GB/T 16886.11-1997
Replaced
YY/T 0316-2016
Active
Industry standards-Medicine
YY/T 0316-2016 Medical devices—Application of risk management to medical devices
YY/T 0316-2016 Medical devices—Application of risk management to medical devices
Basic Information
Standard Code:
YY/T 0316-2016
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Integrated medical equipment
Publish Date:
2016-01-26
Implement Date:
2017-01-01
Pages:
73 pages
Scope
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.
Development Information
Replace the following standards
Adopt standards
ISO 14971:2007
Related Standards
GB/T 16886.3-1997
Replaced
GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.6-1997
Replaced
GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.1-2001
Replaced
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.13-2001
Replaced
GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices
GB/T 16886.7-2001
Replaced