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Glavni meni

ISO 11137-1:2006

Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
19. 4. 2006.
95.99   Povučen   2. 4. 2025.

Опште информације

95.99     2. 4. 2025.

ISO

ISO/TC 198

Međunarodni standard

11.080.01  

engleski   francuski  

Kupovina

Povučen

Jezik na kome želite da primite dokument.

Apstrakt

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.

Životni ciklus

TRENUTNO

POVUČEN
ISO 11137-1:2006
95.99 Povučen
2. 4. 2025.

ISPRAVKE / IZMENE

POVUČEN
ISO 11137-1:2006/Amd 1:2013

POVUČEN
ISO 11137-1:2006/Amd 2:2018

REVIDIRAN OD

NAPUŠTEN
ISO/NP 11137-1

OBJAVLJEN
ISO 11137-1:2025

Nacionalna preuzimanja

Sterilizacija proizvoda za medicinsku upotrebu - Zračenje - Deo 1: Zahtevi za razvoj, validaciju i rutinsku kontrolu procesa sterilizacije medicinskih sredstava

95.99   Povučen

Sterilizacija proizvoda za zaštitu zdravlja – Zračenje – Deo 1: Zahtevi za razvoj, validaciju i rutinsku kontrolu procesa sterilizacije medicinskih sredstava

60.60   Standard objavljen