EN ISO 15883-6:2015
(Main)Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)
Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)
ISO 15883-6:2011 specifies particular requirements for washer-disinfectors (WDs) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which gives general requirements for WDs.
The range of products on which WDs of this particular type can be used is restricted to devices and equipment which are non-invasive and non-critical (i.e. not penetrating skin or contacting mucosal surfaces).
Reinigungs-Desinfektionsgeräte - Teil 6: Anforderungen und Prüfverfahren für Reinigungs-Desinfektionsgeräte mit thermischer Desinfektion für nicht invasive, nicht kritische Medizinprodukte und Zubehör im Gesundheitswesen (ISO 15883-6:2011)
Der vorliegende Teil der ISO 15883 legt besondere Anforderungen an Reinigungs-Desinfektionsgeräte (RDG)
fest, die zur Verwendung vorgesehen sind, wenn der erforderliche Desinfektionssicherheitsgrad durch Reinigung
und thermische Desinfektion (A0 nicht unter 60) erreicht werden kann und es nicht erforderlich ist, eine
unabhängige automatisierte Aufzeichnung kritischer Prozesse aufzubewahren. Er soll zusammen mit
ISO 15883-1, welche allgemeine Anforderungen an RGD festlegt, angewendet werden.
Der Produktbereich, an dem RDG dieses Typs angewendet werden können, ist auf Produkte und Zubehör
beschränkt, die nicht invasiv und nicht kritisch sind (die d. h. nicht die Haut durchdringen oder Kontakt mit den
Schleimhautoberflächen haben).
ANMERKUNG Die thermische Desinfektion kann durch Spülen der Beladung mit heißem Wasser, durch Einwirkung
von Dampf oder durch eine Kombination aus Beidem erreicht werden.
Laveurs désinfecteurs - Partie 6: Exigences et essais pour les laveurs désinfecteurs utilisant une désinfection thermique pour les dispositifs médicaux non invasifs, non critiques et pour l'équipement de soins de santé (ISO 15883-6:2011)
L'ISO 15883-6:2011 spécifie les exigences particulières des laveurs désinfecteurs destinés à être utilisés lorsque le niveau d'assurance de désinfection nécessaire peut être obtenu par nettoyage et désinfection thermique (A0 au moins égal à 60) et ne nécessite pas que soit conservé un enregistrement automatique indépendant des procédés critiques. Elle est destinée à être utilisée conjointement à l'ISO 15883-1, qui donne des exigences générales pour les laveurs désinfecteurs.
La gamme de produits sur lesquels les laveurs désinfecteurs de ce type particulier peuvent être utilisés est limitée aux dispositifs et équipements non invasifs et non critiques (c'est-à-dire qui ne traversent pas la peau et qui ne sont pas en contact avec les muqueuses).
Čistilno-dezinfekcijske naprave - 6. del: Zahteve in preskusi čistilno-dezinfekcijskih naprav s toplotno dezinfekcijo za neinvazivne, nenujne medicinske pripomočke in zdravstveno opremo (ISO 15883-6:2011)
Standard ISO 15883-6:2011 določa posebne zahteve za čistilno-dezinfekcijske naprave (WD), ki so namenjene uporabi, ko je potrebno raven zagotavljanja dezinfekcije mogoče zagotoviti s čiščenjem in toplotno dezinfekcijo (A0 ne manj kot 60) ter ni potrebno neodvisno avtomatizirano shranjevanje kritičnih procesov. Standard je treba uporabljati v povezavi s standardom ISO 15883-1, ki določa splošne zahteve za čistilno-dezinfekcijske naprave.
Nabor izdelkov, pri katerih je mogoče uporabiti čistilno-dezinfekcijske naprave tega tipa, je omejen na neinvazivne in nenujne medicinske pripomočke ter zdravstveno opremo (tj. ne prodirajo skozi kožo ali se dotikajo sluznic).
General Information
Relations
Overview
EN ISO 15883-6:2015 - Washer-disinfectors - Part 6 defines requirements and tests for washer-disinfectors employing thermal disinfection for non‑invasive, non‑critical medical devices and healthcare equipment. Endorsed by CEN and based on ISO 15883-6:2011, this European standard applies where the required assurance level of disinfection can be achieved by cleaning plus thermal disinfection (A0 not less than 60) and where keeping an independent automated record of critical processes is not required. It is intended to be used together with ISO 15883-1, which contains general requirements for washer-disinfectors.
