YY/T 0268-2008
Dentistry.Biological evaluation of medical devices used in dentistry.Part 1:Evaluation and test (English Version)

Standard No.

YY/T 0268-2008

Language

Chinese, Available in English version

Release Date

2008

Published By

Professional Standard - Medicine

Latest

YY/T 0268-2008

Replace

YY/T 0268-2001

Scope

This standard specifies the test methods that should be considered for the biological evaluation and testing of oral medical devices. This standard includes composite devices in which the pharmaceutical ingredients and device are integrated. This standard does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.

YY/T 0268-2008 Referenced Document

• GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*， 2022-04-15 Update
• GB/T 16886.10 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization*， 2017-12-29 Update
• GB/T 16886.11 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity*， 2021-11-26 Update
• GB/T 16886.12 Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials*， 2023-11-27 Update
• GB/T 16886.2 Biological evaluation of medical devices.Part 2: Animal welfare requirements *， 2011-12-30 Update
• GB/T 16886.3 Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity*， 2019-06-04 Update
• GB/T 16886.5 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Tests*， 2018-07-01 Update
• GB/T 16886.6 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation*， 2022-04-15 Update
• GB/T 6387 Vocabulary of dental materials
• GB/T 9258.1 Coated abrasives-Grain size analysis-Part 1: Grain size distribution test
• ISO/TS 22911 Dentistry - Preclinical evaluation of dental implant systems - Animal test methods*， 2016-06-30 Update
• YY/T 0127.1 Biotic experiment method for dental materials Hemolysis test
• YY/T 0127.2 Biological evaluation of medical devices used in dentistry.Part 2:Test method.Acute systemic toxicity:intravenous path*， 2009-06-16 Update
• YY/T 0127.3 Biological evaluation of medical devices used in dentistry.Part 3: Endodontic usage test*， 2014-06-17 Update
• YY/T 0127.4 Biological Evaluation of Oral Medical Devices Part 4: Bone Implant Test*， 2023-11-22 Update
• YY/T 0127.5 Biological evaluation of medical devices used in dentistry.Part 5:Inhalation toxicity test*， 2014-06-17 Update
• YY/T 0127.6 Biological evaluation of dental materials.Unit 2:Biological test methods of dental materials.Dominant lethal test
• YY/T 0127.7 Biological Evaluation of Oral Medical Devices Part 7: Pulp Dentin Application Test*， 2017-03-28 Update
• YY/T 0127.8 Biological evaluation of dental materials.Part 2:Biological evaluation test method of dental materials.Subcutaneous implant test
• YY/T 0127.9 Biological evaluation of medical devices used in dentistry.Part 2:Test method Cytotxicity tests .Agar diffusion test and filter diffusion test*， 2009-12-30 Update

YY/T 0268-2008 history

• 2008 YY/T 0268-2008 Dentistry.Biological evaluation of medical devices used in dentistry.Part 1:Evaluation and test
• 2001 YY/T 0268-2001 Dentistry----Preclinical evaluation of biocompatibility of medical devices used in dentistry----Part 1:Evaluation and test methods selection