GB/T 8600-1988
Replaced
YY/T 0698.1-2011
Active
Industry standards-Medicine
YY/T 0698.1-2011 Packaging materials for terminal sterilized medical devices—Part 1:Co-extrusion plastic films used for vacuum forming packaging—Requirements and test methods
YY/T 0698.1-2011 Packaging materials for terminal sterilized medical devices—Part 1:Co-extrusion plastic films used for vacuum forming packaging—Requirements and test methods
Basic Information
Standard Code:
YY/T 0698.1-2011
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Generally, it refers to microsurgical instruments
ICS Name:
Disinfection and sterilization
Publish Date:
2011-12-31
Implement Date:
2013-06-01
Pages:
6 pages
Scope
This part of YY/T 0698 specifies the requirements and test methods for co-extruded plastic films (hereinafter referred to as "blister films") used for packaging medical devices for final sterilization. This standard applies to co-extruded plastic films used for blister packaging of medical devices in medical device factories.
This part does not add any requirements to the general requirements of ISO 11607-1, so the specific requirements in clauses 4.2 to 4.5 can be used to demonstrate compliance with one or more requirements of ISO 11607-1, but not all of its requirements.
The sterile barrier system of medical devices composed of blister films and other packaging materials enables users to see the contents before opening the packaging, thus facilitating sterile operations.
Development Information
Referenced Standards
GB/T 458-2008 Paper and board—Determination of air permeance
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 6672-2001 Plastics film and sheeting—Determination of thickness by mechanical scanning
GB/T 6673-2001 Determination of length and width of plastics film and sheeting
GB/T 7408-1994 Data elements and interchange formats—Information interchange—Representation of dates and times
GB/T 7408-2005 Data elements and interchange formats—Information interchange—Representation of dates and times
GB/T 7408.1-2023 Date and time—Representations for information interchange—Part 1:Basic rules
GB/T 8809-2015 Pendulum impact resistance of plastic film
GB/T 16578.1-2008 Plastics—Film and sheeting—Determination of tear resistance—Part 1:Trouser tear method
GB/T 1040.1-2025 Plastics—Determination of tensile properties—Part 1:General principles
GB/T 7408.2-2025 Date and time—Representation for information interchange—Part 2:Extensions
Related Standards
GB 8599-1988
Replaced
GB 8599-1988 Specifications for automated autoclave sterilizer
GB 15981-1995
Replaced
GB 15981-1995 Evaluating method and standard for the efficacy of disinfection and sterilization
GB 15982-1995
Replaced
GB 15982-1995 Hygienic standard for disinfection in hospitals
GB 16383-1996
Replaced
GB 16383-1996 Quality control standards for radiation sterilization of medical and hygienical products
GB 18279-2000
Replaced