SIST EN 12791:2005
(Main)Chemical disinfectants and antiseptics - Surgical hand disinfection - Test method and requirement (phase 2/step 2)
Chemical disinfectants and antiseptics - Surgical hand disinfection - Test method and requirement (phase 2/step 2)
This European Standard specifies a test method simulating practical conditions for establishing whether a product for surgical hand disinfection reduces the release of hand flora according to requirements described in clause 4 when used for the disinfection of the clean hands of volunteers.
Chemische Desinfektionsmittel und Antiseptika - Chirurgische Händedesinfektionsmittel - Prüfverfahren und Anforderungen (Phase 2/Stufe 2)
Diese Europäische Norm beschreibt ein Prüfverfahren, das praktische Bedingungen simuliert, um festzustellen, ob ein Produkt zur chirurgischen Händedesinfektion die Abgabe der mikrobiellen Flora der Hand entsprechend den Anforderungen nach Abschnitt 4 verringert, wenn es zur Desinfektion der sauberen Hände von freiwilligen Probanden verwendet wird.
Antiseptiques et désinfectants chimiques - Désinfectants chirurgicaux pour les mains - Méthodes d'essai et prescriptions (phase 2/étape 2)
La présente Norme européenne spécifie une méthode d'essai simulant des conditions pratiques afin d'établir si un produit destiné a la désinfection chirurgicale des mains réduit la flore des mains conformément aux prescriptions décrites a l'Article 4 lorsqu'il est utilisé pour désinfecter les mains propres de volontaires.
Kemična razkužila in antiseptiki – Razkužila za roke v kirurgiji – Preskusna metoda in zahteve (faza 2, stopnja 2)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 12791:2005
01-september-2005
.HPLþQDUD]NXåLODLQDQWLVHSWLNL±5D]NXåLOD]DURNHYNLUXUJLML±3UHVNXVQDPHWRGD
LQ]DKWHYH ID]DVWRSQMD
Chemical disinfectants and antiseptics - Surgical hand disinfection - Test method and
requirement (phase 2/step 2)
Chemische Desinfektionsmittel und Antiseptika - Chirurgische Händedesinfektionsmittel -
Prüfverfahren und Anforderungen (Phase 2/Stufe 2)
Antiseptiques et désinfectants chimiques - Désinfectants chirurgicaux pour les mains -
Méthodes d'essai et prescriptions (phase 2/étape 2)
Ta slovenski standard je istoveten z: EN 12791:2005
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
SIST EN 12791:2005 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 12791:2005
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SIST EN 12791:2005
EUROPEAN STANDARD
EN 12791
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2005
ICS 11.080.20
English Version
Chemical disinfectants and antiseptics - Surgical hand
disinfection - Test method and requirement (phase 2/step 2)
Antiseptiques et désinfectants chimiques - Désinfectants Chemische Desinfektionsmittel und Antiseptika -
chirurgicaux pour les mains - Méthodes d'essai et Chirurgische Händedesinfektionsmittel - Prüfverfahren und
prescriptions (phase 2/étape 2) Anforderungen (Phase 2/Stufe 2)
This European Standard was approved by CEN on 21 March 2005.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Central Secretariat or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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. EN 12791:2005: E
worldwide for CEN national Members.
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SIST EN 12791:2005
EN 12791:2005 (E)
Contents page
Foreword .4
1 Scope .5
2 Normative references .5
3 Terms and definitions.5
4 Requirements .6
5 Test methods.6
5.1 Principle.6
5.2 Experimental design.7
5.3 Volunteers .7
5.4 Media and reagents.7
5.4.1 General .7
5.4.2 Water.7
5.4.3 Tryptone soya agar (TSA).7
5.4.4 Tryptone soya broth (TSB).8
5.4.5 Neutralizer .8
5.4.6 Dilute soft soap, 200 g/1000 g .8
5.4.7 Propan-1-ol 60 % (volume concentration).9
5.5 Apparatus and glassware.9
5.5.1 General .9
5.5.2 Usual microbiological laboratory equipment.9
5.6 Procedure .9
5.6.1 Preparatory handwash .9
5.6.2 Prevalues.10
5.6.3 Surgical hand disinfection procedure .10
5.6.4 Postvalues.11
5.6.5 Incubation.11
5.7 Calculation.11
5.8 Test validation.12
5.9 Evaluation of P .12
5.10 Significance testing .13
5.11 Test report .13
Annex A (normative) Standard handwash/handrub procedure.14
Annex B (informative) Demonstration of antibacterial properties of surgical gloves.15
Annex C (informative) Examples of neutralizers.16
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EN 12791:2005 (E)
Annex D (informative) Preparation of a solution of propan-1-ol 60 % (volume concentration).17
Annex E (informative) Quality control of soft soap.18
Annex F (informative) Examples of reporting of results and significance testing .19
Annex G (informative) Information on the application and interpretation of the European
Standard on chemical disinfectants and antiseptics .27
G.1 Introduction.27
G.2 General guidelines for the application and interpretation of test methods in accordance
with European Standards for chemical disinfectants and antiseptics .27
G.3 Guide to interpretation of tests for chemical disinfectants and antiseptics .28
Bibliography.29
3
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SIST EN 12791:2005
EN 12791:2005 (E)
Foreword
This document (EN 12791:2005) has been prepared by Technical Committee CEN/TC 216 “Chemical
disinfectants and antiseptics”, the secretariat of which is held by AFNOR.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by January 2006, and conflicting national standards shall be withdrawn at
the latest by January 2006.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland
and United Kingdom.
