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CEN

EN 13727:2012/FprA1

(Amendment)

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1)

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1)

This European Standard specifies a test method and the minimum requirements for bactericidal 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 (97 % with a modified method for special cases) as some dilution is always produced by adding the test organisms and interfering substance. This European Standard applies to products that are used in the medical area in the fields of hygienic handrub, hygienic handwash, surgical handrub, surgical handwash, instrument disinfection by immersion, and surface disinfection by wiping, spraying, flooding or other means. This European Standard applies to areas and situations where disinfection or antisepsis 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 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. NOTE 3 This method cannot be used to evaluate the activity of products against Legionella in watersystems and against mycobacteria. EN 14885 specifies in detail the relationship of the various tests to one another and to 'use recommendations'.

Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur Bestimmung der bakteriziden Wirkung im humanmedizinischen Bereich - Prüfverfahren und Anforderungen (Phase 2, Stufe 1)

Antiseptiques et désinfectants chimiques - Essai quantitatif de suspension pour l'évaluation de l'activité bactéricide en médecine - Méthode d'essai et prescriptions (phase 2, étape 1)

Kemična razkužila in antiseptiki - Kvantitativni suspenzijski preskus za vrednotenje baktericidnega delovanja v medicini - Preskusna metoda in zahteve (faza 2, stopnja 1) - Dopolnilo A1

General Information

Status
Not Published
ICS
11.080.20 - Disinfectants and antiseptics
Technical Committee
CEN/TC 216 - Chemical disinfectants and antiseptics
Drafting Committee
CEN/TC 216/WG 1 - Human medicine
Current Stage
5060 - Closure of Vote - Formal Approval
Start Date
13-Sep-2013
Due Date
06-Nov-2014
Completion Date
13-Sep-2013
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/BC/CEN/89/6 - Standardization request to CEN concerning appliances burning gaseous fuels
M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
Ref Project
SIST EN 13727:2012/kFprA1:2013 - Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1)

Relations

Merged Into
EN 13727:2012+A1:2013 - Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1)
Effective Date
25-Sep-2013
Amends
EN 13727:2012 - Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1)
Effective Date
24-Apr-2013

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 13727:2012/kFprA1:2013
01-julij-2013
.HPLþQDUD]NXåLODLQDQWLVHSWLNL.YDQWLWDWLYQLVXVSHQ]LMVNLSUHVNXV]D
YUHGQRWHQMHEDNWHULFLGQHJDGHORYDQMDYPHGLFLQL3UHVNXVQDPHWRGDLQ]DKWHYH
ID]DVWRSQMD 'RSROQLOR$
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation
of bactericidal activity in the medical area - Test method and requirements (phase 2, step
1)
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur
Bestimmung der bakteriziden Wirkung im humanmedizinischen Bereich - Prüfverfahren
und Anforderungen (Phase 2, Stufe 1)
Antiseptiques et désinfectants chimiques - Essai quantitatif de suspension pour
l'évaluation de l'activité bactéricide en médecine - Méthode d'essai et prescriptions
(phase 2, étape 1)
Ta slovenski standard je istoveten z: EN 13727:2012/FprA1
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
SIST EN 13727:2012/kFprA1:2013 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 13727:2012/kFprA1:2013

---------------------- Page: 2 ----------------------

SIST EN 13727:2012/kFprA1:2013


EUROPEAN STANDARD
FINAL DRAFT
EN 13727:2012
NORME EUROPÉENNE

EUROPÄISCHE NORM
FprA1
June 2013
ICS Will supersede EN 13727:2012
English Version
Chemical disinfectants and antiseptics - Quantitative suspension
test for the evaluation of bactericidal activity in the medical area
- 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 bactéricide en Quantitativer Suspensionsversuch zur Bestimmung der
médecine - Méthode d'essai et prescriptions (phase 2, bakteriziden Wirkung im humanmedizinischen Bereich -
étape 1) Prüfverfahren und Anforderungen (Phase 2, 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 13727:2012. 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
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13727:2012/FprA1:2013: E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN 13727:2012/kFprA1:2013
EN 13727:2012/FprA1:2013 (E)
Contents
Page
Foreword . 3
1 Modification to Foreword . 4
2 Modification to 5.4.2 Product test solutions . 4
3 Modification to 5.5.4.1 General . 4
4 Modification to 5.6.1.2 V -values . 4
C
5 Modification to 5.6.2.2 Determination of V -values. 4
C
6 Modification to 5.6.2.3 Calculation of N and N .
...

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