EN ISO 15883-1:2006
(Main)Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)
This part of EN ISO 15883 specifies general performance requirements for washer-disinfectors and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice. It specifies performance requirements for cleaning and disinfection as well as for the accessories which may be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and re-validation, periodically and after essential repairs, are also specified.
Reinigungs-Desinfektionsgeräte - Teil 1: Allgemeine Anforderungen, Begriffe und Prüfverfahren (ISO 15883-1:2006)
Dieser Teil von ISO 15883 legt allgemeine Leistungsanforderungen an Reinigungs-Desinfektionsgeräte (RDG) und deren Zubehör fest, die für die Reinigung und Desinfektion wieder verwendbarer Medizinprodukte und anderer in der medizinischen, zahnmedizinischen, pharmazeutischen und veterinärmedizinischen Praxis verwendeter Artikel vorgesehen sind. Sie legt die Leistungsanforderungen für die Reinigung und Desinfektion sowie für das Zubehör fest, die zum Erreichen der erforderlichen Leistung notwendig sein können. Ebenso werden die Verfahren und Messgeräte festgelegt, die für die Validierung, die Routineüberprüfung sowie, Routineüberwachung und die Revalidierung, die in periodischen Abständen und nach wesentlichen Reparaturen erfolgt, benötigt werden.
Die Anforderungen an die zur Behandlung spezifischer Beladungsgüter bestimmten RDG sind in folgenden Teilen dieser Norm festgelegt. Für Reinigungs-Desinfektionsgeräte, die für die Behandlung von zwei oder mehreren Arten von Beladungsgütern bestimmt sind, gelten die Anforderungen aller sie betreffenden Teile dieser Norm.
Dieser Teil von ISO 15883 legt keine Anforderungen für Geräte fest, die für die Anwendung in Wäschereien oder im Bereich der Lebensmittelzubereitung bestimmt sind.
Dieser Teil von ISO 15883 enthält keine Anforderungen an Geräte, die für die Sterilisation der Beladung bestimmt sind oder als „Sterilisatoren“ bezeichnet werden; diese sind in anderen Normen, z. B. EN 285, festgelegt.
Es ist möglich, dass die in dieser Norm festgelegten Leistungsanforderungen nicht die Inaktivierung oder Beseitigung von Erregern übertragbarer spongiformer Enzephalopathien (Prionenproteine) sicherstellen können.
Laveurs désinfecteurs - Partie 1: Exigences générales, termes et définitions et essais (ISO 15883-1:2006)
Čistilno-dezinfekcijske naprave - 1. del: Osnovne zahteve, termini, definicije in preskusi (ISO 15883-1:2006)
General Information
Relations
Frequently Asked Questions
EN ISO 15883-1:2006 is a standard published by the European Committee for Standardization (CEN). Its full title is "Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)". This standard covers: This part of EN ISO 15883 specifies general performance requirements for washer-disinfectors and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice. It specifies performance requirements for cleaning and disinfection as well as for the accessories which may be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and re-validation, periodically and after essential repairs, are also specified.
This part of EN ISO 15883 specifies general performance requirements for washer-disinfectors and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice. It specifies performance requirements for cleaning and disinfection as well as for the accessories which may be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and re-validation, periodically and after essential repairs, are also specified.
