GB/T 13339-1991
Abolished
YY/T 0869.2-2016
Active
Industry standards-Medicine
YY/T 0869.2-2016 Medical devices—Hierarchical coding structure for adverse events—Part 2:Evaluation codes
YY/T 0869.2-2016 Medical devices—Hierarchical coding structure for adverse events—Part 2:Evaluation codes
Basic Information
Standard Code:
YY/T 0869.2-2016
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Quality management and quality assurance
Publish Date:
2016-01-26
Implement Date:
2017-01-01
Pages:
15 pages
Scope
This part of YY/T 0869 specifies the requirements for a grading coding structure for describing the analysis or evaluation results of adverse events related to medical devices. These codes are primarily intended for use by medical device manufacturers and regulatory authorities. The codes are not only used for failures that may lead to death or serious injury, but also for the analysis or evaluation results of events other than death or serious injury.
This part is not intended to determine whether an accident requires reporting.
Development Information
Same series standard
Replace the following standards
Adopt standards
ISO/TS 19218-2:2012
Related Standards
GB/T 13340-1991
Abolished
GB/T 13340-1991 Methods for determination and calculation of quality grading rate of products
GB/T 13341-1991
Abolished
GB/T 13341-1991 Methods for determination and accounting of quality failure rate
GB/T 19004.3-1994
Abolished
GB/T 19004.3-1994 Quality management and quality system elements—Part 3:Guidelines for processed materials
GB/T 19004.2-1994
Abolished
GB/T 19004.2-1994 Quality management and quality system element—Part 2:Guidelines for services
GB/T 19000.4-1995
Abolished