4
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SIST EN 12791:2005
EN 12791:2005 (E)
1 Scope
This European Standard specifies a test method simulating practical conditions for establishing whether a
product for surgical hand disinfection reduces the release of hand flora according to requirements described in
clause 4 when used for the disinfection of the clean hands of volunteers.
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.
prEN 12054, Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of
bactericidal activity of products for hygienic and surgical handrub and handwash used in human medicine —
Test method and requirements (phase 2/step 1).
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
product
chemical agent or formulation used as a chemical disinfectant or antiseptic
3.2
surgical hand disinfection
preoperative treatment procedure that involves applying a bactericidal product directed against the bacterial
flora of hands to prevent the risk of transmission of bacteria into the surgical wound
NOTE This procedure may consist of a handrub alone or a handwash alone or a combination of both.
This treatment can be performed with products claiming or not claiming to have a sustained effect (see 3.5)
3.3
immediate effect
reduction of the release of skin flora from the hands as assessed immediately after surgical hand disinfection
3.4
3-hour effect
reduction of the release of skin flora from the hands as assessed after wearing surgical gloves for 3 h
following disinfection
3.5
sustained effect
3-hour effect of the product significantly larger than that of a reference disinfection procedure with propan-1-ol
60 % (volume concentration) (see 5.6.3.2)
3.6
prevalue (immediate)
number of colony-forming units (cfu) sampled immediately before treatment from the hand from which the
immediate effect has to be assessed
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3.7
prevalue (3-hour)
number of colony-forming units (cfu) sampled immediately before treatment from the hand from which the
sustained effect has to be assessed
3.8
postvalue (immediate)
number of colony-forming units (cfu) sampled immediately after treatment from the hand sampled for the
prevalue (immediate)
3.9
postvalue (3-hour)
number of colony-forming units (cfu) sampled 3 h after treatment from the hand sampled for the prevalue
(sustained)
3.10
reduction factor (RF) (immediate)
ratio of prevalue (immediate) and postvalue (immediate), generally expressed by decimal logarithms:
lg RF(immediate) = lg prevalue (immediate) − lg postvalue (immediate)
3.11
reduction factor (3-hour)
ratio of prevalue (3-hour) and postvalue (3-hour), generally expressed by decimal logarithms:
lg RF (3-hour) = lg prevalue (3-hour) − lg postvalue (3-hour)
3.12
surgical glove
sterile, un-powdered medical latex glove free of antimicrobial activity, as demonstrated by agar diffusion test
on Mueller-Hinton agar (see Annex B) intended for use in invasive surgery
4 Requirements
When tested and evaluated in accordance with clause 5, the mean reduction factors for immediate (see 3.10)
and 3 hours (3.11) effects shall not be significantly smaller than the respective ones obtained with propan-1-ol
60 % (volume concentration).
If the explicit claim for a sustained effect exists, the mean reduction factor for the 3-hour effect shall,
additionally, be significantly larger than that obtained with propan-1-ol 60 % (volume concentration).
5 Test methods
5.1 Principle
A preparatory handwash (see 5.6.1) is carried-out in order to remove transient flora and foreign material, that
would otherwise influence the presample counts. Hand samples, for bacterial counts, are then taken:
immediately after the prewash (before treatment);
immediately after the disinfection procedure;
3 h after the disinfection procedure.
