EN 455-3:2023

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
...