Cart
0
Product
Products
(empty)
No products
To be determined
Shipping
$0.00
Total
Product successfully added to your shopping cart
Quantity
Total
There are 0 items in your cart.
There is 1 item in your cart.
Total products
Total shipping
To be determined
Total
Sale!
View larger
View larger
AAMI 11607-1
New product
AAMI 11607-1 6th Edition, 2010 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems, and packaging
More info
Description / Abstract:
This part of ISO 11607 specifies the requirements and test
methods for materials, preformed sterile barrier systems, sterile
barrier systems and packaging systems that are intended to maintain
sterility of terminally sterilized medical devices until the point
of use.
This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.
This part of ISO 11607 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations.
This part of ISO 11607 does not describe a quality assurance system for control of all stages of manufacture.
This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.
This part of ISO 11607 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations.
This part of ISO 11607 does not describe a quality assurance system for control of all stages of manufacture.