GB/T 16886.11-1997
Replaced
YY/T 1437-2016
Replaced
Industry standards-Medicine
YY/T 1437-2016 Medical devices—Guidance on the applicantion of ISO 14971
YY/T 1437-2016 Medical devices—Guidance on the applicantion of ISO 14971
Basic Information
Standard Code:
YY/T 1437-2016
Standard Type:
Industry standards
Standard Status:
Replaced
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Integrated medical equipment
Publish Date:
2016-01-26
Implement Date:
2017-01-01
Pages:
14 pages
Scope
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.
Development Information
Superseded by the following standards
Adopt standards
ISO/TR 24971:2013
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