CEN ISO/TS 15883-5:2005
(Main)Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy (ISO/TS 15883-5:2005)
Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy (ISO/TS 15883-5:2005)
ISO/TS 15883-5:2005 includes the test soils and methods that can be used to demonstrate the cleaning efficacy of washer-disinfectors (WD) according to the ISO 15883 series of standards.
The inclusion of the test soils and methods in ISO/TS 15883-5:2005 does not indicate that they are of equivalent sensitivity in their determination of cleaning efficacy.
Acceptance criteria are included, based on visual inspection and/or a microbiological end-point as stated for each method. Where chemical detection of residual soiling is required/sought, methods can be complemented by the specific determination of a residual component of the applied test soil.
NOTE 1 The test soils and methods included in ISO/TS 15883-5:2005 are sourced from national standards and published documents submitted by member bodies of the Technical Committee preparing ISO/TS 15883-5:2005. They have been edited only to provide a uniform format within ISO/TS 15883-5:2005.
NOTE 2 An example of this is the use of the peroxidase test to detect residual blood (haemoglobin) from the test soil applied to surgical instruments or flexible endoscopes (e.g. using the method described in ISO/TS 15883-5:2005). See also ISO 15883-1:2005, Annex D.
Reinigungs-Desinfektionsgeräte - Teil 5: Prüfanschmutzungen und - verfahren zum Nachweis der Reinigungswirkung von Reinigungs- Desinfektionsgeräten (ISO/TS 15883-5:2005)
Diese Technische Spezifikation beschreibt Prüfanschmutzungen und -verfahren, die sich zum Nachweis der Reinigungswirksamkeit von Reinigungs-Desinfektionsgeräten (RDG) nach der ISO-Normenreihe 15883 eignen.
Eine Aufnahme der Prüfanschmutzungen und -verfahren in diese Technische Spezifikation bedeutet nicht, dass sie bei der Bestimmung der Reinigungswirksamkeit von gleichwertiger Empfindlichkeit sind.
Die Spezifikation enthält Akzeptanzkriterien auf der Grundlage einer Sichtprüfung und/oder eines für jedes einzelne Verfahren angegebenen mikrobiologischen Endpunkts. Wo ein chemischer Nachweis eines Anschmutzungsrückstands erforderlich oder erwünscht ist, können die Prüfverfahren durch die spezifische Bestimmung eines Restbestandteils in der verwandten Prüfanschmutzung ergänzt sein.
ANMERKUNG 1 Die in dieser Technischen Spezifikation aufgeführten Prüfanschmutzungen und -verfahren entstammen nationalen Normen und Veröffentlichungen, die den Mitgliedern des Arbeitsausschusses, die diese Norm bearbeiten, vorgelegt wurden. Sie wurden lediglich editiert, um ein einheitliches Format innerhalb dieser Technischen Spezifikation zu schaffen.
ANMERKUNG 2 Ein Beispiel ist die Anwendung des Peroxidasetests (siehe Anhang J) zum Nachweis von Restblut (Hämoglobin) in der Prüfanschmutzung, die für chirurgische Instrumente oder flexible Endoskope verwendet wird (z. B. bei Anwendung des in Anhang G beschriebenen Prüfverfahren). Siehe auch ISO 15883-1:2005, Anhang D.
Laveurs désinfecteurs - Partie 5: Terrains d'essai et méthodes pour démontrer l'efficacité de nettoyage (ISO/TS 15883-5:2005)
L'ISO 15883-5:2005 inclut les terrains d'essai et les méthodes pouvant servir à démontrer l'efficacité du nettoyage des laveurs-désinfecteurs (LD) conformément à la série de normes ISO 15883.
L'inclusion des terrains d'essai et des méthodes dans l'ISO 15883-5:2005 n'indique pas qu'elles fournissent une sensibilité identique lors de la détermination de l'efficacité de la phase de nettoyage.
Les critères d'acceptabilité sont mentionnés et fondés sur un contrôle visuel et/ou un critère d'évaluation microbiologique défini pour chaque méthode. Lorsqu'une détection chimique des souillures résiduelles est requise, les méthodes peuvent être complétées par la détermination spécifique d'un composant résiduel du terrain d'essai appliqué.
Čistila – 5. del: Preskusne nečistoče in metode za prikaz učinka čiščenja (ISO/TS 15883-5:2005)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2006
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Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy
(ISO/TS 15883-5:2005)
Reinigungs-Desinfektionsgeräte - Teil 5: Prüfanschmutzungen und - verfahren zum
Nachweis der Reinigungswirkung von Reinigungs- Desinfektionsgeräten (ISO/TS 15883-
5:2005)
Laveurs désinfecteurs - Partie 5: Terrains d'essai et méthodes pour démontrer l'efficacité
de nettoyage (ISO/TS 15883-5:2005)
Ta slovenski standard je istoveten z: CEN ISO/TS 15883-5:2005
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
TECHNICAL SPECIFICATION
CEN ISO/TS 15883-5
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
November 2005
ICS 11.080.10
English Version
Washer-disinfectors - Part 5: Test soils and methods for
demonstrating cleaning efficacy (ISO/TS 15883-5:2005)
Laveurs désinfecteurs - Partie 5: Terrains d'essai et Prüfanschmutzungen und -verfahren zum Nachweis der
méthodes pour démontrer l'efficacité de nettoyage (ISO/TS Reinigungswirkung von Reinigungs-/Desinfektionsgeräten
15883-5:2005) (ISO/TS 15883-5:2005)
This Technical Specification (CEN/TS) was approved by CEN on 1 March 2005 for provisional application.
