EN ISO 15883-2:2009
(Main)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 15883-2:2006)
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 15883-2:2006)
ISO 15883-2:2006 specifies particular requirements for washer disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of re-usable medical devices such as surgical instruments, anaesthetic equipment, bowls, dishes and receivers, utensils and glassware.
The requirements in ISO 15883-2:2006 apply in addition to the general requirements specified in ISO 15883-1.
The specified performance requirements of ISO 15883-2:2006 may not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.
Reinigungs-Desinfektionsgeräte - Teil 2: Anforderungen und Prüfverfahren von Reinigungs-Desinfektionsgeräten mit thermischer Desinfektion für chirurgische Instrumente, Anästhesiegeräte, Gefäße, Utensilien, Glasgeräte usw. (ISO 15883-2:2006)
Dieser Teil von ISO 15883 legt besondere Anforderungen an Reinigungs-Desinfektionsgeräte (RDG) fest, die
für die Reinigung und thermische Desinfektion wieder verwendbarer medizinischer Produkte wie chirurgische
Instrumente, Anästhesiezubehör/-materialien, Schüsseln, Schalen, Auffanggefäße, Utensilien und Glaswaren
in einem einzigen Prozessablauf bestimmt sind.
ANMERKUNG 1 Die thermische Desinfektion kann durch Spülen der Beladung mit heißem Wasser, die Einwirkung von
Dampf oder Kombination beider erreicht werden.
Die Anforderungen in diesem Teil von ISO 15883 gelten zusätzlich zu den in ISO 15883-1 festgelegten allgemeinen
Anforderungen.
Die in diesem Teil von ISO 15883 festgelegten Leistungsanforderungen können nicht die Inaktivierung oder
Beseitigung von Erregern übertragbarer Spongiformer Enzephalopathien (Prionenproteine) sicherstellen.
ANMERKUNG 2 Wenn daran zu denken ist, dass Prionenproteine vorhanden sein können, ist bei der Wahl der
Desinfektions- und Reinigungsmittel besondere Sorgfalt erforderlich, um sicherzustellen, dass die verwendeten
Chemikalien nicht mit dem Prionenprotein auf eine Weise reagieren, die dessen Beseitigung oder Inaktivierung verhindern
kann.
Laveurs désinfecteurs - Partie 2: Exigences et essais pour laveurs désinfecteurs destinés à la désinfection thermique des instruments chirurgicaux, du matériel d'anesthésie, des bacs, plats, récipients, ustensiles, de la verrerie, etc. (ISO 15883-2:2006)
L'ISO 15883-2:2006 spécifie les exigences particulières relatives aux laveurs désinfecteurs (LD) destinés à être utilisés pour le nettoyage et la désinfection thermique, au cours d'un seul cycle standard, des dispositifs médicaux réutilisables tels que les instruments chirurgicaux, le matériel d'anesthésie, les bacs, plats, récipients, ustensiles, de la verrerie, etc.
Les exigences de l'ISO 15883-2:2006 sont applicables conjointement avec les exigences générales spécifiées dans l'ISO 15883-1.
Les exigences de performances spécifiées dans l'ISO 15883-2:2006 peuvent ne pas assurer l'inactivation ou l'élimination de l'agent ou des agents infectieux (protéine du prion) des encéphalopathies spongiformes transmissibles.
Čistilno-dezinfekcijske naprave - 2. del: Zahteve in preskusi za čistilno-dezinfekcijske naprave s toplotno dezinfekcijo za kirurške instrumente, anestezijsko opremo, posode idr. (ISO 15883-2:2006)
General Information
Relations
Frequently Asked Questions
EN ISO 15883-2:2009 is a standard published by the European Committee for Standardization (CEN). Its full title is "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 15883-2:2006)". This standard covers: ISO 15883-2:2006 specifies particular requirements for washer disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of re-usable medical devices such as surgical instruments, anaesthetic equipment, bowls, dishes and receivers, utensils and glassware. The requirements in ISO 15883-2:2006 apply in addition to the general requirements specified in ISO 15883-1. The specified performance requirements of ISO 15883-2:2006 may not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.
