EN 455-2:2024
(Main)Medical gloves for single use - Part 2: Requirements and testing for physical properties
Medical gloves for single use - Part 2: Requirements and testing for physical properties
This document specifies requirements and gives test methods for physical properties of single-use medical gloves (i.e. surgical gloves and examination/procedure gloves) in order to ensure that they provide and maintain in use an adequate level of protection from cross contamination for both patient and user.
This document does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.
Medizinische Handschuhe zum einmaligen Gebrauch - Teil 2: Anforderungen und Prüfung der physikalischen Eigenschaften
Dieses Dokument legt Anforderungen und Prüfverfahren der physikalischen Eigenschaften medizinischer Handschuhe zum einmaligen Gebrauch (d. h. Operationshandschuhe und Untersuchungs /Behandlungshandschuhe) fest, um sicherzustellen, dass bei Gebrauch ausreichender Schutz vor Kreuzkontamination für Patient und Anwender bereitgestellt und aufrechterhalten wird.
Dieses Dokument legt keine Losgröße fest. Es wird auf die Schwierigkeiten verwiesen, die mit der Verteilung und Kontrolle sehr großer Lose verbunden sein können. Die empfohlene maximale Einzellosgröße für die Herstellung beträgt 500 000.
Gants médicaux non réutilisables - Partie 2 : Exigences et essais pour propriétés physiques
La présente Norme européenne spécifie les exigences et méthodes d’essai relatives aux propriétés physiques des gants médicaux non réutilisables (c’est-à-dire des gants de chirurgie et des gants d’examen et de soins), afin de garantir qu’ils assurent et conservent pendant toute la durée de leur utilisation un niveau de protection suffisant contre toute contamination croisée, à la fois pour le patient et pour l’utilisateur.
Le présent document ne spécifie pas la taille du lot. L’attention est attirée sur les difficultés pouvant être liées à la distribution et à la vérification de lots de volume très important. La taille maximale recommandée d’un lot de production est de 500 000 unités.
Medicinske rokavice za enkratno uporabo - 2. del: Zahteve in preskusi za ugotavljanje fizikalnih lastnosti
Ta dokument določa zahteve in podaja preskusne metode za ugotavljanje fizikalnih lastnosti medicinskih rokavic za enkratno uporabo (tj. operacijskih rokavic in rokavic za pregled/postopek), da se zagotovi in ohrani ustrezna raven zaščite pred navzkrižno kontaminacijo za pacienta in uporabnika.
Ta dokument ne določa velikosti serije. Opozoriti je treba na težave, ki so lahko povezane z razporejanjem in nadzorom zelo velikih serij. Priporočena največja velikost posamezne serije za proizvodnjo je 500.000.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2024
Medicinske rokavice za enkratno uporabo - 2. del: Zahteve in preskusi za
ugotavljanje fizikalnih lastnosti
Medical gloves for single use - Part 2: Requirements and testing for physical properties
Medizinische Handschuhe zum einmaligen Gebrauch - Teil 2: Anforderungen und
Prüfung der physikalischen Eigenschaften
Gants médicaux non réutilisables - Partie 2 : Exigences et essais pour propriétés
physiques
Ta slovenski standard je istoveten z: EN 455-2:2024
ICS:
11.140 Oprema bolnišnic Hospital equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 455-2
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2024
EUROPÄISCHE NORM
ICS 11.140 Supersedes EN 455-2:2015
English Version
Medical gloves for single use - Part 2: Requirements and
testing for physical properties
Gants médicaux non réutilisables - Partie 2 : Exigences Medizinische Handschuhe zum einmaligen Gebrauch -
et essais pour propriétés physiques Teil 2: Anforderungen und Prüfung der physikalischen
Eigenschaften
This European Standard was approved by CEN on 15 April 2024.
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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 455-2:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Dimensions. 6
4.1 General. 6
4.2 Length. 7
4.3 Width . 7
5 Strength . 8
5.1 General. 8
5.2 Force at break . 8
5.3 Force at break after challenge testing . 11
6 Test report . 11
7 Labelling . 11
Annex ZA (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered . 12
Bibliography . 14
European foreword
This document (EN 455-2:2024) 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 November 2024, and conflicting national standards
shall be withdrawn at the latest by November 2024.
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.
This document supersedes EN 455-2:2015.
Compared to the previous edition EN 455-2:2015, the following main changes have been introduced:
a) normative references have been revised;
b) subclause 4.2 has been updated with regard to recording the measured length ("median” has been
removed);
c) Clause 5 has been updated;
d) Clause 6 has been updated;
e) Annex ZA has been updated for harmonization under Medical Device Regulation (EU) 2017/745
(MDR).
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.
The 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.
The following part is under development:
— 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.
