ISO 11607-1:2006

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

Standard Details

ISO 11607-1:2006 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.

ISO 11607-1:2006 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.

ISO 11607-1:2006 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.

ISO 11607-1:2006 does not describe a quality assurance system for control of all stages of manufacture.

General Information

Status : WITHDRAWN

Standard Type: Main

Document No: ISO 11607-1:2006

Document Year: 2006

Pages: 24

Edition: 1

Section Volume:
ISO/TC 198. Sterilization of health care products

ICS:
11.080.30 Sterilized packaging

Preview Document

Life Cycle

Published

ISO 11607-1:2019

Currently Viewing

WITHDRAWN

ISO 11607-1:2006

ISO 11607-1:2006

Standard Details

General Information

Life Cycle

Add Standards To Trackedge

Enquiry Form