ISO 15883-7:2016
(Main)Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
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.
Laveurs désinfecteurs — Partie 7: Exigences et essais pour les laveurs désinfecteurs destinés à la désinfection chimique des dispositifs médicaux thermosensibles, non invasifs et non critiques et des équipements de soins de santé
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.
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DRAFT INTERNATIONAL STANDARD
ISO/DIS 15883-7
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2014-02-27 2014-07-27
Washer-disinfectors —
Part 7:
Requirements and tests for washer-disinfectors employing
chemical disinfection for non-invasive, non-critical
thermolabile medical devices and healthcare equipment
(ISO/DIS 15883-7:2014)
Laveurs désinfecteurs —
Partie 7: Exigences et essais pour les laveurs désinfecteurs utilisant la désinfection chimique pour les
dispositifs médicaux et les équipements de soins thermosensibles non invasifs et non critiques (ISO/DIS
15883-7)
ICS: 11.080.10
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Should this draft be accepted, a final draft, established on the basis of comments
received, will be submitted to a parallel two-month approval vote in ISO and
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PROVIDE SUPPORTING DOCUMENTATION. ISO 2014
ISO/DIS 15883-7:2014(E)
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as
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ii © ISO 2014 – All rights reserved
prEN ISO 15833-7:2014 (E)
Contents
Page
Foreword .3
Introduction .4
1 Scope .5
2 Normative references .5
3 Terms and definitions .6
4 Performance requirements .6
4.1 General .6
4.2 Cleaning .6
4.3 Disinfection .7
4.4 Final rinsing .8
4.5 Self-disinfection .9
4.6 Drying .9
4.7 Water treatment equipment . 10
5 Mechanical requirements and protocol requirements . 11
5.1 Materials – design, manufacture and assembly . 11
5.2 Process verification . 11
6 Testing for conformity . 11
6.1 General . 11
6.2 Test load . 11
6.3 Water used for final (post-disinfection) rinsing . 11
6.4 Load dryness . 12
6.5 Thermometric tests. 12
6.6 Chemical dosing tests . 12
6.7 Tests of cleaning efficacy . 12
6.8 Test of disinfection efficacy . 14
7 Documentation . 16
8 Information to be provided by the manufacturer . 16
9 Marking, labelling and packaging . 17
10 Information to be requested from the purchaser by the manufacturer . 17
Annex A (normative) Summary of test programmes . 18
Annex B (normative) Methods for microbiological evaluation of disinfection of liquid transport
system . 20
Annex C (normative) Tests for microbiological contamination of post-disinfection rinse water . 26
Annex D (normative) Preparation and evaluation of indicators for microbiological testing of the
efficacy of chemical disinfection of the load . 27
Annex E (informative) Examples of test locations for the tests with biological indicators . 31
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices . 35
Bibliography . 39
prEN ISO 15833-7:2014 (E)
Foreword
This document (prEN ISO 15833-7:2013) has been prepared by Technical Committee CEN/TC 102
“Sterilizers for medical purposes”, the secretariat of which is held by DIN, in cooperation with Technical
Committee ISO/TC 198 “Sterilization of health care products”.
This document is currently submitted to the parallel Enquiry.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
prEN ISO 15833-7:2014 (E)
Introduction
It is intended that this introduction is to be read in conjunction with the introduction to ISO 15883-1.
This part of ISO 15883 is the seventh of a series specifying the performance of washer-disinfectors. It
specifies the particular requirements for performance applicable to washer-disinfectors employing chemical
disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment. Its
requirements apply to washer-disinfectors used for cleaning and disinfection of thermolabile equipment for use
without further treatment in healthcare settings. Such reusable equipment needs to be cleaned and
disinfected, but processing in a washer-disinfector for surgical instruments (see ISO 15883-2), for human
waste containers (see ISO 15883-3), for endoscopes (see ISO 15883-4) or for non-invasive, non-critical
medical devices and healthcare equipment (see ISO 15883-6) is inappropriate and/or impractical. Examples
of such equipment are bedsteads and bedside furniture, trolleys and transport carts, operating tables,
footwear, wheelchairs, or aids for the disabled.
Requirements for washer-disinfectors for other applications are specified in other parts of this series of
international standards.
In respect of the potential adverse effects on the quality of water intended for human consumption caused by
the washer-disinfectors, it is noteworthy that:
a) until verifiable international criteria are adopted, the existing national regulations concerning the use
and/or characteristics of the washer-disinfectors remain in force, and
b) the ISO 15883 series of standards provides no information as to whether the washer-disinfectors may be
used without restriction in any of the ISO member states.
prEN ISO 15833-7:2014 (E)
Washer-disinfectors —
Part 7:
Requirements and tests for washer-disinfectors employing
chemical disinfection for non-invasive, non-critical
thermolabile medical devices and healthcare equipment
(ISO/DIS 15883-7:2014)
1 Scope
This part of ISO 15883 specifies the particular requirements for washer-disinfectors (WD) intended to be used for
the cleaning and chemical disinfection, in a single operating cycle, of re-usable items such as:
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.
