EN 16615:2015
(Main)Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of bactericidal and yeasticidal activity on non-porous surfaces with mechanical action employing wipes in the medical area (4- field test) - Test method and requirements (phase 2, step 2)
Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of bactericidal and yeasticidal activity on non-porous surfaces with mechanical action employing wipes in the medical area (4- field test) - Test method and requirements (phase 2, step 2)
This European Standard specifies a test method and the minimum requirements for bactericidal and yeasticidal activity of chemical disinfectant products that form a homogeneous, physically stable preparation when diluted with hard water – or in the case of ready-to-use products – with water.
This European Standard applies to products that are used in the medical area for disinfecting non-porous surfaces including surfaces of medical devices by wiping – regardless if they are covered by the 93/42/EEC Directive on Medical Devices or not.
This European Standard includes ‘ready-to-use wipes‘ which are impregnated with a microbicidal solution.
This European Standard applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:
- in hospitals, in community medical facilities and in dental institutions;
- in clinics of schools, of kindergartens and of nursing homes;
and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patients.
NOTE This method corresponds to a phase 2, step 2. test.
EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.
Chemische Desinfektionsmittel und Antiseptika - Quantitatives Prüfverfahren zur Bestimmung der bakteriziden und levuroziden Wirkung auf nicht-porösen Oberflächen mit mechanischer Einwirkung mit Hilfe von Tüchern im humanmedizinischen Bereich (4-Felder-Test) - Prüfverfahren und Anforderungen (Phase 2, Stufe 2)
Diese Europäische Norm legt ein Prüfverfahren für und die Mindestanforderungen an die bakterizide und levurozide Wirkung von chemischen Desinfektionsmitteln fest, die bei Verdünnung mit Wasser standardi-sierter Härte als homogene, physikalisch stabile Zubereitung vorliegen, bzw. bei gebrauchsfertigen Produkten bei der Verdünnung mit Wasser.
Diese Europäische Norm gilt für Produkte, die im medizinischen Bereich zur Desinfektion von nicht-porösen Oberflächen, einschließlich Oberflächen auf Medizinprodukten, durch Abwischen verwendet werden — unabhängig davon, ob sie in der Richtlinie 93/42/EWG über Medizinprodukte erfasst sind oder nicht.
Diese Europäische Norm gilt auch für „gebrauchsfertige Tücher“, die mit einer mikrobiziden Lösung getränkt sind.
Diese Europäische Norm gilt für Bereiche und unter Bedingungen, wo eine Desinfektion aus medizinischen Gründen angezeigt ist. Indikationen dieser Art liegen z. B. bei der Patientenbetreuung in:
- Krankenhäusern, kommunalen medizinischen Einrichtungen und im Dentalbereich;
- medizinischen Einrichtungen in Schulen, Kindergärten und Heimen;
vor und können auch am Arbeitsplatz und im häuslichen Bereich gegeben sein. Eingeschlossen sein können auch Einrichtungen wie Wäschereien und Küchen, die der direkten Versorgung der Patienten dienen.
ANMERKUNG Dieses Verfahren entspricht einer Prüfung der Phase 2, Stufe 2.
EN 14885 legt im Einzelnen die Beziehung der verschiedenen Prüfungen untereinander sowie zu den „Anwendungsempfehlungen“ fest.
Antiseptiques et désinfectants chimiques - Méthode d’essai quantitative pour l’évaluation de l’activité bactéricide et levuricide sur des surfaces non poreuses, avec action mécanique à l’aide de lingettes dans le domaine médical (essai à 4 zones) - Méthode d'essai et prescriptions (phase 2, étape 2)
La présente Norme européenne décrit une méthode d’essai et les prescriptions minimales relatives à l’activité bactéricide et levuricide des produits désinfectants chimiques qui forment une préparation homogène, physiquement stable, lorsqu’ils sont dilués dans de l’eau dure ou – dans le cas de produits prêts à l’emploi – dans l’eau.
La présente Norme européenne s’applique aux produits utilisés en médecine humaine pour la désinfection des surfaces non poreuses, y compris les surfaces des dispositifs médicaux, par essuyage, qu’ils relèvent ou non de la Directive européenne 93/42/CEE relative aux dispositifs médicaux.
La présente Norme européenne concerne les lingettes prêtes à l’emploi imprégnées de solution microbicide.
La présente Norme européenne s’applique dans les domaines et situations où la désinfection est indiquée en médecine humaine. De telles indications se rencontrent dans le cadre des soins apportés aux patients, par exemple :
- dans des hôpitaux, dans des centres de soins médicaux et des cabinets dentaires ;
- dans des infirmeries d’écoles, de jardins d’enfants et de maisons de retraite.
