ISO 15883-7:2016
(Main)Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
ISO 15883-7:2016 specifies the particular requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of reusable items such as the following: a) bedframes; b) bedside tables; c) transport carts; d) containers; e) surgical tables; f) sterilization containers; g) surgical clogs; h) wheelchairs, aids for the disabled. ISO 15883-7:2016 also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which may be necessary in order to achieve the required performance. Devices identified within the scopes of ISO 15883‑2, ISO 15883‑3, ISO I5883-4, and ISO 15883‑6 do not fall within the scope of this part of ISO 15883. In addition, the methods are specified, as well as instrumentation and instructions required for type testing, works testing, validation (installation, operation, and performance qualification on first installation), routine control, and monitoring, as well as requalifications required to be carried out periodically and after essential repairs. NOTE WDs corresponding to this part of ISO 15883 can also be used for cleaning and chemical disinfection of other thermolabile and reusable devices as recommended by the device manufacturer. The performance requirements specified in this part of ISO 15883 may not ensure the inactivation or removal of the causative agent(s) (prion proteins) of Transmissible Spongiform Encephalopathies.
Laveurs désinfecteurs — Partie 7: Exigences et essais pour les laveurs désinfecteurs destinés à la désinfection chimique des dispositifs médicaux thermosensibles, non invasifs et non critiques et des équipements de soins de santé
ISO 15883-7:2016 spécifie les exigences particulières relatives aux laveurs désinfecteurs (LD) destinés à être utilisés pour le nettoyage et la désinfection chimique, au cours d'un seul cycle standard, d'articles réutilisables tels que les suivants: a) les cadres de lit; b) les tables de chevet; c) les chariots de transport; d) les récipients; e) les tables d'opération; f) les récipients de stérilisation; g) les sabots médicaux; h) les fauteuils roulants et dispositifs auxiliaires pour les personnes handicapées. ISO 15883-7:2016 spécifie également les exigences de performance relatives au nettoyage et à la désinfection du laveur désinfecteur ainsi que de ses composants et accessoires, qui peuvent être nécessaires pour atteindre les performances requises. Les dispositifs identifiés dans les domaines d'application de l'ISO 15883‑2, l'ISO 15883‑3, l'ISO 15883‑4 et l'ISO 15883‑6 ne relèvent pas du domaine d'application de la présente partie de l'ISO 15883. Le présent document spécifie également les méthodes, l'instrumentation et les instructions nécessaires pour les essais de type, les essais de fonctionnement, la validation (qualification de l'installation, qualification opérationnelle et qualification des performances lors de la première installation), le contrôle de routine et la surveillance, de même que les requalifications à effectuer périodiquement et après des réparations importantes. NOTE Les LD relevant de la présente partie de l'ISO 15883 peuvent également être utilisés pour le nettoyage et la désinfection chimique d'autres dispositifs thermosensibles réutilisables, selon les recommandations du fabricant du dispositif. Les exigences de performance spécifiées dans la présente partie de l'ISO 15883 ne peuvent pas garantir l'inactivation ou l'élimination du ou des agents pathogènes (protéine du prion) à l'origine des encéphalopathies spongiformes transmissibles.
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INTERNATIONAL ISO
STANDARD 15883-7
First edition
2016-02-01
Washer-disinfectors —
Part 7:
Requirements and tests for washer-
disinfectors employing chemical
disinfection for non-invasive, non-
critical thermolabile medical devices
and healthcare equipment
Laveurs désinfecteurs —
Partie 7: Exigences et essais pour les laveurs désinfecteurs utilisant la
désinfection chimique pour les dispositifs médicaux et les équipements
de soins thermosensibles non invasifs et non critiques
Reference number
ISO 15883-7:2016(E)
©
ISO 2016
---------------------- Page: 1 ----------------------
ISO 15883-7:2016(E)
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ii © ISO 2016 – All rights reserved
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ISO 15883-7:2016(E)
Contents Page
Foreword .v
Introduction .vi
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 Disinfection . 3
4.4 Final rinsing . 5
4.5 Self-disinfection . 5
4.6 Drying . 6
4.7 Water treatment equipment. 6
4.7.1 General. 6
4.7.2 Disinfection of water treatment equipment . 6
4.7.3 Maintenance of piping . 7
5 Mechanical requirements . 7
5.1 Materials — Design, manufacture, and assembly . 7
5.2 Process verification . 7
6 Testing for conformity . 7
6.1 General . 7
6.2 Test load . 8
6.2.1 Loading with standard goods . 8
6.2.2 Loading with special goods . 8
6.3 Water used for rinsing following disinfection . . 8
6.4 Load dryness . 8
6.4.1 General. 8
6.4.2 Procedure . 8
6.4.3 Results . 8
6.5 Thermometric tests . 8
6.5.1 General. 8
6.5.2 Load temperature test . . 8
6.6 Chemical dosing tests . 9
6.6.1 General. 9
6.6.2 Reused process chemicals . 9
6.7 Tests of cleaning efficacy . 9
6.7.1 General. 9
6.7.2 Materials . 9
6.7.3 Procedure .10
6.7.4 Results .10
6.8 Test of disinfection efficacy .10
6.8.1 General.10
6.8.2 Preliminary tests on chemical disinfectants .10
6.8.3 Self-disinfection tests .11
6.8.4 Chemical disinfection of the load.12
7 Documentation .12
8 Information to be provided by the manufacturer .12
9 Marking, labelling, and packaging .13
10 Information to be requested from the purchaser by the manufacturer .13
Annex A (normative) Summary of test programmes .14
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ISO 15883-7:2016(E)
Annex B (normative) Methods for microbiological evaluation of disinfection of liquid
transport system.16
Annex C (normative) Tests for microbiological contamination of post-disinfection rinse water .21
Annex D (normative) Preparation and evaluation of indicators for microbiological testing
of the efficacy of chemical disinfection of the load .22
Annex E (informative) Examples of test locations for the tests with biological indicators .26
Bibliography .30
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ISO 15883-7:2016(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
ISO 15883-7 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]
— Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive,
non-critical medical devices and healthcare equipment
— Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive,
non-critical thermolabile medical devices and healthcare equipment
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ISO 15883-7:2016(E)
Introduction
It is intended that this introduction is to be read in conjunction with the introduction to ISO 15883-1.
This part of ISO 15883 is the seventh of a series specifying the performance of washer-disinfectors.
It specifies the particular requirements for performance applicable to washer-disinfectors employing
chemical disinfection for non-invasive, non-critical thermolabile medical devices, and healthcare
equipment. Its requirements apply to washer-disinfectors used for cleaning and disinfection of
thermolabile equipment for use without further treatment in healthcare settings. Such reusable
equipment needs to be cleaned and disinfected, but processing in a washer-disinfector for surgical
instruments (see ISO 15883-2), for human waste containers (see ISO 15883-3), for endoscopes
(see ISO 15883-4), or for non-invasive, non-critical medical devices, and healthcare equipment
employing thermal disinfection (see ISO 15883-6) is inappropriate and/or impractical. Examples of
such equipment are bedsteads and bedside furniture, trolleys and transport carts, operating tables,
footwear, wheelchairs, or aids for the disabled.
