GB/T 13339-1991
Abolished
YY/T 0869.1-2016
Active
Industry standards-Medicine
YY/T 0869.1-2016 Medical devices—Hierarchical coding structure for adverse events—Part 1:Event-type codes
YY/T 0869.1-2016 Medical devices—Hierarchical coding structure for adverse events—Part 1:Event-type codes
Basic Information
Standard Code:
YY/T 0869.1-2016
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:
16 pages
Scope
This part of YY/T 0869 specifies the requirements for a classification and coding structure for describing adverse events related to medical devices. This coding is intended to be used by medical device users, manufacturers, regulatory authorities, medical institutions, and other organizations. The coding may be used to encode events unrelated to death or serious injury, or to encode malfunctions that may lead to death or serious injury.
This part is not intended to be used to determine whether an accident requires reporting.
Development Information
Same series standard
Replace the following standards
Adopt standards
ISO/TS 19218-1:2011
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