Chemical disinfectants and antiseptics - Virucidal quantitative suspension test for chemical disinfectants and antiseptics used in human medicine - Test method and requirements (phase 2, step 1)

This document specifies a test method and the minimum requirements for virucidal activity of chemical disinfectants or antiseptic products for instruments, surfaces or hands that form a homogeneous physically stable preparation when diluted with hard water or in the case of ready-to-use products with water.
This document is applicable to a broad spectrum of viruses (Annex B) and to areas and situations where disinfection 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.
It is impossible to determine the virucidal activity of the undiluted product as some dilution is always produced by adding the inoculum and interfering substance.
However, a disinfectant or antiseptic which is used in undiluted form is tested in 80% concentration and shall pass this test prior to further assessment.
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 (see Annex F).

Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch Viruzidie für in der Humanmedizin verwendete chemische Desinfektionsmittel und Antiseptika - Prüfverfahren und Anforderungen (Phase 2, Stufe 1)

Antiseptiques et désinfectants chimiques - Essai virucide quantitatif de suspension pour les antiseptiques et désinfectants chimiques utilisés en médecine humaine - Méthode d'essai et prescriptions (phase 2, étape 1)

Kemična razkužila in antiseptiki - Kvantitativni suspenzijski preskus virucidnosti kemičnih razkužil in antiseptikov, ki se uporabljajo v humani medicini - Preskusna metoda in zahteve (faza 2, stopnja 1) - Dopolnilo A1

General Information

Status
Not Published
Current Stage
5060 - Closure of Vote - Formal Approval
Start Date
25-Aug-2006
Due Date
15-Oct-2007
Completion Date
25-Aug-2006

Relations

Effective Date
19-Jan-2023
Effective Date
22-Dec-2008

Overview

EN 14476:2005/prA1 is a European standard developed by CEN that specifies a quantitative suspension test method for evaluating the virucidal activity of chemical disinfectants and antiseptics used in human medicine. This standard focuses on products intended for disinfecting instruments, surfaces, or hands, verifying their effectiveness against a broad spectrum of viruses under defined test conditions. It is recognized as a Phase 2, Step 1 test method, targeting preparations that are physically stable and homogeneous when diluted or ready-to-use.

The standard addresses the need for reliable virucidal efficacy testing, ensuring chemical disinfectants and antiseptics meet minimum requirements for virus inactivation. The document guides manufacturers, healthcare providers, and regulatory bodies in evaluating the safety and effectiveness of disinfectant products used in medical and related environments.

Key Topics

  • Virucidal quantitative suspension test: Detailed procedures to measure virus inactivation by chemical disinfectants in suspension.
  • Scope of application: Products used on instruments, surfaces, and hands that form stable solutions with hard water or water as a diluent.
  • Broad virus spectrum: Covers a wide range of viruses relevant to healthcare settings, listed in Annex B.
  • Test conditions: Products used undiluted are tested at 80% concentration to simulate real-life application.
  • Minimum requirements: Defines the threshold for acceptable virucidal activity to be met before product approval.
  • Phase 2, Step 1 testing: A standardized step in efficacy validation focusing on product performance under controlled laboratory conditions.

Practical Applications

EN 14476:2005/prA1 is critical for ensuring infection control in multiple medical and community settings:

  • Hospitals and clinics: Ensures disinfectants effectively inactivate viruses to prevent nosocomial infections.
  • Dental and medical offices: Validates antiseptics used on instruments and hands in dental and outpatient procedures.
  • Schools and nursing homes: Supports safe disinfection practices in environments with vulnerable populations.
  • Workplace hygiene: Facilitates approval of disinfectants used in employee welfare settings.
  • Home care and laundries: Assists assessment of disinfectants in domestic and healthcare laundry or kitchen services.

The standard provides a scientifically robust framework to confirm that products will perform reliably during actual use, contributing to infection prevention and control strategies worldwide.