Requirements for washer-disinfectors for other applications are specified in other parts of ISO 15883.
In respect to any potential adverse effects on the quality of water intended for human consumption
caused by use of the washer-disinfector, it is noteworthy that
a) until verifiable international criteria are adopted, the existing national regulations concerning
the use and/or characteristics of the washer-disinfector remain in force (e.g. the requirement of
backflow prevention), and
b) the ISO 15883 series of standards provides no information as to whether the washer-disinfector
may be used without restriction in any of the ISO member states.
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INTERNATIONAL STANDARD ISO 15883-7:2016(E)
Washer-disinfectors —
Part 7:
Requirements and tests for washer-disinfectors employing
chemical disinfection for non-invasive, non-critical
thermolabile medical devices and healthcare equipment
1 Scope
This part of ISO 15883 specifies the particular requirements for washer-disinfectors (WD) intended to
be used for the cleaning and chemical disinfection, in a single operating cycle, of reusable items such as
the following:
a) bedframes;
b) bedside tables;
c) transport carts;
d) containers;
e) surgical tables;
f) sterilization containers;
g) surgical clogs;
h) wheelchairs, aids for the disabled.
This part of ISO 15883 also specifies the performance requirements for the cleaning and disinfection of
the washer-disinfector and its components and accessories which may be necessary in order to achieve
the required performance.
Devices identified within the scopes of ISO 15883-2, ISO 15883-3, ISO I5883-4, and ISO 15883-6 do not
fall within the scope of this part of ISO 15883.
In addition, the methods are specified, as well as instrumentation and instructions required for type
testing, works testing, validation (installation, operation, and performance qualification on first
installation), routine control, and monitoring, as well as requalifications required to be carried out
periodically and after essential repairs.
NOTE WDs corresponding to this part of ISO 15883 can also be used for cleaning and chemical disinfection
of other thermolabile and reusable devices as recommended by the device manufacturer.
The performance requirements specified in this part of ISO 15883 may not ensure the inactivation or
removal of the causative agent(s) (prion proteins) of Transmissible Spongiform Encephalopathies.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
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ISO 15883-7:2016(E)
ISO 15883-1:2006+A1:2014, Washer-disinfectors — Part 1: General requirements, terms and
definitions and tests
ISO 15883-4, Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing
chemical disinfection for thermolabile endoscopes
ISO 15883-6, Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing
thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
ISO/TS 15883-5:2005, Washer-disinfectors — Part 5: Test soils and methods for demonstrating
cleaning efficacy
EN 10088-1, Stainless steels — Part 1: List of stainless steels
EN 10088-2, Stainless steels — Part 2: Technical delivery conditions for sheet/plate and strip of corrosion
resisting steels for general purposes
IEC 61010-2-040:2005, Safety requirements for electrical equipment for measurement, control and
laboratory use — Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat
medical materials
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 15883-1, ISO 15883-4, and
ISO 15883-6 apply.
4 Performance requirements
4.1 General
4.1.1 The WD shall conform to ISO 15883-1:2006+A1:2014 except for the following subclauses:
— 4.3.1 (which refers to thermal disinfection);
— 5.9 [process temperature control limits, excluding 5.9 d) and e)];
— 5.11 (process verification).
4.1.2 The WD shall be designed to clean and chemically disinfect the range of reusable items specified.
4.1.3 When necessary, the WD shall be provided with means to facilitate the correct alignment of the
load in the washing chamber.
4.1.4 The means to control the volume of the process chemical(s) admitted (see ISO 15883-
1:2006+A1:2014, 5.7.4 and 5.7.5) shall be adjustable by means of a key, code, or tool. The accuracy of the
dosing system shall be at least ±10 % or as specified and tested for conformity (see 6.6).
4.1.5 The automatic controller shall ensure that the final concentration of disinfectants are within the
limits specified.
NOTE Confirmation of the concentration of disinfectant can include the measurement of the volume of
disinfectant and water admitted together with a certificate of conformity from the disinfectant supplier for the
concentration of the disinfectant, together with data to support the shelf life, expiry date, etc.
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ISO 15883-7:2016(E)
4.2 Cleaning
4.2.1 Cleaning shall be tested in accordance with the requirements of ISO 15883-1 using the test soils
and methods described in ISO/TS 15883-5 that are relevant to the loads to be processed.
4.2.2 During the washing stage:
a) the washing stage starts when the temperature at the control sensor of the WD is not less than the
specified washing temperature;
b) the washing temperature band shall have the lower limit defined by the washing temperature
and an upper limit of not greater than the specified washing temperature +10 °C (see
ISO 15883-1:2006+A1:2014, 4.2.3).
4.2.3 Cleaning efficacy shall be determined in accordance with 6.7.
4.2.4 If the WD is designed to allow the reuse of the cleaning solution on two or more consecutive
operating cycles, then care shall be taken to ensure that the efficacy and safety (e.g. accumulation of
foreign material, device compatibility) of the cleaning solution is not impaired. This shall include at least
the following:
a) specified methods which shall be used to ensure that the cleaning solution has retained the required
cleaning efficacy. These methods shall be based on validation studies, which would normally be
carried out by the cleaning solution manufacturer, to determine a suitable parameter, parameters
and/or indicators/markers that may be monitored. Suitable parameters may include the concentration
of the active ingredient and other ingredients that may also affect performance (e.g. pH);
NOTE Minor changes in formulation of the cleaning solution can have a significant effect on its stability,
cleaning efficacy, etc.
b) recommendations to the user for the maximum period or number of operating cycles for which the
cleaning solution may be used. This shall be based on validated experimental data;
c) where validated use conditions (maximum period or number of operating cycles) are exceeded, the
automatic controller shall
— operate an audible and visible alarm and prevent the use of the operating cycle until the cleaning
solution is changed, or
— effect an automatic change of the cleaning solution in the WD.
4.3 Disinfection
4.3.1 The cycle shall include a chemical disinfection stage, which may be combined with the cleaning
and shall be deemed to have been achieved when testing requirements in 6.8 are met.
4.3.2 The requirements and tests in this part of ISO 15883 are based on the use of aqueous disinfectant
solutions. Other systems based on gaseous disinfectants are not excluded; equivalent tests are required.
These shall include the following:
a) disinfectant(s) to be used, for which in vitro efficacy has been demonstrated based on relevant
published standards;
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ISO 15883-7:2016(E)
For the purpose of efficacy testing, a validated neutralization method shall be used. This method can be
provided by the disinfectant manufacturer.
b) when tested on surfaces for the minimum exposure time at the minimum concentration and the
minimum temperature to be used in the WD, the disinfectant demonstrates the following:
1) at least a 5 log10 inactivation of vegetative bacteria;
2) at least a 4 log10 inactivation of yeast-like fungi;
3) at least a 4 log10 inactivation of enveloped viruses.
NOTE 2 National Regulatory Authorities can require higher inactivation values and/or efficacy against a
wider range of microorganisms.
