Specifies requirements for validation, process control and routine monitoring in the radiation sterilization of health care products. 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. Does not cover facility design, licensing, operator training, factors related to radiation safety, the assessment of the suitability of the product for its intended use.
Status: WithdrawnPublication date: 1995-03
Edition: 1Number of pages: 61
Technical Committee: ISO/TC 198 Sterilization of health care products
- ICS :
- 11.080.01 Sterilization and disinfection in general
ISO 11137:1995Stage: 95.99
Corrigenda / AmendmentsWithdrawn
ISO 11137:1995/Amd 1:2001Withdrawn
ISO 11137:1995/Cor 1:1997
Got a question?
Check out our FAQs
+41 22 749 08 88
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)
Keep up to date with ISO
Sign up to our newsletter for the latest news, views and product information.