HRN EN ISO 13408-6:2011
Aseptički postupci za proizvode zdravstvene zaštite -- 6. dio: Sustavi izolacije (ISO 13408-6:2005; EN ISO 13408-6:2011)
| Oznaka: | HRN EN ISO 13408-6:2011 |
| Naslov (HR): | Aseptički postupci za proizvode zdravstvene zaštite -- 6. dio: Sustavi izolacije (ISO 13408-6:2005; EN ISO 13408-6:2011) |
| Naslov (EN): | Aseptic processing of health care products -- Part 6: Isolator systems (ISO 13408-6:2005; EN ISO 13408-6:2011) |
| Područje primjene (EN): | ISO 13408-6:2005 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products. ISO 13408-6:2005 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials. ISO 13408-6:2005 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular to national or regional jurisdictions. |
| 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): | 1/2011 () |
| Glasilo (objava): | 4/2011 () |
| Glasilo (povlačenje): | 6/2021 () |
| Način prihvaćanja: | pr - prihvaćanje strane norme u izvorniku |
| Cijena #1: | Cijena: 35,00 € | Jezik: en | Cjenovni razred: F | Broj stranica: 24 |
| Izvornik: | EN ISO 13408-6:2011 |
| Zamjenjuje: | HRN EN 13824:2007 |
| Zamjenjena s: | HRN EN ISO 13408-6:2021 |
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