EN 455-3:2023

Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

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.

Medizinische Handschuhe zum einmaligen Gebrauch - Teil 3: Anforderungen und Prüfung für die biologische Bewertung

Dieser Teil von EN 455 legt Anforderungen für die Bewertung der biologischen Sicherheit von medizinischen Handschuhen zum einmaligen Gebrauch fest. Er enthält Anforderungen an die Kennzeichnung und die Informationsangaben entsprechend den angewendeten Prüfverfahren.

Gants médicaux non réutilisables - Partie 3 : Exigences et essais pour évaluation biologique

La présente partie de l’EN 455 spécifie les exigences permettant d’évaluer la sécurité biologique des gants médicaux non réutilisables. Elle mentionne les exigences d’étiquetage des gants et de diffusion des informations concernant les méthodes d’essai utilisées.

Medicinske rokavice za enkratno uporabo - 3. del: Zahteve in preskušanje za biološko ovrednotenje

Ta del standarda EN 455 določa zahteve za ovrednotenje biološke varnosti medicinskih rokavic za
enkratno uporabo. Določa zahteve za označevanje in razkrivanje informacij, ki so pomembne za uporabljene preskusne metode.

General Information

• Status: Published
• Publication Date: 28-Nov-2023
• ICS: 11.140 - Hospital equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205/WG 3 - Medical gloves
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 29-Nov-2023
• Due Date: 03-Jun-2022
• Completion Date: 29-Nov-2023
• 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/565 - Medical devices and in vitro diagnostic medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746
• 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
• Ref Project: SIST EN 455-3:2024 - Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

Relations

• Replaces: EN 455-3:2015 - Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
• Effective Date: 18-Dec-2019

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2024
Nadomešča:
SIST EN 455-3:2015
Medicinske rokavice za enkratno uporabo - 3. del: Zahteve in preskušanje za
biološko ovrednotenje
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
ICS:
11.140 Oprema bolnišnic Hospital equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN 455-3
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2023
EUROPÄISCHE NORM
ICS 11.140 Supersedes EN 455-3:2015
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 European Standard was approved by CEN on 29 October 2023.

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 COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 455-3:2023 E
worldwide for CEN national Members.

Contents Page
European foreword . 5
Introduction . 7
1 Scope . 8
2 Normative references . 8
3 Terms and definitions . 8
4 Requirements . 9
4.1 General . 9
4.2 Chemicals . 9
4.3 Endotoxins . 10
4.4 Powder-free gloves . 10
4.5 Proteins, leachable . 10
4.6 Labelling . 10
5 Test methods . 12
5.1 Endotoxins . 12
5.2 Powder . 12
5.3 Proteins, leachable . 12
6 Test report . 13
Annex A (normative) Method for the determination of aqueous extractable proteins in
natural rubber gloves using the modified Lowry assay . 14
A.1 General . 14
A.2 Principle . 14
A.3 Reagents . 14
A.4 Apparatus . 15
A.5 Measurement of protein binding capacity . 16
A.5.1 General . 16
A.5.2 Protein binding capacity of centrifuge tubes . 16
A.5.3 Protein binding capacity of filter units . 17
A.6 Procedure. 17
A.6.1 General . 17
A.6.2 Extraction procedure . 18
A.6.3 Protein standard . 18
A.6.4 Precipitation and concentration of protein . 19
A.6.5 Colour development . 19
A.6.6 Measurement . 20
A.7 Expression of results . 20
A.7.1 Calculation . 20
A.7.2 Results . 20
A.7.3 Statistical information . 22
A.8 References . 23
Annex B (informative) Immunological methods for the measurements of natural rubber
latex allergens . 24
B.1 General . 24
B.2 Natural rubber latex allergens in manufactured rubber products . 24
B.3 Methods for measuring natural rubber latex allergens . 25
B.3.1 Qualitative methods . 25
B.3.2 Semiquantitative methods . 25
B.3.3 Specific quantitative methods . 26
B.4 Conclusion . 27
B.5 References . 27
Annex C (informative) Amino acid analysis (AAA) by high pressure liquid chromatography
(HPLC) . 30
C.1 Background . 30
C.2 Principles of the determination of proteins by HPLC . 30
C.3 Material . 30
C.4 Buffers and solutions . 31
C.4.1 Norvalin-100 . 31
C.4.2 Norvalin-1 . 31
C.4.3 o-Phthaldialdehyde (OPA). 31
C.4.4 Boratebuffer . 31
C.4.5 Stop-solution . 32
C.4.6 Phosphate buffer . 32
C.4.7 Solvent 1 . 32
C.4.8 Solvent 2 . 32
C.4.9 Sodium carbonate solution (0,1 M) . 32
C.5 Hydrolysis. 32
C.5.1 Samples . 32
C.5.2 Standards . 32
C.5.3 Incubation (hydrolysis) . 32
C.5.4 Free amino acids . 32
C.6 Analysis (HPLC) . 32
C.6.1 Sample preparation . 32
C.6.2 Derivatisation . 33
C.6.3 HPLC . 33
C.6.4 Calculation. 33
...