ISO 11137:1995 PDF
Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization
Title (English):
ISO 11137:1995
Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization
- Document status:
- Withdrawn
- Format:
- Electronic (PDF)
- Number of pages:
- 61
- Publication date:
- March 9, 1995
- Edition:
- ISO IS 11137 edition 1 version 1
- ICS:
- 11.080.01
Description (English):
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.
Technical details
- Technical committee
- ISO/TC 198 - Sterilization of health care products
- SKU
- ISO 11137:1995
