HRN EN ISO 11607-1:2020
Ambalaža za završno sterilizirane medicinske proizvode -- 1. dio: Zahtjevi za materijale, sustave sterilne obloge i sustave ambalaže (ISO 11607-1:2019; EN ISO 11607-1:2020)
| Oznaka: | HRN EN ISO 11607-1:2020 |
| Naslov (HR): | Ambalaža za završno sterilizirane medicinske proizvode -- 1. dio: Zahtjevi za materijale, sustave sterilne obloge i sustave ambalaže (ISO 11607-1:2019; EN ISO 11607-1:2020) |
| Naslov (EN): | Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019; EN ISO 11607-1:2020) |
| Područje primjene (EN): | This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use. It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized. It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations. It does not describe a quality assurance system for control of all stages of manufacture. It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal. |
| Izdanje: | 4 |
| ICS: | 11.080.30 Sterilizirani zavoji |
| Tehnički odbor/pododbor: | TO 555, Medicinski proizvodi |
| Oznaka faze: | 60.60 - HRN dostupan |
| Glasilo (rasprava): | HZN e-Glasilo 10/2017 () |
| Glasilo (objava): | HZN e-Glasilo 2/2020 () |
| Način prihvaćanja: | pr - prihvaćanje strane norme u izvorniku |
| Cijena #1: | Cijena: 48,00 € | Jezik: en | Cjenovni razred: I | Broj stranica: 48 |
| Izvornik: | EN ISO 11607-1:2020 |
| Zamjenjuje: | HRN EN ISO 11607-1:2017 |
| Direktiva/Uredba: | (EU) 2017/746, (EU) 2017/745 |
Obrazac za naručivanje normativnih dokumenata i/ili publikacija (obrazac ob.025-2):