EN ISO 15883-1:2006 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 15883-1:2006 has the following relationships with other standards: It is inter standard links to prEN ISO 15883-1, EN ISO 15883-1:2009. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 15883-1:2006 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 15883-1:2006 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-julij-2006
ýLVWLOQRGH]LQIHNFLMVNHQDSUDYHGHO 2VQRYQH]DKWHYHWHUPLQLGHILQLFLMHLQ
SUHVNXVL ,62
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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ii © ISO 2006 – All rights reserved
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 . 29
5.28 Trolleys . 30
5.29 Environment . 31
6 Testing for conformity. 31
6.1 General. 31
6.2 Test equipment . 34
6.3 Tests on doors, interlocks and fault indications. 35
6.4 Tests on water quality and water volume . 37
6.5 Tests on pipework . 39
6.6 Tests on instrumentation fitted to the WD .41
ISO 15883-1:2006(E)
6.7 Tests on load carriers. 42
6.8 Thermometric tests. 43
6.9 Chemical dosing tests . 46
6.10 Tests of cleaning efficacy . 47
6.11 Tests of air quality . 48
6.12 Load dryness test . 49
6.13 Automatic control test . 49
7 Documentation . 50
8 Information to be supplied by the manufacturer . 50
8.1 General . 50
8.2 Before delivery of the WD and for installation. 51
8.3 At delivery of the WD . 51
9 Marking, labelling and packaging . 53
9.1 Marking and labelling . 53
9.2 Packaging . 53
10 Information to be requested from the purchaser by the supplier of the WD. 53
Annex A (informative) Test programme . 55
Annex B (informative) A concept — Comparative lethality of moist heat processes . 59
Annex C (normative) Test methods for the detection and assessment of residual proteinaceous
contamination. 63
Annex D (normative) Microbiological recovery medium for estimation of bacterial contamination
of water. 68
Bibliography . 69
iv © ISO 2006 – All rights reserved
ISO 15883-1:2006(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 15883-1 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]
ISO 15883-1:2006(E)
Introduction
This part of ISO 15883 is the first of a series of standards specifying the performance of washer-disinfectors
and specifies the general requirements for performance applicable to all washer-disinfectors. The
requirements given in this part of ISO 15883 are applicable to all washer-disinfectors specified in subsequent
parts of the ISO 15883 series, except insofar as they may be modified or added to by a subsequent part, in
which case the requirements of that particular part will apply.
Fields of application within the scope of ISO 15883 series 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.
Washer-disinfectors should be used only for processing the type of loads specified by the manufacturer of the
washer-disinfector.
In selecting the appropriate washer-disinfector, reference should be made both to this part of ISO 15883 and
to the relevant subsequent parts of ISO 15883 series. It is the user’s responsibility to ensure that the choice of
type of washer-disinfector, operating cycle or quality of services or process chemicals is appropriate for any
particular load.
Safety requirements for washer-disinfectors are given in IEC 61010-2-045.
This part of ISO 15883 has been prepared on the basis that each individual washer-disinfector will be subject
to validation tests (commissioning and performance qualification on first installation) and that in use continued
compliance will be established by periodic tests carried out by, or on behalf of, the user.
Verification of cleaning efficacy is a key aspect of establishing satisfactory performance of a washer-
disinfector. The current state of knowledge has not permitted development of a single test method. As an
interim measure reference has been made to test methods which are currently being applied in a number of
different countries. The specification for these test methods including their test soils can be found in
ISO/TS 15883-5. It remains the intention of the Technical Committee of TC 198 to develop a single test
method.
In respect of the potential adverse effects on the quality of water intended for human consumption caused by
the washer-disinfector:
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-disinfector remain in force;
b) the ISO 15883 series of standards provides no information as to whether the washer-disinfector may be
used without restrictions in any of the member states of the EU or EFTA.
vi © ISO 2006 – All rights reserved
INTERNATIONAL STANDARD ISO 15883-1:2006(E)
Washer-disinfectors —
Part 1:
General requirements, terms and definitions and tests
1 Scope
This part of ISO 15883 specifies general performance requirements for washer-disinfectors (WD) and their
accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other
articles used in the context of medical, dental, pharmaceutical and veterinary practice. It specifies
performance requirements for cleaning and disinfection as well as for the accessories which can be required
to achieve the necessary performance. The methods and instrumentation required for validation, routine
control and monitoring and re-validation, periodically and after essential repairs, are also specified.
The requirements for washer-disinfectors intended to process specific loads are specified in subsequent parts
of this standard. For washer-disinfectors intended to process loads of two or more different types the
requirements of all relevant parts of this standard apply.
