Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Gives the framework for biological evaluation of devices inside a risk management process. It is the first part of the GB/T 16886 series, which covers other parts with test methods.
Recommended national standard, current. It replaced the 2011 edition.
The text of this standard is sold by China national standard and is not reproduced here. This page gives the code, edition, scope and what each market says about it.
Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts
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Related standards: ISO 10993-1, GB/T 16886.4-2022, GB/T 16886.5-2017, GB/T 16886.7-2015, GB/T 16886.10-2017, GB/T 16886.11-2021, GB/T 16886.12-2017, GB/T 16886.18-2022, ISO 10993-9, ISO 10993-15, ISO 10993-4. See .
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