SIST EN ISO 15883-3:2006
(Main)Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)
Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)
This part of prEN ISO 15883 specifies particular requirements for washer-disinfectors (WD) that are intended to be used for emptying, flushing, cleaning and thermal disinfection of containers used to hold human waste for disposal by one operating cycle.
The requirements of this part apply in addition to the general requirements specified in prEN ISO 15883-1.
Reinigungs-Desinfektionsgeräte - Teil 3: Anforderungen an und Prüfverfahren für Reinigungs-Desinfektionsgeräten mit thermischer Desinfektion für Behälter für menschliche Ausscheidungen (ISO 15883-3:2006)
Dieser Teil von ISO 15883 legt besondere Anforderungen an Reinigungs-Desinfektionsgeräte (RDG) fest, die für die Entleerung, Ausspülung, Reinigung und thermische Desinfektion von Behältern für menschliche Ausscheidungen zur Behandlung innerhalb eines Betriebszyklus angewandt werden.
Die Anforderungen in diesem Teil gelten zusätzlich zu den in ISO 15883 1:2006 festgelegten allgemeinen Anforderungen.
Laveurs désinfecteurs - Partie 3: Exigences et essais pour laveurs désinfecteurs destinés a la désinfection thermique de récipients a déjections humaines (ISO 15883-3:2006)
La présente partie du prEN ISO 15883 détermine les exigences spécifiques pour les laveurs-désinfecteurs destinés a etre utilisés pour vider, rincer, nettoyer et désinfecter thermiquement les récipients employés pour contenir les déjections humaines afin de pouvoir les réutiliser apres un cycle standard.
Les exigences de cette partie s'ajoutent a celles spécifiées dans le prEN ISO 15883 1.
Čistilno-dezinfekcijske naprave - 3. del: Zahteve in preskusi za čistilno-dezinfekcijske naprave s toplotno dezinfekcijo za zbiralnike človeških izločkov (ISO 15883-3:2006)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 15883-3:2006
01-julij-2006
ýLVWLOQRGH]LQIHNFLMVNHQDSUDYHGHO =DKWHYHLQSUHVNXVL]DþLVWLOQR
GH]LQIHNFLMVNHQDSUDYHVWRSORWQRGH]LQIHNFLMR]D]ELUDOQLNHþORYHãNLKL]ORþNRY
,62
Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing
thermal disinfection for human waste containers (ISO 15883-3:2006)
Reinigungs-Desinfektionsgeräte - Teil 3: Anforderungen an und Prüfverfahren für
Reinigungs-Desinfektionsgeräten mit thermischer Desinfektion für Behälter für
menschliche Ausscheidungen (ISO 15883-3:2006)
Laveurs désinfecteurs - Partie 3: Exigences et essais pour laveurs désinfecteurs
destinés a la désinfection thermique de récipients a déjections humaines (ISO 15883-
3:2006)
Ta slovenski standard je istoveten z: EN ISO 15883-3:2006
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
SIST EN ISO 15883-3:2006 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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EUROPEAN STANDARD
EN ISO 15883-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2006
ICS 11.080.10
English Version
Washer-disinfectors - Part 3: Requirements and tests for
washer-disinfectors employing thermal disinfection for human
waste containers (ISO 15883-3:2006)
Laveurs désinfecteurs - Partie 3: Exigences et essais pour Reinigungs-Desinfektionsgeräte - Teil 3: Anforderungen an
laveurs désinfecteurs destinés à la désinfection thermale und Prüfungen von Reinigungs-Desinfektionsgeräten mit
de récipients à déjections humaines (ISO 15883-3:2006) thermischer Desinfektion für Behälter für menschliche
Ausscheidungen (ISO 15883-3:2006)
This European Standard was approved by CEN on 16 March 2006.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, 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: rue de Stassart, 36 B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15883-3:2006: E
worldwide for CEN national Members.
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EN ISO 15883-3:2006 (E)
Foreword
This document (EN ISO 15883-2:2006) has been prepared by Technical Committee CEN/TC 102
"Sterilizers for medical purposes", the secretariat of which is held by DIN, in collaboration with
Technical Committee ISO/TC 198 "Sterilization of health care products".
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 October 2006, and conflicting national standards
shall be withdrawn at the latest by October 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 EU Directive(s).
For relationship with EU Directive(s), 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, 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.
2
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EN ISO 15883-3:2006 (E)
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
Essential Requirements of the New Approach Directive 93/42/EEC.
