STN EN ISO 11607-1/Zmena A1
| Označenie: | STN EN ISO 11607-1/Zmena A1 |
| Platnosť: | Platná |
| Počet strán: | 36 |
| Jazyk: |
EN
|
| Listinná verzia: | 17,20€ |
| Elektronická verzia: |
a) Bez možnosti tlače, prenosu textu a obrázkov:
15,48€ b) Bez možnosti tlače, s prenosom textu a obrázkov: 17,20€ c) S možnosťou tlače, prenosu textu a obrázkov: 22,36€ |
| Slovenský názov: | Obaly na sterilizované zdravotnícke pomôcky. Časť 1: Požiadavky na materiály, systémy sterilných bariér a obalové systémy. Zmena A1: Uplatňovanie manažérstva rizika (ISO 11607-1: 2019/Amd 1: 2023) |
| Anglický názov: | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019) |
| Dátum vydania: | 01. 01. 2024 |
| Dátum zrušenia: | |
| ICS: | 11.080.30 |
| Triediaci znak: | 85 6543 |
| Úroveň zapracovania: | idt ISO 11607-1:2019/Amd 1:2023, idt EN ISO 11607-1:2020/A1:2023 |
| Vestník: | 12/23 |
| Zmeny: | |
| Nahradzujúce normy: | |
| Nahradené normy: | |
| Poznámka vo Vestníku: | |
| Predmet normy: | 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. |
| Náhľad normy: | Náhľad normy (PDF) |