sensitization Test

GB/T 16886.11 Biological Evaluation of Medical Devices Part 11.Systemic Toxicity Test

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 of Immunotoxicology Tests for Medical Devices

YY/T 0127.2 Biological Evaluation of Oral Medical Devices Unit 2.Test Method Acute Systemic Toxicity Test. Intravenous Route

YY/T 0127.4 Biological Evaluation of Dental Medical Devices Unit 2.Test Method Bone Implantation Test

YY/T 0127.8 Biological Evaluation of Dental Materials Unit 2.Biological Test Methods of Dental Materials Subcutaneous Implantation Test

YY/T 0127.10 Biological Evaluation of Dental Medical Devices Unit 2.Test Method Salmonella Typhimurium Reversion Test

Test (Ames test)

YY/T 0268 Biological Evaluation of Dental Medical Devices in Dentistry Unit 1.Evaluation and Testing

YY/T 0606.25-2014 Tissue engineered medical products Part 25.Determination of DNA residues in biological materials of animal origin.

Fluorescence staining method

YY 0954-2015 Passive surgical implants Type I collagen implants

YY/T 1511-2017 Collagen sponge

Pharmacopoeia of the People's Republic of China (2020 edition) […]