Medical devices - Application of risk management to medical devices
Sets process requirements for analyzing, evaluating, controlling and monitoring device risk over all life cycle stages.
Recommended industry standard, listed as current. GB/T 42062-2022 on the same subject is also in force.
The text of this standard is sold by China industry standard (YY) 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 14971, GB/T 42062-2022, Q9(R1), JIS T 14971, ISO 22442-1, ISO 22442-2, ISO 22442-3. See all standards.
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