This part of ISO 15883 does not specify requirements intended for machines for use for laundry or general
catering purposes.
This part of ISO 15883 does not include requirements for machines which are intended to sterilize the load, or
which are designated as “sterilizers”, these are specified in other standards e.g. EN 285.
The specified performance requirements of this standard may not ensure the inactivation or removal of the
causative agent(s) (prion protein) of transmissible spongiform encephalopathies.
NOTE If it is considered that prion protein can be present, particular care is needed in the choice of disinfectants and
cleaning agents to ensure that the chemicals used do not react with the prion protein in a manner that may inhibit its
removal or inactivation.
This part of ISO 15883 may be used by prospective purchasers and manufacturers as the basis of agreement
on the specification of a WD. The test methods for demonstration of compliance with the requirements of this
part of ISO 15883 may also be employed by users to demonstrate continued compliance of the installed WD
throughout its working life. Guidance on a routine test programme is given in Annex A.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 228-1, Pipe threads where pressure-tight joints are not made on the threads — Part 1: Dimensions,
tolerances and designation
ISO 7000, Graphical symbols for use on equipment — Index and synopsis
ISO 15883-1:2006(E)
ISO 10012, Measurement management systems — Requirements for measurement processes and
measuring equipment
ISO 14644-3:2005, Cleanrooms and associated controlled environments — Part 3: Test methods
ISO 14971, Medical devices — Application of risk management to medical devices
ISO/TS 15883-5:2005, Washer-disinfectors — Part 5: Test soils and methods for demonstrating cleaning
efficacy
IEC 60417-DB, Graphical symbols for use on equipment
IEC 60584-1:1995, Thermocouples — Part 1: Reference tables
IEC 60751:1983, Industrial platinum resistance thermometer sensors
IEC 61010-2-045, Safety requirements for electrical equipment for measurement, control, and laboratory
use — Part 2-045: Particular requirements for washer disinfectors used in medical, pharmaceutical, veterinary
and laboratory fields
IEC 80416-1, Basic principles for graphical symbols for use on equipment — Part 1: Creation of symbol
originals
European Pharmacopeia, European Directorate for the Quality of Medicines, Council of Europe, Strasbourg,
France
United States Pharmacopeia, USP Pharmacopeia, Rockville, USA
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
A
equivalent time in seconds at 80 °C, delivered by the disinfection process, with reference to a microorganism
with a z value of 10 K
NOTE See Annex B.
3.2
automatic controller
device that, in response to pre-determined cycle variables, operates the apparatus sequentially through the
required stages of the process or processes
3.3
bedpan washer-disinfector
washer-disinfector intended to be used for the emptying, flushing, cleaning and thermal disinfecting of human
waste containers
3.4
bioburden
population of viable microorganisms on a product and/or its container
2 © ISO 2006 – All rights reserved
ISO 15883-1:2006(E)
3.5
calibration
set of operations that establish, under specified conditions, the relationship between values of a quantity
indicated by a measuring instrument or measuring system, or values represented by a material measure or a
reference material, and the corresponding values realized by standard
[EN 285:1996, definition 3.5]
3.6
calorifier
closed vessel, in which water is indirectly heated, by the flow of heated fluid through a heat exchanger, under
a pressure greater than atmospheric
3.7
chamber
that part of the washer-disinfector in which the load is processed
NOTE The chamber does not include steam generators, pipework, e.g. drain and fittings from which it can be isolated.