Related Standards

For comprehensive chemical disinfectant evaluation, EN 14476:2005/prA1 is often complemented with:

  • EN 1276 – Chemical disinfectants and antiseptics – Quantitative suspension test for bactericidal activity.
  • EN 13727 – Quantitative suspension test for bactericidal activity in medical area products.
  • EN 1500 – Hygienic handrub test method for antiseptics.
  • EN 17111 – Test method simulating practical conditions for virucidal activity on surfaces.
  • ISO standards on antiseptics and disinfectants – Guiding product safety and efficacy beyond European markets.

Using EN 14476 in conjunction with other relevant standards supports a thorough and harmonized validation process tailored to medical hygiene requirements.


Keywords: EN 14476, chemical disinfectants, antiseptics, virucidal test, suspension test, human medicine, infection control, disinfectant standards, virus inactivation, CEN, phase 2 step 1 test, healthcare hygiene standards.

Draft

EN 14476:2005/oprA1:2006

English language
3 pages
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Frequently Asked Questions

EN 14476:2005/prA1 is a draft published by the European Committee for Standardization (CEN). Its full title is "Chemical disinfectants and antiseptics - Virucidal quantitative suspension test for chemical disinfectants and antiseptics used in human medicine - Test method and requirements (phase 2, step 1)". This standard covers: This document specifies a test method and the minimum requirements for virucidal activity of chemical disinfectants or antiseptic products for instruments, surfaces or hands that form a homogeneous physically stable preparation when diluted with hard water or in the case of ready-to-use products with water. This document is applicable to a broad spectrum of viruses (Annex B) and to areas and situations where disinfection 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. It is impossible to determine the virucidal activity of the undiluted product as some dilution is always produced by adding the inoculum and interfering substance. However, a disinfectant or antiseptic which is used in undiluted form is tested in 80% concentration and shall pass this test prior to further assessment. 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 (see Annex F).

This document specifies a test method and the minimum requirements for virucidal activity of chemical disinfectants or antiseptic products for instruments, surfaces or hands that form a homogeneous physically stable preparation when diluted with hard water or in the case of ready-to-use products with water. This document is applicable to a broad spectrum of viruses (Annex B) and to areas and situations where disinfection 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. It is impossible to determine the virucidal activity of the undiluted product as some dilution is always produced by adding the inoculum and interfering substance. However, a disinfectant or antiseptic which is used in undiluted form is tested in 80% concentration and shall pass this test prior to further assessment. 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 (see Annex F).

EN 14476:2005/prA1 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 14476:2005/prA1 has the following relationships with other standards: It is inter standard links to EN 14476:2005+A1:2006, EN 14476:2005. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

You can purchase EN 14476:2005/prA1 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-julij-2006
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Chemical disinfectants and antiseptics - Virucidal quantitative suspension test for
chemical disinfectants and antiseptics used in human medicine - Test method and
requirements (phase 2, step 1)
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch
Viruzidie für in der Humanmedizin verwendete chemische Desinfektionsmittel und
Antiseptika - Prüfverfahren und Anforderungen (Phase 2, Stufe 1)
Antiseptiques et désinfectants chimiques - Essai virucide quantitatif de suspension pour
les antiseptiques et désinfectants chimiques utilisés en médecine humaine - Méthode
d'essai et prescriptions (phase 2, étape 1)
Ta slovenski standard je istoveten z: EN 14476:2005/prA1
ICS:
11.080.20
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
FINAL DRAFT
EN 14476:2005
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
May 2006
ICS 11.080.20
English Version
Chemical disinfectants and antiseptics - Virucidal quantitative
suspension test for chemical disinfectants and antiseptics used
in human medicine - Test method and requirements (phase 2,
step 1)
Antiseptiques et désinfectants chimiques - Essai virucide Chemische Desinfektionsmittel und Antiseptika -
quantitatif de suspension pour les antiseptiques et Quantitativer Suspensionsversuch Viruzidie für in der
désinfectants chimiques utilisés en médecine humaine - Humanmedizin verwendete chemische Desinfektionsmittel
Méthode d'essai et prescriptions (phase 2, étape 1) und Antiseptika - 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
...

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