NOTE 3 Efficacy tests against vegetative bacteria can exclude mycobacteria. See also 8 f).
c) the compatibility of the cleaning and disinfection solutions are indicated, including any impact on
disinfection efficacy from carryover of cleaning solution;
d) the experimental conditions of tests intended to demonstrate the microbicidal efficacy of the
disinfectant in vitro shall reflect the conditions of use of the disinfectant. Thus, when cleaning and
disinfection is combined, the disinfectant shall be tested in the presence of applicable interfering
substances that shall include soiling typically found in the loads to be processed.
4.3.3 The temperature of the disinfectant solution throughout the disinfection stage shall be monitored
to ensure that it remains within the specified limits of the disinfectant and be compatible with the
temperature limits for the device(s) to be processed.
This shall be achieved either by controlling the temperature of the disinfectant solution or where the
temperature in the WD is not controlled that the operation of the WD is prevented outside the specified
disinfectant temperature range.
4.3.4 If the WD is designed to allow the reuse of the disinfectant solution on two or more consecutive
operating cycles, then care shall be taken to ensure that the efficacy and safety (e.g. accumulation of
foreign material, device compatibility) of the disinfectant solution is not impaired. This shall include at
least the following:
a) the means which shall be used to ensure that the disinfectant solution has retained the required
antimicrobial disinfection efficacy. These means shall be based on validation studies, which would
normally be carried out by the disinfectant manufacturer, to determine a suitable parameter, or
parameters and/or indicators/markers that may be monitored to indicate the antimicrobial efficacy
of the disinfectant. Suitable parameters may include the concentration of the active ingredient and
other ingredients that may also affect performance (e.g. pH, stability, etc.);
NOTE 1 Minor changes in formulation of the disinfectant can have a significant effect on storage life,
antimicrobial efficacy, etc.
b) recommendations to the user for the maximum period or number of operating cycles for which the
disinfectant may be used. This shall be based on validated experimental data;
c) when validated use conditions (maximum period or number of operating cycles) are exceeded, the
automatic controller shall provide an audible and/or visible indication and prevent the use of the
operating cycle until the disinfectant solution is changed (manually or automatically);
d) provide a method for the user to monitor the disinfectant using a chemical indicator or other
method specific for the disinfectant to show that the disinfectant is at or above the minimum
recommended concentration.
NOTE 2 The minimum recommended concentration is the lowest concentration of active and other ingredients
to meet the label claim of a reusable disinfectant.
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ISO 15883-7:2016(E)
4.4 Final rinsing
The water quality used for rinsing after the disinfection stage shall not impair the result of
cleaning/disinfection when tested in accordance with 6.3.
NOTE WHO definition for potable water or National Regulatory Authorities can be considered.
4.5 Self-disinfection
4.5.1 A self-disinfection cycle shall be provided to ensure that the WD does not become a focus
for contamination of the load and to provide a means of disinfecting the WD after interventions for
maintenance, repairs, or testing (see also ISO 15883-1:2006+A1:2014, 5.3.1.2).
NOTE 1 The self-disinfection process is intended also to deal with the situation where the WD has become
contaminated. Biofilm can easily develop in the piping used to convey rinse water to the load and can contain
microorganisms in a state in which they are highly resistant to disinfection.
Thermal disinfection shall attain a minimum A of 60 and shall be capable to be set to give an
0
A -value of 600.
0
If the use of thermal disinfection is not possible, a chemical disinfectant different from that used for
disinfecting the loads shall be used.
NOTE 2 The use of a disinfectant based on the same active ingredients can carry the risk of allowing organisms
resistant to a particular disinfectant
...
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15883-7
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2014-02-27 2014-07-27
Washer-disinfectors —
Part 7:
Requirements and tests for washer-disinfectors employing
chemical disinfection for non-invasive, non-critical
thermolabile medical devices and healthcare equipment
(ISO/DIS 15883-7:2014)
Laveurs désinfecteurs —
Partie 7: Exigences et essais pour les laveurs désinfecteurs utilisant la désinfection chimique pour les
dispositifs médicaux et les équipements de soins thermosensibles non invasifs et non critiques (ISO/DIS
15883-7)
ICS: 11.080.10
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the European Committee for Standardization
(CEN), and processed under the CEN lead mode of collaboration as defined in the
Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member
bodies for a parallel five month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments
received, will be submitted to a parallel two-month approval vote in ISO and
THIS DOCUMENT IS A DRAFT CIRCULATED
formal vote in CEN.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
To expedite distribution, this document is circulated as received from the
IN ADDITION TO THEIR EVALUATION AS
committee secretariat. ISO Central Secretariat work of editing and text
BEING ACCEPTABLE FOR INDUSTRIAL,
composition will be undertaken at publication stage.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 15883-7:2014(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2014
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ISO/DIS 15883-7:2014(E)
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as
permitted under the applicable laws of the user’s country, neither this ISO draft nor any extract
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Violators may be prosecuted.
ii © ISO 2014 – All rights reserved
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prEN ISO 15833-7:2014 (E)
Contents
Page
Foreword .3
Introduction .4
1 Scope .5
2 Normative references .5
3 Terms and definitions .6
4 Performance requirements .6
4.1 General .6
4.2 Cleaning .6
4.3 Disinfection .7
4.4 Final rinsing .8
4.5 Self-disinfection .9
4.6 Drying .9
4.7 Water treatment equipment . 10
5 Mechanical requirements and protocol requirements . 11
5.1 Materials – design, manufacture and assembly . 11
5.2 Process verification . 11
6 Testing for conformity . 11
6.1 General . 11
6.2 Test load . 11
6.3 Water used for final (post-disinfection) rinsing . 11
6.4 Load dryness . 12
6.5 Thermometric tests. 12
6.6 Chemical dosing tests . 12
6.7 Tests of cleaning efficacy . 12
6.8 Test of disinfection efficacy . 14
7 Documentation . 16
8 Information to be provided by the manufacturer . 16
9 Marking, labelling and packaging . 17
10 Information to be requested from the purchaser by the manufacturer . 17
Annex A (normative) Summary of test programmes . 18
Annex B (normative) Methods for microbiological evaluation of disinfection of liquid transport
system . 20
Annex C (normative) Tests for microbiological contamination of post-disinfection rinse water . 26
Annex D (normative) Preparation and evaluation of indicators for microbiological testing of the
efficacy of chemical disinfection of the load . 27
Annex E (informative) Examples of test locations for the tests with biological indicators . 31
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices . 35
Bibliography . 39
2
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prEN ISO 15833-7:2014 (E)
Foreword
This document (prEN ISO 15833-7:2013) has been prepared by Technical Committee CEN/TC 102
“Sterilizers for medical purposes”, the secretariat of which is held by DIN, in cooperation with Technical
Committee ISO/TC 198 “Sterilization of health care products”.
This document is currently submitted to the parallel Enquiry.
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.
3
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prEN ISO 15833-7:2014 (E)
Introduction
It is intended that this introduction is to be read in conjunction with the introduction to ISO 15883-1.
