GB 12264-1990
Replaced
YY/T 1494-2016
Active
Industry standards-Medicine
YY/T 1494-2016 Packaging materials for haemodialysis and related therapeutic concentrates—General requirements
YY/T 1494-2016 Packaging materials for haemodialysis and related therapeutic concentrates—General requirements
Basic Information
Standard Code:
YY/T 1494-2016
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Extracorporeal circulation, artificial organs, and prosthetic devices
ICS Name:
Surgical implants, prostheses, and orthoses
Publish Date:
2016-07-29
Implement Date:
2017-06-01
Pages:
13 pages
Scope
This standard specifies the general technical requirements for the quality inspection of packaging materials for blood dialysis and related treatment concentrates, including classification and properties, requirements, test methods, and marking, packaging, transportation, and storage.
This standard applies to packaging materials for blood dialysis and related treatment concentrates.
This standard does not apply to packaging materials for centralized fluid supply and hospital-prepared concentrates.
Development Information
Referenced Standards
GB/T 5750.6-2006 Standard examination methods for drinking water— Metal parameters
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods
中华人民共和国药典(2010年版二部)
GB/T 1037-1988 Test method for water vapor transmission of plastic film and sheet—Cup method
GB/T 1037-2021 Test method for water vapor transmission of plastic film and sheet—Desiccant method and water method
GB/T 1038-2000 Plastics—Film and sheeting—Determination of gas transmission—Differential-pressure method
GB/T 1038.1-2022 Plastics—Film and sheeting—Determination of gas-transmission rate—Part 1:Differential-pressure methods
GB/T 1038.2-2022 Plastics—Film and sheeting—Determination of gas-transmission rate—Part 2:Equal-pressure methods
YY 0598-2006 Concentrates for haemodialysis and related therapies
YY 0598-2015 Concentrates for haemodialysis and related therapies
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