The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit their
comments, particularly on the question whether the CEN/TS can be converted into a European Standard.
CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available
promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS)
until the final decision about the possible conversion of the CEN/TS into an EN is reached.
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, 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
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 15883-5:2005: E
worldwide for CEN national Members.
Foreword
This document (CEN ISO/TS 15883-5:2005) 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".
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to announce this CEN Technical Specification: Austria, Belgium, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden,
Switzerland and United Kingdom.
TECHNICAL ISO/TS
SPECIFICATION 15883-5
First edition
2005-11-15
Washer-disinfectors —
Part 5:
Test soils and methods for demonstrating
cleaning efficacy
Laveurs désinfecteurs —
Partie 5: Terrains d'essai et méthodes pour démontrer l'efficacité de
nettoyage
Reference number
ISO/TS 15883-5:2005(E)
©
ISO 2005
ISO/TS 15883-5:2005(E)
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ii © ISO 2005 – All rights reserved
ISO/TS 15883-5:2005(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Applicability. 1
Annex A (normative) Test soil and method for surgical instruments (Austria). 4
Annex B (normative) Test soil and method for anaesthesia equipment (Austria) . 8
Annex C (normative) Test soil and method for bedpans (Austria) . 11
Annex D (normative) Test soil and method for urine bottles (Austria) . 14
Annex E (normative) Test soil and method for flexible endoscopes (Austria). 16
Annex F (normative) Test soil and method for flexible endoscopes (France). 21
Annex G (normative) Test soil and method for surgical instruments, glassware and anaesthesia
equipment (Germany). 25
Annex H (normative) Test soil and method for bedpans (Germany) . 31
Annex I (normative) Test soil and method for flexible endoscopes (Germany). 37
Annex J (normative) Test soil and method for surgical instruments and flexible endoscopes,
Peroxidase test (Germany) . 45
Annex K (normative) Test soil and method for stainless steel items including surgical
instruments (Netherlands) . 48
Annex L (normative) Test soil and method for surrogate devices for endoscope channels
(Netherlands). 51
Annex M (normative) Test soils and methods for surgical instruments, wash bowls, bedpans,
urine bottles, anaesthesia equipment, baby bottles and suction bottles (Sweden). 54
Annex N (normative) Test soil and method for surgical instruments, surgical instrument trays
bowls, dishes and receivers (UK) . 59
Annex O (normative) Test soil and method for anaesthetic accessories (UK). 62
Annex P (normative) Test soil and method for bedpans and commode pans (UK). 64
Annex Q (normative) Test soil and method for urine bottles (UK). 66
Annex R (normative) Test soil and method for flexible endoscopes (UK). 68
Annex S (informative) Test soil and method for reusable medical instruments (USA) . 70
Bibliography . 71
ISO/TS 15883-5:2005(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.
In other circumstances, particularly when there is an urgent market requirement for such documents, a
technical committee may decide to publish other types of normative document:
⎯ an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in
an ISO working group and is accepted for publication if it is approved by more than 50 % of the members
of the parent committee casting a vote;
⎯ an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical
committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting
a vote.
An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed for a
further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is
confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an
International Standard or be withdrawn.
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/TS 15883-5 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
ISO 15883 consists of the following parts, under the general title Washer-disinfectors:
⎯ Part 1: General requirements, terms and definitions and tests
⎯ Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical
instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
⎯ Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste
containers
⎯ Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile
endoscopes
⎯ Part 5: Test soils and methods for demonstrating cleaning efficacy [Technical Specification]
iv © ISO 2005 – All rights reserved
ISO/TS 15883-5:2005(E)
Introduction
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 internationally
acceptable test method. As an interim measure, the Technical Committees responsible for the ISO 15883
series of standards on washer-disinfectors (ISO/TC 198 and CEN/TC 102) have decided that the cleaning
efficacy of washer-disinfectors claiming compliance with the ISO 15883 series of standards be demonstrated
by referring to the test soils and methods that are currently used in a number of different countries. For the
convenience of the user of the ISO 15883 series of standards, these test soils and methods are described in
this Technical Specification. It should be noted that it remains the intention of the Technical Committees to
develop a single test method.
TECHNICAL SPECIFICATION ISO/TS 15883-5:2005(E)
Washer-disinfectors —
Part 5:
Test soils and methods for demonstrating cleaning efficacy
1 Scope
This Technical Specification includes the test soils and methods that can be used to demonstrate the cleaning
efficacy of washer-disinfectors (WD) according to the ISO 15883 series of standards.
The inclusion of the test soils and methods in this Technical Specification does not indicate that they are of
equivalent sensitivity in their determination of cleaning efficacy.
Acceptance criteria are included, based on visual inspection and/or a microbiological end-point as stated for
each method. Where chemical detection of residu
...
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