3.8
chemical disinfection
disinfection achieved by the action of one or more chemicals the primary purpose of which is to be
microbicidal
3.9
cleaning
removal of contamination from an item to the extent necessary for its further processing and its intended
subsequent use
3.10
continuous process machine
machine which automatically transports the load through each stage of the operating cycle
3.11
critical process variables
those process variables for which the values during an operating cycle have been identified by the
manufacturer as sufficient to ensure that the cycle meets the performance defined during validation
3.12
cycle complete
indication that the washing and disinfection cycle has been satisfactorily completed and that the disinfected
load is ready for removal from the chamber
3.13
cycle control recorder
a device which records the values of one or more control variables as seen by the automatic controller
3.14
D value
exposure time required under a defined set of conditions to cause a 1-logarithm or 90 % reduction in the
population of a particular microorganism
3.15
dead volume
volume of pipework which is not purged by the usual flow of liquids during the operating cycle
ISO 15883-1:2006(E)
3.16
disinfection
reduction of the number of viable microorganisms on a product to a level previously specified as appropriate
for its intended further handling or use
3.17
disinfection temperature
minimum temperature of the disinfection temperature band
3.18
disinfection temperature band
range of temperatures, expressed as the disinfection temperature (3.17) and the maximum allowable
temperature which may prevail throughout the load during the disinfection time
3.19
disinfection time
period for which the critical process variable(s) (e.g. temperature of the load, disinfectant concentration in the
chamber) are maintained at or above that specified for disinfection
3.20
door
device provided as a means of closing and sealing the chamber
3.21
double-ended washer-disinfector
washer-disinfector with separate doors for loading and unloading
3.22
endoscope washer-disinfector
washer-disinfector intended to clean and disinfect loads containing flexible endoscopes
3.23
fail safe
attribute of washer-disinfector design, or its associated services, that ensures that a single fault condition will
not give rise to a safety hazard
3.24
fault
recognition by the automatic controller that at least one of the pre-set process variables for the washer-
disinfector cycle have not been attained
3.25
fluid
liquid, gas or vapour
3.26
flushing
removal of gross contamination and/or the contents of a load item, but not necessarily contamination adhering
to the surface of the load item, by displacement with water
3.27
free draining
allowing the unimpeded flow of liquids under the influence of gravity towards the discharge point
3.28
holding time
period during which the critical process variables are maintained at or above the values specified
4 © ISO 2006 – All rights reserved
ISO 15883-1:2006(E)
3.29
human waste
excretions and body fluids including faeces, urine, blood, pus, vomit and mucus
3.30
human waste container
re-usable vessel for holding and transporting human waste
3.31
installation qualification
IQ
process of obtaining and documenting evidence that equipment has been provided and installed in
accordance with its specification
[ISO/TS 11139:2001, definition 2.20]
3.32
instrument washer-disinfector
washer-disinfector intended to clean and disinfect loads containing surgical instruments, anaesthetic
accessories, bowls, dishes, receivers, utensils, glassware and similar items
3.33
load
collective term used to describe all the goods, equipment and materials that are put into a washer-disinfector
at any one time for the purpose of cleaning and disinfecting it by an operating cycle
3.34
loading door
door in a double-ended washer-disinfector through which the load is put into the washer-disinfector prior to
processing
3.35
medical device
any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software,
material or other similar or relative article, intended by the manufacturer to be used, alone or in combination,
for human beings for one more of the specific purpose(s) of
⎯ diagnosis, prevention, monitoring, treatment, or alleviation of disease;
⎯ diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury;
⎯ investigation, replacement, modification or support of the anatomy or of a physiological process;
⎯ supporting or sustaining life;
⎯ control of conception;
⎯ disinfection of medical devices;
⎯ providing information for medical purposes by means of in vitro examination of specimens derived from
the human body,
and which does not achieve its primary intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its function by such means
[ISO 13485:2003, definition 3.7]
ISO 15883-1:2006(E)
3.36
microbial reduction factor
extent to which the bioburden is reduced in tenfold increments expressed as logarithms (base 10)
3.37
monitoring
measurement of physical variables and comparison of the values obtained with the values specified for the
process
3.38
normal operation
operation of the washer-disinfector in accordance with the manufacturer’s instructions and with all process
parameters within the limits specified by the manufacturer
3.39
operating cycle
complete set of stages that is carried out in the sequence as regulated by the automatic controller
3.40
operating pressure
gauge pressure at which a vessel is operated during normal use
3.41
operational qualification
OQ
process of obtaining and documenting evidence that installed equipment operates within predetermined limits
when used in accordance with its operational procedures
[ISO/TS 11139:2001, definition 2.24]
3.42
override
system by which the operating cycle can be interrupted or modified as necessary
3.43
performance qualification
PQ
process of obtaining and documenting evidence that the equipment, as installed and operated in accordance
with operational procedures, consistently performs in accordance with predetermined criteria and thereby
yields product meeting its specification
[ISO/TS 11139:2001, definition 2.26]
NOTE The performance qualification for washer-disinfectors would concern the number of items cleaned and
disinfected to the required standard.