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EN 12791:2005 (E)
The ratio of the resulting values before and after treatment is called the reduction factor. It represents a
measure for the antimicrobial activity of the disinfection product tested. The immediate effect is characterized
by the reduction factor (immediate), which is the ratio of the two values (prevalue and postvalue) assessed on
the hand from which the postvalue (immediate) is derived. The 3-hour effect is characterized by the reduction
factor (3-hour), which is the ratio of prevalue and postvalue (3-hour) of the other hand. To compensate for
extraneous influences, these reduction factors are compared individually with the corresponding reduction
factors of a reference surgical hand disinfection procedure (R) performed in parallel with the same subjects.
5.2 Experimental design
For testing a single product, a crossover design is used. The volunteers are randomly divided into two groups
of the same size. In a first run, volunteers of group 1 use the reference procedure, those of group 2 the
procedure with the test product. After at least one week, allowing reconstitution of the normal skin flora, the
test is repeated with changed roles in a second run.
For testing more than one product at a time, a Latin-square design is used with as many groups of volunteers
and as many experimental runs as there are disinfection products (including the reference propan-1-ol). In
each run all disinfection procedures are employed in parallel. At least one week is required between the
individual experimental runs, allowing reconstitution of the normal skin flora. At the end of the whole series
every subject shall have used each disinfection product, including propan-1-ol, once.
NOTE In a Latin-square design, only products can be simultaneously tested for which either no neutralisation is
necessary or for which the same neutraliser can be used for the assessment of postvalues.
5.3 Volunteers
The test shall be performed on 20 healthy persons who have hands with healthy skin, without cuts or
abrasions, and with short and clean fingernails. Starting from one week prior to the test, they should not use
substances with antimicrobial action (e.g. medicated soaps, medicated hand creams). Although, in general,
age is not a limiting factor, volunteers should be at least 18 years of age.
5.4 Media and reagents
5.4.1 General
The reagents shall be of analytical grade and/or appropriate for microbiological purposes.
NOTE To improve reproducibility, it is recommended that commercially available dehydrated material be used for the
preparation of culture media. The manufacturer's instructions relating to the preparation of these products should be
rigorously followed.
5.4.2 Water
The water shall be free from substances that are toxic or inhibiting to the bacteria. It shall be freshly glass
distilled and not demineralized water.
Sterilize in the autoclave ( 5.5.2.1).
NOTE 1 Sterilization is not necessary if the water is used – e.g. for the preparation of culture media – and
subsequently sterilized.
NOTE 2 If distilled water of adequate quality is not available, water for injectable preparations (see [1]) can be used.
5.4.3 Tryptone soya agar (TSA)
For quantitative surface cultures.
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EN 12791:2005 (E)
Tryptone, pancreatic digest of casein 15,0 g
Soya peptone, papaic digest of Soybean meal 5,0 g
NaCl 5,0 g
Agar 15,0 g
Water (5.4.2) to 1000,0 ml
Sterilize in the autoclave (5.5.2.1). After sterilization the pH of the medium shall be equivalent to 7,2 ± 0,2
when measured at 20 °C ± 1 °C.
5.4.4 Tryptone soya broth (TSB)
Serves as a sampling fluid and diluent.
Tryptone, pancreatic digest of casein 15,0 g
Soya peptone, papaic digest of Soybean meal 5,0 g
NaCl 5,0 g
Water (5.4.2) to 1000,0 ml
Sterilize in the autoclave (5.5.2.1). After sterilization the pH of the medium shall be equivalent to 7,2 ± 0,2
when measured at 20 °C ± 1 °C.
5.4.5 Neutralizer
A neutralizer validated according to prEN 12054 shall be incorporated in the sampling fluids and diluents (TSB,
5.4.4) for the assessment of postvalues in both test and reference procedure, but neither in those for the
prevalues nor in the counting plates.
NOTE A list of neutralizers which may be used is given in Annex C.
5.4.6 Dilute soft soap, 200 g/1000 g
1)
Linseed oil [2] 50 parts
Potassium hydroxide [3] 9,5 parts
Ethanol 96 % (volume concentration) [3] 7parts
Distilled water (see 5.4.2) as needed
Add linseed oil to a solution of potassium hydroxide in 15 parts distilled water and heat up to approximately
70 °C while constantly stirring. Add the ethanol and continue heating while stirring until the saponification
process is completed and a sample dissolves clearly in water and almost clearly in ethanol 96 %. The weight
of the soft soap is then brought up to 100 parts by addition of hot distilled water. Take 200 g of the soft soap,
fill up to 1 000 g with distilled water and sterilize in the autoclave (see 5.5.2.1). The pH of the final dilute soft
soap shall range between 10,0 and 11,0.
For quality control see Annex E.
A.1.1
1) By weight.