ISO 15883-2:2006 specifies particular requirements for washer disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of re-usable medical devices such as surgical instruments, anaesthetic equipment, bowls, dishes and receivers, utensils and glassware. The requirements in ISO 15883-2:2006 apply in addition to the general requirements specified in ISO 15883-1. The specified performance requirements of ISO 15883-2:2006 may not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.
EN ISO 15883-2:2009 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 15883-2:2009 has the following relationships with other standards: It is inter standard links to EN ISO 15883-2:2006, EN ISO 15883-2:2025. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 15883-2:2009 is associated with the following European legislation: EU Directives/Regulations: 2007/47/EC, 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 15883-2:2009 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
01-september-2009
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SIST EN ISO 15883-2:2006
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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 15883-2:2006)
Reinigungs-Desinfektionsgeräte - Teil 2: Anforderungen und Prüfverfahren von
Reinigungs-Desinfektionsgeräten mit thermischer Desinfektion für chirurgische
Instrumente, Anästhesiegeräte, Gefäße, Utensilien, Glasgeräte usw. (ISO 15883-2:2006)
Laveurs désinfecteurs - Partie 2: Exigences et essais pour laveurs désinfecteurs
destinés à la désinfection thermique des instruments chirurgicaux, du matériel
d'anesthésie, des bacs, plats, récipients, ustensiles, de la verrerie, etc. (ISO 15883-
2:2006)
Ta slovenski standard je istoveten z: EN ISO 15883-2:2009
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 15883-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2009
ICS 11.080.10 Supersedes EN ISO 15883-2:2006
English Version
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 15883-2:2006)
Laveurs désinfecteurs - Partie 2: Exigences et essais pour Reinigungs-Desinfektionsgeräte - Teil 2: Anforderungen
laveurs désinfecteurs destinés à la désinfection thermique und Prüfverfahren von Reinigungs-Desinfektionsgeräten
des instruments chirurgicaux, du matériel d'anesthésie, des mit thermischer Desinfektion für chirurgische Instrumente,
bacs, plats, récipients, ustensiles, de la verrerie, etc. (ISO Anästhesiegeräte, Gefäße, Utensilien, Glasgeräte usw.
15883-2:2006) (ISO 15883-2:2006)
This European Standard was approved by CEN on 16 May 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15883-2:2009: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
Foreword
The text of ISO 15883-2:2006 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health
care products” of the International Organization for Standardization (ISO) and has been taken over as EN ISO
15883-2:2009 by 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 December 2009, and conflicting national standards shall be withdrawn
at the latest by March 2010.
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 15883-2:2006.
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 EC Directive.
For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document.