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 Essential requirements (ERs) Qualifying remarks/Notes
this
of EU Directive 93/42/EEC
International Standard
4.1 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, 13.6
4.2 7.3, 8.1
4.3 2, 7.2, 7.5, 8.1, 9.1
4.4 3, 8.1
4.5 3, 8.1
4.6 3, 8.1
4.7 3, 8.1
5.1 3, 8.1
5.2 3, 8.1
5.3 7.2, 7.5, 8.1
6.1 1, 2, 3, 6, 7.1, 8.1 Testing for conformity according
to ISO 15883-1:—
6.2 7.2, 7.5, 8.1, 91
3
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EN ISO 15883-3:2006 (E)
Table ZA.1 (continued)
Clauses/subclauses of this Essential requirements (ERs) Qualifying remarks/Notes
European Standard of EU Directive 93/42/EEC
6.3 3, 8.1
6.4 3, 8.1
6.5.1, 6.5.2 2, 3, 7.2, 7.5, 8.1, 9.1
6.6 3, 8.1
7 9.1, 13.1, 13.3, 13.6
7 a) 9.1
7 g) 3, 8.1
8 1.3, 7.1, 7.2, 7.3, 8.1
8 c) 7.3
8 e) 3, 8.1
7.4, 8.2, 8.3, 8.4, 8.5, 8.6, 8.7, 10.1, not applicable
10.2, 10.3, Clause 11, 12.2, 12.3,
12.4, 12.7.4, 12.8, 13.5, 14
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
4
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INTERNATIONAL ISO
STANDARD 15883-3
First edition
2006-04-15
Washer-disinfectors —
Part 3:
Requirements and tests for washer-
disinfectors employing thermal
disinfection for human waste containers
Laveurs désinfecteurs —
Partie 3: Exigences et essais pour laveurs désinfecteurs destinés à la
désinfection thermale de récipients à déjections humaines
Reference number
ISO 15883-3:2006(E)
©
ISO 2006
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ISO 15883-3:2006(E)
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ii © ISO 2006 – All rights reserved
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ISO 15883-3:2006(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 1
4 Performance requirements . 2
4.1 General. 2
4.2 Chemical dosing systems. 2
4.3 Emptying. 3
4.4 Cleaning. 3
4.4.1 Flushing. 3
4.4.2 Washing. 3
4.4.3 Test requirements. 3
4.5 Disinfecting. 3
4.6 Rinsing. 4
4.7 Drying. 4
5 Mechanical and control requirements. 4
5.1 Instrumentation and control . 4
5.2 Process. 4
5.3 Venting, draining and purging. 4
5.4 Water quality. 5
6 Testing for conformity. 5
6.1 General. 5
6.2 Test for drain seal integrity. 5
6.3 Test for flushing of non-absorbent materials . 5
6.4 Test for flushing of absorbent material (toilet tissue) . 5
6.5 Test for loading/emptying of containers . 5
6.5.1 Automatic emptying . 5
6.5.2 Manual emptying. 6
6.6 Tests for soil removal from chamber walls, load carrier and load . 6
7 Information to be supplied by the manufacturer. 6
8 Information to be requested from the purchaser by the supplier of the WD. 7
Annex A (informative) Summary of test programmes . 8
Annex B (normative) Specification for toilet tissue for use in tests on washer-disinfectors for
human-waste containers. 9
Annex C (informative) Measurement of water absorbency of toilet tissue by the basket method. 10
Bibliography . 11
© ISO 2006 – All rights reserved iii
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ISO 15883-3:2006(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 15883-3 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
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ISO 15883-3:2006(E)
Introduction
It is recommended that this Introduction be read in conjunction with the introduction to ISO 15883-1.
This part of ISO 15883 is the third of a series of standards specifying the performance of washer-disinfectors
and specifies the general requirements for performance applicable to bedpan washer-disinfectors. The
requirements given in this part apply to washer-disinfectors used for emptying, flushing, cleaning and
thermally disinfecting human waste containers intended for re-use such as:
⎯ portable sanitary pans;
⎯ supports for single-use bed pans;
⎯ hospital bowls;
⎯ urine bottles;
⎯ suction bottles; and
⎯ products similar to the above and used for similar purposes.
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 the ISO 15883 series
of standards.
Bedpan washer disinfectors are loaded manually. In order to reduce the risk of spillage and the generation of
aerosols most machines incorporate means to empty human waste containers automatically e.g. by the action
of closing the door.
Where equipment does not provide automatic emptying facilities, extra care is needed by the user to avoid
exposure to human waste and contamination of the work environment including the generation of aerosols.
The reliability of a bedpan washer-disinfector may be adversely affected if the machine is connected to a
poorly designed or constructed drainage system. The purchaser is therefore recommended to ensure that the
drainage system complies with the manufacturer’s recommendations in all respects.
Safety requirements for washer-disinfectors are given in IEC 61010-2-045.
In respect of the potential adverse effects on the quality of water intended for human consumption caused by
the washer-disinfectors:
a) note 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) this part of ISO 15883 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.
© ISO 2006 – All rights reserved v
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INTERNATIONAL STANDARD ISO 15883-3:2006(E)
Washer-disinfectors —
Part 3:
Requirements and tests for washer-disinfectors employing
thermal disinfection for human waste containers
1 Scope
This part of ISO 15883 specifies particular
...
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