Ces conditions peuvent aussi se rencontrer sur des lieux de travail ou à domicile. Elles peuvent également concerner des services tels que des blanchisseries et des cuisines qui fournissent des produits directement aux patients.
NOTE Cette méthode correspond à un essai de phase 2, étape 2.
L’EN 14885 spécifie de façon détaillée les relations des différents essais entre eux et avec les « recommandations d’emploi ».
Kemična razkužila in antiseptiki - Kvantitativna preskusna metoda za vrednotenje baktericidnega delovanja ali delovanja na kvasovke na neporoznih površinah z odvzemom brisa v medicini (4-področni preskus) - Preskusna metoda in zahteve (faza 2, stopnja 2)
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Chemische Desinfektion und Antiseptika - Quantitativer Prüfversuch zur Bestimmung der bakteriziden und levuroziden Wirkung auf nicht-porösen Oberflächen mit mechanischer Einwirkung mit Hilfe von Tüchern oder Mops im humanmedizinischen Bereich (4-Felder-Test) - Prüfverfahren und Anforderungen (Phase 2, Stufe 2)Antiseptiques et désinfectants chimiques - Méthode d’essai quantitative pour l’évaluation de l’activité bactéricide et levuricide sur des surfaces non poreuses, avec action mécanique à l’aide de lingettes et de lavettes dans le domaine médical (essai à 4 zones) - Méthode d'essai et prescriptions (phase 2, étape 2)Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of bactericidal and yeasticidal activity on non-porous surfaces with mechanical action employing wipes in the medical area (4- field test) - Test method and requirements (phase 2, step 2)11.080.20Dezinfektanti in antiseptikiDisinfectants and antisepticsICS:Ta slovenski standard je istoveten z:EN 16615:2015SIST EN 16615:2015en,fr,de01-junij-2015SIST EN 16615:2015SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 16615
April 2015 ICS 11.080.20 English Version
Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of bactericidal and yeasticidal activity on non-porous surfaces with mechanical action employing wipes in the medical area (4- field test) - Test method and requirements (phase 2, step 2)
Antiseptiques et désinfectants chimiques - Méthode d'essai quantitative pour l'évaluation de l'activité bactéricide et levuricide sur des surfaces non poreuses, avec action mécanique à l'aide de lingettes dans le domaine médical (essai à 4 zones) - Méthode d'essai et prescriptions (phase 2, étape 2)
Chemische Desinfektionsmittel und Antiseptika - Quantitatives Prüfverfahren zur Bestimmung der bakteriziden und levuroziden Wirkung auf nicht-porösen Oberflächen mit mechanischer Einwirkung mit Hilfe von Tüchern im humanmedizinischen Bereich (4-Felder-Test) - Prüfverfahren und Anforderungen (Phase 2, Stufe 2) This European Standard was approved by CEN on 3 January 2015.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 16615:2015 ESIST EN 16615:2015
................................................................................. 10 5.4 Preparation of test organism suspensions and product test solutions ....................................... 13 5.4.1 Test organism suspensions .............................................................................................................. 13 5.4.2 Product test solution .......................................................................................................................... 15 5.5 Procedure for assessing the bactericidal and yeasticidal activity of the product ...................... 15 5.5.1 General ................................................................................................................................................. 15 5.5.2 Method ................................................................................................................................................. 17 5.6 Experimental data and calculation.................................................................................................... 20 5.6.1 Explanation of terms and abbreviations .......................................................................................... 20 5.6.2 Calculation ........................................................................................................................................... 20 5.7 Verification of methodology .............................................................................................................. 25 5.7.1 General ................................................................................................................................................. 25 5.7.2 Control of weighted mean counts ..................................................................................................... 25 5.7.3 Basic limits .......................................................................................................................................... 26 5.8 Expression of results and precision ................................................................................................. 26 5.8.1 Overview of the different suspensions / test mixtures ................................................................... 26 5.8.2 VC-values .............................................................................................................................................. 26 5.8.3 Limiting test organism and bactericidal and yeasticidal concentration ....................................... 27 5.8.4 Precision, repetitions ......................................................................................................................... 27 5.9 Interpretation of results – conclusion .............................................................................................. 27 5.10 Test report ........................................................................................................................................... 28 Annex A (informative)