Key topics and requirements
- Scope and applicability: Restricts use to non‑invasive, non‑critical devices (no penetration of skin or mucosal contact).
- Performance requirements: Specifies cleaning and thermal disinfection performance criteria that washer‑disinfectors must meet.
- Thermal disinfection parameter: Requires an A0 value not less than 60 as the measure of thermal disinfection effectiveness.
- Testing and validation: Defines test methods for demonstrating conformity with cleaning and disinfecting performance (used alongside ISO 15883-1 normative references).
- Documentation and conformity: Guidance for documentation, risk considerations and relationship to EU medical device directives (Annex ZA links the standard to Directive 93/42/EEC).
- Normative references: Cross-references ISO 15883-1 and related technical specifications (EN ISO 15883-1, ISO/TS 15883-5, and relevant electrical/safety standards where applicable).
Practical applications
- Selection and procurement of washer‑disinfectors for hospitals, outpatient clinics, dental practices, long‑term care and other healthcare facilities where devices are non‑critical.
- Development and verification of cleaning/disinfection validation protocols for biomedical engineering and sterile services departments.
- Manufacturer design and type‑testing of washer‑disinfectors that use thermal disinfection methods.
- Regulatory compliance where conformity to CEN standards supports alignment with EU medical device essential requirements.
Who uses this standard
- Manufacturers and designers of washer‑disinfectors
- Sterile Services Departments (CSSD) and infection prevention teams
- Biomedical engineers and maintenance personnel
- Test laboratories and conformity assessment bodies
- Procurement specialists and regulatory affairs professionals
Related standards
- ISO 15883-1 / EN ISO 15883-1 (general requirements for washer‑disinfectors) - intended companion standard.
- ISO/TS 15883-5 and applicable electrical/safety standards referenced in EN ISO 15883-6:2015.
Keywords: EN ISO 15883-6:2015, washer-disinfectors, thermal disinfection, A0 not less than 60, non-invasive non-critical medical devices, ISO 15883-1, CEN, testing and requirements, healthcare equipment.
Frequently Asked Questions
EN ISO 15883-6:2015 is a standard published by the European Committee for Standardization (CEN). Its full title is "Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)". This standard covers: ISO 15883-6:2011 specifies particular requirements for washer-disinfectors (WDs) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which gives general requirements for WDs. The range of products on which WDs of this particular type can be used is restricted to devices and equipment which are non-invasive and non-critical (i.e. not penetrating skin or contacting mucosal surfaces).
ISO 15883-6:2011 specifies particular requirements for washer-disinfectors (WDs) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which gives general requirements for WDs. The range of products on which WDs of this particular type can be used is restricted to devices and equipment which are non-invasive and non-critical (i.e. not penetrating skin or contacting mucosal surfaces).
EN ISO 15883-6:2015 is classified under the following ICS (International Classification for Standards) categories: 11.080.10 - Sterilizing equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 15883-6:2015 has the following relationships with other standards: It is inter standard links to EN ISO 15883-6:2011, FprEN ISO 15883-6. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 15883-6:2015 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase EN ISO 15883-6:2015 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
Standards Content (Sample)
SLOVENSKI STANDARD
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Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing
thermal disinfection for non-invasive, non-critical medical devices and healthcare
equipment (ISO 15883-6:2011)
Reinigungs-Desinfektionsgeräte - Teil 6: Anforderungen und Prüfverfahren für
Reinigungs-Desinfektionsgeräte mit thermischer Desinfektion für nicht invasive, nicht
kritische Medizinprodukte und Zubehör im Gesundheitswesen (ISO 15883-6:2011)
Laveurs désinfecteurs - Partie 6: Exigences et essais pour les laveurs désinfecteurs
utilisant une désinfection thermique pour les dispositifs médicaux non invasifs, non
critiques et pour l'équipement de soins de santé (ISO 15883-6:2011)
Ta slovenski standard je istoveten z: EN ISO 15883-6:2015
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 15883-6
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2015
ICS 11.080.10 Supersedes EN ISO 15883-6:2011
English Version
Washer-disinfectors - Part 6: Requirements and tests for
washer-disinfectors employing thermal disinfection for non-
invasive, non-critical medical devices and healthcare equipment
(ISO 15883-6:2011)
Laveurs désinfecteurs - Partie 6: Exigences et essais pour Reinigungs-Desinfektionsgeräte - Teil 6: Anforderungen
les laveurs désinfecteurs utilisant une désinfection und Prüfverfahren für Reinigungs-Desinfektionsgeräte mit
thermique pour les dispositifs médicaux non invasifs, non thermischer Desinfektion für nicht invasive, nicht kritische
critiques et pour l'équipement de soins de santé (ISO Medizinprodukte und Zubehör im Gesundheitswesen (ISO
15883-6:2011) 15883-6:2011)
This European Standard was approved by CEN on 4 August 2015.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15883-6:2015 E
worldwide for CEN national Members.
