iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
CEN

EN 14476:2013/FprA1

(Amendment)

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity in the medical area - Test method and requirements (Phase 2/Step 1)

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal 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 virucidal 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, i. e, products that are not diluted when
applied,– with water. Products can only be tested at a concentration of 80 % (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, instrument disinfection by immersion, surface disinfection by wiping, spraying,
flooding or other means and textile disinfection.
This European Standard applies 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.

Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur Bestimmung der viruziden 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 virucide dans le domaine médical - Méthode d’essai et prescriptions (Phase 2/Étape 1)

Kemična razkužila in antiseptiki - Kvantitativni suspenzijski preskus za vrednotenje virucidnega delovanja v 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
26-Jun-2015
Due Date
08-Jun-2016
Completion Date
26-Jun-2015
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
SIST EN 14476:2013/kFprA1:2015 - Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity in the medical area - Test method and requirements (Phase 2/Step 1)

Relations

Merged Into
EN 14476:2013+A1:2015 - Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity in the medical area - Test method and requirements (Phase 2/Step 1)
Effective Date
19-Jan-2023
Amends
EN 14476:2013 - Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity in the medical area - Test method and requirements (Phase 2/Step 1)
Effective Date
05-Dec-2014

Buy Standard

EN 14476:2013/kFprA1:2015EN 14476:2013/kFprA1:2015
PreviousNext
Draft
EN 14476:2013/kFprA1:2015
English language
7 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 14476:2013/kFprA1:2015
01-junij-2015
.HPLþQDUD]NXåLODLQDQWLVHSWLNL.YDQWLWDWLYQLVXVSHQ]LMVNLSUHVNXV]D
YUHGQRWHQMHYLUXFLGQHJDGHORYDQMDYPHGLFLQL3UHVNXVQDPHWRGDLQ]DKWHYH ID]D
VWRSQMD
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation
of virucidal activity in the medical area - Test method and requirements (Phase 2/Step 1)
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur
Bestimmung der viruziden 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 virucide dans le domaine médical - Méthode d’essai et
prescriptions (Phase 2/Étape 1)
Ta slovenski standard je istoveten z: EN 14476:2013/FprA1
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
SIST EN 14476:2013/kFprA1:2015 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

SIST EN 14476:2013/kFprA1:2015

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

SIST EN 14476:2013/kFprA1:2015

EUROPEAN STANDARD
FINAL DRAFT
EN 14476:2013
NORME EUROPÉENNE

EUROPÄISCHE NORM
FprA1
March 2015
ICS 11.080.20
English Version
Chemical disinfectants and antiseptics - Quantitative suspension
test for the evaluation of virucidal 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 virucide dans le Quantitativer Suspensionsversuch zur Bestimmung der
domaine médical - Méthode d'essai et prescriptions (Phase viruziden Wirkung im humanmedizinischen Bereich -
2/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 14476:2013. 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 14476:2013/FprA:2015 E
worldwide for CEN national Members.

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

SIST EN 14476:2013/kFprA1:2015
EN 14476:2013/FprA1:2015 (E)
Contents
Page
Foreword .3
1 Modifications to Foreword .4
2 Modifications to Clause 4, Table 1 .4
3 Modifications to 5.2.1 .5
4 Modification to 5.5.1.1 .5
5 Modification to 5.5.4.1 .6
6 Modification to 5.7 .
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

CEN
EN 17430:2024(Main)
Chemical disinfectants and antiseptics - Hygienic handrub virucidal - Test method and requirements (phase 2/step 2)
kSIST FprEN 17430:2023

This document specifies a test method simulating practical conditions for establishing whether a product for hygienic handrub reduces the release of virus contamination on hands when rubbed onto the artificially contaminated hands of volunteers.
NOTE 1   Attention is drawn to the fact that tests on human volunteers are the subject of legal provisions in certain European countries/regions.
This document is applicable to products for hygienic handrub for use in 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 can occur in the workplace and in the home. It can also include services such as laundries and kitchens supplying products directly for the patient.
EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.
NOTE 2   This method corresponds to a phase 2, step 2 test.