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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 15883-2:2006 has been approved by CEN as a EN ISO 15883-2:2009 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC
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 Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the 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.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on medical
devices
Clauses/subclauses of this Essential requirements (ERs) of EU Qualifying remarks/Notes
International Standard Directive 93/42/EEC
4.1.1 1, 2, 3, 4, 5, 6, 7.1, 7.2, 7.3, 7.5, 7.6, 8.1, 9.1, The WD shall comply with the
9.2, 9.3, 12.1, 12.5, 12.6, 12.7.1, 12.7.2, 12.7.3, requirements of ISO 15883-1:—
12.7.5, 13.1, 13.3, 13.4
4.1.2 1, 3, 4, 6, 7.1, 8.1, 9.1
4.1.3 1, 3, 4, 6, 7.1, 8.1, 9.1
4.1.5 3, 7.1
4.1.6 7.3, 8.1
4.2 3, 8.1
4.3 3, 8.1
4.4 3, 8.1
5.1 3, 8.1
5.2 3, 8.1
5.3 3, 8.1
6.1 1, 2, 3, 4, 7.1, 8.1 Testing for conformity according
to ISO 15883-1:—
6.2 3, 8.1
6.3 3, 8.1
7 9.1, 13.6
8 1, 3, 7.1, 7.2, 8.1
7.4, 8.2, 8.3, 8.4, 8.5, 8.6, 8.7, 10.1, 10.2, 10.3, not applicable
Clause 11, 12.2, 12.3, 12.4, 12.7.4, 12.8, 13.5,
- 12.1a) This relevant Essential
Requirement is not addressed in
this European Standard
4.1.1 13.3 a) This relevant Essential
Requirement is partly addressed
in this European Standard
- 13.6 q) This relevant Essential
Requirement is not addressed in
this European Standard
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
EN Requirements (EHSRs) of
Directive 2006/42/EC
4.1.1 1.1.7, 1.2.2, 1.2.3, 1.2.4, 1.2.5, This relevant EHSR are
1.3.2, 1.3.3, 1.3.4, 1.5.1, 1.5.2, addressed in this Standard
1.5.3, 1.5.5, 1.5.6, 1.5.8, 1.5.13,
1.5.14, 1.6.2, 1.6.3, 1.6.4, 1.6.5
4.1.1 1.1.3, 1.1.5, 1.1.6, 1.2.1, 1.2.6, This relevant EHSR are
1.3.1, 1.3.7, 1.3.8.1, 1.3.8.2, 1.5.4, partly addressed in this
1.6.1, 1.7.1, 1.7.2, ,1.7.3, 1.7.4 Standard
1.3.9, 1.4.1, 1.4.2, 1.4.3, 1.5.9, 4 This relevant EHSR are not
addressed in this Standard
INTERNATIONAL ISO
STANDARD 15883-2
First edition
2006-04-15
Washer-disinfectors —
Part 2:
Requirements and tests for washer-
disinfectors employing thermal
disinfection for surgical instruments,
anaesthetic equipment, bowls, dishes,
receivers, utensils, glassware, etc.
Laveurs désinfecteurs —
Partie 2: Exigences et essais pour laveurs désinfecteurs destinés à la
désinfection thermale des instruments chirurgicaux, du matériel
d'anesthésie, des récipients, des ustensiles et de la verrerie, etc.
Reference number
ISO 15883-2:2006(E)
©
ISO 2006
ISO 15883-2:2006(E)
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ii © ISO 2006 – All rights reserved
ISO 15883-2:2006(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. 3
4.3 Disinfecting. 3
4.4 Temperature of internal surfaces of processed devices. 4
5 Mechanical and control requirements. 4
5.1 Load connectors . 4
5.2 Control systems. 5
5.3 Process verification. 5
6 Testing for conformity. 5
6.1 General. 5
6.2 Tests for soil removal from chamber walls, load carrier and load . 5
6.3 Thermometric tests. 6
7 Information to be supplied by the manufacturer. 8
8 Information to be requested from the purchaser by the supplier of the WD. 8
Annex A (informative) Summary of test programmes . 9
Bibliography . 10
ISO 15883-2:2006(E)
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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 15883-2 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: Test soils and methods for demonstrating cleaning efficacy [Technical specification]
iv © ISO 2006 – All rights reserved
ISO 15883-2:2006(E)
Introduction
It is recommended that this Introduction be read in conjunction with the introduction to ISO 15883-1:2006.
This part of ISO 15883 is the second of a series of standards specifying the performance of washer-
disinfectors and specifies the general requirements for performance applicable to instrument washer-
disinfectors. The requirements given in this part apply to washer-disinfectors used for cleaning and thermal
disinfection of medical devices intended for re-use such as:
⎯ surgical instruments;
⎯ powered devices;
⎯ instrument trays;
⎯ instruments for minimally invasive surgery;
⎯ lumen devices and tubing;
⎯ rigid endoscopes;
⎯ anaesthetic and respiratory equipment;
⎯ bowls, dishes and receivers;
⎯ glassware;
⎯ containers for transit.
