SIST EN 455-5:2025

SLOVENSKI STANDARD
01-oktober-2025
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: EN 455-5:2025
ICS:
11.140 Oprema bolnišnic Hospital equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN 455-5
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2025
EUROPÄISCHE NORM
ICS 11.140
English Version
Medical gloves for single use - Part 5: Extractable chemical
residues
Gants médicaux non réutilisables - Partie 5 : Résidus de Medizinische Handschuhe zum einmaligen Gebrauch -
substances chimiques extractibles Teil 5: Extrahierbare chemische Rückstände
This European Standard was approved by CEN on 30 June 2025.

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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 455-5:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Test methods . 6
4.1 General. 6
4.2 Extraction and assay methods . 7
5 Test report . 7
Annex A (normative) Outline method for the determination of simulated-use extractable
chemicals in medical gloves . 8
Annex B (informative) Analysis of chemical residues by high performance liquid
chromatography (HPLC), method 1 . 12
Annex C (informative) Analysis of chemical residues by high performance liquid
chromatography (HPLC), method 2 . 14
Annex D (informative) Analysis of chemical residues by high performance liquid
chromatography (HPLC), method 3 . 16
Annex E (informative) Known contact allergens in medical gloves . 18
Annex F (informative) Rationale . 20
Bibliography . 23

European foreword
This document (EN 455-5:2025) has been prepared by Technical Committee CEN/TC 205 “Non-active
medical devices”, the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by February 2026, and conflicting national standards
shall be withdrawn at the latest by February 2026.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
EN 455-series 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.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: 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 the
United Kingdom.
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 localized to the area of
contact with the offending chemicals and unlike Type I allergic reactions do not show any systemic non-
localized 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:
— concentration and ease of release of the chemicals;
— duration and frequency of skin contact with gloves;
— occlusive nature of the glove/skin interaction during glove use.
EN ISO 10993 series specifies requirements and test methods for biological evaluation of medical
devices. Historically EN ISO 10993-10 has used animal testing to determine irritation and sensitization
potential of products which is related to their residual chemical content. This is a fairly crude screen
and simply prevents poor quality products containing excessive levels of bioavailable chemicals from
reaching the market. It can neither predict changes in chemical availability during product shelf life nor
potential for sensitization or provocation of allergic responses in users.
This document specifies a method for quantitative measurement of potentially harmful residual
extractable chemicals in medical gloves as part of a risk management process, in accordance with the
EN ISO 10993 series.
EN 455-3 specifies requirements for the evaluation of biological safety for medical gloves for single use
including requirements for labelling and the disclosure of information relevant to the test methods
used. At the time of publication of EN 455-5 the intention is that EN 455-3 will be revised to include
further requirements related to EN 455-5.
Considering that this is the first version of EN 455-5, it is recognized that laboratories need several
months after publication to obtain accreditation and begin offering accredited testing to this new
standard.
1 Scope
This document specifies a test method for the measurement of residual chemicals used in product
manufacture, particularly potentially Type IV allergenic substances employed and remaining in medical
gloves. It also provides information on the extraction medium, 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.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp/
— IEC Electropedia: available at https://www.electropedia.org/
3.1
allergenic
having the potential to provoke an allergic response
Note 1 to entry: The allergens of concern in this document are those that provoke Type IV delayed contact
dermatitis reactions. A non-exhaustive list of chemicals which are relevant contact allergens often found in
medical gloves is provided in Annex E.
3.2
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.
3.3
curing agent
chemical which causes crosslinking to occur
Note 1 to entry: For glove materials, this is commonly sulfur, or can be a sulfur donor in a process known as
vulcanisation. Examples of other curing agents would include those employed in peroxide or radiation curing.
3.4
leachable
substance that is released from a medical device or material during its clinical use
Note 1 to entry: For many medical devices, a leachables study is not practical due to challenges with reproducing
actual clinical conditions, so simulated-use extraction studies are often performed instead. See definition for
simulated-use extraction.
[SOURCE: EN ISO 10993-18:2020, 3.22]
3.5
extractable
substance that is released from a medical device or material of construction when the medical device or
material is extracted using laboratory extraction conditions and mediums
[SOURCE: EN ISO 10993-18:2020, 3.16, modified – “vehicles” was changed to “mediums” in the
definition]
3.6
extraction medium
solution or solvent which is used to extract (or leach) a test article for the purpose of establishing the
test article’s extractables or leachables profile
Note 1 to entry: It is preferred that extraction mediums be analytically expedient.
[SOURCE: EN ISO 10993-18:2020, 3.18, modified – “vehicle” was changed to “medium”, “medium” was
deleted in the definition and Note 2 to entry was deleted.]
3.7
simulated-use extraction
extraction using a method that simulates clinical use
Note 1 to entry: A simulated-use extraction is performed to estimate the type and amount of substances that are
expected to be released from a medical device during its clinical use. A simulated-use extraction is designed to
produce an extractables profile that represents the worst-case leachables profile, meaning that all leachables are
also extractables and the levels of all individual extractables are at least equal to the level of all individual
leachables.
[SOURCE: EN ISO 10993-18:2020, 3.35]
3.8
contact allergen
substance known or suspected to cause Type IV allergy
3.9
accelerator
chemical which catalyses the chemical reactions necessary to bring about curing (vulcanisation)
Note 1 to entry: A catalyst is a substance which speeds up a chemical reaction without being consumed by the
process.
4 Test methods
4.1 General
All test methods used to show conformity to this document shall be validated and documented by the
laboratory. Annex F provides a rationale for the test method detailed in this document.
NOTE Sources of guidance on test method validation can be found in [3] and [4].
There is no single assay to analyse every residual chemical, therefore no reference method can be
specified. For assay methods that can be used see Table E.1 in Annex E.
4.2 Extraction and assay methods
The extraction method that shall be used is specified in Annex A. Examples of suitable assay m
...