SIST EN 455-3:2024/oprA1:2025

SLOVENSKI STANDARD
01-december-2025
Medicinske rokavice za enkratno uporabo - 3. del: Zahteve in preskušanje za
biološko ovrednotenje - Dopolnilo A1
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
Medizinische Handschuhe zum einmaligen Gebrauch - Teil 3: Anforderungen und
Prüfung für die biologische Bewertung
Gants médicaux non réutilisables - Partie 3 : Exigences et essais pour évaluation
biologique
Ta slovenski standard je istoveten z: EN 455-3:2023/prA1
ICS:
11.140 Oprema bolnišnic Hospital equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
EUROPEAN STANDARD
EN 455-3:2023
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
September 2025
ICS 11.140
English Version
Medical gloves for single use - Part 3: Requirements and
testing for biological evaluation
Gants médicaux non réutilisables - Partie 3 : Exigences Medizinische Handschuhe zum einmaligen Gebrauch -
et essais pour évaluation biologique Teil 3: Anforderungen und Prüfung für die biologische
Bewertung
This draft amendment is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 205.

This draft amendment A1, if approved, will modify the European Standard EN 455-3:2023. 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, 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.
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: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 455-3:2023/prA1:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
1 Modification to Clause 2, “Normative references” . 4
2 Modification to Clause 3, “Terms and definitions” . 4
3 Modification to 4.2, “Chemicals” . 4
4 Addition of 4.3, “Leachable chemicals” . 5
5 Modification to 4.4, “Powder-free gloves” . 5
6 Modification to 4.5, “Proteins, leachable” . 5
7 Modification to 4.6, “Labelling” . 5
8 Modification to Annex ZA . 5
European foreword
This document (EN 455-3:2023/prA1:2025) has been prepared by Technical Committee CEN/TC 205
“Non-active medical devices”, the secretariat of which is held by DIN.
This document is currently submitted to the CEN Enquiry.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
EN 455 consists of the following parts under the general title “Medical gloves for single use”:
— Part 1: Requirements and testing for freedom from holes;
— Part 2: Requirements and testing for physical properties;
— Part 3: Requirements and testing for biological evaluation;
— Part 4: Requirements and testing for shelf life determination;
— Part 5: Extractable chemical residues.
A list of all parts in a series can be found on the CEN website.
1 Modification to Clause 2, “Normative references”
Add the following normative reference:
“EN 455-5:2025, Medical gloves for single use — Part 5: Extractable chemical residues”
Change the following reference to become:
th
“European Pharmacopoeia, 11 edition, General chapter 2.6.14 Bacterial Endotoxins: publisher EDQM -
Council of Europe; 7 allée Kastner, CS 30026, F-67081 Strasbourg; France http://www.edqm.eu/”
2 Modification to Clause 3, “Terms and definitions”
Update the reference in Note 1 to entry of term 3.4 from “see 4.4” to “see 4.5”.
Replace term 3.6 “proteins, allergenic” with “allergenic proteins”.
Replace term 3.7 “proteins, leachable” with “leachable proteins”.
Add the following terms and definitions:
“
3.9
chemical
substance added or formed during any step of the manufacturing process, including sterilisation, or in
storage which can be available in the final product
Note 1 to entry: These can include but are not limited to lubricants, chemical coatings and sterilizing agents.
Several chemical ingredients are commonly used during processing of gloves, some of them are known to cause
Type IV allergic reactions. The type and amount of residual chemicals added and finally present are variable.
[SOURCE: EN 455-5:2025, 3.2]
3.10
leachable
substance that is released from a me
...