Contents Page
European foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices .5
European foreword
This document (EN ISO 15883-6:2015) has been prepared by Technical Committee ISO/TC 198 “Sterilization
of healthcare products” in collaboration with CEN/TC 102 “Sterilizers for medical purposes”, the secretariat of
which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by February 2016, and conflicting national standards shall be withdrawn
at the latest by February 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 15883-6:2011.
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.
The following referenced documents are indispensable for the application of this document. For undated
references, the latest edition of the referenced document (including any amendments) applies. For dated
references, only the edition cited applies. However, for any use of this standard ‘within the meaning of Annex
ZA’, the user should always check that any referenced document has not been superseded and that its
relevant contents can still be considered the generally acknowledged state-of-art.
When an IEC or ISO standard is referred to in the ISO standard text, this should be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version of the
ISO or IEC standard as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in
whole or in part) to which they apply.
Table — Correlation between normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of the ISO
EN ISO
standard
ISO 15883-1 EN ISO 15883-1:2009+A1:2014 ISO 15883-1:2006+Amd1:2014
ISO/TS 15883-5 CEN/ISO/TS 15883-5:2005 ISO/TS 15883-5:2005
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 15883-6:2011 has been approved by CEN as EN ISO 15883-6:2015 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to the Essential Requirements of
the Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the normative clauses of
this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC, as amended by 2007/47/EC. This means that
risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’,
according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential
requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC
on medical devices
Clauses/subclauses of this Essential requirements (ERs) Qualifying remarks/Notes
European Standard of EU Directive 93/42/EEC
9 7.2 In addition requirements of EN
ISO 15883-1 apply.
4.1.1,8 7.2 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
4.1.1, 4.1.5 7.3 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
4.1.1 7.5 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
4.1.1 7.6 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
Clauses/subclauses of this Essential requirements (ERs) Qualifying remarks/Notes
European Standard of EU Directive 93/42/EEC
are covered
4.1.1 8.1 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
4.1.2, 4.1.3, 4.1.5, 4.2, 4.3, 8.1
5.1, 5.2, 6.2, 6.3, 8
6.1 8.1 Testing for conformity according to
EN ISO 15883-1
4.1.1 9.1 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
4.1.2, 4.1.3, 7 9.1
4.1.1 9.2, 9.3 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
4.1.1 12.1 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
4.1.1 12.5 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
4.1.1 12.6 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
4.1.1 12.7.1 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
4.1.1 12.7.2 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
4.1.1 12.7.3 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
4.1.1 12.7.5 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
Clauses/subclauses of this Essential requirements (ERs) Qualifying remarks/Notes
European Standard of EU Directive 93/42/EEC
4.1.1 13.1 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
4.1.1 13.3 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
4.1.1 13.4 This part shall comply also with the
requirements of EN ISO 15883-1 in
which the essential requirements
are covered
4.1.1 13.3 a) This relevant Essential
Requirement is partly addressed in
EN ISO 15883-1
7 13.6
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on
Machinery, in accordance with Article 3 of Directive 93/42/EEC the following Table ZA.2 details the relevant
essential requirements of Directive 2006/42/EC on Machinery to the extent to which they are more specific
than those of Directive 93/42/EEC along with the corresponding clauses of this European Standard.
Table ZA.2, however, does not imply any citation in the OJEU under the machinery directive and thus does
not provide presumption of conformity for the machinery directive.
