National foreword

This British Standard is the UK implementation of EN 17430:2024.

The UK participation in its preparation was entrusted to Technical Committee CH/216, Chemical disinfectants and antiseptics.

A list of organizations represented on this committee can be obtained on request to its committee manager.

Contractual and legal considerations

This publication has been prepared in good faith, however no representation, warranty, assurance or undertaking (express or implied) is or will be made, and no responsibility or liability is or will be accepted by BSI in relation to the adequacy, accuracy, completeness or reasonableness of this publication. All and any such responsibility and liability is expressly disclaimed to the full extent permitted by the law.

This publication is provided as is, and is to be used at the recipient’s own risk.

The recipient is advised to consider seeking professional guidance with respect to its use of this publication.

This publication is not intended to constitute a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2024.

This European Standard was approved by CEN on 19 February 2024.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and United Kingdom.

European foreword

This document (EN 17430:2024) has been prepared by Technical Committee CEN/TC 216 “Chemical disinfectants and antiseptics”, the secretariat of which is held by AFNOR.

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2024, and conflicting national standards shall be withdrawn at the latest by September 2024.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

Any feedback and questions on this document should be directed to the users’ national standards body. A complete listing of these bodies can be found on the CEN website.

According to the CEN-CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the United Kingdom.

1 Scope

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.

2 Normative references

3 Terms and definitions

4 Requirements

5 Test methods

5.1 Principle

5.2 Materials and reagents

5.3 Apparatus and glassware

5.4 Preparation of test organism suspensions and product test solutions

5.5 Cell culture preparation for virucidal testing

5.6 Infectivity assay

5.7 Procedure for assessing the virucidal activity of the product on volunteers' hands

6 Experimental data and calculation

6.1 Protocol of the results

6.2 Calculation of virus titre

6.3 Calculation of PFU

6.4 Calculation of the lg reduction R (lg prevalue minus lg postvalue)

6.5 Verification of the methodology — Test validation

6.6 Statistical evaluation (significance testing), expression of results and precision

6.7 Conclusion

6.8 Test report

Bibliography

BS EN 17430:2024

Chemical disinfectants and antiseptics. Hygienic handrub virucidal. Test method and requirements (phase 2/step 2)

Current

Published:

30 Apr 2024