ISO 11607 Packaging for terminally sterilized medical devices

	Purchase Information Use this form to request purchase information on ISO online subscriptions. ISO Collections First Name: Last Name: Email address:

Document ISO 11607 is offered by IHS as part of an online subscription. This subscription contains many documents on the same topic.

You may also purchase this document alone from the IHS Standards Store.

ISO 11607 Document Information:

Title
Packaging for terminally sterilized medical devices

International Organization for Standardization

Publication Date:
Feb 15, 2003

Scope:

This International Standard specifies the requirements for single-use materials and reusable containers used for packaging of terminally sterilized medical devices, whether produced industrially or in health care facilities (see clause 6).

This International Standard outlines principal requirements for packaging process development and validation for the manufacturer of terminally sterilized medical devices (see clause 7). Forming and sealing are considered to be the most critical processes. Other process operations that can affect the final package are addressed also. Guidelines are provided for the most common practices and techniques.

This International Standard specifies requirements for essential criteria used to evaluate the performance of packages for sterile medical devices (see clause 7). The intent is to provide designers and manufacturers of medical devices with a framework of laboratory tests and evaluations that can be used to qualify the overall performance of the package used to protect device components during handling, distribution and storage.

This International Standard does not cover all requirements for packaging for products manufactured aseptically; in such cases, additional requirements are necessary to ensure that the packaging and packaging process do not present a source of contamination of the product.

This International Standard is not applicable to protocols for sampling plans or the number and duration of replicate runs.

NOTE For the purposes of this International Standard, hospitals or other organizations that package medical devices are considered to be manufacturers.

About IHS
IHS (NYSE: IHS) is a leading global provider of critical technical information, decision-support tools and related services in a number of industries including aerospace and defense, automotive, construction, electronics, and energy. IHS serves customers ranging from large governments and multinational corporations to smaller companies and technical professionals in more than 100 countries. IHS been in business for more than 45 years and employ more than 2,300 people around the world.