Table ZA.2 — Relevant Essential Health and Safety Requirements from Directive 2006/42/EC on
machinery that are addressed by this European Standard (according to article 3 of amended
Directive 93/42/EEC)
Clause(s)/sub-clause(s) of this Essential Health and Safety Qualifying remarks/Notes
European Standard Requirements (EHSRs) of
Directive 2006/42/EC
4.1.1 1
4.1.1 1.1.3 See in addition
EN ISO 15883-1:2009+A1:2014,
5.1.1, 5.1.2, 5.2 and 5.3.2 a)
4.1.1 1.1.5 See in addition EN
ISO 15883-1:2009+A1:2014, 9.2
4.1.1 1.1.6 See in addition EN
ISO 15883-1:2009+A1:2014,
5.12.3, 5.27.1 and 6.6.2
4.1.1 1.1.7 See in addition EN
ISO 15883-1:2009+A1:2014, 5.2
st nd
4.1.1 1.2.1, 1 and 2 dash See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.2, 5.2.4, 5.12.1, 5.20 and 5.22
Clause(s)/sub-clause(s) of this Essential Health and Safety Qualifying remarks/Notes
European Standard Requirements (EHSRs) of
Directive 2006/42/EC
st
4.1.1 1.2.2, 1 dash See in addition EN
ISO 15883-1:2009+A1:2014, 5.2,
5.12.3, 5.12.8 and 5.12.9
4.1.1 1.2.3 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1
4.1.1 1.2.4
4.1.1 1.2.5 See in addition EN
ISO 15883-1:2009+A1:2014, 5.18
and 5.19
4.1.1 1.2.6 See in addition EN
ISO 15883-1:2009+A1:2014, 5.2
and 5.4.1.9
4.1.1 1.3.1 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1
Including reference to EN 61010-
2-040:2005, 7.3
4.1.1 1.3.2 See in addition EN
ISO 15883-1:2009+A1:2014, 5.1,
5.2.1 and 8.3 g)
4.1.1 1.3.3 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1
4.1.1 1.3.4 See in addition EN
ISO 15883-1:2009+A1:2014,
5.1.6 and 5.2.1
Including reference to EN 61010-
2-040:2005, clause 7
4.1.1 1.3.7 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1
4.1.1 1.3.8 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1
4.1.1 1.5.1 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1
4.1.1 1.5.2 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1
4.1.1 1.5.3 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1
4.1.1 1.5.4 See in addition EN
ISO 15883-1:2009+A1:2014,
Clause(s)/sub-clause(s) of this Essential Health and Safety Qualifying remarks/Notes
European Standard Requirements (EHSRs) of
Directive 2006/42/EC
5.2.1 and 8.3
4.1.1 1.5.5 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1
4.1.1 1.5.6 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1 and 5.8
4.1.1 1.5.8 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1
4.1.1 1.5.13 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1 and 8.1 b)
Including reference to EN 61010-
2-040:2005, clause 11
4.1.1 1.5.14 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1
Including reference to EN 61010-
2-040:2005, clause 15
4.1.1 1.6.1 See in addition EN
ISO 15883-1:2009+A1:2014,
5.1.5 and 5.2.1
4.1.1 1.6.2 See in addition EN
ISO 15883-1:2009+A1:2014,
5.1.5 and 5.2.1
4.1.1 1.6.3 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1 and 8.2 a) and b)
4.1.1 1.6.4 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1 and 5.4.1.6
4.1.1 1.6.5 See in addition EN
ISO 15883-1:2009+A1:2014,
4.2.1.1 and 5.1.10
4.1.1 1.7.1 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1, 5.10.2, 5.10.3 and 5.20 h)
4.1.1 1.7.2 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1 and 8 f)
4.1.1 1.7.3 See in addition EN
ISO 15883-1:2009+A1:2014,
5.2.1 and 9.1
4.1.1 1.7.4 See in addition EN
ISO 15883-1:2009+A1:2014,
Clause(s)/sub-clause(s) of this Essential Health and Safety Qualifying remarks/Notes
European Standard Requirements (EHSRs) of
Directive 2006/42/EC
Clause 7 and Clause 8
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL ISO
STANDARD 15883-6
First edition
2011-04-15
Washer-disinfectors —
Part 6:
Requirements and tests for
washer-disinfectors employing thermal
disinfection for non-invasive, non-critical
medical devices and healthcare
equipment
Laveurs désinfecteurs —
Partie 6: Exigences et essais pour les laveurs désinfecteurs utilisant
une désinfection thermique pour les dispositifs médicaux non invasifs,
non critiques et pour l'équipement de soins de santé
Reference number
ISO 15883-6:2011(E)
©
ISO 2011
ISO 15883-6:2011(E)
© ISO 2011
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
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ii © ISO 2011 – All rights reserved
