SN/T 3062.3-2011 (English Version) PDF

Scope: This part of SN/T 3062 specifies the test methods and requirements for sealed bags and rolls used for sterilized medical device packaging. The main purpose of this section is to establish standards for sterile barriers or packaging systems to ensure the sterility of sterilized medical devices. All devices specified in this section are single use.

SN/T 3062.3-2011 Referenced Document

EN 868-2 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods*， 2017-02-01 Update
EN 868-3 Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods*， 2017-02-01 Update
EN 868-6 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods*， 2017-02-01 Update
EN 868-7 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods*， 2017-02-01 Update
EN 868-9 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
EN ISO 11140-1 Sterilization of health care products - Chemical indicators - Part 1: General requirements*， 2014-11-01 Update
EN ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials@ sterile barrier systems and packaging systems
ISO 8601 Data elements and interchange formats - Information interchange - Representation of dates and times

2011 SN/T 3062.3-2011 Packaging materials for terminally sterilized medical devices for import. Part 3:Sealable pouches and reels of porous materials and plastic film construction. Requirements and test methods