prEN 455-2
(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 Chargengröße fest. Es wird auf die Schwierigkeiten verwiesen, die mit der Verteilung und Kontrolle sehr großer Chargen verbunden sein können. Die empfohlene maximale Einzelchargengröße 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
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN 455-2:2023
01-marec-2023
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: prEN 455-2
ICS:
11.140 Oprema bolnišnic Hospital equipment
oSIST prEN 455-2:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN 455-2:2023
---------------------- Page: 2 ----------------------
oSIST prEN 455-2:2023
DRAFT
EUROPEAN STANDARD
prEN 455-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2023
ICS 11.140 Will supersede 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 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 455-2:2023 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
oSIST prEN 455-2:2023
prEN 455-2:2023 (E)
Contents Page
European foreword . 3
1 Scope . 4
2 Normative references . 4
3 Terms and definitions . 4
4 Dimensions. 5
4.1 General. 5
4.2 Length. 5
4.3 Width . 6
5 Strength . 7
5.1 General. 7
5.2 Force at break . 7
5.3 Force at break after challenge testing . 9
6 Test report . 10
7 Labelling . 10
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered . 11
Bibliography . 14
2
---------------------- Page: 4 ----------------------
oSIST prEN 455-2:2023
prEN 455-2:2023 (E)
European foreword
This document (prEN 455-2:2023) 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 will supersede EN 455-2:2015.
In comparison with the previous edition, the following technical modifications have been made:
a) normative references revised;
b) update of 4.2 in regard of recording the measured length;
c) Clause 5 has been updated;
d) update of Annex ZA for harmonization under Medical Device Regulation (EU) 2017/745 (MDR);
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports General Safety and Performance Requirements (GSPRs)
of EU Regulation(s).
For relationship with EU 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.
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.
3
---------------------- Page: 5 ----------------------
oSIST prEN 455-2:2023
prEN 455-2:2023 (E)
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/DIS 188:2022, 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 terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at https://www.electropedia.org/
— ISO Online browsing platform: available at https://www.iso.org/obp
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 may or may not be anatomically shaped, intended for
conducting medical examinations, diagnostic and therapeutic procedures and for handling
contaminated medical material
4
---------------------- Page: 6 ----------------------
oSIST prEN 455-2:2023
prEN 455-2:2023 (E)
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 Tables 1 and 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.
5
---------------------- Page: 7 ----------------------
oSIST prEN 455-2:2023
prEN 455-2:2023 (E)
For greater ease of measurement, the ruler may 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.
6
---------------------- Page: 8 ----------------------
oSIST prEN 455-2:2023
prEN 455-2:2023 (E)
Table 2 — Dimensions of examination/procedure gloves
a b c
Median length Median width
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.