HRN EN ISO 11137-1:2015
Sterilizacija proizvoda za zdravstvenu skrb -- Zračenje -- 1. dio: Zahtjevi za razvoj, vrednovanje i kontrolu provedbe sterilizacijskog postupka za medicinske proizvode (ISO 11137-1:2006, uključujući Amd 1:2013; EN ISO 11137-1:2015)
| Oznaka: | HRN EN ISO 11137-1:2015 |
| 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, uključujući Amd 1:2013; EN ISO 11137-1:2015) |
| 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, including Amd 1:2013; EN ISO 11137-1:2015) |
| 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: | 2 |
| ICS: | 11.080.01 Sterilizacija i dezinfekcija općenito |
| Tehnički odbor/pododbor: | TO 555, Medicinski proizvodi |
| Oznaka faze: | 60.60 - HRN dostupan |
| Glasilo (rasprava): | HZN e-Glasilo 4/2015 () |
| Glasilo (objava): | HZN e-Glasilo 5/2015 () |
| Način prihvaćanja: | pr - prihvaćanje strane norme u izvorniku |
| Cijena #1: | Cijena: 50,00 € | Jezik: en | Cjenovni razred: J | Broj stranica: 50 |
| Izvornik: | EN ISO 11137-1:2015 |
| Zamjenjuje: | HRN EN ISO 11137-1:2007 |
| Direktiva/Uredba: | (EU) 2017/746, (EU) 2017/745 |
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