SIST EN 455-3:2024/oprA1:2025

• Abstract:

  This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labelling and the disclosure of information relevant to the test methods used.

• Status: Not Published
• Public Enquiry End Date: 17-Dec-2025
• ICS: 11.140 - Hospital equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 17-Oct-2025
• Due Date: 06-Mar-2026
• Completion Date: 18-Dec-2025
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Mandate: M/575 AMD 2 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medicial devices in support of Regulation (EU) 2017746
• Ref Project: EN 455-3:2023/FprA1 - Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

• Amends: SIST EN 455-3:2024 - Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
• Effective Date: 05-Jun-2024

SIST EN 455-3:2024/oprA1:2025 is the Slovenian adoption of the CEN draft amendment EN 455-3:2023/prA1:2025, published by SIST. It updates the requirements for the biological evaluation of medical gloves for single use, especially the treatment of leachable chemicals and the related labelling and disclosure rules that manufacturers, test laboratories and compliance teams need to use.

What does SIST EN 455-3:2024/oprA1:2025 specify?

SIST EN 455-3:2024/oprA1:2025 specifies changes to Part 3 of EN 455 for single-use medical gloves, with the focus on biological safety evaluation. It also sets requirements for labelling and for disclosing information that is relevant to the test methods used.

The document is organised as an amendment to EN 455-3:2023. Its main parts are:

• Clause 2 - normative references
• Clause 3 - terms and definitions
• Clause 4.2 to 4.7 - chemicals, leachable chemicals, endotoxins, powder-free gloves, leachable proteins and labelling
• Annex ZA - relationship with Regulation (EU) 2017/745

Annex	What it covers
ZA	Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745, including the correspondence table

What are the key requirements of SIST EN 455-3:2024/oprA1:2025?

SIST EN 455-3:2024/oprA1:2025 strengthens how glove manufacturers address chemical residues, how they report test-related information, and how the standard aligns with EU medical device law. In practice, the document matters most where a supplier needs to show what chemical residues remain in the glove, what was tested, and what can be stated on the pack.

Chemical residues and leachables

Clause 4.3 adds a specific requirement for leachable chemicals. The manufacturing process shall aim to minimize the leachable chemical level, and the leachable potentially allergenic chemical content in finished gloves shall be assayed by the method specified in EN 455-5:2025. This means manufacturers need a defined analytical route, documented results and a way to provide those results on request.

Clause 4.2 also refines the chemical wording and note. It points to chemical ingredients that can cause adverse health effects, including curing agents, accelerators, stabilisers, surfactants, antioxidants, plasticisers and biocides. For a buyer or quality manager, this shows that chemical residue control is not limited to one substance type.

Labelling and claims

Clause 4.7 tightens what can be said on the label. A claim about extractable chemical content shall not be based on analytical methods that have not been fully validated and verified. If leachable chemical content is claimed, the packaging or accompanying information shall give the chemical name and the process limit, measured according to EN 455-5:2025.

That matters in practice because it links the claim directly to the test method and the reported limit, so product comparisons and technical file review are based on traceable data rather than general statements.

Related safety topics

The amendment also updates the wording around powder-free gloves, leachable proteins and endotoxins. These updates keep the biological evaluation terminology aligned inside the document and support consistent interpretation when gloves are assessed for residues, proteins and other safety-related contaminants.

EU regulatory linkage

Annex ZA is replaced to map the standard to Regulation (EU) 2017/745. Table ZA.1 shows which clauses partially cover selected General Safety and Performance Requirements. For conformity work, this is the part that helps users see how the standard may support regulatory assessment when it is cited in the Official Journal of the European Union.

What terms does SIST EN 455-3:2024/oprA1:2025 define?

• chemical - a substance added or formed during manufacturing, sterilisation or storage that can be present in the final product; in practice, this is the residue category manufacturers need to control and disclose.
• leachable - a substance released from a medical device or material during clinical use; in practice, this is the kind of release the glove testing and documentation address.
• allergenic proteins - the Clause 3 term used for proteins relevant to allergic reactions; in practice, it separates protein-related safety concerns from chemical residue concerns.
• leachable proteins - the Clause 3 term used for proteins that can be released from the glove; in practice, it supports the protein-related part of biological evaluation.

Who uses SIST EN 455-3:2024/oprA1:2025?

SIST EN 455-3:2024/oprA1:2025 is used by glove manufacturers, importers and their technical file teams when they prepare biological evaluation evidence and labels. Test and analytical laboratories use it to understand what must be measured and how results are reported. Quality managers, regulatory specialists, notified bodies and compliance assessors use it to review claims, documentation and conformity to EU medical device requirements. Hospital buyers and procurement teams can use it to compare products that make chemical-content or biological-safety claims.

What changed in SIST EN 455-3:2024/oprA1:2025 from the previous edition?

SIST EN 455-3:2024/oprA1:2025 is a draft amendment to EN 455-3:2023. The changes stated in the document are:

• addition of EN 455-5:2025 to the normative references
• update of the terms section, including revised protein terms and new definitions for chemical and leachable
• insertion of a new clause on leachable chemicals
• updates to powder-free gloves, leachable proteins and labelling cross-references
• replacement of Annex ZA

Which standards are used with SIST EN 455-3:2024/oprA1:2025?

• EN 455-5:2025 - supplies the method for assaying leachable potentially allergenic chemical content, and its Annex E is used for examples of relevant chemicals.
• European Pharmacopoeia, 11th edition, General chapter 2.6.14 Bacterial Endotoxins - provides the referenced endotoxin test chapter.
• EN 455-1 - covers requirements and testing for freedom from holes in the EN 455 series.
• EN 455-2 - covers requirements and testing for physical properties.
• EN 455-4 - covers requirements and testing for shelf life determination.
• EN 455-5 - covers extractable chemical residues as part of the EN 455 series.

What does the SIST EN 455-3:2024/oprA1:2025 document contain?

SIST EN 455-3:2024/oprA1:2025 contains clause-by-clause amendment text rather than a full standalone test method. The main content is revised wording for chemicals, leachable chemicals, endotoxins, powder-free gloves, leachable proteins and labelling. It also includes Annex ZA with Table ZA.1, which links the standard to the General Safety and Performance Requirements of Regulation (EU) 2017/745. For users, the practical value is in the updated test reference, the disclosure rules for chemical-content claims, and the regulatory mapping.

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.

EN 455-3:2023/prA1:2025 (E)
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
EN 455-3:2023/prA1:2025 (E)
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.
EN 455-3:2023/prA1:2025 (E)
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
...