1. Sterile barrier system (SBS): In the ISO/EN standard […]
1. Sterile barrier system (SBS): In the ISO/EN standard, medical device packaging is referred to as a sterile barrier system.
2. Basic requirements for all types of sterile barrier systems (SBS):
Can make sterilizing agent enter
Can be sterilized
Protects the contents of the bag
Can sterilize (if applicable)
Maintain sterility of the contents during the following process
(1) Storage
(2) Transportation
(3) When applicable
3. Relevant standards for SBS confirmation:
ISO 11607-1,-2; EN868-1,-2,-3,-4,-5,-6; ASTM-various test methods; AAMI ST77
4. Applicable test methods for SBS confirmation: physical test, microbiological test
5. The 2014 revision of EN ISO 11607-1 defines a microbial barrier as a property that demonstrates the ability to prevent microbial invasion of a sterile barrier system under test conditions such as sterilization, handling, distribution, transport and storage.
6. SBS packaging type of medical equipment:
Microbial barrier material for disposable sealing edges: aseptic packaging bags, permeable materials
A disposable, reusable microbial barrier material that creates a tortuous path through folding techniques: sterile cloth, non-woven fabric, cotton
Reusable microbial barrier material that creates a tortuous path through filters or valves: rigid containers
7. Test by package type: disposable bag, disposable/reusable packaging, reusable container
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