Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment (ISO/DIS 15883-7:2024)

ISO 15883-7:2016 specifies the particular 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 the following:
a) bedframes;
b) bedside tables;
c) transport carts;
d) containers;
e) surgical tables;
f) sterilization containers;
g) surgical clogs;
h) wheelchairs, aids for the disabled.
ISO 15883-7:2016 also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which may be necessary in order to achieve the required performance.
Devices identified within the scopes of ISO 15883‑2, ISO 15883‑3, ISO I5883-4, and ISO 15883‑6 do not fall within the scope of this part of ISO 15883.
In addition, the methods are specified, as well as instrumentation and instructions required for type testing, works testing, validation (installation, operation, and performance qualification on first installation), routine control, and monitoring, as well as requalifications required to be carried out periodically and after essential repairs.
NOTE WDs corresponding to this part of ISO 15883 can also be used for cleaning and chemical disinfection of other thermolabile and reusable devices as recommended by the device manufacturer.
The performance requirements specified in this part of ISO 15883 may not ensure the inactivation or removal of the causative agent(s) (prion proteins) of Transmissible Spongiform Encephalopathies.

Reinigungs-Desinfektionsgeräte - Teil 7: Anforderungen und Prüfverfahren für Reinigungs-Desinfektionsgeräte mit chemischer Desinfektion für nicht kritische thermolabile Medizinprodukte und Zubehör im Gesundheitswesen (ISO/DIS 15883-7:2024)

Laveurs désinfecteurs - Partie 7: Exigences et essais pour les laveurs désinfecteurs destinés à la désinfection chimique des dispositifs médicaux thermosensibles non critiques et des équipements de soins de santé (ISO/DIS 15883-7:2024)

ISO 15883-7:2016 spécifie les exigences particulières relatives aux laveurs désinfecteurs (LD) destinés à être utilisés pour le nettoyage et la désinfection chimique, au cours d'un seul cycle standard, d'articles réutilisables tels que les suivants:
a) les cadres de lit;
b) les tables de chevet;
c) les chariots de transport;
d) les récipients;
e) les tables d'opération;
f) les récipients de stérilisation;
g) les sabots médicaux;
h) les fauteuils roulants et dispositifs auxiliaires pour les personnes handicapées.
ISO 15883-7:2016 spécifie également les exigences de performance relatives au nettoyage et à la désinfection du laveur désinfecteur ainsi que de ses composants et accessoires, qui peuvent être nécessaires pour atteindre les performances requises.
Les dispositifs identifiés dans les domaines d'application de l'ISO 15883‑2, l'ISO 15883‑3, l'ISO 15883‑4 et l'ISO 15883‑6 ne relèvent pas du domaine d'application de la présente partie de l'ISO 15883.
Le présent document spécifie également les méthodes, l'instrumentation et les instructions nécessaires pour les essais de type, les essais de fonctionnement, la validation (qualification de l'installation, qualification opérationnelle et qualification des performances lors de la première installation), le contrôle de routine et la surveillance, de même que les requalifications à effectuer périodiquement et après des réparations importantes.
NOTE Les LD relevant de la présente partie de l'ISO 15883 peuvent également être utilisés pour le nettoyage et la désinfection chimique d'autres dispositifs thermosensibles réutilisables, selon les recommandations du fabricant du dispositif.
Les exigences de performance spécifiées dans la présente partie de l'ISO 15883 ne peuvent pas garantir l'inactivation ou l'élimination du ou des agents pathogènes (protéine du prion) à l'origine des encéphalopathies spongiformes transmissibles.

Čistilno-dezinfekcijske naprave - 7. del: Zahteve in preskusne metode za čistilno-dezinfekcijske naprave s kemično dezinfekcijo za nekritične termolabilne medicinske pripomočke in zdravstveno opremo (ISO/DIS 15883-7:2024)

General Information

Status
Not Published
Public Enquiry End Date
29-Apr-2024
Technical Committee
Current Stage
4020 - Public enquire (PE) (Adopted Project)
Start Date
26-Feb-2024
Due Date
15-Jul-2024

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SLOVENSKI STANDARD
oSIST prEN ISO 15883-7:2024
01-april-2024
Nadomešča:
SIST EN ISO 15883-7:2016
Čistilno-dezinfekcijske naprave - 7. del: Zahteve in preskusne metode za čistilno-
dezinfekcijske naprave s kemično dezinfekcijo za nekritične termolabilne
medicinske pripomočke in zdravstveno opremo (ISO/DIS 15883-7:2024)
Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing
chemical disinfection for non-critical thermolabile medical devices and health care
equipment (ISO/DIS 15883-7:2024)
Reinigungs-Desinfektionsgeräte - Teil 7: Anforderungen und Prüfverfahren für
Reinigungs-Desinfektionsgeräte mit chemischer Desinfektion für nicht kritische
thermolabile Medizinprodukte und Zubehör im Gesundheitswesen (ISO/DIS 15883-
7:2024)
Laveurs désinfecteurs - Partie 7: Exigences et essais pour les laveurs désinfecteurs
destinés à la désinfection chimique des dispositifs médicaux thermosensibles non
critiques et des équipements de soins de santé (ISO/DIS 15883-7:2024)
Ta slovenski standard je istoveten z: prEN ISO 15883-7
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
oSIST prEN ISO 15883-7:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 15883-7:2024

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oSIST prEN ISO 15883-7:2024
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15883-7
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2024-02-02 2024-04-26
Washer-disinfectors —
Part 7:
Requirements and tests for washer-disinfectors employing
chemical disinfection for non-critical thermolabile medical
devices and health care equipment
ICS: 11.080.10
This document is circulated as received from the committee secretariat.
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oSIST prEN ISO 15883-7:2024
ISO/DIS 15883-7:2024(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15883-7
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Voting begins on: Voting terminates on:

Washer-disinfectors —
Part 7:
Requirements and tests for washer-disinfectors employing
chemical disinfection for non-critical thermolabile medical
devices and health care equipment
ICS: 11.080.10
This document is circulated as received from the committee secretariat.
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oSIST prEN ISO 15883-7:2024
ISO/DIS 15883-7:2023(E)
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Foreword .v
Introduction .
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