Hello. Sign In
Standards Store




Look Inside

ISO 11607-1

1st Edition, April 15, 2006

Base Document Only

View complete document

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

Includes all amendments and changes through Change/Amendment , April 15, 2006


Detail Summary

EN
Additional Comments:
ENGLISH
Format
Details
Price (USD)
PDF
Single User
$82.00
Print
In Stock
$82.00
Add to Cart

Product Details:


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.
The 9000 Store