EN 13727:2012/FprA1

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
• 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/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

Overview

EN 13727:2012/FprA1 is a European Standard developed by CEN that specifies a quantitative suspension test method for evaluating the bactericidal activity of chemical disinfectants and antiseptics used in medical settings. This test focuses on products that form homogeneous, physically stable preparations when diluted with hard water or water, and applies to both concentrated and ready-to-use formulations. Designed as a phase 2, step 1 test, it sets mandatory minimum bactericidal performance requirements under defined testing conditions mimicking practical applications in healthcare environments.

The standard is crucial for ensuring that disinfectants used for hand hygiene, instrument disinfection, and surface decontamination meet strict efficacy thresholds to prevent infections in patient care areas such as hospitals, dental clinics, nursing homes, and community medical facilities. It excludes tests against Legionella and mycobacteria, which require different protocols.

Key Topics

• Scope and Application
  The test method targets disinfectants and antiseptics utilized in:

  • Hygienic handrubs and handwashes
  • Surgical handrubs and handwashes
  • Instrument disinfection by immersion
  • Surface disinfection via wiping, spraying, or flooding

• Product Testing Constraints

  • Products tested at ≤80% concentration (up to 97% for ready-to-use products with modified methods)
  • Dilution occurs upon addition of test organisms and interfering substances
  • Emphasizes validated neutralization procedures with a neutralization time shortened to 10 seconds for fast-acting products (≤10 minutes contact time)

• Quantitative Suspension Test Method

  • Utilizes hard water for dilution to simulate realistic conditions
  • Applies dilution-neutralization techniques to calculate surviving bacterial counts
  • Includes specific adjustments for handrub and handwash products (e.g., volume variations in plate counts)

• Performance Criteria

  • Requires ≥5 log reduction in bacterial count under dirty conditions within defined contact times for hygienic and surgical hand disinfection
  • Specifies validation of active and non-active test solutions for accuracy and reproducibility

• Regulatory Compliance

  • Aligns with CEN/CENELEC internal regulations binding national standard organizations across multiple European countries
  • Harmonizes testing approaches under EN 14885 guidelines for disinfectant and antiseptic efficacy testing

Applications

EN 13727:2012/FprA1 is essential for product manufacturers, regulatory bodies, and healthcare institutions aiming to:

• Certify Disinfectant Efficacy: Manufacturers demonstrate compliance with bactericidal activity requirements to support product registration and market access.
• Ensure Patient Safety: Hospitals and medical facilities implement tested disinfectants to reduce healthcare-associated infections (HAIs).
• Guide Infection Control Protocols: Enables infection prevention teams to select effective antiseptic products for hand hygiene and instrument sterilization.
• Quality Control Testing: Laboratories perform suspension tests during product development and batch verification to maintain consistent antimicrobial performance.
• Standardize Testing Procedures: Facilitates uniform testing methodologies within Europe, supporting mutual recognition and regulatory enforcement.

Related Standards

• EN 14885 – Chemical disinfectants and antiseptics - Application of European Standards for hygiene products
  Provides comprehensive guidance on applying various test methods (including EN 13727) and relating efficacy data to practical use recommendations.

• EN 1500 – Hygienic handrub - Test method and requirements for evaluating bactericidal activity
  Complements EN 13727 by focusing on handrub efficacy through in vivo testing under practical conditions.

• Other phase 2 step 2 and in-use tests addressing different microorganism groups or product applications.

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Keywords: EN 13727, bactericidal activity, chemical disinfectants, antiseptics, quantitative suspension test, medical disinfection, hand hygiene, instrument disinfection, surface disinfection, CEN standards, healthcare-associated infection prevention, product efficacy testing, phase 2 step 1 test.

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2013
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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 .
...