GB 12264-1990
Replaced
YY/T 1800-2021
Active
Industry standards-Medicine
YY/T 1800-2021 Deafness gene mutations testing kit
YY/T 1800-2021 Deafness gene mutations testing kit
Basic Information
Standard Code:
YY/T 1800-2021
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical optical instruments and equipment, and endoscopes
ICS Name:
Surgical implants, prostheses, and orthoses
Publish Date:
2021-09-06
Implement Date:
2023-03-01
Pages:
12 pages
Scope
This standard specifies the requirements, testing methods, labels, and user manuals, packaging, transportation, and storage for deafness gene mutation detection kits.
This standard applies to deafness gene mutation detection kits using methods such as chip technology, mass spectrometry, and PCR (e.g., fluorescence PCR, PCR-fluorescence probe method, fluorescence PCR melting curve method, etc.), but it does not apply to deafness gene mutation detection kits based on sequencing technology.
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 12279-1990
Replaced
GB 12279-1990 Cardiac valve prostheses general technical specification
GB 12417-1990
Replaced
GB 12417-1990 The general technological conditions of surgical metal implant
GB/T 13461-1992
Replaced
GB/T 13461-1992 Synthetic resin blow knee prostheses
GB/T 14191-1993
Replaced
GB/T 14191-1993 Terminology for prosthetics and orthotics
GB 14722-1993
Replaced