EN 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 (ISO 15883-7:2016)
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)
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 invasive, nicht kritische thermolabile Medizinprodukte und Zubehör im Gesundheitswesen (ISO 15883-7:2016)
Dieser Teil von ISO 15883 legt die besonderen Anforderungen an Reinigungs-Desinfektionsgeräte (RDG) fest, die für das Reinigen und die chemische Desinfektion von wiederverwendbarem Behandlungsgut in einem Betriebszyklus vorgesehen sind, wie:
a) Bettgestelle;
b) Nachttische;
c) Transportwagen;
d) Container;
e) OP-Tische;
f) Sterilisationsbehälter;
g) OP-Schuhe;
h) Rollstühle, Hilfsmittel für Behinderte.
Dieser Teil von ISO 15883 legt außerdem die Leistungsanforderungen an die Reinigung und Desinfektion des Reinigungs-Desinfektionsgeräts sowie von dessen Bauteilen und Zubehör fest, die zum Erreichen der erforderlichen Leistung notwendig sein können.
Geräte, die unter den Anwendungsbereich von ISO 15883-2, ISO 15883-3, ISO I5883-4 und ISO 15883-6 fallen, gehören nicht zum Anwendungsbereich dieses Teils von ISO 15883.
Des Weiteren sind die Verfahren, Ausrüstungen und Anweisungen festgelegt, die für die Typprüfung, Werksprüfung, Validierung (Installation, Betriebs- und Leistungsbeurteilung nach erstmaliger Installation), Routinekontrolle und Überwachung sowie die regelmäßig und nach größeren Reparaturen durchzuführende Revalidierung erforderlich sind.
ANMERKUNG RDG, die diesem Teil von ISO 15883 entsprechen, können auch zum Reinigen und zur chemischen Desinfektion von anderen thermolabilen und wiederverwendbaren medizinischen Geräten verwendet werden, bei denen der Hersteller der Geräte dieses Desinfektionsverfahren empfohlen hat.
Es ist möglich, dass die in diesem Teil von ISO 15883 festgelegten Leistungsanforderungen nicht die Inaktivierung oder die Beseitigung des (der) verursachenden Agens (Agenzien) (Prionenproteine) von transmissiblen spongiformen Enzephalopathien sicherstellen.
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)
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 neinvazivne, nekritične termolabilne medicinske pripomočke in zdravstveno opremo (ISO 15883-7:2016)
Ta del standarda ISO 15883 določa posebne zahteve za čistilno-dezinfekcijske naprave (WD), namenjene uporabi za čiščenje in kemično dezinfekcijo (v enem samem operativnem ciklu) predmetov za večkratno uporabo, kot so: a) posteljni okviri; b) nočne omarice; c) transportni vozički; d) vsebniki; e) operativne mize; f) vsebniki za steriliziranje; g) kirurški natikači; h) invalidski vozički, pripomočki za invalidne osebe. Ta del standarda ISO 15883 določa tudi zahteve za učinkovitost čiščenja in dezinfekcije čistilno-dezinfekcijske naprave in njenih sestavnih delov ter dodatkov, kot je lahko potrebno za doseganje potrebne učinkovitosti. Pripomočki znotraj področja uporabe standardov ISO 15883-2:2006, ISO 15883-3:2006, ISO I5883-4:2008 in ISO 15883-6:2011 so zunaj področja uporabe tega dela standarda ISO 15883. Poleg tega so določeni metode, instrumenti ter navodila, potrebni za tipsko preskušanje, tovarniško preskušanje, potrjevanje (namestitev, obratovanje in kvalifikacija delovanja ob prvi namestitvi), rutinski nadzor in spremljanje ter ponovna potrjevanja, ki jih je treba izvajati redno in po nujnih popravilih. OPOMBA: Čistilno-dezinfekcijske naprave, ki ustrezajo temu delu standarda ISO 15883, se lahko uporabljajo tudi za čiščenje in kemično dezinfekcijo drugih termolabilnih medicinskih pripomočkov za ponovno uporabo v skladu s priporočili proizvajalca pripomočka. Zahteve za učinkovitost, določene v tem delu standarda ISO 15883, morda ne zagotavljajo inaktivacije ali odstranitve vzročnih povzročiteljev (prionskih beljakovin) prenosljivih spongiformnih encefalopatij.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2016
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GH]LQIHNFLMVNHQDSUDYHVNHPLþQRGH]LQIHNFLMR]DQHLQYD]LYQHQHNULWLþQH
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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)
Reinigungs-Desinfektionsgeräte - Teil 7: Anforderungen und Prüfverfahren für
Reinigungs-Desinfektionsgeräte mit chemischer Desinfektion für nicht invasive, nicht
kritische thermolabile Medizinprodukte und Zubehör im Gesundheitswesen (ISO 15883-
7:2016)
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 15883-7:2016)
Ta slovenski standard je istoveten z: EN ISO 15883-7:2016
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 15883-7
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2016
EUROPÄISCHE NORM
ICS 11.080.10
English Version
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)
Laveurs désinfecteurs - Partie 7: Exigences et essais Reinigungs-Desinfektionsgeräte - Teil 7:
pour les laveurs désinfecteurs utilisant la désinfection Anforderungen und Prüfverfahren für Reinigungs-
chimique pour les dispositifs médicaux et les Desinfektionsgeräte mit chemischer Desinfektion für
équipements de soins thermosensibles non invasifs et nicht invasive, nicht kritische thermolabile
non critiques (ISO 15883-7:2016) Medizinprodukte und Zubehör im Gesundheitswesen
(ISO 15883-7:2016)
This European Standard was approved by CEN on 8 February 2016.