Fields of application within the scope of the ISO 15883 series of standards include laboratory, veterinary,
dental and pharmaceutical applications and other specific applications, such as washer-disinfectors for
bedsteads and transport carts and the disinfection of crockery and cutlery intended for use with
immunologically compromised patients.
Requirements for washer-disinfectors for other applications are specified in other parts of the ISO 15883
series of standards.
When processed in the instrument washer-disinfector, the medical devices might be intended for immediate
use or might be intended for packing and sterilization. In both cases, the efficacy of the cleaning and
disinfection is of major importance. In either case, this is for the well being of the patient. In the latter case, it is
also for the safety of the staff who handles the instruments in the process of inspection, testing and packing as
well as ensuring that the sterilization process is not unduly challenged by residual soil.
The efficacy of disinfection can be impaired if soil removal is incomplete before the start of the disinfection
process. Users should be aware that some medical devices might require pre-treatment e.g. soaking,
brushing, ultra sonic pre-cleaning, lumen irrigation or any combination of these techniques. Reference should
be made to the medical manufacturer's instructions for reprocessing (see also ISO 17664).
Safety requirements for washer-disinfectors are given in IEC 61010-2-045.
ISO 15883-2:2006(E)
In respect of the potential adverse effects on the quality of water intended for human consumption caused by
the washer-disinfectors:
a) it should be noted that, until verifiable European criteria are adopted, existing national regulations
concerning the use and/or the characteristics of the washer-disinfectors remain in force;
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 member states of the EU or EFTA.
vi © ISO 2006 – All rights reserved
INTERNATIONAL STANDARD ISO 15883-2:2006(E)
Washer-disinfectors —
Part 2:
Requirements and tests for washer-disinfectors employing
thermal disinfection for surgical instruments, anaesthetic
equipment, bowls, dishes, receivers, utensils, glassware, etc.
1 Scope
This part of ISO 15883 specifies particular requirements for washer-disinfectors (WD) that are intended for
use for the cleaning and thermal disinfection, in a single operating cycle, of re-usable medical devices such as
surgical instruments, anaesthetic equipment, bowls, dishes and receivers, utensils and glassware.
NOTE 1 Thermal disinfection can be achieved by rinsing the load with hot water, exposure to steam or combination of
the two.
The requirements specified in this part of ISO 15883 are applicable in conjunction with the general
requirements specified in ISO 15883-1.
The specified performance requirements of this part of ISO 15883 may not ensure the inactivation or removal
of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.
NOTE 2 If it is considered that prion protein can be present, particular care is needed in
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SIST EN ISO 15883-2:2009 표준은 의료 기기의 청소 및 열 소독을 위한 세척 소독기(Washer-disinfectors, WD)에 관한 중요한 요구사항을 명시하고 있습니다. 이 표준은 수술 기구, 마취 장비, 그릇, 접시, 수신기, 조리 도구 및 유리 제품과 같은 재사용 가능한 의료 기기에 대해 단일 작업 사이클 내에서 청소와 열 소독을 동시에 수행할 수 있도록 설계된 WD의 적합성을 보장합니다. 이 표준의 강점 중 하나는 세척 소독기의 기초적인 성능 요구 사항을 체계적으로 규명함으로써 사용자의 안전과 제품의 신뢰성을 높인다는 점입니다. 특히, ISO 15883-2:2006에서는 소독기 사용 시 재사용 가능한 의료 기기에 대한 구체적인 테스트와 요구 사항을 명시하여 운영자가 효과적으로 기기를 운영할 수 있도록 도와줍니다. 일반 요구 사항인 ISO 15883-1의 요구 사항 이외에 추가적인 내용을 포함하고 있어 표준의 포괄적인 적용 범위를 더욱 넓히고 있습니다. 그러나 ISO 15883-2:2006의 성능 요구 사항은 전염성 해면뇌병증의 원인 물질인 프리온 단백질의 비활성화나 제거를 보장하지 않는 점은 주의할 필요가 있습니다. 이는 의료 기기의 안전성과 관련하여 사용자가 추가적인 소독 절차를 고려해야 함을 의미합니다. 그러나 전반적으로 이 표준은 의료 기기의 세척 및 소독 프로세스의 신뢰성을 높이고, 의료 환경에서의 감염 예방에 기여하는 데 매우 중요한 역할을 합니다. 따라서, SIST EN ISO 15883-2:2009는 세척 소독기 운영 및 관리에 있어 필수적인 기준으로 자리 잡고 있으며, 이는 의료 기기 관리의 품질을 높이는 데 필수적입니다.