This part of ISO 15883 is the seventh of a series specifying the performance of washer-disinfectors. It
specifies the particular requirements for performance applicable to washer-disinfectors employing chemical
disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment. Its
requirements apply to washer-disinfectors used for cleaning and disinfection of thermolabile equipment for use
without further treatment in healthcare settings. Such reusable equipment needs to be cleaned and
disinfected, but processing in a washer-disinfector for surgical instruments (see ISO 15883-2), for human
waste containers (see ISO 15883-3), for endoscopes (see ISO 15883-4) or for non-invasive, non-critical
medical devices and healthcare equipment (see ISO 15883-6) is inappropriate and/or impractical. Examples
of such equipment are bedsteads and bedside furniture, trolleys and transport carts, operating tables,
footwear, wheelchairs, or aids for the disabled.
Requirements for washer-disinfectors for other applications are specified in other parts of this series of
international standards.
In respect of the potential adverse effects on the quality of water intended for human consumption caused by
the washer-disinfectors, it is noteworthy that:
a) until verifiable international criteria are adopted, the existing national regulations concerning the use
and/or characteristics of the washer-disinfectors remain in force, and
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 ISO member states.
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prEN ISO 15833-7:2014 (E)
Washer-disinfectors —
Part 7:
Requirements and tests for washer-disinfectors employing
chemical disinfection for non-invasive, non-critical
thermolabile medical devices and healthcare equipment
(ISO/DIS 15883-7:2014)
1 Scope
This part of ISO 15883 specifies the particular requirements for washer-disinfectors (WD) intended to be used for
the cleaning and chemical disinfection, in a single operating cycle, of re-usable items such as:
a) bedframes;
b) bedside tables;
c) transport carts;
d) containers;
e) surgical tables;
f) sterilization containers;
g) surgical clogs;
h) wheelchairs, aids for the disabled.
This Part of ISO 15883 also specifies the performance requirements for the cleaning and disinfection of the
washer-disinfector and its components and accessories which may be necessary in order to achieve the
required performance.
Devices identified within the Scopes of ISO 15883-2, ISO 15883-3, ISO I5883-4, and ISO 15883-6 do not fall
within the scope of this part of ISO 15883.
In addition, the methods are specified as well as instrumentation and instructions required for type testing, works
testing, validation (installation, operation, and performance qualification on first installation), routine control and
monitoring as well as re-validations required to be carried out periodically and after essential repairs.
NOTE WDs corresponding to this part of ISO 15883 can also be used for cleaning and chemical disinfection of other
thermolabile and re-usable devices as recommended by the device manufacturer.
The performance requirements specified in this part of ISO 15883 may not ensure the inactivation or removal
of the causative agent(s) (prion proteins) of Transmissible Spongiform Encephalopathies.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 11731-2, Water quality — Detection and enumeration of Legionella — Part 2: Direct membrane filtration
method for waters with low bacterial counts
ISO 15883-1:2006, Washer-disinfectors — Part 1: General requirements, terms and definitions and tests
ISO 15883-2, 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 15883-3, Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing
thermal disinfection for human waste containers
ISO 15883-4, Washer-disinfectors — Part 4: Requirements and tests for washer disinfectors employing
chemical disinfection for thermolabile endoscopes
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prEN ISO 15833-7:2014 (E)
ISO 15883-6, Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing
thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
ISO TS 15883-5:2005, Washer-disinfectors — Part 5: Test soils and methods for demonstrating cleaning
efficacy
IEC 61010-2-40:2005, Safety requirements for electrical equipment for measurement, control and laboratory
use — Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical
materials
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 15883-1, ISO 15883-4 and
ISO 15883-6 apply.
4 Performance requirements
4.1 General
4.1.1 The WD shall conform to ISO 15883-1:2006 except for the following sub-clauses:
4.3.1 (which refers to thermal disinfection; see Clause 1 of this part of ISO 15883)
5.9 (process temperature control limits; without 5.9 d and e);
5.11 (process verification);
5.27.1°c) (force required to remove the load).
4.1.2 The WD shall be designed to clean and chemically disinfect the range of re-usable items specified by
the WD manufacturer.
4.1.3 When necessary the WD shall be provided with means to facilitate the correct alignment of the load
in the washing chamber.
4.1.4 The means to control the volume of the process chemical(s) admitted (see ISO 15883-1:2006, 5.7.4
and 5.7.5) shall be adjustable by means of a key, code or tool. The accuracy of the dosing system shall be at
least ±10 % or as specified and tested for conformity by the manufacturer (see 6.7).
4.1.5 The automatic controller shall ensure that the final concentration of disinfectant and the volume of
disinfectant solution (±10 %) are within the limits specified by the WD manufacturer.
NOTE Confirmation of the concentration of disinfectant can include the measurement of the volume of disinfectant
and water admitted together with a certificate of conformity from the disinfectant supplier for the concentration of the
disinfectant, together with data to support the shelf life, expiry date etc.
4.2 Cleaning
4.2.1 Cleaning shall be tested in accordance with the requirements of ISO 15883-1 using the test soils and
methods described in ISO/TS 15883-5 that are relevant to the loads to be processed.
4.2.2 During the washing stage:
a) the washing time starts when the temperature at the control sensor of the WD is not less than the
specified washing temperature.
b) the washing temperature band shall have the lower limit defined by the washing temperature and an
upper limit of no greater than the specified washing temperature +10 °C (see ISO 15883-1:2006, 4.2.3);
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prEN ISO 15833-7:2014 (E)
4.2.3 Cleaning efficacy shall be determined in accordance with 6.8.
4.2.4 If the WD is designed to allow the reuse of the cleaning solution on two or more consecutive operating
cycles then care shall be taken to ensure that the activity and safety (e.g. accumulation of foreign material,
device compatibility) of the cleaning solution is not impaired during its working life. This shall include at least
the following:
a) The WD manufacturer shall specify the means which shall be used to ensure that the cleaning solution
has retained the required cleaning activity. These means shall be based on validation studies, which
would normally be carried out by the cleaning solution manufacturer, to determine a suitable parameter or
parameters that may be monitored. Suitable parameters may include the concentration of the active
ingredient and excipients (that may also affect performance), pH, stability etc.
NOTE Minor changes in formulation of the cleaning solution can have a significant effect on storage life, cleaning
activity etc.
b) The WD manufacturer shall recommend to the user the maximum period or number of operating cycles
for which the cleaning solution may be used. This shall be based on validated experimental data.
c) When validated use conditions (maximum period or number of operating cycles) are exceeded, the
automatic controller shall:
operate an audible and visible alarm and prevent the use of the operating cycle until the cleaning
solution is changed; or
effect an automatic change of the cleaning solution in the WD.
4.3 Disinfection
4.3.1 The cycle shall include a chemical disinfection stage, which may be combined with the cleaning and
shall be deemed to have been achieved when testing requirements in 6.9 are met.
4.3.2 The requirements and tests in this standard are based on the use of aqueous solutions of a
disinfectant. Other systems based on gaseous disinfectants are not excluded; equivalent tests are required.
4.3.2.1 The in vitro efficacy of the disinfectant shall be demonstrated based on relevant published standards.
4.3.2.2 A specific neutralization method for the disinfectant shall be validated.
NOTE These data can be provided by the disinfectant manufacturer.
