HRN EN ISO 13408-6:2021
Aseptički postupci za proizvode zdravstvene zaštite -- 6. dio: Sustavi izolacije (ISO 13408-6:2021; EN ISO 13408-6:2021)
| Oznaka: | HRN EN ISO 13408-6:2021 |
| Naslov (HR): | Aseptički postupci za proizvode zdravstvene zaštite -- 6. dio: Sustavi izolacije (ISO 13408-6:2021; EN ISO 13408-6:2021) |
| Naslov (EN): | Aseptic processing of health care products -- Part 6: Isolator systems (ISO 13408-6:2021; EN ISO 13408-6:2021) |
| Područje primjene (EN): | This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products. This document does not specify requirements for restricted access barrier systems (RABS). This document does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and/or compendia requirements that pertain in particular to national or regional jurisdictions. This document does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document could be applicable to this application. This document does not define biosafety containment requirements. |
| 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 4/2019 () |
| Glasilo (objava): | HZN e-Glasilo 6/2021 () |
| Način prihvaćanja: | pr - prihvaćanje strane norme u izvorniku |
| Cijena #1: | Cijena: 45,00 € | Jezik: en | Cjenovni razred: H | Broj stranica: 34 |
| Izvornik: | EN ISO 13408-6:2021 |
| Zamjenjuje: | HRN EN ISO 13408-6:2011 |
| Direktiva/Uredba: | (EU) 2017/746, (EU) 2017/745 |
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