EN 455-3:2023/FprA1
(Amendment)Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
General Information
- 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
- Publication Date
- 24-Feb-2027
- Technical Committee
- CEN/TC 205 - Non-active medical devices
- Drafting Committee
- CEN/TC 205/WG 3 - Medical gloves
Overview
EN 455-3:2023/FprA1 is a key part of the European series of standards for medical gloves for single use, developed by CEN (European Committee for Standardization). Part 3 of this standard focuses on the requirements and testing for biological evaluation of medical gloves, ensuring the biological safety of these essential medical devices. This standard outlines methods for assessing biological risks, specifies information required for labelling, and mandates disclosure of relevant test methods. Biological evaluation covers potential risks from chemical residues, proteins, and other leachable substances that could cause allergic reactions or adverse health effects to both patients and healthcare professionals.
Key Topics
- Biological Safety Evaluation: Requirements for evaluating the potential biological risks associated with medical gloves for single use, taking into account chemicals and proteins that might cause adverse health reactions.
- Leachable Chemicals: Addition of requirements for minimizing and accurately measuring levels of leachable chemicals in finished gloves, referencing EN 455-5 for methods.
- Chemicals and Allergens: Updates on the identification, evaluation, and disclosure of chemicals used in glove production, including those capable of causing Type IV allergies.
- Labelling and Information Disclosure: Strict requirements for labelling regarding chemical content and claims related to extractable chemicals. Mandates clear disclosure of test results and chemical process limits.
- Alignment with EU Medical Device Regulation: The standard helps manufacturers demonstrate conformity with General Safety and Performance Requirements (GSPR) of Regulation (EU) 2017/745 for medical devices.
Applications
EN 455-3:2023/FprA1 is essential for:
- Manufacturers of Medical Gloves: Implementing robust safety assessments during product development and production stages, reducing risks associated with chemical residues and proteins.
- Quality Assurance and Regulatory Compliance: Supporting manufacturers in conforming with the latest EU requirements for medical devices. Use of this standard helps achieve CE marking for glove products.
- Healthcare Providers: Ensuring that gloves supplied meet stringent safety standards, reducing the risk of allergic reactions and enhancing patient and user protection.
- Inspection and Certification Bodies: Offering a clear framework for verifying both the safety testing and correctness of information provided by manufacturers.
- Procurement and Supply Chain Professionals: Providing reliable criteria for evaluating and selecting medical gloves, guaranteeing that purchased gloves comply with EU regulatory requirements.
Related Standards
- EN 455-1: Requirements and testing for freedom from holes in medical gloves for single use.
- EN 455-2: Requirements and testing for physical properties of medical gloves.
- EN 455-4: Requirements and testing for shelf life determination of medical gloves.
- EN 455-5: Requirements and testing related to extractable chemical residues in medical gloves.
- EN ISO 10993-18: Biological evaluation of medical devices - Chemical characterization of materials.
Practical Value
Applying EN 455-3:2023/FprA1 helps manufacturers ensure the highest level of biological safety for single-use medical gloves by implementing rigorous chemical and protein testing protocols. The standard delivers clear requirements for labelling, chemical residue assessment, and supports EU market access by aligning with the Medical Device Regulation. Ultimately, compliance with this standard leads to safer medical supplies, improved health outcomes, and enhanced trust among users and healthcare professionals.
Keywords: EN 455-3, biological evaluation, medical gloves for single use, leachable chemicals, chemical residues, EU MDR, Regulation (EU) 2017/745, glove labelling, glove safety, allergenic proteins, CEN standards, medical device compliance.
Relations
- Effective Date
- 05-Jun-2024
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Frequently Asked Questions
EN 455-3:2023/FprA1 is a draft published by the European Committee for Standardization (CEN). Its full title is "Medical gloves for single use - Part 3: Requirements and testing for biological evaluation". This standard covers: 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.
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.
EN 455-3:2023/FprA1 is classified under the following ICS (International Classification for Standards) categories: 11.140 - Hospital equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 455-3:2023/FprA1 has the following relationships with other standards: It is inter standard links to EN 455-3:2023. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 455-3:2023/FprA1 is associated with the following European legislation: EU Directives/Regulations: 2017/745; Standardization Mandates: M/575, M/575 Amd 2. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 455-3:2023/FprA1 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
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
...