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EN 12791:2005 (E)
5.4.7 Propan-1-ol 60 % (volume concentration)
See [1] and for preparation see Annex D.
5.5 Apparatus and glassware
5.5.1 General
Sterilize all glassware and parts of the apparatus that will come into contact with the culture media and
reagents or the sample, except those that are supplied sterile, by one of the following methods:
a) in the autoclave (5.5.2.1);
b) in the dry heat sterilizer (5.5.2.1).
2)
5.5.2 Usual microbiological laboratory equipment
and, in particular, the following:
5.5.2.1 Apparatus for sterilization
+3
a) For moist heat sterilization an autoclave capable of being maintained at (121 ) °C for a minimum
0
holding time of 15 min;
+5
b) For dry heat sterilization a hot air oven capable of being maintained at (180 ) °C for a minimum
0
+5 +5
holding time of 30 min, at (170 ) °C for a minimum holding time of 1 h or at (160 ) °C for a minimum
0 0
holding time of 2 h.
5.5.2.2 Incubator, capable of being controlled at 37 °C ± 1 °C.
5.5.2.3 pH-meter, having a precision of 0,1 pH units at 25 °C.
5.5.2.4 Stopwatch
5.5.2.5 Graduated pipettes of nominal capacities 10 ml, 1 ml and 0,1 ml. Calibrated automatic pipettes
may be used.
5.5.2.6 Petri dishes, having a diameter of 90 mm.
5.5.2.7 Glass spreaders
5.5.2.8 Water bath, adjustable to 20 °C ± 1 °C.
5.6 Procedure
5.6.1 Preparatory handwash
Hands are prepared by washing without use of a brush for 1 min with 10 ml soft soap (5.4.6). After being
rinsed with running tap water, they are thoroughly dried with paper towels.
A.1.1
2) Disposable equipment is an acceptable alternative to reusable equipment.
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EN 12791:2005 (E)
5.6.2 Prevalues
Immediately after drying, rub the fingertips (including that of the thumb) for 1 min on the base of a Petri dish
(5.5.2.6) containing 10 ml of TSB (5.4.4) without neutralizer in order to assess the release of skin bacteria
before treatment of hands (prevalues). A separate dish is used for each hand.
-1 -2
Dilutions of 10 and 10 of these sampling fluids are prepared in TSB (5.4.4). For each dilution, 0,1 ml is
spread over the surface of a TSA plate (see 5.4.3) using glass spreaders. The interval between sampling and
plating shall not exceed 30 min.
5.6.3 Surgical hand disinfection procedure
5.6.3.1 General
Immediately after sampling for the prevalues, the fingertips are rubbed against each other until dry.
Subsequently, either the reference disinfection procedure, R, or (one of) the procedure(s) under test, P (1 to
n), is (are) performed.
5.6.3.2 Reference surgical hand disinfection procedure (R)
Pour 3 ml of propan-1-ol 60 % (5.4.7) into the cupped dry hands and rub vigorously onto the skin up to the
wrists in accordance with the standard handrub procedure shown in Annex A (Figure A.1) to ensure total
coverage of the hands. This comprises five strokes backwards and forwards, palm to palm, right over left
dorsum, left palm over right dorsum, palm to palm with fingers interlaced, back of fingers to opposing palms
with fingers interlocked, rotational rubbing of right thumb clasped in left palm and left thumb clasped in right
palm, rotational rubbing with clasped fingers of right hand in palm of left hand and clasped fingers of left hand
in palm of right hand. When nearly dry, additional aliquots of 3 ml of propan-1-ol are applied as it evaporates.
As many applications of the alcohol are necessary as are needed to keep the hands wet for 3 min, the total
application time of R.
The volume of the alcohol used per person shall be recorded.
5.6.3.3 Surgical hand disinfection procedure with product under test (P)
This procedure shall be performed according to information provided by the manufacturer. For products
involving rubbing hands this shall include: volume of product, total time of application and frequency of
application. The latter requirement may also include the instructions to keep hands wet with the product for a
given time. For details of the rubbing procedure see 5.6.3.2 and Annex A.
For products involving washing hands this information shall include: the need for pre-wetting of hands,
volume of product, total time and frequency of its application and any special instructions on the use of water.
In addition to this information hands are washed according to a standard handwash procedure (see Annex A).
This comprises five strokes backwards and forwards, palm to palm, right over left dorsum, left palm over right
dorsum, palm to palm with fingers interlaced, back of fingers to opposing palms with fingers interlocked,
rotational rubbing of right thumb clasped in left palm and left thumb clasped in right palm, rotational rubbing
with clasped fingers of right hand in palm of left hand and clasped fingers of left hand in palm of right hand.