4.3.2.3 When tested on surfaces for the minimum exposure time at the minimum concentration and the
minimum temperature to be used in the WD the disinfectant shall demonstrate:
5
a) at least a log inactivation of vegetative bacteria and yeast-like fungi;
10
4
b) at least a log inactivation of enveloped viruses.
10
NOTE 1 National Regulatory Authorities can require higher inactivation values and/or activity against a wider range of
microorganisms.
NOTE 2 Efficacy against vegetative bacteria can exclude mycobacteria. See also Clause 8.
4.3.2.4 The WD manufacturer shall ensure the compatibility of the cleaning and disinfection solutions,
including an impact on disinfection efficacy from carryover of cleaning solution.
4.3.2.5 The experimental conditions of tests intended to demonstrate the microbicidal activity of the
disinfectant in vitro shall reflect the conditions of use of the disinfectant. Thus, when cleaning and disinfection
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prEN ISO 15833-7:2014 (E)
is combined the disinfectant shall be tested in the presence of applicable interfering substances that shall
include soiling typically found in the loads to be processed.
4.3.3 The temperature of the disinfectant solution throughout the disinfection stage shall be monitored to
ensure that it remains within the limits specified by the manufacturer of the disinfectant and be compatible with
the temperature limits for the device(s) to be processed.
This shall be achieved either by controlling the temperature of the disinfectant solution or, where appropriate,
by operating the WD at ambient temperature with means to prevent operation of the WD when the disinfectant
temperature is outside the specified temperature range.
4.3.4 If the WD is designed to allow the reuse of the disinfectant solution on two or more consecutive
operating cycles then care shall be taken to ensure that the activity and safety (e.g. accumulation of foreign
material, device compatibility) of the disinfectant solution is not impaired during its working life. This shall
include at least the following:
a) The WD manufacturer shall specify the means which shall be used to ensure that the disinfectant solution
has retained the required anti-microbial activity. These means shall be based on validation studies, which
would normally be carried out by the disinfectant manufacturer, to determine a suitable parameter or
parameters that may be monitored to indicate the anti-microbial activity of the disinfectant. Suitable
parameters may include the concentration of the active ingredient and excipients/adjuvants (that may also
affect performance), pH, stability etc.
NOTE 1 Minor changes in formulation of the disinfectant can have a significant effect on storage life, anti-microbial
activity etc.
b) The WD manufacturer shall recommend to the user the maximum period or number of operating cycles
for which the disinfectant may be used. This shall be based on validated experimental data.
c) When validated use conditions (maximum period or number of operating cycles) are exceeded, the
automatic controller shall:
operate an audible and visible alarm and prevent the use of the operating cycle until the disinfectant
solution is changed; or
effect an automatic change of the disinfectant solution in the WD.
d) The WD manufacturer shall provide a method for the user to monitor the disinfectant using a chemical
indicator or other method specific for the disinfectant to show that the disinfectant is at or above the
minimum effective concentration.
NOTE 2 The minimum effective concentration is the lowest concentration of active ingredient and excipients/adjuvant
necessary to meet the label claim of a reusable disinfectant.
4.4 Final rinsing
The quality of the final rinse water used after the disinfection stage shall not impair the result of
cleaning/disinfection and conform to WHO definition for potable water, when tested in accordance with 6.3.
NOTE National Regulatory Authorities can require specific standards for final rinse water quality.
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prEN ISO 15833-7:2014 (E)
4.5 Self-disinfection
4.5.1 A self-disinfection cycle shall be provided to ensure that the WD does not become a focus for
contamination of the load and to provide a means of disinfecting the WD after interventions for maintenance,
repairs or testing (see also ISO 15883-1:2006, 5.3.1.2).
NOTE 1 The self-disinfection process is intended also to deal with the situation where the WD has become
contaminated. Biofilm can easily develop on the piping used to convey rinse water to the load, and can contain
microorganisms in a state in which they are highly resistant to disinfection.
Thermal disinfection shall attain a minimum A of 60 and shall be capable to be set to give an A -value of 600.
0 0
If the use of thermal disinfection is not possible, a chemical disinfectant different from that used for disinfecting
the loads shall be used.
NOTE 2 The use of the same disinfectant carries the risk of allowing organisms resistant to that particular disinfectant
to proliferate.
4.5.2 The manufacturer shall provide details of the parts of the WD subjected to the self-disinfection cycle
and whether this cycle includes other components such as the water treatment equipment.
4.5.3 When different from the normal operating cycle the WD self-disinfection cycle shall:
a) be operated under the control of the automatic controller;
b) be a user selectable cycle;
c) provide for disinfection of the chamber and all liquid transport systems;
d) include means to warn the user that the WD shall be operated without any load in the chamber and, so
far as may be practicable, include means to verify that no device is present before the cycle will operate;
e) in the case of thermal self-disinfection of the WD, ensure that all the parts of the heating system and the
associated pipework, via which the water or the steam reach the WD tank, attain an A -value of at least
0
60.
4.5.4 The self-disinfection cycle shall ensure that a WD that has become contaminated through failure of
the water treatment equipment can be effectively disinfected. Compliance shall be verified by testing in
accordance with 6.3.
4.5.5 Thermal disinfection systems shall be evaluated by thermometric monitoring of the system with
sensors placed at those parts of the system specified by the WD manufacturer as representative of the lowest
temperatures in the system. The entire system subjected to thermal disinfection shall attain the required
disinfection temperature.
4.5.6 For chemical self-disinfection cycles a microbiological test shall be required. The capability of the WD
to provide self-disinfection shall be deemed to have been established when tested in accordance with
Annex B.
4.6 Drying
4.6.1 The WD shall, unless otherwise specified, be provided with equipment to allow drying of the load.
4.6.2 Drying of the load in the WD shall be deemed to have been achieved when plain surfaces of the items
are visually dry (see 6.5).
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prEN ISO 15833-7:2014 (E)
4.7 Water treatment equipment
4.7.4 General
Means shall be provided to ensure that water treatment equipment that is part of the WD (softeners, de-
ionizers, filters etc.) is operated within the limits (e.g. flow rates, supply pressures) specified by the
manufacturer of the water treatment equipment.
4.7.5 Disinfection of water treatment equipment
4.7.2.1 When the water treatment equipment is a part of the WD, the former shall be designed and
constructed so that it can be periodically submitted to a disinfection procedure. Guidance on the minimum
frequency with which the equipment shall be disinfected shall be stated by the WD manufacturer in
accordance with the information supplied by the purchaser for the quality of the water supply and the
manufacturer of the water treatment equipment [see 8 h)].
NOTE The disinfection of the water treatment equipment can be carried out during a self-disinfection cycle.
The actual frequency should be decided by the user based upon known, e.g. seasonal, variations in the
quality of water supplied to the WD and the operational history of the water treatment equipment.
The disinfection method shall not cause any damage to, nor impair the efficacy of, the treatment equipment.
The efficacy of the water equipment disinfection procedure to provide self-disinfection shall be deemed to
have been established if, when tested in accordance with 6.3 there shall be less than 10 cfu recovered from
each of two 100 ml samples and other controlling parameters have been achieved.
4.7.2.2 If the water treatment equipment is not part of the WD, the WD manufacturer shall specify the
requirements for water supplied to the WD. This shall include specification of the permissible microbial
contamination of the water supply [see 8 h)].
