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发表于 2009-11-25 23:49
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BS EN ISO 14971:2009- F5 _) c0 F' N3 \* ^
1 `# J M- i. h. _# e*New* Medical Devices. Medical devices. Application of risk management to medical devices( z6 \/ h# r/ i8 ~5 j
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This standard specifies a procedure by which a manufacturer can identify the hazards associated with medical devices and their accessories, including in vitro diagnostic medical devices. It also specifies a procedure to estimate and evaluate the identified risks, control these risks and monitor the effectiveness of the control.$ J( Z9 K6 A) i f6 U3 a
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The requirements of BS EN ISO 14971:2009 are applicable to all stages of the lifecycle of a medical device, but do not apply to clinical judgements relating to the use of a medical device and it does not specify acceptable risk levels.0 B. ]; E" `) b. q& s
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