prEN 455-5
(Main)Medical gloves for single use - Part 5: Extractable chemical residues
Medical gloves for single use - Part 5: Extractable chemical residues
This document specifies a test method for the measurement of residual chemicals used in product manufacture, particularly potentially allergenic substances employed and remaining in medical gloves. It also provides information on the extraction vehicle, the method of extraction and quantitative assay of residual chemicals.
This document does not provide information on the allergenic potential, biological evaluation, or safety to the user of any product.
Medizinische Handschuhe zum einmaligen Gebrauch - Teil 5: Extrahierbare chemische Rückstände
Dieses Dokument enthält Anforderungen an die Kennzeichnung von Chemikalien, die bei der Herstellung von Produkten verwendet werden, insbesondere von potenziell allergenen Stoffen, die in medizinischen Handschuhen verwendet werden und dort verbleiben. Es enthält auch Informationen über Extraktionsmedien, Extraktionsverfahren und die quantitative Bestimmung von chemischen Rückständen.
Dieses Dokument enthält keine Informationen über das allergieauslösende Potential oder die Sicherheit eines Produkts für den Anwender. Es wird erwartet, dass dies unter Berücksichtigung aller verfügbaren Daten zur Toxizität und Biokompatibilität der betreffenden Produkte als Teil eines Risikomanagementprozesses bewertet wird.
Gants médicaux non réutilisables - Partie 5 : Résidus de substances chimiques extractibles
Le présent document fournit les exigences d'étiquetage des substances chimiques utilisées lors de la fabrication de produits, en particulier les substances potentiellement allergisantes employées et restant dans les gants médicaux. Il fournit des informations sur les milieux d’extraction ainsi que sur les méthodes d’extraction et de dosage quantitatif des substances chimiques résiduelles.
Le présent document ne fournit pas d'informations sur le potentiel allergisant ou la sécurité pour l’utilisateur du produit. Cela devrait être évalué à la lumière de toutes les données de toxicité et de biocompatibilité disponibles sur les produits concernés, dans le cadre du processus de gestion des risques.
Medicinske rokavice za enkratno uporabo - 5. del: Izločljivi kemični ostanki
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2023
Medicinske rokavice za enkratno uporabo - 5. del: Izločljivi kemični ostanki
Medical gloves for single use - Part 5: Extractable chemical residues
Medizinische Handschuhe zum einmaligen Gebrauch - Teil 5: Extrahierbare chemische
Rückstände
Gants médicaux non réutilisables - Partie 5: Résidus de substances chimiques
extractibles
Ta slovenski standard je istoveten z: prEN 455-5
ICS:
11.140 Oprema bolnišnic Hospital equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2023
ICS 11.140
English Version
Medical gloves for single use - Part 5: Extractable chemical
residues
Medizinische Handschuhe zum einmaligen Gebrauch -
Teil 5: Extrahierbare chemische Rückstände
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 205.
If this draft becomes a European Standard, 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.
This draft European Standard 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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 455-5:2023 E
worldwide for CEN national Members.
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Requirements . 8
4.1 General. 8
4.2 Chemicals . 8
4.3 Chemicals leachable . 8
4.4 Labelling . 9
5 Test methods . 9
5.1 General. 9
5.2 Chemicals leachable . 9
5.3 Extraction and assay methods . 9
6 Test report . 9
Annex A (normative) Outline method for the determination of solvent extractable
chemicals in medical gloves . 11
A.1 General. 11
A.2 Principle . 11
A.3 Procedure . 11
Annex B (normative) Outline method for the determination of leachable chemicals in
medical gloves . 13
B.1 General. 13
B.2 Principle . 13
B.3 Reagents . 13
B.4 Apparatus . 13
B.5 Procedure . 14
Annex C (normative) Known contact allergens in medical gloves . 16
Annex D (informative) Test method validation . 18
Annex E (informative) Analysis of chemical residues by high pressure liquid
chromatography (HPLC), method 1 . 19
E.1 General. 19
E.2 Chemicals . 19
E.3 Solutions . 19
E.4 Apparatus . 19
E.5 Procedure . 20
E.6 References . 20
Annex F (informative) Analysis of chemical residues by high pressure liquid
chromatography (HPLC), method 2 . 21
F.1 General . 21
F.2 Chemicals . 21
F.3 Solutions . 21
F.4 Apparatus . 21
F.5 Procedure . 22
F.6 References . 22
Annex G (informative) Analysis of chemical residues by high pressure liquid
chromatography (HPLC), method 3 . 23
G.1 General . 23
G.2 Chemicals . 23
G.3 Solutions . 23
G.4 Apparatus . 23
G.5 Procedure . 23
G.6 References . 24
Annex H (informative) Example for exhaustive extraction method . 25
H.1 General . 25
H.2 Extraction solvent. 25
H.3 Apparatus . 25
H.4 Procedure . 25
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered . 27
Bibliography . 29
European foreword
This document (prEN 455-5:2023) 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 given to CEN by the European
Commission and the European Free Trade Association, and supports essential requirements of
EU Directive(s) / Regulation(s).
For relationship with EU Directive(s) / Regulation(s), 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.
Introduction
Adverse reactions to residual chemicals present in medical gloves have been reported over many years
in variable rates of prevalence. These chemicals are part of the manufacturing process including but not
limited to accelerators, activators, antioxidants, or donning aids. Reactions range from dermal irritation
to contact dermatitis including type IV allergic responses. These effects are localised to the area of
contact with the offending chemicals and unlike type I allergic reactions do not show any systemic non-
localised effects. Though they are potentially career altering, they do not escalate to more serious life-
threatening responses.
Such adverse reactions are possible with gloves made of any material whose manufacture involves use
of chemical additives at any stage of the manufacturing process. Factors which contribute to the risk of
reaction include
— the concentration and ease
...
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