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.

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 kemičnih razkužil in antiseptikov v humani medicini - Preskusna metoda in zahteve (faza 2, stopnja 1)

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
02-Jul-2015
Due Date
11-Jun-2016
Completion Date
02-Jul-2015
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
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+A1:2014/kFprA2:2015 - 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+A2:2015 - 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
18-Jan-2023
Amends
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
10-Dec-2014

Overview

EN 13727:2012+A1:2013/FprA2:2015 is a European Standard developed by CEN for evaluating the bactericidal activity of chemical disinfectants and antiseptics in medical settings. This standard outlines a quantitative suspension test method (phase 2, step 1) focused on precise measurement of bactericidal efficacy. It applies to products that form a homogeneous, physically stable preparation when diluted with hard water or used ready-to-use with water.

The standard supports critical healthcare practices by ensuring disinfectant and antiseptic products meet minimum bactericidal activity requirements. It helps safeguard patient care by providing standardized testing protocols universally accepted across Europe.

Key Topics

  • Test Methodology
    The standard specifies the procedures for quantitative suspension tests, including sample preparation, dilution steps, neutralization, incubation, and bacterial enumeration methods such as pour plate, spread plate, and membrane filtration techniques.

  • Product Scope
    Applicable to a variety of chemical disinfectants and antiseptics, including hygienic handrub, hygienic handwash, surgical handrub, surgical handwash, instrument disinfection by immersion, and surface disinfection through wiping, spraying, or flooding.

  • Test Organisms and Validation
    Includes detailed instructions for handling test organisms and validation suspensions, ensuring reliable and reproducible results. The standard defines dilution factors and neutralizing substances critical for accurate activity assessment.

  • Performance Requirements
    Products must demonstrate at least a 5 log reduction (lg R ≥ 5) of bacteria in the tested conditions, with a 3 log reduction (lg R ≥ 3) accepted for hygienic handwash products. These thresholds indicate the minimum bactericidal efficacy.

  • Reproducibility and Reporting
    Testing requires repetition with separately prepared test batches to confirm consistency. Results must be averaged before logarithmation and recorded for compliance verification.

Applications

EN 13727 is essential for manufacturers, regulatory bodies, and healthcare providers to:

  • Validate Disinfectants and Antiseptics
    Ensure products used for hand hygiene, surgical preparation, instrument decontamination, and surface disinfection meet stringent bactericidal activity standards suitable for medical areas.

  • Support Infection Control Programs
    Assist hospitals, clinics, dental offices, nursing homes, schools, and other healthcare-related environments in selecting effective disinfectants to reduce infection risks.

  • Regulatory Compliance
    Provide documentation and certified testing methods aligned with EU Directive 93/42/EEC requirements for medical devices and related products.

  • Product Development and Quality Assurance
    Facilitate product formulation improvements and quality control by enabling accurate, standardized testing of bactericidal efficacy during R&D and production phases.

Related Standards

EN 13727:2012+A1:2013/FprA2:2015 complements and interacts with other standards in the chemical disinfectant and antiseptic sectors, including:

  • EN 1500 – Hygienic handrub: Test method and requirements for hand disinfection.
  • EN 14476 – Quantitative suspension test for virucidal activity evaluation.
  • EN 14561 – Quantitative suspension test for bactericidal activity with regard to instrument disinfection.
  • ISO 15883 – Washer-disinfectors standards for medical equipment cleaning and disinfection.

These standards collectively form a harmonized framework ensuring reliable assessment and regulatory compliance of disinfectant and antiseptic products across healthcare environments.

Keywords: EN 13727, bactericidal activity, chemical disinfectants, antiseptics, quantitative suspension test, medical area disinfection, hygienic handrub, surgical handwash, instrument disinfection, surface disinfection, European Standard, CEN, EU Directive compliance.

EN 13727:2012+A1:2014/kFprA2:2015 - Page 3 previewEN 13727:2012+A1:2014/kFprA2:2015 - Page 1 previewEN 13727:2012+A1:2014/kFprA2:2015 - Page 2 previewEN 13727:2012+A1:2014/kFprA2:2015 - Page 4 preview
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EN 13727:2012+A1:2014/kFprA2:2015

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Frequently Asked Questions

EN 13727:2012+A1:2013/FprA2:2015 is a draft published by the European Committee for Standardization (CEN). Its full title is "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 standard covers: 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.

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.

EN 13727:2012+A1:2013/FprA2:2015 is classified under the following ICS (International Classification for Standards) categories: 11.080.20 - Disinfectants and antiseptics. The ICS classification helps identify the subject area and facilitates finding related standards.

EN 13727:2012+A1:2013/FprA2:2015 has the following relationships with other standards: It is inter standard links to EN 13727:2012+A2:2015, EN 13727:2012+A1:2013. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN 13727:2012+A1:2013/FprA2:2015 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/BC/CEN/89/9. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.

You can purchase EN 13727:2012+A1:2013/FprA2:2015 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.

Standards Content (Sample)


SLOVENSKI STANDARD
01-junij-2015
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YUHGQRWHQMHEDNWHULFLGQHJDGHORYDQMDNHPLþQLKUD]NXåLOLQDQWLVHSWLNRYYKXPDQL
PHGLFLQL3UHVNXVQDPHWRGDLQ]DKWHYH ID]DVWRSQMD
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+A1:2013/FprA2:2015
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
SIST EN en,fr,de
13727:2012+A1:2014/kFprA2:2015
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
FINAL DRAFT
EN 13727:2012+A1:2013
NORME EUROPÉENNE
EUROPÄISCHE NORM
FprA2
April 2015
ICS 11.080.20
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 A2, if approved, will modify the European Standard EN 13727:2012+A1:2013. 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

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN
worldwide for CEN national Members. 13727:2012+A1:2013/FprA2:2015:2015 E

Contents
Page
Foreword .3
1 Modification to 5.5.2.2 d) .4
2 Modification to 5.5.2.4 a), NOTE .4
3 Modification to 5.5.3.2 .4
4 Modification to 5.6.2.2 b) .4
5 Modifications to 5.6.2.4 a) and Examples a1 and a2 .4
6 Modifications to 5.6.2.4 b), NOTE and Example b1 .5
7 Modification to 5.6.2.4 b), Example b2 .5
8 Modification to 5.8.3 .6
9 Modifications to 5.8.4 .6

Foreword
This document (EN 13727:2012+A1:2013/FprA2:2015) has been prepared by Technical Committee
CEN/TC 216 “Chemical disinfectants and antiseptics”, the secretariat of which is held
...

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