SSH EN ISO 11137-1:2006/A1:2013

Sterilizimi i produkteve të kujdesit shëndetsor- Rrezatimi - Kërkesa për zhvillimin, vlerësimin dhe kontrolli rutinë të një procesi sterilizimi për pajisjet mjeksore(ISO 11137-1:2006/Amd 1:2013)

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006/Amd 1:2013)

Publication date: 6 maj 2014

95.99 Withdrawal of Standard 30 mar 2016

General information

Current stage: 95.99 Effective date: 30 mar 2016

Originator: DPS

Owner: DPS/KT 316

Type: European Norm

ICS: 11.080.01

Gjuha: anglisht

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Statusi: Shfuqizuar

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Related directives

Directives related to this standards.

98/79/EC

Pajisje mjekësore të diagnostikimit "in-vitro"

Directive 98/79/EC

93/42/EEC

Pajisje Mjekësore

Të harmonizuara

Directive 93/42/EEC

90/385/EEC

Pajisjet mjekësore aktive transplatuese

Të harmonizuara

Directive 90/385/EEC

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WITHDRAWN
SSH EN ISO 11137-1:2006/A1:2013
95.99 Withdrawal of Standard
30 mar 2016

REVISED BY

PUBLISHED
SSH EN ISO 11137-1:2015

SSH EN ISO 11137-1:2006/A1:2013

Sterilizimi i produkteve të kujdesit shëndetsor- Rrezatimi - Kërkesa për zhvillimin, vlerësimin dhe kontrolli rutinë të një procesi sterilizimi për pajisjet mjeksore(ISO 11137-1:2006/Amd 1:2013)

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006/Amd 1:2013)

95.99 Withdrawal of Standard 30 mar 2016

General information

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Scope

Related directives

Life cycle

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REVISED BY

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Adopted from EN ISO 11137-1:2006/A1:2013