3.44
process chemical
formulation of chemical compounds intended for use in a washer-disinfector
NOTE Process chemicals include for example detergents, surfactants, rinse aids, disinfectants, enzymatic cleaners.
3.45
process variable
physical and chemical properties that influence the efficacy of all stages of the process
EXAMPLE Times, temperatures, disinfectant concentration, pressures and flows.
6 © ISO 2006 – All rights reserved
ISO 15883-1:2006(E)
3.46
process verification recorder
device that, independently of the automatic controller, records values obtained for some, or all, of the control
variables
3.47
recorder
system fitted to the washer-disinfector, or connected to the washer-disinfector, producing a permanent record
of information graphically, digitally or electronically
3.48
re-qualification
repeat of part or all of the validation test requirements for the purpose of confirming process reliability
3.49
rinsing
removal of process residues by displacement and dilution with water
3.50
routine test
periodic checking and testing carried out to establish that the operational performance of the washer-
disinfector remains within the limits established during validation
3.51
steam generator
vessel designed to contain water and a heating system (e.g. a steam coil or a fully immersed electric element)
which is used to heat water to its vapour state
3.52
tank
process vessel, integral to the washer-disinfector, designed to hold fluids that are used during processing
3.53
test microorganism
microbial strain from a recognised culture collection used in microbiological testing of the performance of a
washer-disinfector
NOTE A recognized culture collection is an international depository under the Budapest Treaty on “The International
Recognition of the Deposit of Microorganisms for the Purpose of Patent and Regulation".
3.54
test soil
formulation used to test the efficacy of cleaning in a washer-disinfector
3.55
thermal disinfection
disinfection achieved by the action of moist heat
3.56
type test
test programme to verify conformity of a washer-disinfector type to this standard and establish data for
reference in subsequent tests
3.57
unloading door
door in a double-ended (3.21) washer-disinfector through which the load is removed after an operating cycle
ISO 15883-1:2006(E)
3.58
validation
documented procedure for obtaining, recording and interpreting the results required to establish that a process
will consistently yield product complying with predetermined specifications
[ISO/TS 11139:2001, definition 2.50]
3.59
verification
confirmation through the provision of objective evidence, that specified requirements have been fulfilled
[ISO 9000:2005, definition 3.8.4]
3.60
viable microorganism
microorganisms, including viruses, which are capable of multiplication under specified culture conditions
3.61
warning pipe
secondary overflow pipe so fitted that its outlet, whether inside or outside the machine, is in a conspicuous
position to indicate an overflow condition
3.62
washer-disinfector
WD
machine intended to clean and disinfect medical devices and other articles used in the context of medical,
dental, pharmaceutical and veterinary practice
3.63
washing
removal of adherent contamination from surfaces to be cleaned by means of an aqueous medium, with or
without process chemicals, as necessary
3.64
works test
series of tests performed prior to delivery to demonstrate compliance of each washer-disinfector with its
specification
3.65
z value
change in temperature in kelvins (K) required to achieve a tenfold change in the rate of microbial inactivation
by a moist heat disinfection process
4 Performance requirements
4.1 General
4.1.1 Compliance with the performance requirements shall be tested in accordance with the methods given
in Clause 6.