NOTE 1 To meet the specification of the permissible microbial contamination of the water supply, it can be necessary
for the user to make provision for disinfection of the external water treatment equipment.
Means shall be provided to disinfect incoming water used for the final rinse. The disinfection process shall
ensure that
a) there are fewer than 10 cfu/100 ml sample of final rinse water;
b) the water is free from legionellae, Pseudomonas and mycobacteria (see 6.3).
NOTE 2 The following methods can be suitable for control of the microbial contamination of rinse water:
— maintained in a dedicated reservoir at a temperature not less than 65 °C for the time demonstrated to achieve
disinfection of the incoming supply; or
— disinfected immediately prior to use; or
— filtered to remove suspended particles of a size greater than 0,2 μm; or
— sterile, in a closed container, with a connection to the WD designed and constructed to provide aseptic transfer.
4.7.2.3 The connection between the water supply, which has been treated to remove microbial
contamination and the circulation system for rinsing the endoscope shall be designed and constructed to
provide aseptic transfer.
Provision shall be made for disinfection of this connection to be made periodically. The frequency and method
of carrying out this disinfection shall be specified by the WD manufacturer.
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prEN ISO 15833-7:2014 (E)
4.7.2.4 From before the rinsing stage until the end of the processing cycle, as appropriate, the final water
treatment used to fulfill the requirements of 4.4 shall be mo
...
NORME ISO
INTERNATIONALE 15883-7
Première édition
2016-02-01
Laveurs désinfecteurs —
Partie 7:
Exigences et essais pour les
laveurs désinfecteurs destinés à la
désinfection chimique des dispositifs
médicaux thermosensibles, non
invasifs et non critiques et des
équipements de soins de santé
Washer-disinfectors —
Part 7: Requirements and tests for washer-disinfectors employing
chemical disinfection for non-invasive, non-critical thermolabile
medical devices and healthcare equipment
Numéro de référence
ISO 15883-7:2016(F)
©
ISO 2016
---------------------- Page: 1 ----------------------
ISO 15883-7:2016(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2016, Publié en Suisse
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite ni utilisée
sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie, l’affichage sur
l’internet ou sur un Intranet, sans autorisation écrite préalable. Les demandes d’autorisation peuvent être adressées à l’ISO à
l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – Tous droits réservés
---------------------- Page: 2 ----------------------
ISO 15883-7:2016(F)
Sommaire Page
Avant-propos .v
Introduction .vi
1 Domaine d’application . 1
2 Références normatives . 2
3 Termes et définitions . 2
4 Exigences de performance . 2
4.1 Généralités . 2
4.2 Nettoyage . 3
4.3 Désinfection . 3
4.4 Rinçage final . 5
4.5 Autodésinfection . 5
4.6 Séchage . 6
4.7 Système de traitement de l’eau . 6
4.7.1 Généralités . 6
4.7.2 Désinfection du système de traitement de l’eau . 6
4.7.3 Maintenance des canalisations . 7
5 Exigences mécaniques . 7
5.1 Matériaux: conception, fabrication et assemblage . 7
5.2 Vérification du procédé . 7
6 Essais de conformité . 8
6.1 Généralités . 8
6.2 Charge d’essai . 8
6.2.1 Chargement avec des articles standard . 8
6.2.2 Chargement avec des articles spéciaux . 8
6.3 Eau utilisée pour le rinçage après désinfection . 8
6.4 Siccité de la charge. 8
6.4.1 Généralités . 8
6.4.2 Mode opératoire . 8
6.4.3 Résultats . 9
6.5 Essais thermométriques . 9
6.5.1 Généralités . 9
6.5.2 Essai de température de la charge. 9
6.6 Essais de dosage des produits chimiques . 9
6.6.1 Généralités . 9
6.6.2 Produits chimiques réutilisés . 9
6.7 Essais d’efficacité du nettoyage . 9
6.7.1 Généralités . 9
6.7.2 Matériel .10
6.7.3 Mode opératoire .10
6.7.4 Résultats .10
6.8 Essais d’efficacité de la désinfection .10
6.8.1 Généralités .10
6.8.2 Essais préliminaires sur les désinfectants chimiques .11
6.8.3 Essais d’autodésinfection .12
6.8.4 Désinfection chimique de la charge .12
7 Documentation .13
8 Informations devant être fournies par le fabricant .13
9 Marquage, étiquetage et emballage .14
10 Informations devant être demandées par le fabricant à l’acheteur .14
Annexe A (normative) Récapitulatif des programmes d’essais .15
© ISO 2016 – Tous droits réservés iii
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ISO 15883-7:2016(F)
Annexe B (normative) Méthodes d’évaluation microbiologique de la désinfection du
système de transport des liquides .17
Annexe C (normative) Essais de contamination microbiologique de l’eau de rinçage utilisée
après la phase de désinfection .22
Annexe D (normative) Préparation et évaluation des indicateurs pour les essais
microbiologiques de l’efficacité de la désinfection chimique de la charge .23
Annexe E (informative) Exemples de points de prélèvement pour les essais avec
indicateurs biologiques .27
Bibliographie .32
iv © ISO 2016 – Tous droits réservés
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ISO 15883-7:2016(F)
Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes
nationaux de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est
en général confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude
a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,
gouvernementales et non gouvernementales, en liaison avec l’ISO participent également aux travaux.
L’ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui
concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents
critères d’approbation requis pour les différents types de documents ISO. Le présent document a été
rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir www.
iso.org/directives).
L’attention est appelée sur le fait que certains des éléments du présent document peuvent faire l’objet de
droits de propriété intellectuelle ou de droits analogues. L’ISO ne saurait être tenue pour responsable
de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant
les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de
l’élaboration du document sont indiqués dans l’Introduction et/ou dans la liste des déclarations de
brevets reçues par l’ISO (voir www.iso.org/brevets).
Les appellations commerciales éventuellement mentionnées dans le présent document sont données
pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un
engagement.
Pour une explication de la signification des termes et expressions spécifiques de l’ISO liés à
l’évaluation de la conformité, ou pour toute information au sujet de l’adhésion de l’ISO aux principes
de l’OMC concernant les obstacles techniques au commerce (OTC), voir le lien suivant: Avant-propos —
Informations supplémentaires.
L’ISO 15883-7 a été élaborée par le Comité technique CEN/TC 102, Stérilisateurs à usage médical, du
Comité européen de normalisation (CEN), en collaboration avec le Comité technique ISO/TC 198,
Stérilisation des produits de santé, conformément à l’Accord de coopération technique entre l’ISO et
le CEN (Accord de Vienne).
L’ISO 15883 comprend les parties suivantes, présentées sous le titre général Laveurs désinfecteurs:
— Partie 1: Exigences générales, termes et définitions et essais
— 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.
