ISO 11137:1995

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

Publication date: 9 mar 1995

95.99 Withdrawal of Standard 19 pri 2006

General information

Current stage: 95.99 Effective date: 19 pri 2006

Originator: ISO

Owner: ISO/TC 198

Type: International Standard

ICS: 11.080.01

Gjuha: frëngjisht anglisht

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Statusi: Shfuqizuar

PDF - 7 350 Lekë

Paper - 7 350 Lekë

CD - 7 350 Lekë

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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WITHDRAWN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
19 pri 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WITHDRAWN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WITHDRAWN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WITHDRAWN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WITHDRAWN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WITHDRAWN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