ISO 11137:1995

Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization

Publication date: Mar 9, 1995

95.99 Withdrawal of Standard Apr 19, 2006

General information

Current stage: 95.99 Effective date: Apr 19, 2006

Originator: ISO

Owner: ISO/TC 198

Type: International Standard

ICS: 11.080.01

Languages: French English

Buying

Status: Withdrawn

PDF - ALL 7,350

Paper - ALL 7,350

CD - ALL 7,350

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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.

Life cycle

NOW

WITHDRAWN
ISO 11137:1995
95.99 Withdrawal of Standard
Apr 19, 2006

CORRIGENDA / AMENDMENTS

WITHDRAWN
ISO 11137:1995/Cor 1:1997

WITHDRAWN
ISO 11137:1995/Amd 1:2001

REVISED BY

ABANDON
ISO/WD 11137

WITHDRAWN
ISO 11137-1:2006

WITHDRAWN
ISO 11137-2:2006

WITHDRAWN
ISO 11137-3:2006