This Part of ISO 15883 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 re-validations 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 re-usable 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.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 11731-2, Water quality — Detection and enumeration of Legionella — Part 2: Direct membrane filtration
method for waters with low bacterial counts
ISO 15883-1:2006, Washer-disinfectors — Part 1: General requirements, terms and definitions and tests
ISO 15883-2, Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing
thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils,
glassware, etc.
ISO 15883-3, Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing
thermal disinfection for human waste containers
ISO 15883-4, Washer-disinfectors — Part 4: Requirements and tests for washer disinfectors employing
chemical disinfection for thermolabile endoscopes
prEN ISO 15833-7:2014 (E)
ISO 15883-6, Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing
thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
ISO TS 15883-5:2005, Washer-disinfectors — Part 5: Test soils and methods for demonstrating cleaning
efficacy
IEC 61010-2-40:2005, Safety requirements for electrical equipment for measurement, control and laboratory
use — Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical
materials
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 15883-1, ISO 15883-4 and
ISO 15883-6 apply.
4 Performance requirements
4.1 General
4.1.
...
INTERNATIONAL ISO
STANDARD 15883-7
First edition
2016-02-01
Washer-disinfectors —
Part 7:
Requirements and tests for washer-
disinfectors employing chemical
disinfection for non-invasive, non-
critical thermolabile medical devices
and healthcare equipment
Laveurs désinfecteurs —
Partie 7: Exigences et essais pour les laveurs désinfecteurs utilisant la
désinfection chimique pour les dispositifs médicaux et les équipements
de soins thermosensibles non invasifs et non critiques
Reference number
©
ISO 2016
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Performance requirements . 2
4.1 General . 2
4.2 Cleaning . 3
4.3 Disinfection . 3
4.4 Final rinsing . 5
4.5 Self-disinfection . 5
4.6 Drying . 6
4.7 Water treatment equipment. 6
4.7.1 General. 6
4.7.2 Disinfection of water treatment equipment . 6
4.7.3 Maintenance of piping . 7
5 Mechanical requirements . 7
5.1 Materials — Design, manufacture, and assembly . 7
5.2 Process verification . 7
6 Testing for conformity . 7
6.1 General . 7
6.2 Test load . 8
6.2.1 Loading with standard goods . 8
6.2.2 Loading with special goods . 8
6.3 Water used for rinsing following disinfection . . 8
6.4 Load dryness . 8
6.4.1 General. 8
6.4.2 Procedure . 8
6.4.3 Results . 8
6.5 Thermometric tests . 8
6.5.1 General. 8
6.5.2 Load temperature test . . 8
6.6 Chemical dosing tests . 9
6.6.1 General. 9
6.6.2 Reused process chemicals . 9
6.7 Tests of cleaning efficacy . 9
6.7.1 General. 9
6.7.2 Materials . 9
6.7.3 Procedure .10
6.7.4 Results .10
6.8 Test of disinfection efficacy .10
6.8.1 General.10
6.8.2 Preliminary tests on chemical disinfectants .10
6.8.3 Self-disinfection tests .11
6.8.4 Chemical disinfection of the load.12
7 Documentation .12
8 Information to be provided by the manufacturer .12
9 Marking, labelling, and packaging .13
10 Information to be requested from the purchaser by the manufacturer .13
Annex A (normative) Summary of test programmes .14
Annex B (normative) Methods for microbiological evaluation of disinfection of liquid
transport system.16
Annex C (normative) Tests for microbiological contamination of post-disinfection rinse water .21
Annex D (normative) Preparation and evaluation of indicators for microbiological testing
of the efficacy of chemical disinfection of the load .22
Annex E (informative) Examples of test locations for the tests with biological indicators .26
Bibliography .30
iv © ISO 2016 – All rights reserved
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
ISO 15883-7 was prepared by the European Committee for Standardization (CEN) Technical Committee
CEN/TC 102, Sterilizers for medical purposes, in collaboration with Technical Committee ISO/TC 198,
Sterilization of health care products, in accordance with the Agreement on technical cooperation
between ISO and CEN (Vienna Agreement).
ISO 15883 consists of the following parts, under the general title Washer-disinfectors:
— Part 1: General requirements, terms and definitions and tests
— Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical
instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
— Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human
waste containers
— Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for
thermolabile endoscopes
— Part 5: Tes
...
