ISO 11137:1995
Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization

Standard No.

ISO 11137:1995

Release Date

1995

Published By

International Organization for Standardization (ISO)

Status

Withdraw

Replace By

ISO 11137:1995/Cor 1:1997

Latest

ISO 11137:1995/Amd 1:2001

Scope

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.

ISO 11137:1995 history

• 2001 ISO 11137:1995/Amd 1:2001 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization; Amendment 1: Selection of terms for dose setting
• 1997 ISO 11137:1995/Cor 1:1997 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization; Technical Corrigendum 1
• 1995 ISO 11137:1995 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization