SIST-TS CEN ISO/TS 15883-5:2006
(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)
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 residual soiling is required/sought, methods can be complemented by the specific determination of a residual component of the applied test soil.
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
SIST-TS CEN ISO/TS 15883-5:2006
01-februar-2006
ýLVWLOD±GHO 3UHVNXVQHQHþLVWRþHLQPHWRGH]DSULND]XþLQNDþLãþHQMD ,6276
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
SIST-TS CEN ISO/TS 15883-5:2006 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST-TS CEN ISO/TS 15883-5:2006
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SIST-TS CEN ISO/TS 15883-5:2006
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.
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SIST-TS CEN ISO/TS 15883-5:2006
CEN ISO/TS 15883-5:2005 (E)
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.
2
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SIST-TS CEN ISO/TS 15883-5:2006
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
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SIST-TS CEN ISO/TS 15883-5:2006
ISO/TS 15883-5:2005(E)
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ii © ISO 2005 – All rights reserved
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SIST-TS CEN ISO/TS 15883-5:2006
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
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SIST-TS CEN ISO/TS 15883-5:2006
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]
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SIST-TS CEN ISO/TS 15883-5:2006
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.
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SIST-TS CEN ISO/TS 15883-5:2006
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SIST-TS CEN ISO/TS 15883-5:2006
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 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 this Technical Specification are sourced from national standards and
published documents submitted by member bodies of the Technical Committee preparing this Technical Specification.
They have been edited only to provide a uniform format within this Technical Specification.
NOTE 2 An example of this is the use of the peroxidase test (see Annex J) to detect residual blood (haemoglobin) from
the test soil applied to surgical instruments or flexible endoscopes (e.g. using the method described in Annex G). See also
ISO 15883-1:2005, Annex D.
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 3166-1, Codes for the representation of names of countries and their subdivisions — Part 1: Country
codes
ISO 15883-1:2005, Washer-disinfectors — Part 1: General requirements, terms and definitions and tests
3 Applicability
3.1 Where any of the test methods specified below deviate from the test method for cleaning efficacy
specified in ISO 15883-1, the method given in ISO 15883-1 shall be used (see ISO 15883-1:2005, 6.10).
Cleaning efficacy, for example, shall be determined after exposure to only the cleaning part of the operating
cycle.
3.2 Table 1 includes a summary of the test soils which are included in this Technical Specification. The test
soils are listed for the specific type of WD loads for which they were specified; the same test soils may be
used also for other types of loads: for example, soils specified for surgical instrument may be used for other
metal components.
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SIST-TS CEN ISO/TS 15883-5:2006
ISO/TS 15883-5:2005(E)
Table 1 — Summary of test soils including their allocation to the type of load
Annex in this
Country Reference in
Load type Constituents of soil Technical
a
code Bibliography
Specification
Surgical instruments AT [34] Heparinzed sheep blood coagulated with Annex A
(including rigid protamine
endoscopes)
b
DE [32], [33] Annex G
Sheep blood, E. faecium
b
Egg yolk, E. faecium
Semolina, butter, sugar, milk powder,
b
E. faecium
DE [41], [42], [43] Tetramethylbenzidine, Annex J
hydrogen peroxide solution,
bovine haemoglobin
NL [39] Bovine serum albumin fraction 5, Annex K
porcine gastric mucin type 3,
bovine fibrinogen fraction 1,
bovine thrombin
SE [24] Citrated cattle blood coagulated with Annex M
calcium chloride
UK [28], [30] Defibrinated horse/sheep blood, egg Annex N
yolk, dehydrated hog mucin
US [31] Protein/organic soil (user preference), Annex S
B. atrophaeus endospores
[47] Albumin, haemoglobin, fibrinogen,
thrombin
Bowls, dishes, SE [24] Citrated cattle blood coagulated with Annex M
receivers calcium chloride
UK [28], [30] Defibrinated horse/sheep blood, egg Annex N
yolk, dehydrated hog mucin
Anaesthesia AT [36] Nigrosin, wheat flour, hens egg Annex B
equipment /
b
DE [32], [33] Annex G
Sheep blood, E. faecium
accessories
SE [24] Citrated cattle blood coagulated with Annex M
calcium chloride
UK [28], [30] Glycerol, dehydrated hog mucin, horse Annex O
serum, unbleached plain flour, aqueous
safranine solution, water
b
Infant feeding bottles DE [32], [33] Annex G
Sheep blood, E. faecium
b
egg yolk, E. faecium
