Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (JIS version)
general principles of biological evaluation within risk management, device categories by contact type and duration, and biological safety risk assessment. Identical adoption of the international standard.
The text of this standard is sold by Japanese Industrial Standards Committee 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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Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: ISO 10993-1, GB/T 16886.1-2022, 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. See .
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