ISO 11135:2014

Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices

Publication date: 7 korr 2014

General information

Current stage: 90.92 Effective date: 22 korr 2024

Originator: ISO

Owner: ISO/TC 198

Type: International Standard

ICS: 11.080.01

Gjuha: anglisht frëngjisht

Buying

Statusi: Publikuar

PDF - 25 441 Lekë

Paper - 25 441 Lekë

CD - 25 441 Lekë

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Scope

ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 11135-1:2007

WITHDRAWN
ISO/TS 11135-2:2008

WITHDRAWN
ISO/TS 11135-2:2008/Cor 1:2009

NOW

PUBLISHED
ISO 11135:2014
90.92 Standard to be revised
22 korr 2024

CORRIGENDA / AMENDMENTS

PUBLISHED
ISO 11135:2014/Amd 1:2018

REVISED BY

ABANDON
ISO/DIS 11135

IN_DEVELOPMENT
ISO/DIS 11135