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YY/T 1437-2016
YY/T 1437-2016 Medical devices—Guidance on the applicantion of ISO 14971
Abstract
When implementing risk management, this standard provides guidance for specific areas described in YY/T 0316.
This standard aims to help manufacturers and other users of the standard:
——Understand the role of product safety standards and process standards in risk management;
——Establish guidelines for determining risk acceptability criteria;
——Include production and post-production feedback loops (information, cycles, processes) in risk management;
——Distinguish between "safety information" and "disclosure of residual risks"; and
——Evaluate the comprehensive residual risk.
General Product Information
| Document Type | Industry standards-Medicine |
|---|---|
| Standard Status | Replaced |
| Standard Code | YY/T 1437-2016 |
| CCS | Medical devices |
| ICS | Integrated medical equipment |
| Implement Date | 2017-01-01 |
Price
$ 32.00
Subtotal
$ 32.00
Tax
$ 0.00
Order Total (incl. tax)
$ 32.00