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Standards GB are Chinese national standards, which are issued by China's Standardization Administration Office (SAC).
Chinese national standards are used all over China commonly labeled as GB standards. They determine the united production requirements regarding product safety and quality .
GB standards are often modified or created according to the international standards of ISO, IEC or any other international level.
Although, they are largely harmonized, GB standards may differ from international standards .
Approximately 15% of all GB standards are obligatory and they can be identified according to the prefix GB, after which the code of the standards follows:
GB – Obligatory national standards
GB/T – Optional national standards
GB/Z – National steering technical document
Biological evaluation of medical devices—Part 16:Toxicokinetic study design for degradation products and leachables
Standard published on 26.11.2021
Selected format:Biological evaluation of medical devices—Part 17:Establishment of allowable limits for leachable substances
Standard published on 4.11.2005
Selected format:
Biological evaluation of medical devices—Part 17:Toxicological risk assessment of medical device constituents
Execute Date: september 2026
Standard published on 29.8.2025
Selected format:Biological evaluation of medical devices—Part 18:Chemical characterization of medical device materials within a risk management process
Standard published on 30.12.2022
Selected format:Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials
Standard published on 30.12.2022
Selected format:Biological evaluation of medical devices - Part 2: Animal welfare requirements
Standard published on 30.12.2011
Selected format:
Biological evaluation of medical devices—Part 2: Animal welfare requirements
Execute Date: february 2027
Standard published on 28.1.2026
Selected format:Biological evaluation of medical devices—Part 20:Principles and methods for immunotoxicology testing of medical devices
Standard published on 10.12.2015
Selected format:Biological evaluation of medical devices—Part 22:Guidance on nanomaterials
Standard published on 30.12.2022
Selected format:Biological evaluation of medical devices—Part 23:Tests for irritation
Standard published on 27.11.2023
Selected format:Latest update: 2026-08-26 (Number of items: 2 298 418)
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