HRN EN 868-5:2010
Ambalaža za završno sterilizirane medicinske proizvode -- 5. dio: Ljepljive vrećice i svitci od poroznih tvari i izrađeni od plastičnog filma -- Zahtjevi i ispitne metode (EN 868-5:2009)
| Oznaka: | HRN EN 868-5:2010 |
| Naslov (HR): | Ambalaža za završno sterilizirane medicinske proizvode -- 5. dio: Ljepljive vrećice i svitci od poroznih tvari i izrađeni od plastičnog filma -- Zahtjevi i ispitne metode (EN 868-5:2009) |
| Naslov (EN): | Packaging for terminally sterilized medical devices -- Part 5: Sealable pouches and reels of porous materials and plastic film construction -- Requirements and test methods (EN 868-5:2009) |
| Područje primjene (EN): | This part of EN 868 provides test methods and values for sealable pouches and reels manufactured from porous materials complying with either EN 868 part 2, 3, 6, 7, 9 or 10 and plastic film complying with Clause 4 used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. NOTE 1 The need for a protective packaging may be determined by the manufacturer and the user. This part of EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part of EN 868 but does not add or modify the general requirements specified in EN ISO 11607-1. As such, the particular requirements in 4.2 to 4.5 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. The materials specified in this part of EN 868 are intended for single use only. NOTE 2 When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, container filter, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities, may apply. |
| Izdanje: | 2 |
| ICS: | 11.080.30 Sterilizirani zavoji |
| Tehnički odbor/pododbor: | TO 555, Medicinski proizvodi |
| Oznaka faze: | 95.99 - povlačenje HRN |
| Glasilo (rasprava): | 1/2010 () |
| Glasilo (objava): | 2/2010 () |
| Glasilo (povlačenje): | 1/2019 () |
| Način prihvaćanja: | pr - prihvaćanje strane norme u izvorniku |
| Cijena #1: | Cijena: 32,00 € | Jezik: en | Cjenovni razred: E | Broj stranica: 19 |
| Izvornik: | EN 868-5:2009 |
| Zamjenjuje: | HRN EN 868-5:2008 |
| Zamjenjena s: | HRN EN 868-5:2019 |
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