Die Norm EN ISO 15883-2:2009 legt spezifische Anforderungen und Prüfmethoden für Wascherdesinfektoren fest, die zur thermischen Desinfektion von wiederverwendbaren medizinischen Geräten vorgesehen sind. Der Anwendungsbereich dieser Norm umfasst eine Vielzahl von Geräten, darunter chirurgische Instrumente, Anästhesiegeräte, Geschirr, Behälter, Utensilien und Glaswaren. Diese umfassende Abdeckung macht die Norm besonders relevant für Einrichtungen im Gesundheitswesen, die höchste Hygiene- und Desinfektionsstandards einhalten müssen. Eine der Stärken dieser Norm ist die detaillierte Spezifikation der Leistungsanforderungen, die an Wascherdesinfektoren gestellt werden. Diese Anforderungen garantieren, dass die Geräte in einem einzigen Arbeitszyklus sowohl die Reinigung als auch die thermische Desinfektion dieser anspruchsvollen Objekte effizient durchführen können. Der klare Fokus auf die spezifischen Anforderungen für die Desinfektion von medizinischen Geräten sorgt dafür, dass Anwender die notwendigen Maßnahmen ergreifen können, um die Sicherheit der Patienten zu gewährleisten. Zudem berücksichtigt die EN ISO 15883-2:2009 die allgemeinen Anforderungen, die in der ISO 15883-1 festgelegt sind. Diese Verbindung zwischen den beiden Normen gewährleistet eine umfassende Herangehensweise an die Hygiene und Sicherheit in der Anwendung von Wascherdesinfektoren. Es ist jedoch wichtig zu beachten, dass die Norm keine vollständige Inaktivierung oder Entfernung von Überträgern von transmissiblen spongiformen Enzephalopathien (wie zum Beispiel Prionen) garantiert. Daher sollten Anwender der Norm stets zusätzliche Sicherheitsmaßnahmen in Betracht ziehen, um die Wirksamkeit von Desinfektionsprocedere zu maximieren. Insgesamt stellt die EN ISO 15883-2:2009 einen wichtigen Standard für Hersteller und Anwender von Wascherdesinfektoren dar, der die Grundlage für effektive Reinigungs- und Desinfektionsprozesse in der modernen Medizin bietet. Die Norm ist nicht nur entscheidend für das Verständnis der technischen Anforderungen, sondern auch für die Implementierung effizienter Hygienepraktiken in gesundheitsbezogenen Einrichtungen.
The standard EN ISO 15883-2:2009 outlines essential requirements for washer-disinfectors designed specifically for thermal disinfection of a wide array of reusable medical devices, such as surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, and glassware. The scope of this document is pivotal, as it establishes the guidelines for the cleaning and thermal disinfection processes that must occur in a single operating cycle, ensuring that medical facilities can maintain high standards of hygiene and safety. One of the significant strengths of EN ISO 15883-2:2009 is its comprehensive nature in addressing the specific requirements related to washer-disinfectors. The standard builds upon the general requirements specified in ISO 15883-1, thereby providing a structured approach that complements existing protocols for the cleaning and disinfection of medical devices. This layered methodology ensures that institutions implementing these standards are equipped with robust procedures that enhance patient safety and operational efficiency. Moreover, the relevance of EN ISO 15883-2:2009 cannot be overstated in the current healthcare environment, where infection control is paramount. By providing detailed performance requirements for washer-disinfectors, the standard aids healthcare professionals in achieving the desired levels of cleanliness and disinfection, essential for preventing cross-contamination and healthcare-associated infections. However, it is also important to highlight that the performance requirements may not ensure the complete inactivation or removal of prion proteins associated with transmissible spongiform encephalopathies, underlining the need for additional measures to address these specific risks. In summary, EN ISO 15883-2:2009 serves as a crucial framework for the effective usage of washer-disinfectors in the healthcare industry, fostering an environment of safety and compliance. Its strength lies in its detailed requirements tailored to various medical devices, making it relevant for today’s healthcare needs and enhancing the overall quality of care provided to patients.
