Certification and Registration
Antibacterial Testing, Biocompatibility (Toxicity Testing)
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Biocompatibility
Toxicological Testing — Non-Medical Device Standards (General Samples)
GB/T 21804-2008 Chemicals.Test method of acute oral toxicity-fixed dosed procedure
GB/T 21804 specifies the scope, terms and definitions, basic principles, test methods, test data requirements, and reporting requirements for the fixed-dose procedure for acute oral toxicity testing of chemicals.
GB/T 21804 is applicable to the determination of acute oral toxicity of chemicals.
GB/T 21603-2008 Chemicals.Test method for acute oral toxicity
GB/T 21603 specifies the test methods, procedures, and result evaluation requirements for determining the acute oral toxicity of chemicals in experimental animals.
GB/T 21603 is applicable to the evaluation of acute oral toxicity of chemicals.
GB/T 21606-2008 Test method of acute dermal toxicity for chemicals
GB/T 21606 specifies the test purpose, basic principles, test methods, result evaluation, test reports, and interpretation requirements for acute dermal toxicity testing in experimental animals.
GB/T 21606 is applicable to the evaluation of acute dermal toxicity of chemicals.
GB/T 21605-2008 Test method of acute inhalation toxicity for chemicals
GB/T 21605 specifies the test purpose, terms and definitions, basic principles, test methods, test reporting requirements, and result interpretation for acute inhalation toxicity testing in experimental animals.
GB/T 21605 is applicable to the evaluation of acute inhalation toxicity of chemicals, including gases, volatile substances, aerosols, and particulate matter.
GB/T 16886.5-2017 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Tests
GB/T 16886.5 describes test methods for evaluating the in vitro cytotoxicity of medical devices.
GB/T 16886.5 specifies that test specimens shall be brought into contact with cultured cells either directly or through diffusion, including:
a) extracts of the medical device, and/or
b) direct contact with the medical device.
GB/T 16886.5 is applicable to the evaluation of in vitro biological responses of mammalian cells using appropriate biological parameters.
GB/T 16886.3-2008 Biological evaluation of medical devices.Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.3 specifies strategies for identifying hazards associated with medical devices and testing methods related to biological effects, including genotoxicity, carcinogenicity, and reproductive and developmental toxicity.
GB/T 16886.3 is applicable to the evaluation of medical devices identified as having potential genotoxic, carcinogenic, or reproductive toxicity risks.
GB 15193.3-2014 National Food Safety Standard Acute Oral Toxicity Test
GB 15193.3 specifies the basic test methods and technical requirements for acute oral toxicity testing.
GB 15193.3 is applicable to the evaluation of the acute oral toxicity effects of test substances.
Technical Specification for Cosmetic Safety (2015 Edition)
The Technical Specification for Cosmetic Safety (2015 Edition) specifies safety requirements for cosmetics, including general requirements, requirements for prohibited and restricted ingredients, requirements for permitted ingredients, and testing and evaluation methods.
The Technical Specification for Cosmetic Safety (2015 Edition) applies to cosmetics manufactured and marketed within the territory of the People’s Republic of China, excluding products intended solely for overseas sale.
Technical Standard for Disinfection (2002 Edition) — 2.3.1 Acute Oral Toxicity Test
This test evaluates the intensity of acute toxicity effects of disinfectants on experimental animals.
It provides a basis for selecting dosage levels for subacute and chronic toxicity studies.
Technical Standard for Disinfection (2002 Edition) — 2.3.3 Skin Irritation Test
This test evaluates the irritation and/or corrosion effects and severity of disinfectants on the skin of experimental animals.
Technical Standard for Disinfection (2002 Edition) — 2.3.4 Acute Eye Irritation Test
This test evaluates the acute irritation and corrosive effects of disinfectants on the eyes of experimental animals.
Technical Standard for Disinfection (2002 Edition) — 2.3.6 Skin Sensitization Test
This test evaluates the potential and severity of skin sensitization reactions in experimental animals after repeated exposure to disinfectants.
ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
ISO 10993-5 describes test methods for evaluating the in vitro cytotoxicity of medical devices.
ISO 10993-5 specifies the culture of cells exposed directly or indirectly through diffusion to medical devices and/or extracts of medical devices.
ISO 10993-5 is intended to evaluate the biological response of mammalian cells in vitro using appropriate biological parameters.
US Cosmetic Testing — 16 CFR 1500.3
Toxicological Testing — Medical Device Standards
GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization
GB/T 16886.10 describes procedures for evaluating the potential irritation and delayed-type hypersensitivity reactions caused by medical devices and their constituent materials.
GB/T 16886.10 includes: a) considerations before testing; b) test procedures; and c) key factors for interpretation of results.
Annex A provides specific preparation instructions for materials related to the above tests. Annex B provides supplementary tests specifically required for devices intended for intradermal injection and devices used in ocular, oral, rectal, penile, and vaginal applications.
ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
ISO 10993-5 describes test methods for evaluating the in vitro cytotoxicity of medical devices.
ISO 10993-5 specifies the culture of cells exposed directly or through diffusion to medical devices and/or extracts of medical devices.
ISO 10993-5 is intended to determine the biological response of mammalian cells in vitro using appropriate biological parameters.
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO 10993-10 describes procedures for evaluating the potential irritation and skin sensitization caused by medical devices and their components.
ISO 10993-10 includes:(a) pre-test irritation evaluation, including silicone and in vitro skin exposure procedures; (b) details of in vivo testing (irritation and sensitization); and (c) key factors for interpretation of results.
Annex A provides specific preparation instructions for materials related to the above tests. Annex B describes several specific irritation tests applicable to medical devices used in areas other than the skin.
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