SSH EN ISO 11135:2014

Sterilizimi i produkteve të kujdesit shëndetësor - Oksid etileni - Kërkesat për zhvillimin, vlerësimin dhe kontrolli i zakonshëm i procesit të sterilizimit për pajisjet mjekësore (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 (ISO 11135:2014)

Publication date: 27 nën 2015

General information

Current stage: 60.60 Effective date: 27 nën 2015

Originator: DPS

Owner: DPS/KT 316

Type: European Norm

ICS: 11.080.01

Gjuha: anglisht

Buying

Statusi: Publikuar

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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.

Related directives

Directives related to this standards.

90/385/EEC

Pajisjet mjekësore aktive transplatuese

Të harmonizuara

më tepër

93/42/EEC

Pajisje Mjekësore

Të harmonizuara

më tepër

2017/745

Të harmonizuara

më tepër

2017/746

Të harmonizuara

më tepër

Life cycle

PREVIOUSLY

Replaces
SSH EN ISO 11135-1:2007

Replaces
DS CEN ISO/TS 11135-2:2008/AC:2009

Replaces
DS CEN ISO/TS 11135-2:2008

NOW

PUBLISHED
SSH EN ISO 11135:2014
60.60 Standard published
27 nën 2015

Related project

Adopted from EN ISO 11135:2014

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