Referenced strains in national collections . 30 Annex B (informative)
Neutralizers . 31 Annex C (informative)
Graphical representations of the test method . 32 Annex D (informative)
Example of a typical test report . 35 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC . 39 Bibliography . 40
1) See 5.5.1.1 b). 2) The ATCC numbers are the collection numbers of strains supplied by the American Type Culture Collections (ATCC). This information is given for the convenience of users of this European Standard and does not constitute an endorsement by CEN of the product named. SIST EN 16615:2015
3) The ATCC numbers are the collection numbers of strains supplied by the American Type Culture Collections (ATCC). This information is given for the convenience of users of this European Standard and does not constitute an endorsement by CEN of the product named. SIST EN 16615:2015
to 1 000,0 ml Sterilize in the autoclave (5.3.1). After sterilization the pH (5.3.2.4) of the medium shall be equivalent to 7,2 ± 0,2. In case of encountering problems with neutralization (5.5.1.2) it may be necessary to add neutralizer to TSA. Annex B gives guidance on the neutralizers that may be used. It is recommended not to use a neutralizer that causes opalescence in the agar. b) Malt Extract Agar (MEA) Malt extract agar, consisting of: — Malt extract 30,0 g — Agar 15,0 g — Water (5.2.2.2) to 1 000,0 ml Sterilize in the autoclave (5.3.1). After sterilization, the pH of the medium shall be equivalent to 5,6 ± 0,2 when measured at (20 ± 1) °C (5.3.2.4). In case of an encountering problems with neutralization (5.5.1.2) it may be necessary to add neutralizer to MEA. Annex B gives guidance on the neutralizers that may be used. It is recommended not to use neutralizer that causes opalescence in the agar. 5.2.2.4 Diluent a) General Diluent Tryptone Sodium Chloride Solution: — Tryptone, pancreatic digest of casein 1,0 g — Sodium chloride (NaCl) 8,5 g — Water (5.2.2.2) to 1 000,0 ml Sterilize in the autoclave (5.3.1). After sterilization the pH (5.3.2.4) of the general diluent shall be equivalent to 7,0 ± 0,2. b) Glycerol Diluent (for Pseudomonas aeruginosa only) Tryptone Sodium Chloride Glycerol Solution: — Tryptone, pancreatic digest of casein 1,0 g — Sodium chloride (NaCl)
8,5 g SIST EN 16615:2015
to 1 000,0 ml Sterilize in the autoclave (5.3.1). After sterilization the pH (5.3.2.4) of the diluent shall be equivalent to 7,0 ± 0,2. This modified diluent [5.2.2.4 b)] should be only used for the preparation of the test suspension of Pseudomonas aeruginosa (5.4.1.4). All further dilutions should be done with the general diluent [5.2.2.4 a)]. 5.2.2.5 Neutralizer The neutralizer shall be validated for the product being tested in accordance with 5.5.1.2 and 5.5.2. It shall be sterile. Information on neutralizer that has been found to be suitable for some categories of products is given in Annex B. 5.2.2.6 Sterile defibrinated sheep blood The sterile defibrinated sheep blood can be acquired from a commercial supplier. 5.2.2.7 Hard water for dilution of products a) Hard water general For the preparation of 1 l of hard water, the procedure is as follows: — Prepare solution A: dissolve 19,84 g magnesium chloride (MgCl2) and 46,24 g calcium chloride (CaCl2) in water (5.2.2.2) and dilute to 1 000 ml. Sterilize by membrane filtration (5.3.2.7) or in the autoclave [5.3.2.1 a)]. Autoclaving – if used - may cause a loss of liquid. In this case make up to 1 000 ml with water (5.2.2.2) under aseptic conditions. Store the solution in a refrigerator (5.3.2.8) for no longer than one month. — Prepare solution B: dissolve 35,02 g sodium bicarbonate (NaHCO3) in water and dilute to 1 000 ml. Sterilize by membrane filtration (5.3.2.7). Store the solution in a refrigerator (5.3.2.8) for no longer than one week. — Place 600 ml to 700 ml water (5.2.2.2) in a 1 000 ml volumetric flask (5.3.2.12) and add 6,0 ml (5.3.2.9) of solution A, then 8,0 ml of solution B. Mix and dilute to 1 000 ml with water (5.2.2.2). The pH (5.3.2.4) of the hard water shall be 7,0 ± 0,2 (5.3.2.4). If necessary adjust the pH by using a solution of approximately 40 g/l (about 1 mol/l) of sodium hydroxide (NaOH) or approximately 36,5 g/l (about 1 mol/l) of hydrochloric acid (HCl). The hard water shall be freshly prepared under aseptic conditions and used within 12 h. When preparing the product test solutions (5.4.2), the addition of the product to the hard water produces a different final water hardness in each test tube. In any case the final hardness expressed as calcium carbonate (CaCO3) is in the test tube lower than 375 mg/l. b) Hard water with the addition of polysorbate 80 Use the procedure described in 5.2.2.7 a). At the end add 1 ml of polysorbate 80 per litre. Sterilized by membrane filtration. The hard water with the addition of polysorbate 80 shall be freshly prepared under aseptic conditions and used within 12 h.
