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SSH EN ISO 11137-1:2007

Sterilizimi i produkteve të kujdesit të shëndetit - Pjesa 1: Kërkesat për kryerjen, vlerësimin dhe kontrollin rutinë të një procesi sterilizimi për pajisjet mjekësore

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)
1 jan 2007
95.99 Withdrawal of Standard   30 mar 2016

General information

95.99     30 mar 2016

DPS

DPS/KT 316

European Norm

11.080.01  

anglisht  

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Scope

ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.
ISO 11137-1:2006 covers radiation processes employing irradiators using the radionuclide 60Co or 137Cs, a beam from an electron generator or a beam from an X-ray generator.
ISO 11137-1:2006 does not:
specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease;
detail specified requirements for designating a medical device as sterile;
specify a quality management system for the control of all stages of production of medical devices;
specify requirements for occupational safety associated with the design and operation of irradiation facilities;
specify requirements for the sterilization of used or reprocessed devices.

Related directives

Directives related to this standards.

98/79/EC

Pajisje mjekësore të diagnostikimit "in-vitro"

90/385/EEC

Pajisjet mjekësore aktive transplatuese

Të harmonizuara
93/42/EEC

Pajisje Mjekësore

Të harmonizuara

Life cycle

NOW

WITHDRAWN
SSH EN ISO 11137-1:2007
95.99 Withdrawal of Standard
30 mar 2016

REVISED BY

PUBLISHED
SSH EN ISO 11137-1:2015

Related project

Adopted from EN ISO 11137-1:2006