GB 11243-2000
Replaced
YY/T 0639-2019
Active
Industry standards-Medicine
YY/T 0639-2019 In vitro diagnostic medical devices—Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
YY/T 0639-2019 In vitro diagnostic medical devices—Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
Price:
$ 34.00
Basic Information
Standard Code:
YY/T 0639-2019
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Diagnostic equipment
Publish Date:
2019-07-24
Implement Date:
2020-08-01
Pages:
16 pages
Scope
This standard specifies the requirements for the information provided by manufacturers of reagents for biological staining.
This standard applies to producers, suppliers, and retailers of dyes, staining agents, color-developing reagents, and other products used for histological and cytological staining (microbiology, hematology, histochemistry). These reagents are used in medical laboratories for routine staining and in all fields of biological staining for microbiological research. The requirements for the information provided by manufacturers specified in this standard are a prerequisite for obtaining comparable and reproducible results.
Development Information
Replace the following standards
Referenced Standards
GB/T 29791.1-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer(labelling)—Part 1:Terms,definitions and general requirements
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
ISO 80000-1
ISO 80000-9
GB/T 19001-2000 Quality management systems—Requirements
GB/T 19001-2008 Quality management systems—Requirements
GB/T 19001-2016 Quality management systems—Requirements
YY/T 0287-2003 Medical devices—Quality management systems—Requirements for regulatory purposes
YY/T 0287-2017 Medical devices—Quality management systems—Requirements for regulatory purposes
Adopt standards
ISO 19001:2013
Related Standards
GB 1588-2001
Replaced
GB 1588-2001 Clinical thermometer
YY 0109-2003
Replaced
YY 0109-2003 Medical ultrasonic nebulizer
YY 0455-2003
Replaced
YY 0455-2003 Medical electrical equipment—Part 2:Particular requirments for the safety of infant radiant warmers
YY/T 1036-2004
Active
YY/T 1036-2004 Impression tonometers
GB/T 19665-2005
Replaced