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YY/T 0316-2016 Active
YY/T 0316-2016 Medical devices—Application of risk management to medical devices
Abstract
This standard prescribes a process for manufacturers to identify the hazards (sources) associated with medical devices [including in vitro diagnostic (IVD) medical devices], estimate and evaluate the associated risks, control these risks, and monitor the effectiveness of the controls.
The requirements of this standard apply to all stages of the life cycle of medical devices.
This standard is not intended for clinical decision-making.
This standard does not specify acceptable risk levels.
This standard does not require manufacturers to have an appropriate quality system. However, risk management can be an integral part of a quality management system.
General Product Information
| Document Type | Industry standards-Medicine |
|---|---|
| Standard Status | Active |
| Standard Code | YY/T 0316-2016 |
| CCS | Medical devices |
| ICS | Integrated medical equipment |
| Implement Date | 2017-01-01 |
Price
$ 147
Subtotal
$ 147
Tax
$ 0.00
Order Total (incl. tax)
$ 147