1 Scope
This document specifies requirements and gives test methods for physical properties of single-use
medical gloves (i.e. surgical gloves and examination/procedure gloves) in order to ensure that they
provide and maintain in use an adequate level of protection from cross contamination for both patient
and user.
This document does not specify the size of a lot. Attention is drawn to the difficulties that can be
associated with the distribution and control of very large lots. The recommended maximum individual
lot size for production is 500 000.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN ISO 15223-1:2021, Medical devices — Symbols to be used with information to be supplied by the
manufacturer — Part 1: General requirements (ISO 15223-1:2021)
EN ISO 20417:2021, Medical devices — Information to be supplied by the manufacturer (ISO 20417:2021,
Corrected version 2021-12)
ISO 23529:2016, Rubber — General procedures for preparing and conditioning test pieces for physical
test methods
ISO 188:2023, Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests
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
medical gloves for single use
gloves intended for use in the medical field to protect patient and user from cross-contamination
3.2
surgical gloves
sterile, anatomically shaped medical gloves with the thumb positioned towards the palmar surface of
the index finger rather than lying flat, and intended for use in invasive surgery
3.3
examination gloves
procedure gloves
sterile or non-sterile medical gloves, which can be anatomically shaped, intended for conducting
medical examinations, diagnostic and therapeutic procedures and for handling contaminated medical
material
3.4
lot
collection of gloves of the same design, colour, shape, size and formulation, manufactured at essentially
the same time, using the same process, raw materials of the same specifications, common equipment
and packed in the same type of individual container
[SOURCE: EN 455-4:2009, 3.4]
4 Dimensions
4.1 General
When measured as described in 4.2 and 4.3 taking 13 samples from each lot, the median value obtained
for the dimensions shall be as given in Table 1 and Table 2.
Key
w width
l length
Figure 1 — Designation of length and width of gloves
4.2 Length
Measure the length (dimension l, as designated in Figure 1) by freely suspending the glove with the
middle finger on a vertical graduated rule having a rounded tip so as to fit the shape of the finger tip of
the glove. Remove wrinkles and folds without stretching the glove. Record the measured length.
For greater ease of measurement, the ruler can be angled backwards slightly so that the glove is in
contact with the ruler.
4.3 Width
Measure the width (dimension w, as designated in Figure 1), to the nearest mm, using a ruler, with the
glove placed on a flat surface. Do not stretch the glove.
Table 1 — Dimensions of surgical gloves
a b c
Median length Median width
Size
l w
in mm in mm
5 ≥ 250 67 ± 4
5,5 ≥ 250 72 ± 4
6 ≥ 260 77 ± 5
6,5 ≥ 260 83 ± 5
7 ≥ 270 89 ± 5
7,5 ≥ 270 95 ± 5
8 ≥ 270 102 ± 6
8,5 ≥ 280 108 ± 6
9 ≥ 280 114 ± 6
9,5 ≥ 280 121 ± 6
a
Dimension l as designated in Figure 1.
b
Dimension w as designated in Figure 1.
c
The width requirements are for gloves made from natural rubber latex and all other elastomeric materials.
These dimensions may not be appropriate for gloves made from other materials.
Table 2 — Dimensions of examination/procedure gloves
a b c
Median length Median width
Size l w
in mm in mm
Extra Small ≥ 240 ≤ 80
Small 80 ± 10
Medium 95 ± 10
Large 110 ± 10
Extra Large ≥ 110
a
Dimension l as designated in Figure 1.
b
Dimension w as designated in Figure 1.
c
The width requirements are for gloves made from natural rubber latex and all other elastomeric
materials. These dimensions may not be appropriate for gloves made from other materials.
Manufacturers may optionally use the sizes and dimensions given in Table 1 in order to provide a wider
range of examination / procedure glove sizes.
5 Strength
5.1 General
Different glove materials require different force at break requirements to ensure an acceptable
performance. Absolute force at break values do not directly correlate with the in-use performance.
Selection of appropriate glove materials for the intended application shall be part of the risk
management process.
When the strength of the glove is tested as described in 5.2 at a temperature of (23 ± 2) °C and a relative
humidity of (50 ± 10) % RH the force at break of gloves shall be as given in Table 3.
5.2 Force at break
5.2.1 Obtain one dumb-bell test piece from each of 13 gloves taken from a single lot (from seven pairs
of gloves where applicable) using a cutter as specified in Figure 2 from the palm, back of the hand or
cuff areas of each glove in the test sample, avoiding textured areas if possible and taking the test pieces
in the direction of the longitudinal axis of the glove.
NOTE To ensure accurate measurements, it is advised to flatten the glove's surface to avoid creases without
stretching the film before cutting test pieces.
Reject and replace samples with cutting imperfections.
Dimensions in millimetres
Key
1 grind minimum 6 mm.
2 spacer
3 bolts
Figure 2 — Cutt
...
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