Skip to main content
Tagasi

EVS-EN ISO 15883-7:2025

Pesur-desinfektorid. Osa 7: Mittekriitiliste mitteinvasiivsete termolabiilsete meditsiiniseadmete ja tervishoiuseadmete keemiliseks desinfektsiooniks ette nähtud pesur-desinfektoritele kohaldatavad nõuded ja katsed

Üldinfo

Kehtiv alates 15.05.2025
Alusdokumendid
ISO 15883-7:2025; EN ISO 15883-7:2025
Tegevusala (ICS grupid)
11.080.10 Steriliseerimisvahendid
Direktiivid või määrused
puuduvad

Standardi ajalugu

Staatus
Kuupäev
Tüüp
Nimetus
15.05.2025
Põhitekst
04.04.2016
Põhitekst
This document specifies the requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of reusable items such as:
a)       bed frames;
b)       bedside tables;
c)        transport carts;
d)       containers;
e)       surgical tables;
f)         sterilization containers;
g)       surgical clogs;
h)       wheelchairs;
i)         aids for persons with disabilities.
This document also specifies the performance requirements for the cleaning and disinfection of the WD and its components and accessories.
Devices identified within the scopes of ISO 15883-2, ISO 15883-3, ISO 15883-4, and ISO 15883-6 do not fall within the scope of this document.
In addition, this document specifies the methods for type testing, works testing, validation (installation, operation, and performance qualification on first installation), routine control, and monitoring, as well as requalifications to be carried out periodically and after essential repairs.
NOTE 1        WD covered by this document can also be used for cleaning and chemical disinfection of other thermolabile and reusable devices as recommended in the instructions for use (IFU) for those devices.
NOTE 2        The performance requirements specified in this document cannot ensure the inactivation or removal of the causative agent(s) (prion proteins) of transmissible spongiform encephalopathies.

Nõutud väljad on tähistatud *

*
*
*
PDF
27,28 € koos KM-ga
PDF redline
35,46 € koos KM-ga
Paber
27,28 € koos KM-ga
Sirvi standardit alates 2,48 € koos KM-ga
Standardi monitooring

Teised on ostnud veel

Muudatus

EVS-EN ISO 10993-5:2009/A11:2025

Meditsiinivahendite bioloogiline hindamine. Osa 5: Katsed tsütotoksilisuse hindamiseks - in vitro meetodid
Kehtiv alates 15.05.2025
Põhitekst

EVS-EN ISO 14119:2025

Masinaohutus. Kaitsepiiretega ühendatud blokeerimisseadised. Kavandamise ja valiku põhimõtted
Uusim versioon Kehtiv alates 15.04.2025