SIST EN 1650:2008/kFprA1:2012
(Amendment)Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas - Test method and requirements (phase 2, step 1)
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas - Test method and requirements (phase 2, step 1)
This document specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water or - in the case of ready-to-use-products - with water. Products can only be tested at a concentration of 80 % or less as some dilution is always produced by adding the test organisms and interfering substance. This document applies to products that are used in food, industrial, domestic and institutional areas excluding areas and situations where disinfection is medically indicated and excluding products used on living tissues except those for hand hygiene in the above considered areas. The following areas are at least included:a) processing, distribution and retailing of: 1) food of animal origin: milk and milk products; meat and meat products; fish, seafood, and related products; eggs and egg products; animal feeds; etc. 2) food of vegetable origin: beverages; fruits, vegetables and derivatives (including sugar, distillery ...); flour, milling and baking; animal feeds; etc.b) institutional and domestic areas: catering establishments; public areas; public transports; schools; nurseries; shops; sports rooms; waste containers (bins ...); hotels; dwellings; clinically non-sensitive areas of hospitals; offices; etc.c) other industrial areas: packaging material; biotechnology (yeast, proteins, enzymes, ...); pharmaceutical; cosmetics and toiletries; textiles; space industry, computer industry; etc. EN 14885 specifies in detail the relationship of the various tests to one another and to use recommendations NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used. NOTE 2 This method corresponds to a phase 2 step 1 test.
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur Bestimmung der fungiziden oder levuroziden Wirkung chemischer Desinfektionsmittel und Antiseptika in den Bereichen Lebensmittel, Industrie, Haushalt und öffentliche Einrichtungen - Prüfverfahren und Anforderungen (Phase 2, Stufe 1)
Antiseptiques et désinfectants chimiques - Essai quantitatif de suspension pour l'évaluation de l'activité fongicide ou levuricide des antiseptiques et des désinfectants chimiques utilisés dans le domaine de l'agro-alimentaire, dans l'industrie, dans les domaines domestiques et en collectivité - Méthode d'essai et prescriptions (phase 2, étape 1)
Kemična razkužila in antiseptiki - Kvantitativni suspenzijski preskus za vrednotenje fungicidnega delovanja ali delovanja kemičnih razkužil in antiseptikov na kvasovke v živilski in drugih industrijah, gospodinjstvu in javnih ustanovah - Preskusna metoda in zahteve (faza 2, stopnja 1) - Dopolnilo A1
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 1650:2008/kFprA1:2012
01-november-2012
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YUHGQRWHQMHIXQJLFLGQHJDGHORYDQMDDOLGHORYDQMDNHPLþQLKUD]NXåLOLQDQWLVHSWLNRY
QDNYDVRYNHYåLYLOVNLLQGUXJLKLQGXVWULMDKJRVSRGLQMVWYXLQMDYQLKXVWDQRYDK
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Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation
of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in food,
industrial, domestic and institutional areas - Test method and requirements (phase 2,
step 1)
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur
Bestimmung der fungiziden oder levuroziden Wirkung chemischer Desinfektionsmittel
und Antiseptika in den Bereichen Lebensmittel, Industrie, Haushalt und öffentliche
Einrichtungen - Prüfverfahren und Anforderungen (Phase 2, Stufe 1)
Antiseptiques et désinfectants chimiques - Essai quantitatif de suspension pour
l'évaluation de l'activité fongicide ou levuricide des antiseptiques et des désinfectants
chimiques utilisés dans le domaine de l'agro-alimentaire, dans l'industrie, dans les
domaines domestiques et en collectivité - Méthode d'essai et prescriptions (phase 2,
étape 1)
Ta slovenski standard je istoveten z: EN 1650:2008/FprA1
ICS:
71.100.35 Kemikalije za dezinfekcijo v Chemicals for industrial and
industriji in doma domestic disinfection
purposes
SIST EN 1650:2008/kFprA1:2012 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 1650:2008/kFprA1:2012
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SIST EN 1650:2008/kFprA1:2012
EUROPEAN STANDARD
FINAL DRAFT
EN 1650:2008
NORME EUROPÉENNE
EUROPÄISCHE NORM
FprA1
September 2012
ICS 71.100.35
English Version
Chemical disinfectants and antiseptics - Quantitative suspension
test for the evaluation of fungicidal or yeasticidal activity of
chemical disinfectants and antiseptics used in food, industrial,
domestic and institutional areas - Test method and requirements
(phase 2, step 1)
Antiseptiques et désinfectants chimiques - Essai quantitatif Chemische Desinfektionsmittel und Antiseptika -
de suspension pour l'évaluation de l'activité fongicide ou Quantitativer Suspensionsversuch zur Bestimmung der
levuricide des antiseptiques et des désinfectants chimiques fungiziden oder levuroziden Wirkung chemischer
utilisés dans le domaine de l'agro-alimentaire, dans Desinfektionsmittel und Antiseptika in den Bereichen
l'industrie, dans les domaines domestiques et en Lebensmittel, Industrie, Haushalt und öffentliche
collectivité - Méthode d'essai et prescriptions (phase 2, Einrichtungen - Prüfverfahren und Anforderungen (Phase 2,
étape 1) Stufe 1)
This draft amendment is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee
CEN/TC 216.
