EN ISO 15883-1:2006

SLOVENSKI STANDARD
01-julij-2006
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Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO
15883-1:2006)
Reinigungs-Desinfektionsgeräte - Teil 1: Allgemeine Anforderungen, Begriffe und
Prüfverfahren (ISO 15883-1:2006)
Laveurs désinfecteurs - Partie 1: Exigences générales, termes et définitions et essais
(ISO 15883-1:2006)
Ta slovenski standard je istoveten z: EN ISO 15883-1:2006
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 15883-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2006
ICS 11.080.10
English Version
Washer-disinfectors - Part 1: General requirements, terms and
definitions and tests (ISO 15883-1:2006)
Laveurs désinfecteurs - Partie 1: Exigences générales, Reinigungs-Desinfektionsgeräte - Teil 1: Allgemeine
termes et définitions et essais (ISO 15883-1:2006) Anforderungen, Definitionen und Prüfungen (ISO 15883-
1:2006)
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 15883-1:2006: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 15883-1:2006) 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.

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 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) Qualifying remarks/Notes
European Standard of EU Directive 93/42/EEC

4 1, 4, 3, 6, 7.1, 8.1, 9.1, 7.2, 9.2
5.1 2, 7.3
5.1.3 4
5.1.7 7.5
5.1.8 7.5
5.2 1, 2, 6, 7.1, 7.2, 7.3, 7.5, 8.1, The WD shall comply with the
9.1, 9.2, 9.3, 12.5, 12.6, 12.7.1, requirements of IEC 61010-2-045
12.7.2, 12.7.3, 12.7.4, 12.7.5,
13.1
5.4 7.5 Refers only to leakage
5.4.1.2 7.2, 7.5
5.4.1.3 13.1
5.4.1.5 1, 2
5.4.1.6 1, 2
5.4.1.7 1, 2
5.4.1.8 1, 2
Table ZA.1 (continued)
Clauses/subclauses of this Essential requirements (ERs) Qualifying remarks/Notes
European Standard of EU Directive 93/42/EEC

5.4.2 13.1
5.4.3 8.1
5.4.4 8.1
5.4.5.2 2
5.4.5.3 2, 7.5
5.5.1 2, 7.2
5.5.2 2
5.7 3, 7.2, 7.3
5.8 2, 12.1, 12.7.5
5.9 3
5.10. 13.2
5.11.1 3
5.11.2 2, 3
5.11.3 2, 3 The choice of process verification
system shall be based on a
documented risk analysis
5.11.4 2, 3
5.12 3, 12.9
5.13 3
5.14 3
5.15 3
5.16 3
5.17 3
5.18 3
5.19 3
5.20 12.1
5.21 12.1
5.22 2, 3
5.23 3, 13.1
5.24 7.2, 7.5
5.25 7.2, 7.5
5.27 3
5.28 3
Table ZA.1 (continued)
Clauses/subclauses of this Essential requirements (ERs) Qualifying remarks/Notes
European Standard of EU Directive 93/42/EEC

5.29 3
6.1 1, 2, 3, 6, 7.1, 8.1 Testing for conformity
6.2 1, 2, 3, 6, 7.1, 8.1 Testing for conformity
6.3.5 2, 3
6.3.6 2, 3
6.3.7 2, 3
6.4 3
6.5.3 7.5
6.5.4 3
6.5.5 3
6.5.6 3
6.6 3
6.7 3
6.8 3
6.9 3, 7.3
6.10 3, 7.2, 7.5
6.11 3, 7.2, 7.5
6.12 3, 7.2, 7.5
6.13 3, 7.2, 7.5
7 13
8 13.1, 13.3, 13.4, 13.6
9 5, 13.3
10 1
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.

INTERNATIONAL ISO
STANDARD 15883-1
First edition
2006-04-15
Washer-disinfectors —
Part 1:
General requirements, terms
and definitions and tests
Laveurs désinfecteurs —
Partie 1: Exigences générales, termes et définitions et essais

Reference number
ISO 15883-1:2006(E)
©
ISO 2006
ISO 15883-1:2006(E)
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ISO 15883-1:2006(E)
Contents Page
Foreword. v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 Performance requirements . 8
4.1 General. 8
4.2 Cleaning. 10
4.3 Disinfection . 10
4.4 Rinsing. 11
4.5 Drying. 11
4.6 Process chemicals. 12
5 Mechanical and process requirements . 12
5.1 Materials, design and manufacture/construction. 12
5.2 Safety . 14
5.3 Calorifiers and tanks . 14
5.4 Loading and unloading doors and their controls. 15
5.5 Pipework and fittings. 17
5.6 Spray systems. 17
5.7 Dosing systems . 18
5.8 Load temperature protection. 18
5.9 Process temperature control limits . 19
5.10 Switches, gauges and indicating devices. 20
5.11 Process verification. 20
5.12 Instrumentation and controls . 21
5.13 Temperature indicating systems. 22
5.14 Pressure indicating systems . 23
5.15 Timing equipment. 23
5.16 Operating cycle indicating equipment. 23
5.17 Recording instruments (if fitted). 23
5.18 Control systems. 25
5.19 Override of automatic control . 26
5.20 Microprocessor control systems . 27
5.21 Access to software . 27
5.22 Fault indication systems. 27
5.23 Water supply . 28
5.24 Venting and drainage systems. 28
5.25 Drainage. 29
5.26 Air filters installed within the WD. 29
5.27 Load handling and supports for use within the WD .
...