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
New Sale! 
View larger
View larger ISO 11607-2:2019
New product
ISO 11607-2:2019
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processesMore info
This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.
It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
| Author | ISO/TC 198 Sterilization of health care products |
|---|---|
| Editor | ISO |
| Document type | Standard |
| Format | Paper |
| Edition | 2 |
| ICS | 11.080.30 : Sterilized packaging |
| Number of pages | 13 |
| Replace | ISO 11607-2:2006 ISO 11607-2:2006/Amd 1:2014 |
| Weight(kg.) | 0.1221 |
| Year | 2019 |
| Country | Switzerland |