STN P CEN ISO/TS 17664-3
| Označenie: | STN P CEN ISO/TS 17664-3 |
| Platnosť: | Platná |
| Počet strán: | 24 |
| Jazyk: |
EN
|
| Listinná verzia: | 14,10€ |
| Elektronická verzia: |
a) Bez možnosti tlače, prenosu textu a obrázkov:
12,69€ b) Bez možnosti tlače, s prenosom textu a obrázkov: 14,10€ c) S možnosťou tlače, prenosu textu a obrázkov: 18,33€ |
| Slovenský názov: | Úprava výrobkov na zdravotnú starostlivosť. Informácie poskytované výrobcom zdravotníckych pomôcok na úpravu zdravotníckych pomôcok. Časť 3: Pokyny k zaradeniu opakovane použiteľnej zdravotníckej pomôcky do klasifikácie čistenia (ISO/TS 17664-3: 2026) |
| Anglický názov: | Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 3: Guidance on the designation of a reusable medical device to a cleaning classification (ISO/TS 17664-3:2026) |
| Dátum vydania: | 01. 10. 2026 |
| Dátum zrušenia: | |
| ICS: | 11.080.01 |
| Triediaci znak: | 85 6536 |
| Úroveň zapracovania: | idt CEN ISO/TS 17664-3:2026, idt ISO/TS 17664-3:2026 |
| Vestník: | 09/26 |
| Zmeny: | |
| Nahradzujúce normy: | |
| Nahradené normy: | |
| Poznámka vo Vestníku: | Táto predbežná slovenská technická norma je určená na overenie. Prípadné pripomienky pošlite do júla 2028 Úradu pre normalizáciu, metrológiu a skúšobníctvo Slovenskej republiky. |
| Predmet normy: | This document gives guidance on designating medical devices to cleaning classification categories, attributes used for medical device cleaning classification category, and designation of a cleaning process. The cleaning classification category is comprised of two parts: designate medical devices to a product family; designate product families to cleaning processes. NOTE 1 This allows grouping of medical devices into cleaning classification categories during cleaning and identification of master products during cleaning validation. This document is applicable to manufacturers devising cleaning methods and instructions for processing. It also applies to any processing facility where medical devices are cleaned. This document does not cover processing of single-use medical devices provided as sterile before use and textile devices. NOTE 2 Manual cleaning steps before automated cleaning do not include steps that are considered point of use treatment that can be specified. NOTE 3 ... |
| Náhľad normy: | Náhľad normy (PDF) |