4) Disposable sterile equipment is an acceptable alternative to reusable glassware. SIST EN 16615:2015
+) °C for a minimum holding time of 30 min, at (17050
+) °C for a minimum holding time of 1 h or at (16050
+) °C for a minimum holding time of 2 h. 5.3.2.2
Water baths, capable of being controlled at 20° C ± 1 °C and at 45 °C ± 1 °C [to maintain melted TSA in case of pour plate technique and at additional test temperatures ± 1 °C (5.5.1)]. 5.3.2.3
Incubator, capable of being controlled at either 36 °C ± 1 °C or at 37 °C ± 1 °C (bacteria) or 30 °C ± 1 °C (yeasts). The same temperature shall be used for all incubations of the bacteria performed during a test and its controls and validation. 5.3.2.4
pH-meter, having an inaccuracy of calibration of no more than ± 0,1 pH units at 20 °C ± 1 °C. A puncture electrode or a flat membrane electrode should be used for measuring the pH of the agar-media (5.2.2.3). 5.3.2.5
Stopwatch. 5.3.2.6
Shakers a)
Electromechanical agitator, e.g. Vortex® mixer5). b)
Mechanical shaker. 5.3.2.7
Membrane filtration apparatus, constructed of a material compatible with the substances to be filtered, with a filter holder of at least 50 ml volume, and suitable for use of filters of diameter 47 mm to 50 mm and 0,45 µm pore size for sterilization of hard water (5.2.2.7) and bovine albumin (5.2.2.8.2 and 5.2.2.8.3). The vacuum source used shall give an even filtration flow rate. 5.3.2.8
Refrigerator, capable of being controlled at 2 °C to 8 °C. 5.3.2.9
Graduated pipettes of nominal capacities 10 ml and 1 ml and 0,1 ml. Calibrated automatic pipettes may be used. 5.3.2.10
Petri dishes (plates) of size 90 mm to 100 mm. 5.3.2.11
Glass beads (diameter: 3 mm to 4 mm). 5.3.2.12
Volumetric flasks. 5.3.2.13
Centrifuge (800 gN). 5.3.2.14
Rectangular glass spatula (4 cm edge length). 5.3.2.15
Loop (metal or plastic).
5) Vortex® in an example of a suitable product available commercially. This information is given for the convenience of users of this European Standard and does not constitute an endorsement by CEN of this product. SIST EN 16615:2015
Key Schematic representation of the test-surface a = 50 cm b = 20 cm
with four test areas T1 to T4 (5 cm x 5 cm) and a given range of wiper wipe. c = 5 cm d = 10 cm e = 5 cm
Size of the unitary weight: f = 8,6 cm g = 12,1 cm
Test field 1 is inoculated with 0,05 ml of the test organisms / interfering substance mixture (bacteria 1,5 to 5,0 × 109 cfu/ml, corresponding to a final number on test field 1 of 6,75 × 107 to 2,25 × 108 cfu; for Candida albicans 1,5 to 5,0 × 108 cfu/ml, corresponding to a final number on test field 1 of 6,75 × 106 to 2,25 × 107 cfu). The arrow shows the cleaning sweep with the wipe. The starting point is in front of test field 1 and the turn is immediately after test field 4. The end point of the wiping process is the starting point after passing test field 1 for the second time. Figure 1 — Scheme of the markings and the wipe sweep over four test fields on the test-surface 5.3.2.17
Tools for mechanical action, wipe of 17,5 cm x 28 cm, Composition: 55 % pulp, 45 % Polyethylenterephthalat (PET); (example: “Tork Premium Spezial Tücher”, art. nr. 90491, supplier: “SCA Tork”7) . Wipes are used only once. Other tools than described above are allowed to be used (see 5.9). The manufacturer is responsible to describe precisely how the wipes are to be used (e.g. the number of layers). 5.3.2.18
Unitary weight, granite block, 12,1 cm long, 8,6 cm wide and 8,6 cm high (the height may differ with other materials), weighing (2,3 to 2,5) kg. The use of the unitary weight standardizes the wiping procedure and simulates the average pressure when wiping is performed in practice.