NORME ISO
INTERNATIONALE 15883-7
Première édition
2016-02-01
Laveurs désinfecteurs —
Partie 7:
Exigences et essais pour les
laveurs désinfecteurs destinés à la
désinfection chimique des dispositifs
médicaux thermosensibles, non
invasifs et non critiques et des
équipements de soins de santé
Washer-disinfectors —
Part 7: Requirements and tests for washer-disinfectors employing
chemical disinfection for non-invasive, non-critical thermolabile
medical devices and healthcare equipment
Numéro de référence
©
ISO 2016
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2016, Publié en Suisse
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Tel. +41 22 749 01 11
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copyright@iso.org
www.iso.org
ii © ISO 2016 – Tous droits réservés
Sommaire Page
Avant-propos .v
Introduction .vi
1 Domaine d’application . 1
2 Références normatives . 2
3 Termes et définitions . 2
4 Exigences de performance . 2
4.1 Généralités . 2
4.2 Nettoyage . 3
4.3 Désinfection . 3
4.4 Rinçage final . 5
4.5 Autodésinfection . 5
4.6 Séchage . 6
4.7 Système de traitement de l’eau . 6
4.7.1 Généralités . 6
4.7.2 Désinfection du système de traitement de l’eau . 6
4.7.3 Maintenance des canalisations . 7
5 Exigences mécaniques . 7
5.1 Matériaux: conception, fabrication et assemblage . 7
5.2 Vérification du procédé . 7
6 Essais de conformité . 8
6.1 Généralités . 8
6.2 Charge d’essai . 8
6.2.1 Chargement avec des articles standard . 8
6.2.2 Chargement avec des articles spéciaux . 8
6.3 Eau utilisée pour le rinçage après désinfection . 8
6.4 Siccité de la charge. 8
6.4.1 Généralités . 8
6.4.2 Mode opératoire . 8
6.4.3 Résultats . 9
6.5 Essais thermométriques . 9
6.5.1 Généralités . 9
6.5.2 Essai de température de la charge. 9
6.6 Essais de dosage des produits chimiques . 9
6.6.1 Généralités . 9
6.6.2 Produits chimiques réutilisés . 9
6.7 Essais d’efficacité du nettoyage . 9
6.7.1 Généralités . 9
6.7.2 Matériel .10
6.7.3 Mode opératoire .10
6.7.4 Résultats .10
6.8 Essais d’efficacité de la désinfection .10
6.8.1 Généralités .10
6.8.2 Essais préliminaires sur les désinfectants chimiques .11
6.8.3 Essais d’autodésinfection .12
6.8.4 Désinfection chimique de la charge .12
7 Documentation .13
8 Informations devant être fournies par le fabricant .13
9 Marquage, étiquetage et emballage .14
10 Informations devant être demandées par le fabricant à l’acheteur .14
Annexe A (normative) Récapitulatif des programmes d’essais .15
Annexe B (normative) Méthodes d’évaluation microbiologique de la désinfection du
système de transport des liquides .17
Annexe C (normative) Essais de contamination microbiologique de l’eau de rinçage utilisée
après la phase de désinfection .22
Annexe D (normative) Préparation et évaluation des indicateurs pour les essais
microbiologiques de l’efficacité de la désinfection chimique de la charge .23
Annexe E (informative) Exemples de points de prélèvement pour les essais avec
indicateurs biologiques .27
Bibliographie .32
iv © ISO 2016 – Tous droits réservés
Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes
nationaux de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est
en général confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude
a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,
gouvernementales et non gouvernementales, en liaison avec l’ISO participent également aux travaux.
L’ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui
concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents
critères d’approbation requis pour les différents types de documents ISO. Le présent document a été
rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir www.
iso.org/directives).
L’attention est appelée sur le fait que certains des éléments du présent document peuvent faire l’objet de
droits de propriété intellectuelle ou de droits analogues. L’ISO ne saurait être tenue pour responsable
de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant
les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de
l’élaboration du document sont indiqués dans l’Introduction et/ou dans la liste des déclarations de
brevets reçues par l’ISO (voir www.iso.org/brevets).
Les appellations commerciales éventuellement mentionnées dans le présent document sont données
pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un
engagement.
Pour une explication de la signification des termes et expressions spécifiques de l’ISO liés à
l’évaluation de la conformité, ou pour toute information au sujet de l’adhésion de l’ISO aux principes
de l’OMC concernant les obstacles techniques au commerce (OTC), voir le lien suivant: Avant-propos —
Informations supplémentaires.
L’ISO 15883-7 a été élaborée par le Comité technique CEN/TC 102, Stérilisateurs à usage médical, du
Comité européen de normalisation (CEN), en collaboration avec le Comité technique ISO/TC 198,
Stérilisation des produits de santé, conformément à l’Accord de coopération technique entre l’ISO et
le CEN (Accord de Vienne).
L’ISO 15883 comprend les parties suivantes, présentées sous le titre général Laveurs désinfecteurs:
— Partie 1: Exigences générales, termes et définitions et essais
— Partie 2: Exigences et essai
...
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