YY/T 0698.1-2011 (English Version) PDF

Scope: This part of YY/T 0698 specifies the requirements and test methods for co-extruded plastic films for blister packaging for final medical device packaging (hereinafter referred to as "blister films"). This standard applies to co-extruded plastic films used for blister packaging of medical devices in medical device factories. This section does not add requirements to the general requirements of ISO 110607-1, so that the specific requirements in 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 medical device sterile barrier system is composed of blister film and other packaging materials, which allows users to see the contents before opening the package to facilitate aseptic operation.

YY/T 0698.1-2011 Referenced Document

GB/T 1040.1-2006 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 1040.3-2006 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 Plastic.Determination of tensile properties.Part 5:Test conditions for unidirectional fibre-reinforced plastic composites
GB/T 16578.1 Plastics.Film and sheeting.Determination of tear resistance.Part 1:Trouser tear method
GB/T 458-2008 Paper and board.Determination of air permeance
GB/T 6672 Plastics film and sheeting Determination of thickness by mechanical scanning
GB/T 6673 Plastics film and sheeting determination of length and width
GB/T 7408 Data elements and interchange formats-Information interchange-Representation of dates and times
GB/T 8809 Pendulum impact resistance of plastic film*， 2015-09-11 Update

2011 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