ISO 11137 Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization
 |
| Purchase Information |
| Use this form to request purchase information on ISO online subscriptions. |
|
|
Document ISO 11137 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 11137 Document Information:
Title
Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization
International Organization for Standardization
Publication Date:
Mar 1, 1995
Scope:
This International Standard specifies requirements for validation, process control and routine monitoring in the radiation sterilization of health care products. It applies to continuous and batch type gamma irradiators using the radionuclides 60 Co and 137 Cs, and to irradiators using a beam from an electron or x-ray generator.
Annexes are also included to provide supplementary information.
Facility design, licensing, operator training and factors related to radiation safety are outside the scope of this International Standard. It does not cover the assessment of the suitability of the product for its intended use. The use of biological indicators for validation or process monitoring, or the use of sterility testing for product release, are also not covered, as they are not recommended practices for radiation sterilization.
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.
