ISO/TR 24971:2013 PDF Download
Standard EN Sample
Medical devices — Guidance on the application of ISO 14971
Also Known As:
SKU916399232
Published by
International Organization for Standardization
ISO
Publication Date2013-07
Pages CountPages20
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.
Details
History and complementary documents
History
| Edition | 1 |
| ICS Codes | 11.040.01 - Medical equipment in general |
| Language(s) | English |
| File Size | 419.8 KB |
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