ISO TR 24971:2013 Withdrawn
Medical devices -- Guidance on the application of ISO 14971
Abstract
ISO TR 24971:2013 provides guidance in addressing specific areas of ISO 14971 when implementing risk management. This guidance is intended to assist manufacturers and other users of the standard to understand the role of international product safety and process standards in risk management, develop the policy for determining the criteria for risk acceptability, incorporate production and post-production feedback loop into risk management, differentiate between "information for safety" and "disclosure of residual risk", and evaluate overall residual risk.
Additional information
Publication type | Technical Report |
---|---|
Publication date | 2013-06-19 |
Withdrawal date | 2020-06-16 |
Edition | 1.0 |
Available language(s) | English, Russian |
TC/SC | TC 62/SC 62A - Common aspects of medical equipment, software, and systemsrss |
ICS | 11.040.01 - Medical equipment in general |
Stability date | 2020 |
Pages | 12 |
File size | 584 KB |
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