NOTE Conformity of a WD to this part of ISO 15883 and subsequent relevant parts of ISO 15883 can be tested and
documented as the condition of the WD as supplied by the manufacturer (“as supplied” is defined in 6.1.2) and as the
condition of the WD as installed by the manufacturer, user, or third party (“as installed” is defined in 6.1.3).
4.1.2 Any item which has been processed in a WD conforming to the ISO 15883 series shall have been
cleaned, disinfected, rinsed and, when appropriate, dried.
8 © ISO 2006 – All rights reserved
ISO 15883-1:2006(E)
NOTE The performance requirements depend on a number of factors, which include the nature of the item(s) to be
processed, the disinfection efficacy required (as determined by the level of risk associated with the use of the item), the
nature of the contamination to be removed, the nature and extent of any pre-treatment, the temperature, the physical
energy (type, power, duration), detergent system, permissible extent of process residues, etc.
4.1.3 The specified performance shall be achieved by an operating cycle under the control of an automatic
controller and including, when appropriate, the stages for:
a) cleaning, which may include several stages;
b) disinfecting;
c) rinsing;
d) drying (when appropriate).
When appropriate, two or more stages specified above can be combined as a single stage.
4.1.4 Throughout the operating cycle the rate and extent of any change in temperature, pressure [see
8.1 b) 6)] or concentration of process chemicals [see 8.1 b) 5)] shall be within limits specified by the device
manufacturer as those which are compatible with the item(s) which the WD is intended to process [see
8.1 b) 2)].
4.1.5 Disinfection is specified by reference to time and temperature for thermal disinfection or as time,
temperature and concentration for chemical disinfection.
Whenever practicable, thermal disinfection is preferred. Thermal disinfection processes are more easily
controlled and avoid the hazards to staff, patients and the environment that can occur through the use of
chemical disinfectants.
The required disinfection conditions or the minimum microbial reduction factor necessary, i.e. the A value, are
specified in subsequent parts of ISO 15883.
Disinfection performances specified in subsequent parts of ISO 15883 are minimum requirements. Regulatory
authorities can specify more stringent requirements within the territories for which they are responsible.
4.1.6 Within the WD each chamber which is used to contain the load shall be capable of being disinfected
under the control of the automatic controller. For single chamber machines this shall be part of the normal
operating cycle. For machines with two or more chambers the disinfection cycle may be separate from the
normal operating cycle. For multi-chamber machines a disinfection cycle shall not be required for any
chamber which is used only for drying.
4.1.7 Chambers in which process fluid may be present during the process cycle shall be free draining (see
6.5.2 and 6.5.4).
4.1.8 Continuous process WDs shall be designed in such a way that the WD, the load carriers and the load
are not re-contaminated by the simultaneous processing of other loads.
4.1.9 The environment in contact with the load during the final rinse and drying stages shall be of at least
the purity (chemical and microbial) specified by the device manuf
...
The standard EN ISO 15883-1:2006 provides a comprehensive framework governing washer-disinfectors' performance specifications, essential for ensuring the effective cleaning and disinfection of re-usable medical devices across various healthcare domains, including medical, dental, pharmaceutical, and veterinary practices. One of the key strengths of this standard is its detailed definition of terms and requirements which serve to clarify the operational expectations for washer-disinfectors and their accessories. This clarity is particularly vital in the medical field, where rigorous hygiene practices are non-negotiable. Moreover, the document establishes not only the general performance requirements but also specifies the necessary performance parameters for cleaning and disinfection processes. This ensures that washer-disinfectors meet the highest standards necessary for infection control, critical in safeguarding health in clinical environments. Another noteworthy aspect of EN ISO 15883-1:2006 is its inclusion of comprehensive methodologies and instrumentation guidelines. These specifications are crucial for validation, routine control, monitoring, and re-validation, allowing healthcare facilities to maintain compliance consistently. The emphasis on periodic reviews and necessary repairs ensures that standards are upheld over time, further enhancing safety and efficacy. The relevance of this standard extends to its potential alignment with regulatory requirements, promoting interoperability within various healthcare settings. The focus on accessories required for optimal performance also highlights the standard’s holistic approach to ensuring safety throughout the disinfection process. Overall, the EN ISO 15883-1:2006 standard plays an instrumental role in promoting high-quality practices within the medical field, addressing critical aspects of washer-disinfectors that are necessary for effective infection prevention. Its detailed specifications, performance criteria, and comprehensive monitoring practices assert this document as a fundamental asset for healthcare professionals seeking to uphold exemplary cleaning and disinfection standards.