— Partie 3: Exigences et essais pour laveurs désinfecteurs destinés à la désinfection thermique de récipients
à déjections humaines
— Partie 4: Exigences et essais pour les laveurs désinfecteurs destinés à la désinfection chimique des
endoscopes thermolabiles
— Partie 5: Essais de souillures et méthodes pour démontrer l’efficacité de nettoyage [Spécification
technique]
— Partie 6: Exigences et essais pour les laveurs désinfecteurs utilisant une désinfection thermique pour les
dispositifs médicaux non invasifs, non critiques et pour l’équipement de soins de santé
— Partie 7: Exigences et essais pour les laveurs désinfecteurs destinés à la désinfection chimique des
dispositifs médicaux thermosensibles, non invasifs et non critiques et des équipements de soins de santé
© ISO 2016 – Tous droits réservés v
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ISO 15883-7:2016(F)
Introduction
Cette introduction est destinée à être lue conjointement avec l’introduction de l’ISO 15883-1.
La présente partie de l’ISO 15883 est la septième d’une série de normes spécifiant les performances des
laveurs désinfecteurs. Elle définit les exigences de performance particulières applicables aux laveurs
désinfecteurs destinés à la désinfection chimique des dispositifs médicaux thermosensibles, non
invasifs et non critiques et des équipements de soins de santé. Ses exigences s’appliquent aux laveurs
désinfecteurs utilisés pour nettoyer et désinfecter des équipements thermosensibles destinés à être
employés sans traitement additionnel dans des environnements de soins. Les équipements réutilisables
de ce type doivent être nettoyés et désinfectés, mais leur traitement dans un laveur désinfecteur destiné
aux instruments chirurgicaux (voir l’ISO 15883-2), un laveur désinfecteur destiné aux récipients
à déjections humaines (voir l’ISO 15883-3), un laveur désinfecteur destiné aux endoscopes (voir
l’ISO 15883-4) ou un laveur désinfecteur destiné à la désinfection thermique des dispositifs médicaux
non invasifs et non critiques et à l’équipement de soins de santé (voir l’ISO 15883-6) est inapproprié,
voire impossible dans la pratique. Les cadres de lit et le mobilier de lit, les supports sur roulettes et
les chariots de transport, les tables d’opération, les articles chaussants, les fauteuils roulants ou les
dispositifs auxiliaires pour personnes handicapées sont des exemples de ce type d’équipements.
Les exigences applicables aux laveurs désinfecteurs utilisés pour d’autres applications sont spécifiées
dans d’autres parties de l’ISO 15883.
Pour ce qui concerne tout effet défavorable éventuel sur la qualité de l’eau destinée à la consommation
humaine lié à l’utilisation du laveur désinfecteur, il convient de noter que
a) dans l’attente de l’adoption de critères internationaux vérifiables, les réglementations nationales
existantes concernant l’utilisation et/ou les caractéristiques du laveur désinfecteur restent en
vigueur (par exemple, l’exigence en matière de prévention de la pollution par retour), et
b) aucune information n’est fournie par la série de normes ISO 15883 sur les restrictions possibles
d’utilisation du laveur désinfecteur dans un État membre de l’ISO.
vi © ISO 2016 – Tous droits réservés
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NORME INTERNATIONALE ISO 15883-7:2016(F)
Laveurs désinfecteurs —
Partie 7:
Exigences et essais pour les laveurs désinfecteurs destinés
à la désinfection chimique des dispositifs médicaux
thermosensibles, non invasifs et non critiques et des
équipements de soins de santé
1 Domaine d’application
La présente partie de l’ISO 15883 spécifie les exigences particulières relatives aux laveurs
désinfecteurs (LD) destinés à être utilisés pour le nettoyage et la désinfection chimique, au cours d’un
seul cycle standard, d’articles réutilisables tels que les suivants:
a) les cadres de lit;
b) les tables de chevet;
c) les chariots de transport;
d) les récipients;
e) les tables d’opération;
f) les récipients de stérilisation;
g) les sabots médicaux;
h) les fauteuils roulants et dispositifs auxiliaires pour les personnes handicapées.
La présente partie de l’ISO 15883 spécifie également les exigences de performance relatives au
nettoyage et à la désinfection du laveur désinfecteur ainsi que de ses composants et accessoires, qui
peuvent être nécessaires pour atteindre les performances requises.
Les dispositifs identifiés dans les domaines d’application de l’ISO 15883-2, l’ISO 15883-3, l’ISO 15883-4
et l’ISO 15883-6 ne relèvent pas du domaine d’application de la présente partie de l’ISO 15883.
Le présent document spécifie également les méthodes, l’instrumentation et les instructions nécessaires
pour les essais de type, les essais de fonctionnement, la validation (qualification de l’installation,
qualification opérationnelle et qualification des performances lors de la première installation), le
contrôle de routine et la surveillance, de même que les requalifications à effectuer périodiquement et
après des réparations importantes.
NOTE Les LD relevant de la présente partie de l’ISO 15883 peuvent également être utilisés pour le nettoyage
et la désinfection chimique d’autres dispositifs thermosensibles réutilisables, selon les recommandations du
fabricant du dispositif.
Les exigences de performance spécifiées dans la présente partie de l’ISO 15883 ne peuvent pas
garantir l’inactivation ou l’élimination du ou des agents pathogènes (protéine du prion) à l’origine des
encéphalopathies spongiformes transmissibles.
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ISO 15883-7:2016(F)
2 Références normatives
Les documents ci-après, dans leur intégralité ou non, sont des références normatives indispensables à
l’application du présent document. Pour les références datées, seule l’édition citée s’applique. Pour les
références non datées, la dernière édition du document de référence s’applique (y compris les éventuels
amendements).
ISO 15883-1:2006+A1:2014, Laveurs désinfecteurs — Partie 1: Exigences générales, termes et définitions
et essais
ISO 15883-4, Laveurs désinfecteurs — Partie 4: Exigences et essais pour les laveurs désinfecteurs destinés à
la désinfection chimique des endoscopes thermolabiles
ISO 15883-6, Laveurs désinfecteurs — Partie 6: Exigences et essais pour les laveurs désinfecteurs utilisant
une désinfection thermique pour les dispositifs médicaux non invasifs, non critiques et pour l’équipement de
soins de santé
ISO/TS 15883-5:2005, Laveurs désinfecteurs — Partie 5: Essais de souillures et méthodes pour démontrer
l’efficacité de nettoyage
EN 10088-1, Aciers inoxydables — Partie 1: Liste des aciers inoxydables
EN 10088-2, Aciers inoxydables — Partie 2: Conditions techniques de livraison des tôles et bandes en acier
de résistance à la corrosion pour usage général
IEC 61010-2-040:2005, Règles de sécurité pour appareils électriques de mesurage, de régulation et de
laboratoire — Partie 2-040: Exigences particulières pour stérilisateurs et laveurs désinfecteurs utilisés
pour traiter le matériel médical
3 Termes et définitions
Pour les besoins du présent document, les termes et définitions donnés dans l’ISO 15883-1, l’ISO 15883-4
et l’ISO 15883-6 s’appliquent.
4 Exigences de performance
4.1 Généralités
4.1.1 Le LD doit être conforme à l’ISO 15883-1:2006+A1:2014, à l’exception des paragraphes suivants:
— 4.3.1 (qui se réfère à la désinfection thermique, voir Article 1);
— 5.9 [limites du contrôle thermique du procédé, à l’exclusion des alinéas 5.9 d) et e)];
— 5.11 (vérification de procédé).