ISO 15883-6:2011(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .2
4 Performance requirements.2
4.1 General .2
4.2 Cleaning .
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Die Norm EN ISO 15883-6:2015 legt spezifische Anforderungen für Waschdesinfektoren (WDs) fest, die für die thermische Desinfektion nicht-invasiver und nicht-kritischer medizinischer Geräte sowie von Medizinprodukten in Einrichtungen des Gesundheitswesens bestimmt sind. Diese Norm ist besonders relevant, da sie die Effizienz und Sicherheit beim Umgang mit medizinischen Geräten gewährleistet, die nicht in das Gewebe eindringen oder Schleimhäute berühren. Die Stärke der Norm liegt in der klaren Definition der Desinfektionsanforderungen, wobei ein Hygienegrad von A0 nicht weniger als 60 gefordert wird. Diese Maßgabe sichert eine effektive thermische Desinfektion und bietet eine angemessene Sicherheit für den täglichen Einsatz von Waschdesinfektoren in der Gesundheitsbranche. Darüber hinaus verhindert die Anforderung, dass keine unabhängige automatisierte Aufzeichnung kritischer Prozesse erforderlich ist, den administrativen Aufwand für Kliniken und Einrichtungen. Die Norm wird in Verbindung mit ISO 15883-1 verwendet, die allgemeine Anforderungen an Waschdesinfektoren definiert. Dies unterstreicht die kohärente Struktur und das umfassende Verständnis der Prozesse, die für eine effektive Reinigung und Desinfektion benötig werden. Sie setzt zudem einen Standard hinsichtlich der Qualifikation und der Leistungsfähigkeit dieser Geräte und fördert damit den vertrauenswürdigen Einsatz in der medizinischen Versorgung. Insgesamt stellt EN ISO 15883-6:2015 eine essenzielle Richtlinie dar, die nicht nur die Qualität und Sicherheit von Reinigungs- und Desinfektionsprozessen in der Gesundheitsversorgung verbessert, sondern auch dazu beiträgt, die Hygienestandards auf einem hohen Niveau zu halten. Die Norm hat sich als besonders relevant für Einrichtungen des Gesundheitswesens erwiesen, die mit nicht-invasiven und nicht-kritischen Geräten arbeiten, und ermöglicht eine optimale Kombination von Effizienz und Benutzerfreundlichkeit in der Praxis.
표준 EN ISO 15883-6:2015는 비침습적이고 비중요한 의료 기기 및 의료 장비에 대한 열 소독을 적용하는 세척 소독기의 요구 사항과 테스트에 대해 규정하고 있습니다. 이 표준은 세척 소독기가 제공해야 하는 소독의 신뢰성 수준을 충족하기 위해 필요한 특정 요건을 명시합니다. 특히 이 표준은 청소와 열 소독을 통해 A0 값이 60 이상으로 소독을 보장할 수 있는 경우에 적용됩니다. 이 표준의 강점 중 하나는 비침습적이고 비중요한 장치 및 장비에 한정된 사용 범위를 두어 사용자의 안전을 보장한다는 점입니다. 또한, ISO 15883-1과 함께 사용될 수 있도록 설계되어 있어, 일반적인 세척 소독기 요구 사항을 따르면서도 특정 요구 사항을 명확하게 구분합니다. 이러한 아웃라인은 사용자가 적절한 세척 소독기를 선택하고 운영하는 데 필요한 정보를 제공합니다. EN ISO 15883-6:2015는 비침습적 기기 및 장비의 세척과 소독에서 중요한 역할을 합니다. 독립적으로 자동 기록을 유지할 필요가 없는 장비에 적합하게 설계됨으로써, 의료 환경에서 실용성을 높이며 비용 효율성을 제공합니다. 이러한 특징은 병원과 클리닉에서 사용되는 다양한 의료 장비를 안전하게 관리하는 데 필수적입니다. 결국 이 표준은 비침습적 및 비중요한 의료 기기 및 장비의 안전한 세척과 소독을 위한 신뢰할 수 있는 지침을 제공하여, 의료 서비스 제공자들이 환자의 안전을 최우선으로 고려할 수 있도록 돕습니다.