Die Norm EN ISO 15883-1:2006 legt umfassende Anforderungen an die Leistung von Wasch-desinfektionsgeräten und deren Zubehör fest, die für die Reinigung und Desinfektion von wiederverwendbaren medizinischen Geräten sowie anderen Artikeln eingesetzt werden, die im medizinischen, zahnmedizinischen, pharmazeutischen und veterinärmedizinischen Bereich Verwendung finden. Ein wesentlicher Aspekt der Norm ist die klare Definition von Begriffen und Anforderungen, die für die Sicherstellung einer effektiven Reinigung und Desinfektion von entscheidender Bedeutung sind. Dadurch ermöglicht die Norm eine einheitliche Bewertung der Leistungsfähigkeit von Wasch-desinfektionsgeräten und stellt sicher, dass diese Geräte die notwendigen hygienischen Standards erfüllen. Die Stärken der EN ISO 15883-1:2006 liegen in ihrer umfassenden Herangehensweise an Leistungstests und Validierungsverfahren. Die Norm beschreibt nicht nur die erforderlichen Leistungsanforderungen, sondern gibt auch präzise Anweisungen zu den Methoden und Instrumenten, die für die Validierung, die routinemäßige Kontrolle und das Monitoring unerlässlich sind. Dies stellt sicher, dass die Geräte nicht nur bei der ersten Inbetriebnahme, sondern auch bei regelmäßigen Überprüfungen nach wesentlichen Reparaturen weiterhin effektiv arbeiten. Ein weiterer wichtiger Punkt ist die Relevanz der Norm im Kontext der heutigen Anforderungen an Hygiene und Sicherheit in der Gesundheitsversorgung. Mit dem wachsenden Fokus auf Infektionskontrolle und -prävention ist die EN ISO 15883-1:2006 von zentraler Bedeutung, um sicherzustellen, dass medizinische Instrumente und Geräte ordnungsgemäß gereinigt und desinfiziert werden. Diese Norm trägt entscheidend dazu bei, das Risiko von Kontamination und Infektion zu minimieren, was in der medizinischen Praxis oberste Priorität hat. Zusammenfassend lässt sich sagen, dass die EN ISO 15883-1:2006 eine maßgebliche Norm ist, die durch ihre klaren Anforderungen und umfassenden Testmethoden die Qualität und Sicherheit von Wasch-desinfektionsgeräten garantiert. Die Einhaltung dieser Norm ist für alle Einrichtungen, die mit medizinischen Geräten arbeiten, unerlässlich.
