HRN EN ISO 11137-1:2007
Sterilizacija proizvoda za zdravstvenu skrb -- Zračenje -- 1. dio: Zahtjevi za razvoj, vrednovanje i kontrolu provedbe sterilizacijskog postupka za medicinske proizvode (ISO 11137-1:2006; EN ISO 11137-1:2006)
| Oznaka: | HRN EN ISO 11137-1:2007 |
| Naslov (HR): | Sterilizacija proizvoda za zdravstvenu skrb -- Zračenje -- 1. dio: Zahtjevi za razvoj, vrednovanje i kontrolu provedbe sterilizacijskog postupka za medicinske proizvode (ISO 11137-1:2006; EN ISO 11137-1:2006) |
| Naslov (EN): | 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; EN ISO 11137-1:2006) |
| Područje primjene (EN): | 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. |
| Izdanje: | 1 |
| ICS: | 11.080.01 Sterilizacija i dezinfekcija općenito |
| Tehnički odbor/pododbor: | TO 555, Medicinski proizvodi |
| Oznaka faze: | 95.99 - povlačenje HRN |
| Glasilo (rasprava): | HZN Glasilo 3/2007 () |
| Glasilo (objava): | HZN Glasilo 4/2007 () |
| Glasilo (povlačenje): | HZN e-Glasilo 5/2015 () |
| Način prihvaćanja: | pr - prihvaćanje strane norme u izvorniku |
| Cijena #1: | Cijena: 48,00 € | Jezik: en | Cjenovni razred: I | Broj stranica: 41 |
| Izvornik: | EN ISO 11137-1:2006 |
| Zamjenjena s: | HRN EN ISO 11137-1:2015 |
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