The hands and wrists are washed in this way until the end of the appropriate time period.
The maximum allowable application time for any procedure for surgical hand disinfection is 5 min.
If P includes the use of a disinfectant-detergent this shall be rinsed off under running tap water for 15 s after
the end of the required application time.
If the manufacturer's instructions require the wearing of gloves on hands still covered with the remainder of
the disinfectant (-detergent), only the hand allotted for assessment of the postvalue (immediate) is rinsed.
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EN 12791:2005 (E)
5.6.4 Postvalues
5.6.4.1 Postvalue (immediate)
After treatment and drying, a similar sampling procedure is used on one hand as described for the prevalues
-1
(5.6.2) but volumes of 1,0 ml and 0,1 ml of undiluted sampling fluid and 0,1 ml from its 10 dilution are plated
out for quantitative culture. If a neutralizer is necessary it shall be contained in the sampling and the dilution
fluids for both the test and the reference surgical hand disinfection procedure.
Meanwhile the other hand is dried in the air (for alcohol-based products) or by using a sterile towel (for
detergent-based products) taking care to avoid contamination of it.
5.6.4.2 Postvalue (3-hour)
After treatment and drying, the other hand is protected from extraneous contamination by wearing a surgical
glove (3.12) for 3 h. Then, the glove is removed and a similar sampling procedure is used on this hand as
described for the postvalue (immediate) (5.6.4.1).
5.6.5 Incubation
All plates are incubated aerobically at 37 °C ± 1 °C for 18 h to 24 h; then, the colonies are counted and the
plates re-incubated for a further 24 h in order to detect any slow-growing colonies.
5.7 Calculation
Record the number of colony forming units (cfu) per plate for each dilution step. Calculate the dilution factor by
multiplying the sample dilution and the sample volume (ml). Calculate the number of cfu per ml of sampling
fluid by multiplying the plate count (cfu) by the dilution factor.
NOTE 1 Whenever possible, the counts should be obtained from plates showing 15 to 300 colonies. With very efficient
handrubs some counting plates for postvalues may show fewer than 15 colonies or no growth at all even if inoculated with
1 ml of undiluted sampling fluid (TSB, 5.4.4). These values can then be accepted.
If suitable counts are obtained from two adjacent dilution steps, calculate the number of cfu per ml undiluted
sampling fluid as the weighted arithmetic mean from these counts using the following equation:
C
∑
N = (1)
v × d + v × d
1 1 2 2
Where
N is the weighted mean cfu per ml undiluted sampling fluid;
ΣC is the sum of the colonies counted on plates retained for calculation;
v is the volume of inoculum on the plate retained at the first dilution in ml;
1
v is the volume of inoculum on the plate retained at the second dilution in ml;
2
d is the dilution factor corresponding to the first dilution of sampling fluid retained;
1
d is the dilution factor corresponding to the second dilution of sampling fluid retained;
2
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EN 12791:2005 (E)
EXAMPLE
()299 + 31 330
N = = = 3000 cfu/ml
0 −1
0,11
0,1×10 + 0,1×10
NOTE 2 If colony counts of different dilution steps are grossly disproportional, insufficient neutralization of the
antimicrobial agent should be suspected.
All viable counts per ml sampling fluid are transformed to decimal logarithms. For computational reasons
values of "0" (lg 0 = -∞) shall be set at "1" (lg 1 = 0).
NOTE 3 Since 0-values should be found only among postvalues and should occur only with the most active products,
this adjustment can, at worst, introduce a conservative bias of underestimating the antimicrobial efficiency of a product.
From the difference of lg prevalue minus the lg postvalue (immediate) or (3-hours) derived from the same
hand, a lg reduction factor (immediate) or (3-hour) is established for each volunteer.
Then, the arithmetic means of all individual lg reduction factors are calculated separately for immediate and
3-hours effects of both R and P.
If the data meet all requirements of the test validation (see 5.8) mean reduction factors of both procedures, P
and R, may be compared with each other for separate evaluation of the immediate and 3-hour effects of the
test procedure.
5.8 Test validation
The results of a test shall be accepted for further evaluation if they conform to the following criteria, otherwise
the test shall be repeated.
Requirements for acceptance of test results are:
All results from at least 18 volunteers shall be available;
All means of the lg prevalues (i.e. for immediate and 3-hour effects of both the reference and the test
procedure) shall be at least 3,5.
5.9 Evaluation of P
If the quality of the data has been found to be acceptable (see 5.8) they shall be u
...
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