EN ISO 15883-1:2006は、医療、歯科、製薬および獣医の実践において使用される再利用可能な医療機器や他の物品の洗浄と消毒を目的とした洗浄消毒装置およびその付属品に関する一般的な性能要件を定めています。この標準化文書は、洗浄消毒装置の性能要件だけでなく、必要な性能を達成するために必要な付属品に関する要件を明確にしています。 この標準の強みは、その包括的な範囲にあります。洗浄消毒装置が満たすべき性能要件を詳細に規定しているため、関連する業界での信頼性と安全性が確保されます。また、洗浄消毒装置の性能を検証するために必要な方法や機器についても明記されており、定期的な管理や再検証のプロセスを整備することで、運用の一貫性が維持されます。このように、標準は実務において非常に重要な役割を果たしています。 EN ISO 15883-1:2006は、医療及び関連分野での洗浄と消毒のクオリティを高めるための基準として、不可欠な存在であり、洗浄消毒装置が一貫して要求される水準を満たすことを保証します。このスタンダードに則ることにより、医療現場で使用される機器の安全性と効果を向上させることが可能となり、医療機関だけでなく、患者の安心にも寄与することが期待されます。
La norme EN ISO 15883-1:2006 est essentielle pour garantir l'efficacité et la sécurité des appareils de nettoyage et de désinfection dans le domaine médical. Elle définit des exigences de performance générales pour les laveurs-désinfecteurs ainsi que pour leurs accessoires destinés à la nettoyage et désinfection des dispositifs médicaux réutilisables, ainsi que d'autres articles utilisés dans les pratiques médicales, dentaires, pharmaceutiques et vétérinaires. L’un des points forts de cette norme est sa portée claire. Elle englobe non seulement les exigences relatives à la performance des laveurs-désinfecteurs, mais également celles des accessoires nécessaires pour atteindre le niveau de performance requis. Cela fournit un cadre complet qui aide les fabricants et les utilisateurs à maintenir des normes de propreté élevées, cruciales pour la prévention des infections nosocomiales. En outre, la norme EN ISO 15883-1:2006 spécifie également les méthodes et instruments indispensables pour la validation, le contrôle de routine et le suivi, ainsi que la revalidation périodique et après des réparations essentielles. Cette approche méthodique permet d'assurer que les équipements fonctionnent de manière optimale et conforme aux exigences de sécurité, renforçant ainsi la confiance des utilisateurs dans la fiabilité des dispositifs médicaux. La pertinence de cette norme dans le secteur de la santé et des soins est indéniable, car elle établit des critères précis qui aident à protéger les patients tout en assurant l’efficacité des procédures de nettoyage et de désinfection. En intégrant les concepts de validation et de contrôle dans son cadre, la norme s’assure que les pratiques sont non seulement conformes, mais également adaptées à l'évolution des technologies et des exigences réglementaires. En résumé, la norme EN ISO 15883-1:2006 constitue un outil précieux qui répond aux besoins de l'industrie en matière de sécurité et d'efficacité, offrant ainsi une base solide pour l'utilisation des laveurs-désinfecteurs dans divers contextes médicaux.
SIST EN ISO 15883-1:2006 문서는 재사용 가능한 의료 기기 및 기타 의료, 치과, 제약 및 수의학에 사용되는 제품의 세척 및 소독을 위한 세척 소독기에 대한 일반 요구 사항, 용어 및 정의, 테스트를 규정합니다. 이 표준은 세척과 소독을 위한 성능 요구 사항뿐만 아니라, 해당 성능을 달성하기 위해 필요한 액세서리에 대한 세부 요구 사항을 명확히 하고 있습니다. 이 표준의 강점은 체계적인 접근법을 통해 세척 소독기의 효율성을 극대화할 수 있도록 하는 점입니다. 성능 요구 사항을 구체적으로 정의함으로써, 의료 분야에서의 위생 관리 기준이 강화됩니다. 또한, 문서에서는 기기의 검증, 일상적인 관리 및 모니터링, 필수 수리 후의 재검증에 필요한 방법 및 기구를 명시함으로써 신뢰성을 높이고 있습니다. 이 표준은 특히 병원 및 다양한 의료 환경에서 재사용 가능한 기기의 안전하도록 보장하는 데 필수적인 역할을 합니다. 의료 기기의 세척 및 소독 과정에서의 품질 및 안전성을 보장하는 것은 환자의 건강 보호에 direct적인 기여를 하므로, EN ISO 15883-1:2006의 적절한 준수는 매우 중요합니다. 이러한 이유로 이 표준은 현대 의료 및 관련 산업에서 필수적인 기준으로 자리잡고 있습니다.
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