semolina, butter, sugar, milk powder,
b
E. faecium
Baby bottles and SE [24] Citrated cattle blood coagulated with Annex M
suction bottles calcium chloride
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SIST-TS CEN ISO/TS 15883-5:2006
ISO/TS 15883-5:2005(E)
Table 1 (continued)
Annex in this
Country Reference in
Load type Constituents of soil Technical
a
code Bibliography
Specification
Bedpans AT [36] Nigrosin, wheat flour, hens egg, instant Annex C
potato flakes,
DE [22], [23], [38] Bovine albumin, mucin, maize starch Annex H
b
E. faecium
SE [24] Citrated cattle blood coagulated with Annex M
calcium chloride
UK [27], [30] Unbleached plain flour, water soluble Annex P
adhesive wallpaper paste, hens egg,
black Indian ink, water
Urine bottles AT [36] Nigrosin, wheat flour, hens egg Annex D
SE [24] Citrated cattle blood coagulated with Annex M
calcium chloride
UK [27], [30] Defibrinated horse/sheep blood, water Annex Q
soluble adhesive wallpaper paste, hens
egg, black Indian ink, water
Flexible endoscopes AT [34], [44] Nigrosin, wheat flour, hens egg, Annex E
b
E. faecium
b
DE [34], [35] Annex I
Blood, E. faecium
DE [41], [42], [43] Tetramethylbenzidine, hydrogen Annex J
peroxide solution, bovine haemoglobin
FR [37] Biofilm formed by Pseudomonas Annex F
aeruginosa
NL [40] Bovine serum albumin, procine mucin, Annex L
bovine thrombin, bovine fibrinogen
UK [30] Glycerol, dehydrated hog mucin, horse Annex R
serum, unbleached plain flour, aqueous
safranine solution, water
US [31] Protein/organic soil (user preference), Annex S
B. atrophaeus endospores
[47] Bacteria, protein, carbohydrate,
endotoxin, haemoglobin
Stainless steel items NL [39] Bovine albumin fraction 5, porcine Annex K
(including bedpans, gastric mucin type 3, bovine fibrinogen
urine bottles) fraction 1, bovine thrombin
Wash bowls SE [24] Calcium stearate generated in situ from Annex M
soap and calcium chloride solution
Reusable medical US [31] Protein/organic soil (user preference), Annex S
instruments including B. atrophaeus endospores
flexible endoscopes
a
Country code as specified in ISO 3166-1.
b
The test soils and methods may also be used for microbial testing of disinfection efficacy of WDs according to the ISO 15883 series
when requested by the user.
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SIST-TS CEN ISO/TS 15883-5:2006
ISO/TS 15883-5:2005(E)
Annex A
(normative)
Test soil and method for surgical instruments (Austria)
A.1 Reference
The test methods using a heparinized blood test soil for testing and evaluating the cleaning efficacy of
automated WDs for surgical instruments as an optional type test and operational test are based on
Reference [34] and were adapted or complemented for the presentation in this Technical Specification.
A.2 Materials
⎯ Blood from a laboratory sheep.
1)
⎯ Heparin .
1)
⎯ Protamine sulphate or hydrochloride .
Optional:
1)
⎯ Cleaning-indicators for ordinary surgical instruments .
1)
⎯ Cleaning-indicators for instruments for minimally invasive surgery .
A.3 Apparatus
⎯ Normal laboratory equipment.
⎯ Paintbrush, 25 mm in width and 4 mm of thickness.
⎯ Syringes, of 20 ml capacity.
A.4 Preparation of test soil
A.4.1 Heparinized sheep blood
Add 0,1 ml heparin per 100 ml of sheep blood immediately after the blood is drawn (heparinized sheep blood).
A.4.2 Completion of the test soil
Directly before use bring the blood to room temperature.
Pour the heparinized blood into a clean and dry bowl, add 0,15 ml of protamine sulphate to each 10 ml of
blood and mix well. The blood should coagulate within approximately 10 min to 20 min.
1) Guidance on suitable commercially available products may be obtained from Austrian Standards Institute,
Heinestr. 38, 1020 Vienna, Austria.
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ISO/TS 15883-5:2005(E)
A.5 Storage
Store the blood and the protamine sulphate (or hydrochloride) in a refrigerator at 4 °C to 8 °C and according to
the manufacturer's instructions respectively.
A.6 Test pieces
A.6.1 Ordinary surgical instruments
Surgical instruments with joints (scissors with joints and clamps with box locks at a ratio of 1:1) in sufficient
numbers to provide a full load of the WD under test when using 20 test pieces per tray.
A.6.2 Instruments for minimally invasive surgery
As a surrogate for rigid endoscopes, dummies made of stainless steel tubing should be used with a wall
thickness of approximately 1 mm and either:
⎯ a length of 150 mm, inner diameter of 8 mm; or
⎯ a length of 300 mm, inner diameter of 4 mm and 6 mm.
A.7 Inoculation of test pieces
A.7.1 Ordinary surgical instruments
Allow the blood to equilibrate to room temperature before use. Clean and dry the test instruments thoroughly.
Apply the test soil to joints and corrugate surfaces of the instruments at ambient temperature using a
paintbrush. Take care that the blood is used within approximately 10 min (in any case before complete
coagulation). The total amount of the test soil should be about 0,05 % of the amount of water for the cleaning
phase in the tank of the WD (e.g. 20 l water; 10 ml blood).