  • Draft
    30 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN 17846:2023(Main)
Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of sporicidal activity against Clostridioides difficile on non-porous surfaces with mechanical action employing wipes in the medical area (4-field test) - Test method and requirements (phase 2, step 2)
SIST EN 17846:2023

requirements for sporicidal activity against spores of Clostridioides difficile of chemical disinfectant products 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 products that are used in the medical area for disinfecting non-porous surfaces including surfaces of medical devices by wiping - regardless if they are covered by the 93/42/EEC Directive on Medical Devices or not.
Due to the new methods of application of surface disinfectants like pre-impregnated wipes this document was established to cover the different application method.
The document is applicable for four method of application of products for wiping and/or mopping:
a)   soaking any non-specified wipe or mop with product;
b)   spraying the product on any non-specified wipe and / or mop or a specified wipe or mop.
c)   impregnation of specified wipes or mops by the user with the product according to the manufacturer’s recommendation;
d)   pre-impregnation of specified wipes or mops by the manufacturer as ready-to-use wipes or mops.
In all types of application the water control has to be done with the standard wipe [5.3.2.17 a)], because it is a process or method control.
This document does not apply to products that are sprayed on or flooding surfaces, then left until the contact application phase 2, step 2 standards without mechanical action should be used and their methods performed.
The test surface (5.3.2.16) was selected as standard surface and should cover all non-porous surfaces. It was not intended to cover the influence of each different surface.
This document is applicable 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.
NOTE   This method corresponds to a phase 2, step 2 test.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".

  • Standard
    42 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN 14885:2022/AC:2023(Corrigendum)
Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics
SIST EN 14885:2022/AC:2023
  • Corrigendum
    3 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
CEN/TR 17825:2022(Main)
Chemical disinfectants and antiseptics - Interpretation of water controls in EN 16615:2015
SIST-TP CEN/TR 17825:2023

This document defines rules for the interpretation of data according to EN 16615: 2015 regarding water controls in order to avoid problems in discussions with legal bodies on the validity of data to support product claims.

  • Technical report
    6 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN 16616:2022(Main)
Chemical disinfectants and antiseptics - Chemical-thermal textile disinfection - Test method and requirements (phase 2, step 2)
SIST EN 16616:2022

This document specifies a test method and the minimum requirements for the microbicidal activity of a specified disinfection process for the treatment of contaminated textile. This procedure is carried out by using a washing machine as specified in 5.3.2.18 and refers to the disinfection step without prewash. This procedure is not limited to certain types of textile. The suppliers' instructions are expected to be sufficient if they content the process parameters identified in the test (e.g. dosing disinfectant in whatever washing phase e.g. main wash, rinsing, disinfecting at 40 °C).
This document applies 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 could occur in the workplace and in the home.
It could also include services such as laundries and kitchens supplying products directly for the patients.
The method described is intended to determine the activity of a product or product combination under the conditions in which they are used. This is a phase 2, step 2 laboratory test that simulates the conditions of application of the product.
EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.

  • Standard
    48 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN 14885:2022(Main)
Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics
SIST EN 14885:2022

This document specifies the European Standards to which products have to conform in order to support the claims for microbicidal activity which are referred to in this document.
This document also specifies terms and definitions which are used in European Standards.
It is applicable to products for which activity is claimed against the following microorganisms: vegetative bacteria (including mycobacteria and Legionella), bacterial spores, yeasts, fungal spores and viruses (including bacteriophages).
It is intended to:
a)   enable manufacturers of products to select the appropriate standards to be used in order to provide data which support their claims for a specific product;
b)   enable users of the product to assess the information provided by the manufacturer in relation to the use for which they intend to use the product;
c)   assist regulatory authorities in assessing claims made by the manufacturer or by the person responsible for placing the product on the market.
It is applicable to products to be used in the area of human medicine, the veterinary area and in food, industrial, domestic and institutional areas.
In the area of human medicine (Working Group 1, i.e. WG 1), it is applicable to chemical disinfectants and antiseptics to be used in areas and situations where disinfection or antisepsis is medically indicated. Such indications occur in patient care
—   in hospitals, in community medical facilities, dental institutions and medical laboratories for analyses and research,
—   in clinics of schools, of kindergartens and of nursing homes,
—   and may also occur in the workplace and in the home. It may also include services such as in laundries and kitchens supplying products directly for the patient.
In the veterinary area (WG 2) it is applicable to chemical disinfectants and antiseptics to be used in the areas of breeding, husbandry, veterinary care facilities, production, transport and disposal of animals and veterinary laboratories for analyses and research. It is not applicable to chemical disinfectants used in the food chain following death and entry to the processing industry.
In food, industrial, domestic and institutional areas (WG 3) it is applicable to chemical disinfectants and antiseptics to be used in processing, distribution and retailing of food of animal or vegetable origin. It is also applicable to products for all public areas where disinfection is not medically indicated (homes, catering, schools, nurseries, transports, hotels, offices etc.) and products used in packaging, biotechnology, laboratories (except laboratories for veterinary and medical analyses and research), pharmaceutical, cosmetic etc. industries.
This document is also applicable to active substances and products under development for which no area of application has yet been specified.
This document will be periodically updated to reflect the current published versions of each standard developed in CEN/TC 216. Independent of this update newly published standards are to be used, even if they are not yet mentioned in EN 14885.
This document does not refer to methods for testing the toxicological and ecotoxicological properties of products or active substances.