SIST EN ISO 15883-2:2009は、外科用器具や麻酔機器、ボウル、皿、受容器、器具、ガラス製品などの再利用可能な医療機器の洗浄と熱消毒を単一の操作サイクルで行うための要求事項を詳細に定めている標準です。この文書は、洗浄消毒器（WD）の要件および試験方法に特化しており、使用者が安全かつ効果的に機器を操作できるように設計されています。 この標準の強みは、ISO 15883-1で定められた一般的な要件に加え、特定の性能要件を提示している点にあります。これにより、使用者は洗浄消毒器の機能を十分に理解し、遵守するための基準が明確に示されています。特に、洗浄消毒器がどのようにして医療機器を清潔に保つかの具体的なガイドラインが提供されており、医療現場における衛生管理の向上に寄与することが期待されます。 ただし、ISO 15883-2:2006は、移行性海綿状脳症の原因物質であるプリオンタンパク質の不活化や除去を保証するわけではないことを明記しており、使用者はこれを理解した上で利用する必要があります。この点を踏まえ、標準は医療機関が消毒を行う上での重要な指針となり、洗浄消毒器を適切に運用することで感染管理に寄与することが期待されます。 全体として、SIST EN ISO 15883-2:2009は、医療機器の洗浄と消毒に関連する標準として、実用性と適用範囲の両方において非常に重要であり、医療業界における品質管理の強化に貢献する内容となっています。
Le document SIST EN ISO 15883-2:2009 propose des recommandations précises concernant les laveurs-désinfecteurs (LD) destinés à la désinfection thermique des instruments chirurgicaux, équipements anesthésiques, récipients, ustensiles, verreries, etc. Ce standard s'inscrit dans le cadre des exigences fondamentales pour assurer une désinfection efficace tout en respectant les différents aspects de nettoyage requis pour les dispositifs médicaux réutilisables. Le champ d'application de cette norme est particulièrement pertinent, car elle spécifie les exigences techniques que doivent respecter les laveurs-désinfecteurs. En intégrant les normes générales énoncées dans l'ISO 15883-1, le document enrichit le cadre de référence en matière de sécurité et d'efficacité des processus de désinfection. En outre, la possibilité de réaliser le nettoyage et la désinfection thermique en un seul cycle de fonctionnement constitue un atout majeur pour les établissements de santé, permettant de gagner en efficacité opérationnelle tout en garantissant une désinfection adéquate. Parmi les forces de la norme ISO 15883-2:2006, on retrouve la précision dans les critères de performance, qui sont cruciaux pour évaluer l'efficacité de ces dispositifs. Toutefois, il est important de noter que, bien que les exigences définies puissent ne pas garantir l'inactivation ou l'élimination des agents pathogènes tels que les protéines prion, cela souligne l'importance d'une approche globale en matière d'hygiène et de sécurité sanitaire. En résumé, le SIST EN ISO 15883-2:2009 est un document de référence incontournable pour les fabricants et utilisateurs de laveurs-désinfecteurs, car il établit un cadre clair pour la désinfection thermique des instruments médicaux. Sa pertinence réside dans sa capacité à répondre aux besoins d'une pratique médicale sécurisée à travers des exigences strictes et des tests rigoureux, renforçant ainsi la confiance dans les procédés de désinfection des dispositifs médicaux.
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