GB 8662-1988
Replaced
YY/T 1597-2017
Active
Industry standards-Medicine
YY/T 1597-2017 Neonatal phenylalanine testing kit
YY/T 1597-2017 Neonatal phenylalanine testing kit
Basic Information
Standard Code:
YY/T 1597-2017
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Surgical instruments and materials
Publish Date:
2017-12-05
Implement Date:
2018-12-01
Pages:
7 pages
Scope
This standard specifies the technical requirements, testing methods, marking, labeling, instructions, packaging, transportation, and storage for neonatal phenylalanine determination kits.
This standard applies to the technical methods used in quantitative detection of neonatal umbilical cord blood or dried blood samples on heel filter paper, such as fluorescence method and enzyme method.
Development Information
Referenced Standards
GB/T 191-2000 Packaging—Pictorial marking for handling of goods
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
GB/T 29791.2-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 2:In vitro diagnostic reagents for professional use
GB/T 191-2025 Graphical symbols marking for handling and storage of packages
Related Standards
GB 2766-1995
Replaced
GB 2766-1995 Haemostatic forceps with box joint—General specifications
GB/T 10160-1995
Abolished
GB/T 10160-1995 Test methods of locking force and opening force for medical use forceps
GB 9706.4-1999
Replaced
GB 9706.4-1999 Medical electrical equipment—Part 2:Particular requirements for the safety of high frequency surgical equipment
YY 0464-2003
Replaced
YY 0464-2003 Single use hemoperfutor
YY 0054-2003
Replaced