  • Standard
    72 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN 13624:2021(Main)
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1)
SIST EN 13624:2022

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 (97 % with a modified method for special cases) as some dilution is always produced by adding the test organisms and interfering substance.
This document 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 document 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 can occur in the workplace and in the home. It can 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.
EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.

  • Standard
    57 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN 12353:2021(Main)
Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
SIST EN 12353:2022

This document specifies methods for keeping test organisms used and defined in European Standards for the determination of bactericidal (incl. Legionella pneumophila), mycobactericidal, sporicidal, fungicidal and virucidal (incl. bacteriophages) activity of chemical disinfectants and antiseptics drawn up by CEN/TC 216. These methods for keeping test organisms can only be carried out in connection with at least one of those standards where a reference to this document is established.
NOTE 1   Annex A (informative) contains a non-exhaustive list of test organisms for which this document can be applied.
NOTE 2   European Standards (EN) where this document is referenced are listed in the Bibliography.
NOTE 3   A specific description on the preservation of bacterial spores could be added once the results of the ongoing ring trials are available.

  • Standard
    36 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN 17387:2021(Main)
Chemical disinfectants and antiseptics - Quantitative test for the evaluation of bactericidal and yeasticidal and/or fungicidal activity of chemical disinfectants in the medical area on non-porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)
SIST EN 17387:2022

This document specifies a test method and the minimum requirements for bactericidal and yeasticidal and additionally fungicidal activity of chemical disinfectant products that form a homogeneous, physically stable preparation when diluted with hard water - or in the case of ready-to-use products - with water.
NOTE   Dilutions are necessary as three concentrations in the active to non-active range are tested.
This document applies to products that are used in the medical area for disinfecting non-porous surfaces without mechanical action.
This document 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 can occur in the workplace and in the home. It can also include services such as laundries and kitchens supplying products directly for the patients.
EN 14885 specifies in detail the relationship of the various tests to one another and to use recommendations.
Using this document, it is possible to determine the activity of products like commercial formulations or active substances on bacteria and/or fungi in the conditions in which they are used and therefore it corresponds to a phase 2, step 2 test.
This method excludes the evaluation of the activity of products against mycobacteria and bacterial spores.

  • Standard
    38 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN 17272:2020(Main)
Chemical disinfectants and antiseptics - Methods of airborne room disinfection by automated process - Determination of bactericidal, mycobactericidal, sporicidal, fungicidal, yeasticidal, virucidal and phagocidal activities
SIST EN 17272:2020

The test methods described are designed to determine the disinfectant activity of processes used in the 1) medical area, 2) veterinary area, 3) food, industrial, domestic and institutional area using automated processes for distributing chemicals by air diffusion with no operator manually applying the disinfectant. This document covers the disinfection of nonporous surfaces but not that of the air.
The objective of the described processes is to disinfect the surfaces of the overall area including the external surfaces of the equipment contained in such rooms. Air handling and products or processes specifically designed for the disinfection of medical devices are excluded from the scope of this document. The test methods and volumes described provide a defined challenge.
This document is applicable to processes for which activity is claimed against the following groups of microorganisms:
—   vegetative bacteria,
—    mycobacteria,
—   bacterial spores,
—   yeasts,
—   fungal spores,
—   viruses,
—   bacteriophages.
This document does not cover processes for which the mode of action is based on immersing and/or circulation, flooding, spraying, wiping or other processes where the product is directly applied to the surfaces and not via air dispersion.

  • Standard
    64 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Standard
    64 pages
    English language
    sale 10% off
    e-Library read for
    1 day