4.1.2 Le LD doit être conçu pour nettoyer et désinfecter chimiquement la gamme d’articles réutilisables
spécifiée.
4.1.3 Si nécessaire, le LD doit être doté de moyens facilitant l’alignement correct de la charge dans la
cuve de lavage.
4.1.4 Le système de contrôle du volume de produit(s) chimique(s) admis (voir l’ISO 15883-
1:2006+A1:2014, 5.7.4 et 5.7.5) doit pouvoir être réglé à l’aide d’une clé, d’un code ou d’un outil.
L’exactitude du système de dosage doit être d’au moins ± 10 % ou telle que spécifiée et soumise à un
essai de conformité (voir 6.6).
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ISO 15883-7:2016(F)
4.1.5 L’automate doit garantir que la concentration finale en désinfectant est conforme aux limites
spécifiées.
NOTE La confirmation de la concentration de désinfectant peut inclure le mesurage du volume de
désinfectant et d’eau admis, accompagné d’un certificat de conformité délivré par le fournisseur du désinfectant
quant à la concentration du désinfectant et de données corroborant la durée de conservation, la date de
péremption, etc.
4.2 Nettoyage
4.2.1 L’essai relatif au nettoyage doit être réalisé conformément aux exigences de l’ISO 15883-1, à
l’aide des souillures d’essai et des méthodes de l’ISO/TS 15883-5 applicables aux charges à traiter.
4.2.2 Pendant la phase de lavage:
a) la phase de lavage démarre lorsque la température au niveau du capteur de contrôle du LD n’est pas
inférieure à la température de lavage spécifiée;
b) la bande de températures de lavage doit être définie par une limite inférieure correspondant à la
température de lavage et une limite supérieure ne dépassant pas la température de lavage spécifiée
+ 10 °C (voir l’ISO 15883-1:2006+A1:2014, 4.2.3).
4.2.3 L’efficacité du nettoyage doit être déterminée conformément à 6.7.
4.2.4 Si le LD est conçu pour permettre la réutilisation de la solution de nettoyage durant au moins
deux cycles standard consécutifs, alors des précautions doivent être prises pour s’assurer que l’efficacité
et la sécurité (par exemple, accumulation de matières étrangères, compatibilité avec les dispositifs)
de la solution de nettoyage ne sont pas altérées. Ces précautions doivent inclure au moins les mesures
suivantes:
a) des méthodes spécifiées, qui doivent être utilisées pour vérifier que la solution de nettoyage a
conservé l’efficacité de nettoyage requise. Ces méthodes doivent être fondées sur des études de
validation, normalement réalisées par le fabricant de la solution de nettoyage, afin de déterminer
un/des paramètre(s) approprié(s) et/ou des indicateurs/marqueurs pouvant être contrôlés. Les
paramètres appropriés peuvent notamment comprendre la concentration de la substance active et
des d’autres constituants qui peuvent également affecter les performances (par exemple, le pH);
NOTE Des modifications mineures de la formulation de la solution de nettoyage peuvent avoir un impact
important sur sa stabilité, sur l’efficacité de nettoyage, etc.
b) des recommandations à l’attention de l’utilisateur sur la durée maximale ou le nombre maximal de
cycles standard pendant lesquels la solution de nettoyage peut être utilisée. Ces recommandations
doivent être fondées sur des données d’essais validées;
c) lorsque les conditions d’utilisation validées (durée maximale ou nombre maximal de cycles
standard) sont dépassées, l’automate doit:
— déclencher une alarme sonore et visuelle et empêcher la mise en route du cycle standard jusqu’à
ce que la solution de nettoyage soit remplacée; ou
— procéder au remplacement automatique de la solution de nettoyage dans le LD.
4.3 Désinfection
4.3.1 Le cycle doit comprendre une phase de désinfection chimique, qui peut être combinée au
nettoyage et doit être considérée comme réalisée lorsque les exigences des essais décrits en 6.8 sont
satisfaites.
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ISO 15883-7:2016(F)
4.3.2 Les exigences et essais de la présente partie de l’ISO 15883 sont fondés sur l’utilisation de
solutions désinfectantes aqueuses. L’utilisation d’autres systèmes, fondés sur des désinfectants gazeux,
n’est pas exclue; des essais équivalents sont alors nécessaires. Ceux-ci doivent couvrir les éléments
suivants:
a) le ou les désinfectants à utiliser, pour lesquels l’efficacité in vitro a été démontrée en se référant à
des normes publiées applicables;
Pour les besoins des essais d’efficacité, une méthode de neutralisation validée doit être utilisée.
Cette méthode peut être fournie par le fabricant du désinfectant.
b) lorsqu’il est soumis à essai sur des surfaces pendant la durée d’exposition minimale, à la
concentration et à la température minimales prévues dans le LD, le désinfectant démontre les
caractéristiques suivantes:
1) une inactivation d’au moins 5 unités log10 des bactéries végétatives;
2) une inactivation d’au moins 4 unités log10 des champignons levuriformes;
3) une inactivation d’au moins 4 unités log10 des virus à enveloppe.
NOTE 1 Les autorités de réglementation nationales peuvent exiger des valeurs d’inactivation et/ou une
efficacité supérieure(s) contre une plus grande variété de micro-organismes.
NOTE 2 Les essais d’efficacité contre les bactéries végétatives peuvent exclure les mycobactéries. Voir
également 8 f).
c) la compatibilité des solutions de nettoyage et de désinfection est indiquée, notamment tout impact
sur l’efficacité de la désinfection d’une contamination de la solution désinfectante par la solution de
nettoyage;
d) les conditions expérimentales des essais visant à démontrer l’efficacité microbicide du désinfectant
in vitro doivent refléter ses conditions d’utilisation. Ainsi, si le nettoyage et la désinfection sont
combinés, le désinfectant doit être soumis à essai en présence des substances interférentes
appropriées, qui doivent inclure les souillures généralement observées sur les charges à traiter.
4.3.3 Pendant toute la phase de désinfection, la température de la solution désinfectante doit être
surveillée, afin de garantir le respect des limites spécifiées pour le désinfectant, et doit être compatible
avec les limites de température qui s’appliquent au(x) dispositif(s) à traiter.
Cette surveillance doit être assurée en contrôlant la température de la solution désinfectante ou,
lorsque la température dans le LD n’est pas contrôlée, en vérifiant que le fonctionnement du LD est
empêché en dehors de la plage de températures spécifiée du désinfectant.
4.3.4 Si le LD est conçu pour permettre la réutilisation de la solution désinfectante durant au moins
deux cycles standard consécutifs, alors des précautions doivent être prises pour s’assurer que l’efficacité
et la sécurité (par exemple, accumulation de matières étrangères, compatibilité avec les dispositifs) de
la solution désinfectante ne sont pas altérées. Ces précautions doivent inclure au moins les mesures
suivantes:
a) les moyens qui doivent être utilisés pour vérifier que la solution désinfectante a conservé
l’efficacité de désinfection antimicrobienne requise. Ces moyens doivent être fondés sur des
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