GB 18278-2000
Replaced
YY/T 0884-2013
Active
Industry standards-Medicine
YY/T 0884-2013 Evaluation of materials of health care product subject to radiation sterilization
YY/T 0884-2013 Evaluation of materials of health care product subject to radiation sterilization
Basic Information
Standard Code:
YY/T 0884-2013
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Public medical equipment
ICS Name:
Integrated disinfection and sterilization
Publish Date:
2013-10-21
Implement Date:
2014-10-01
Pages:
18 pages
Scope
This standard provides procedures and information for evaluating the suitability of the constituent materials of healthcare products (including packaging), including polymers, metals, ceramics/glass, and other materials, for radiation sterilization processing. It provides guidance for selecting and identifying materials for healthcare products and packaging.
Development Information
Referenced Standards
GB/T 1041-2008 Plastics—Detemination of compressive properties
GB/T 2410-2008 Determination of the luminous transmittance and haze of transparent plastics
GB/T 2411-2008 Plastics and ebonite—Determination of indentation hardness by means of a durometer(shore hardness)
GB/T 3398.2-2008 Plastics—Determination of hardness—Part 2:Rockwell hardness
GB/T 9341-2008 Plastics—Determination of flexural properties
GB/T 16578.1-2008 Plastics—Film and sheeting—Determination of tear resistance—Part 1:Trouser tear method
ISO 11137-1:2006
GB/T 1040.1-2006 Plastics—Determination of tensile properties—Part 1:General principles
GB/T 1040.1-2018 Plastics—Determination of tensile properties—Part 1:General principles
GB/T 1040.2-2006 Plastics—Determination of tensile properties—Part 2:Test conditions for moulding and extrusion plastics
GB/T 1040.2-2022 Plastics—Determination of tensile properties—Part 2:Test conditions for moulding and extrusion plastics
GB/T 1040.3-2006 Plastics—Determination of tensile properties—Part 3:Test conditions for films and sheets
GB/T 1040.4-2006 Plastics—Determination of tensile properties—Part 4:Test conditions for isotropic and orthotropic fibre-reinforced plastic composites
GB/T 1040.5-2008 Plastics—Determination of tensile properties—Part 5:Test conditions for unidirectional fibre-reinforced plastic composites
GB/T 13525-1992 Test method for tensile-impact property of plastics
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
HG/T 3862-2006 Plastics--Yellow index test method
GB/T 1040.1-2025 Plastics—Determination of tensile properties—Part 1:General principles
Related Standards
GB 18281.1-2000
Replaced
GB 18281.1-2000 Sterilization of health care products—Biological indicators—Part 1:General
GB 18281.2-2000
Replaced
GB 18281.2-2000 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization
GB 18281.3-2000
Replaced
GB 18281.3-2000 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization
GB 18282.1-2000
Replaced
GB 18282.1-2000 Sterilization of health care products—Chemical indicators—Part 1:General requirements
YY/T 0567.2-2005
Replaced