This draft amendment A1, if approved, will modify the European Standard EN 1650:2008. If this draft becomes an amendment, CEN
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment
into the relevant national standard without any alteration.
This draft amendment was established by CEN 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.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 1650:2008/FprA1:2012: E
worldwide for CEN national Members.
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SIST EN 1650:2008/kFprA1:2012
EN 1650:2008/FprA1:2012 (E)
Contents Page
Foreword .3
1 Modification to 5.2.2.3, Malt extract agar (MEA) .4
2 Modification to 5.3.2, Usual microbiological laboratory equipment and in particular, the
following: .4
3 Modification to 5.4.1.3.2, Aspergillus niger (mould) .5
4 Modification to 5.4.1.4.2, Aspergillus niger .6
5 Modification to 5.7, Verification of methodology .8
6 Modification to Annex D, Example of a typical test report .8
2
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SIST EN 1650:2008/kFprA1:2012
EN 1650:2008/FprA1:2012 (E)
Foreword
This document (EN 1650:2008/FprA1:2012) has been prepared by Technical Committee CEN/TC 216
“Chemical disinfectants and antiseptics”, the secretariat of which is held by AFNOR.
This document is currently submitted to the Unique Acceptance Procedure.
3
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SIST EN 1650:2008/kFprA1:2012
EN 1650:2008/FprA1:2012 (E)
1 Modification to 5.2.2.3, Malt extract agar (MEA)
Replace the whole sub-clause 5.2.2.3 with the following:
"Malt extract agar, consisting of:
Malt extract 30,0 g
Agar 15,0 g
Water (5.2.2.2) to 1 000,0 ml
The malt extract should be food grade (e.g. Cristomalt powder from Difal) or equivalent that is not highly
1)
purified and not only based on maltose (e.g. Malt extract from OXOID) . However if there are problems
producing at least 75 % spiny spores see 5.4.1.4.2.
Sterilize in the autoclave [5.3.2.1a)]. After sterilization, the pH of the medium shall be equivalent to 5,6 ± 0,2
when measured at (20 ± 1) °C.
NOTE In case of encountering problems with neutralization (5.5.1.2 and 5.5.1.3), it may be necessary to add
neutralizer to the MEA. Annex B gives guidance on the neutralizers that may be used."
2)
2 Modification to 5.3.2, Usual microbiological laboratory equipment and in
particular, the following:
Replace the whole sub-clause 5.3.2 with the following:
“
5.3.2.1 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 holding
0
+5 +5
time of 30 min, at (170 ) °C for a minimum holding time of 1 h or at (160 )°C for a minimum holding
0 0
time of 2 h.
5.3.2.2 Water baths, capable of being controlled at (20 ± 1) °C, at (45 ± 1) °C (to maintain melted MEA 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 (30 ± 1) °C.
5.3.2.4 pH-meter, having an inaccuracy of calibration of no more than ± 0,1 pH units at (20 ± 1) °C.
1)
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. Equivalent products may be used if they can be shown to lead to the same
results.
2)
Disposable sterile equipment is an acceptable alternative to reusable glassware.
4
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SIST EN 1650:2008/kFprA1:2012
EN 1650:2008/FprA1:2012 (E)
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 Shaker
® 3)
a) Electromechanical agitator, e.g. Vortex mixer .
b) Mechanical shaker
5.3.2.7 Membrane filtration apparatus constructed of a material compatible with the substances to be
fil
...
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