Place 20 pieces of the soiled instruments horizontally and at random on each of the trays.
All instruments shall be prepared and arranged on the tray within 30 min.
Leave the instruments on the tray to dry at ambient temperature and humidity for approximately 30 min. Then
take each of the instruments and check them for excessive test soil (e.g. coagulated test soil spots W 5 mm in
diameter on the surface of the instruments) which shall be removed by means of an absorbent pad. Then
place the instruments upside down on another tray and leave them to dry for at least 30 min but not more than
60 min.
A.7.2 Instruments for minimally invasive surgery
Allow the blood to equilibrate to room temperature before use. Fill the lumens with the test soil in a way that
the inner surfaces are completely wetted. Take care that the blood is used within approximately 10 min (in any
case before complete coagulation). Make sure that the lumens are open after this procedure (e.g. by blowing
through the lumens with compressed air). Then, apply a thin layer of blood to the outer surfaces of the
dummies using a paintbrush.
Connect the soiled dummies to the appropriate nozzles and luer-locks (at least three per connection type) and
place them on or in the load carrier according to the manufacturer's instructions.
All instruments shall be prepared and arranged on the load carrier within 30 min.
Leave the instruments on the load carrier to dry for at least 60 min but not more than 90 min.
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SIST-TS CEN ISO/TS 15883-5:2006
ISO/TS 15883-5:2005(E)
A.8 Test method
A.8.1 Ordinary surgical instruments
Load the WD with the test instruments on their tray and start the WD with a full load. Run the cleaning cycle of
the “surgical instrument” programme in accordance with the manufacturer’s instructions.
Immediately after the cleaning cycle, interrupt the programme and unload the WD.
For each type of load, at least three cycles shall be run in the WD.
If there are not enough test instruments available to provide a full load, run as many cycles as necessary to
check every position possible in the WD and fill the blank positions with clean items on their trays according to
the manufacturer’s instructions.
In addition, suitable industrially produced cleaning-indicators may be used which should be placed on the
trays and evaluated after completion of the cleaning cycle in accordance with the manufacturer’s instructions.
A.8.2 Instruments for minimally invasive surgery
Load the WD with test instruments and start the WD with a full load. Run the cleaning cycle of the adequate
programme in accordance with the manufacturer’s instructions.
Immediately after the cleaning cycle, interrupt the programme and unload the WD.
For each type of load, at least three cycles, shall be run in the WD.
Blank nozzles shall be connected to clean items according to the manufacturer’s instructions.
In addition, suitable industrially produced cleaning-indicators may be used. At least one of them should be
connected to each type of connection nozzle and evaluated after completion of the cleaning cycle in
accordance with the manufacturer’s instructions.
A.9 Results
A.9.1 Ordinary surgical instruments
A.9.1.1 Detection of residual soil
After cleaning in the WD, examine the instruments visually. Examine every single instrument by opening and
closing box locks and joints. Record the number of clean (no remains of blood visible to the naked eye at
normal light with any optical corrections required for normal visual acuity) and not clean instruments. Calculate
the ratio of the test pieces with residual soil to the originally soiled instruments. Express the result in percent.
Items other than the inoculated test pieces shall not be considered.
In cases of doubt, protein detection tests (e.g. biuret reaction) should be carried out to confirm whether the
visible residue is due to the test soil.
If applicable, examine the cleaning-indicators and check the results for compliance with the manufacturer's
instructions.
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SIST-TS CEN ISO/TS 15883-5:2006
ISO/TS 15883-5:2005(E)
A.9.1.2 Acceptance criteria
The cleaning efficacy of the WD shall be regarded as satisfactory if
⎯ at least 95 % of all test pieces show no visible residue of the test soil,
⎯ the amount of protein on the instruments is below the detection level or within the limits of the acceptance
criteria given by the manufacturer of the test as applicable (see also ISO 15883-1:2005, Annex C),
⎯ the results of the cleaning-indicators are within limits of the acceptance criteria of the manufacturer, if
applicable.
A.9.2 Instruments for minimally invasive surgery
A.9.2.1 Detection of residual soil
Examine the outer surfaces of the instruments for minimally invasive surgery visually (see above). Record the
number of clean (no remains of blood visible to the naked eye at normal light with any optical corrections
required for normal visual acuity) and not clean instruments.
In addition, examine the inner surfaces by swabbing the tubes and examining the swabs for visible
contamination. If no contamination is visible, check the swab for protein with protein detection tests (e.g. biuret
reaction). Evaluate the tests in accordance with the manufacturer's instructions.
Items other than the inoculated test pieces shall not be considered.
A.9.2.2 Acceptance criteria
The cleaning efficacy of the WD should be regarded as satisfactory if
⎯ none of the test pieces show visible residue of the test soil on the outer surfaces,
⎯ the amount of protein in the lumen instruments is below the detection level or within the limits of the
acceptance criteria given by the manufacturer of the test as
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