SIST EN ISO 15883-6:2015は、医療機器および医療設備に対する洗浄消毒器（WD）の要件と試験方法を規定した標準であり、特に非侵襲的かつ非重要な医療機器向けに熱消毒を採用する洗浄消毒器に焦点を当てています。この標準は、ISO 15883-1と併用されることを意図しており、一般の洗浄消毒器に関する要件を提供します。 この標準の範囲は、洗浄消毒器が必要とされる消毒レベルを達成できる特定の要件を明確に示しています。具体的には、A0が60以上で、独立した自動記録が必要ない場合に使用されることを前提としています。これにより、ユーザーは不必要な複雑さを排除し、効率的な消毒プロセスを確保することが可能になります。 SIST EN ISO 15883-6:2015の強みは、特に非侵襲的で非重要な医療機器に適した洗浄消毒器の要件を詳細に設定している点です。これにより、医療現場における安全性と効果的な保障を提供します。また、この標準は機器の選定や使用において明確なガイドラインを提供するため、利用者が自施設に適した洗浄消毒器を容易に選定できるようになっています。 この文書は、医療機関や関連する機器の製造業者にとって有益であり、標準化された要件を通じて品質を向上させると同時に、消毒プロセスの信頼性を強化します。したがって、SIST EN ISO 15883-6:2015の重要性は、医療業界における適切な衛生管理と感染予防において、ますます高まっていると言えるでしょう。
La norme EN ISO 15883-6:2015 se concentre sur les exigences et les tests des laveurs-désinfecteurs (WD) utilisant la désinfection thermique pour les dispositifs médicaux non invasifs et non critiques. Cette norme est essentielle dans le domaine de la santé, offrant des directives claires et précises pour assurer un niveau de désinfection adéquat, en garantissant que le processus de nettoyage et de désinfection thermique atteint un niveau d'assurance (A0) d’au moins 60. L'un des principaux atouts de la norme ISO 15883-6:2011 réside dans sa spécificité. Contrairement à d'autres normes qui traitent de la désinfection de manière générale, elle s'applique explicitement aux WDs destinés à des dispositifs non invasifs et non critiques, ce qui limite les ambiguïtés et assure que les pratiques mises en œuvre sont appropriées pour les catégories de matériel concernées. En restreignant son champ d'application, la norme garantit que les utilisateurs appliquent des procédés adaptés à leurs besoins sans exiger de registre automatisé indépendant des processus critiques, ce qui simplifie la gestion des tâches de désinfection. De plus, la norme est conçue pour compléter ISO 15883-1, qui fixe les exigences générales des laveurs-désinfecteurs. Cette complémentarité renforce la cohérence des normes applicables et améliore la compréhension des exigences technique et opérationnelle des dispositifs concernés. Cette synergie entre les deux normes assure une approche intégrée dans la gestion hygiénique des dispositifs médicaux, favorisant ainsi la sécurité des patients et la conformité aux normes de qualité en milieu hospitalier. La pertinence de la norme EN ISO 15883-6:2015 dans le cadre des établissements de santé ne peut être sous-estimée, car le respect des exigences de désinfection thermique est crucial pour prévenir les infections nosocomiales. En dotant les utilisateurs d'un cadre normalisé, la norme contribue à garantir que les procédures opératoires sont suivies de manière rigoureuse, soutenant ainsi la mission des établissements de santé de fournir des soins sûrs et efficaces.
The EN ISO 15883-6:2015 standard establishes a comprehensive framework for washer-disinfectors (WDs) specifically designed for thermal disinfection of non-invasive, non-critical medical devices and healthcare equipment. This standard is vital for ensuring that the necessary level of disinfection is met through effective cleaning and thermal disinfection processes, with an assurance level of A0 not less than 60. One of the key strengths of this standard is its clear specification of requirements tailored for washer-disinfectors. By focusing on thermal disinfection methods, it provides a well-defined protocol that facilitates the safe reprocessing of medical devices that do not penetrate skin or contact mucosal surfaces. This specificity not only enhances the safety and efficacy of the disinfection process but also reduces the risk of infection transmission in healthcare settings. Furthermore, EN ISO 15883-6:2015 complements ISO 15883-1, which lays out general requirements for washer-disinfectors, ensuring that users have a holistic understanding of both the specific and general operational criteria. This interconnectedness enhances the standard's relevance, providing a cohesive approach that is essential for healthcare facilities striving for high standards in infection control and prevention. The scope of EN ISO 15883-6:2015 limits its application to non-invasive, non-critical devices, which strengthens its focus and effectiveness. By not requiring an independent automated record of critical processes, the standard acknowledges the practical needs of healthcare environments while maintaining stringent gross level disinfection requirements. In conclusion, EN ISO 15883-6:2015 is a pivotal standard that strengthens the reliability of washer-disinfectors in achieving effective thermal disinfection for non-invasive, non-critical medical devices. Its detailed guidelines, combined with its alignment with broader standards, ensure that healthcare professionals can implement best practices for equipment disinfection, thus promoting patient safety and public health.
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