6) This test-surface is an example of a suitable product available commercially. This information is given for the convenience of users of this European Standard and does not constitute an endorsement by CEN of this product. 7) This tool is an example of a suitable product available commercially. This information is given for the convenience of users of this European Standard and does not constitute an endorsement by CEN of this product. SIST EN 16615:2015
Swabs (sterile for single use only), the soakable part shall be made from pure cotton, free from substances which might inhibit or promote the action of the product test solution and from substances inhibiting the test organisms. 5.3.2.20
Parafilm (for single use only), to protect the lower horizontal surface and the vertical surfaces of the unitary weight from any contamination during the wiping procedure a parafilm covering these parts is used. This parafilm shall be replaced by a new one after each wiping procedure.(example: Parafilm®8) M (100 mm) Art.Nr. 7016 05, BRAND GMBH + CO KG, Postfach 11 55, 97861 Wertheim, Germany). 5.4 Preparation of test organism suspensions and product test solutions 5.4.1 Test organism suspensions 5.4.1.1 General For each test organism, two different suspensions shall be prepared: the “test suspension” to perform the test and the “validation suspension” to perform the controls and method validation. 5.4.1.2 Preservation and stock cultures of test organisms The test organism and its stock cultures shall be prepared and kept in accordance with EN 12353. 5.4.1.3 Working culture of test organisms In order to prepare the working culture of test organisms (5.2.1), prepare a subculture from the stock culture (5.4.1.2) by streaking onto TSA [5.2.2.3 a)] slopes or plates and incubate (5.3.2.3). After 18 h to 24 h prepare a second subculture from the first subculture in the same way and incubate for 18 h to 24 h. From this second subculture, a third subculture may be produced in the same way. The second and/or the third subculture are the working culture(s). If it is not possible to prepare the second subculture on a particular day, a 48 h subculture may be used for subsequent sub-culturing, provided that the subculture has been kept in the incubator (5.3.2.3) during the 48 h period. In the case of Candida albicans use MEA [5.2.2.3 b)] instead of TSA and incubate 42 h to 48 h instead of 18 h to 24h. The potential prolonged subculturing of 48 h for bacteria requires 72 h in the case of Candida albicans. Never produce and use a fourth subculture. 5.4.1.4 Test suspension (N) a) Take 10 ml of general diluent [(5.2.2.4 a)] and place in a 100 ml flask with 5 g of glass beads (5.3.2.11). Take the working culture (5.4.1.3) and transfer loopfuls (5.3.2.15) of the cells into the general diluent [(5.2.2.4 a)]. The cells should be suspended in the diluent by rubbing the loop against the wet wall of the flask to dislodge the cells before immersing in the diluent. Shake the flask for 3 min using a mechanical shaker [5.3.2.6 b)]. Aspirate the suspension from the glass beads and transfer to a tube. In the case of Pseudomonas aeruginosa use glycerol diluent [5.2.2.4 b)] instead of general diluent. b) Adjust the number of cells in the suspension to 1,5 x 109 cfu/ml9) to 5,0 x 109 cfu/ml (Candida albicans 1,5 x 108 cfu/ml to 5,0 x 108 cfu/ml) using the general diluent [(5.2.2.4 a)] estimating the numbers of units
8) Parafilm is an example of a suitable product available commercially. This information is given for the convenience of users of this European Standard and does not constitute an endorsement by CEN of this product. 9) cfu/ml = colony forming unit(s) per millilitre. SIST EN 16615:2015
(in °C): 1) the temperature to be tested is between 4 °C and 30 °C; the deviation for each selected test temperature is ± 2,5 °C. b) contact time t (in min): 1) The contact times to be tested are those recommended by the manufacturer but not longer than 60 min; the allowed deviation is ± 1 min, for contact times of shorter than 15 min ± 15 s. 2) The contact times for surface disinfectants are chosen on the basis of the practical conditions of the product. The recommended contact time for the use of the product is within the responsibility of the manufacturer. Products intended to disinfect surfaces that are likely to come into contact with the patient and / or the medical staff and surfaces, which are frequently touched by different people, leading to the transmission of microorganisms to the patient, shall be tested with a contact time of maximum 5 min. The same applies where the contact time of the product shall be limited for practical reasons. Products for other surfaces than stated above may be tested with a contact time of maximum 60 min. SIST EN 16615:2015
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