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
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15883-7:2016 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 5
European foreword
This document (EN ISO 15883-7:2016) has been prepared by Technical Committee ISO/TC 198
“Sterilization of health care products” in collaboration with Technical Committee 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 September 2016, and conflicting national standards
shall be withdrawn at the latest by September 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 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 11737-1 EN ISO 11737-1:2006 + ISO 11737-1:2006 +
EN ISO 11737-1:2006/AC:2009 ISO 11737-1:2006/Cor 1:2007
ISO 11737-2 EN ISO 11737-2:2009 ISO 11737-2:2009
ISO 15883-1 EN ISO 15883-1:2009 + ISO 15883-1:2006 +
EN ISO 15883-1:2009/A1:2014 ISO 15883-1:2006/Amd1:2014
ISO 15883-2 EN ISO 15883-2:2009 ISO 15883-2:2006
ISO 15883-3 EN ISO 15883-3:2009 ISO 15883-3:2006
ISO 15883-4 EN ISO 15883-4:2009 ISO 15883-4:2008
ISO 15883-6 EN ISO 15883-6:2015 ISO 15883-6:2011
ISO/TS 15883-5 CEN ISO/TS 15883-5:2005 ISO/TS 15883-5:2005
IEC 61010–2-040 EN 61010-2-040:2005 IEC 61010-2-040:2005
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 15883-7:2016 has been approved by CEN as EN ISO 15883-7:2016 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
This European Standard has been prepared under a Commission's standardization request M/023
concerning the development of European standards to medical devices to provide one voluntary means
of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning
medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under that Directive,
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
Annex I of Directive 93/42/EEC [OJ L 169]
Essential Requirements of EU Clause(s)/subclause(s) of this Remarks/Notes
Directive 93/42/EEC European Standard
7.2 9 In addition requirements of
EN ISO 15883-1 apply.
Reference to
IEC 61010-2-040:2005, Clause 5
included in respect of packaging
only
7.3 4.1.1, 4.1.4
7.4 WD is not designed to deal with
such medical products
7.5 4.1.1 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.24.1
Essential Requirements of EU Clause(s)/subclause(s) of this Remarks/Notes
Directive 93/42/EEC European Standard
7.6 4.1.1, 4.7.1
8.1 4.1.1, 4.3, 4.5, 4.7.2 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
4.3.1
9.1 4.1.1, 4.1.3, 5.1.1, 8 a) Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.1.9, 5.1.10, 5.6 and 5.28
9.2 4.1.1, 4.1.3, 5.1.1, 5.1.2 Including reference to
IEC 61010-2-040:2005, 5.4.3 and
7.5
9.3 WDs are unlikely to be
manufactured of or to contain
flammable or explosive substances
10.1 Not likely to apply, see MEDDEV 2.1
11 Intended hazardous radiation is
unlikely to be emitted by a WD
12.1 4.1.1
12.5 4.1.1 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.2
12.6 4.1.1 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1
12.7.1 4.1.1 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1
12.7.2 4.1.1 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1
12.7.3 4.1.1 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1
12.7.5 4.1.1 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1
Essential Requirements of EU Clause(s)/subclause(s) of this Remarks/Notes
Directive 93/42/EEC European Standard
12.9 4.1.1
13.1 4.1.1
13.2 4.1.1 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.10.3
13.3 a), b), d) 4.1.1 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014, 9.1
13.3 i) 4.1.1 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.29
13.3 k) 4.1.1 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.3
13.3 I) 4.1.1 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014, 9.1
13.4 4.1.1 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
8.1 b)
13.6 a) Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014, 9.1
13.6 b) 8 f) Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014, 8.3
13.6 c) 4.1.4, 4.3.4 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
8.2 h)
13.6 d) 8 a), c), h) Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
6.1.3.2, 8.1 and 8.3 g)
13.6 q) 8 Including reference to
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
Clause 8
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)
Essential Health and Safety Clause(s)/sub-clause(s) of this Qualifying remarks/Notes
Requirements (EHSRs) of European Standard
Directive 2006/42/EC
1 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.3 and 5.2.4
1.1.2 4.1.1, 5.1.1, 5.1.2 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014, 5.1
1.1.3 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.1.1, 5.1.2, 5.2 and 5.3.2 a)
1.1.5 4.1.1 See in addition
EN ISO 15883-1:2009, 9.2
1.1.6 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.12.3, 5.27.1 and 6.6.2
1.1.7 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014, 5.2
1.2.1, 1st dash and 2nd dash 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.2, 5.2.4, 5.12.1, 5.20 and 5.22
1.2.2, 1st dash 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014, 5.2,
5.12.3, 5.12.8 and 5.12.9
1.2.3 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:2014,
5.2.1
1.2.4.1 4.1.1 See in addition
EN ISO 15883-1:2009 +
EN ISO 15883-1:2009/A1:
...
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