SIST EN 455-1:2020
(Main)Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
This document specifies requirements and provides the test method for medical gloves for single use in order to determine freedom from holes.
Medizinische Handschuhe zum einmaligen Gebrauch - Anforderungen und Prüfung auf Dichtheit
Dieses Dokument legt Anforderungen und Prüfung auf Dichtheit von medizinischen Handschuhen zum einmaligen Gebrauch fest.
Gants médicaux non réutilisables - Partie1 : Exigences et essais pour la détection de l'absence de trous
Le présent document spécifie des exigences et indique la méthode d’essai permettant de déterminer l'absence de trous dans les médicaux non réutilisables.
Medicinske rokavice za enkratno uporabo - 1. del: Zahteve in preskusi za ugotavljanje odsotnosti lukenj
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 455-1:2020
01-september-2020
Nadomešča:
SIST EN 455-1:2001
Medicinske rokavice za enkratno uporabo - 1. del: Zahteve in preskusi za
ugotavljanje odsotnosti lukenj
Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
Medizinische Handschuhe zum einmaligen Gebrauch - Anforderungen und Prüfung auf
Dichtheit
Gants médicaux non réutilisables - Partie1 : Exigences et essais pour la détection de
l'absence de trous
Ta slovenski standard je istoveten z: EN 455-1:2020
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN 455-1:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 455-1:2020
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SIST EN 455-1:2020
EN 455-1
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2020
EUROPÄISCHE NORM
ICS 11.140 Supersedes EN 455-1:2000
English Version
Medical gloves for single use - Part 1: Requirements and
testing for freedom from holes
Gants médicaux non réutilisables - Partie1 : Exigences Medizinische Handschuhe zum einmaligen Gebrauch -
et essais pour la détection de l'absence de trous Teil 1: Anforderungen und Prüfung auf Dichtheit
This European Standard was approved by CEN on 13 April 2020.
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, Turkey 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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 455-1:2020 E
worldwide for CEN national Members.
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SIST EN 455-1:2020
EN 455-1:2020 (E)
Contents Page
European foreword . 3
1 Scope . 4
2 Normative references . 4
3 Terms and definitions . 4
4 Requirement . 4
5 Water tightness test for detection of holes . 4
5.1 Referee testing . 4
5.2 Routine testing . 5
6 Sampling, inspection level and AQL. 5
7 Test report . 5
Annex A (informative) Guidance on relationship between this European Standard and the
General Safety and Performance Requirements of Regulation (EU)
2017/745 [OJ L 117] aimed to be covered . 7
Bibliography . 8
2
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SIST EN 455-1:2020
EN 455-1:2020 (E)
European foreword
This document (EN 455-1:2020) 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 2020, and conflicting national standards
shall be withdrawn at the latest by November 2020.
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 455-1:2000.
Compared to the previous edition the following main changes have been introduced:
a) The term 3.1 “medical gloves for single-use” has been amended by a Note to entry;
b) The term 3.2 “hole” has been added;
c) In 5.1 the referee testing has been enhanced to cover the issue on extension of the glove when it is
filled with water;
d) In Clause 6 the first paragraph has been slightly changed to accommodate the EU commission rules
for referencing ISO standards which are not available as EN standards;
e) Due to that there is currently no standardization request by the EU commission for this part of
EN 455 the harmonization process to provide presumption of conformity to the Medical Device
Regulation (MDR) cannot be applied. However, to provide at least guidance on the relationship
between this European Standard and the General Safety and Performance Requirements of
Regulation (EU) 2017/745 [OJ L 117] aimed to be covered, an Annex A has been added.
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.
According to the CEN-CENELEC Internal Regulations, the national standards
...
SLOVENSKI STANDARD
oSIST prEN 455-1:2019
01-september-2019
Medicinske rokavice za enkratno uporabo - 1. del: Zahteve in preskusi za
ugotavljanje odsotnosti lukenj
Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
Medizinische Handschuhe zum einmaligen Gebrauch - Anforderungen und Prüfung auf
Dichtheit
Gants médicaux non réutilisables - Partie1 : Exigences et essais pour la détection de
l'absence de trous
Ta slovenski standard je istoveten z: prEN 455-1
ICS:
11.140 Oprema bolnišnic Hospital equipment
oSIST prEN 455-1:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN 455-1:2019
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oSIST prEN 455-1:2019
DRAFT
EUROPEAN STANDARD
prEN 455-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2019
ICS 11.140 Will supersede EN 455-1:2000
English Version
Medical gloves for single use - Part 1: Requirements and
testing for freedom from holes
Gants médicaux non réutilisables - Partie 1: Détection Medizinische Handschuhe zum einmaligen Gebrauch -
des trous - Prescriptions et essais Teil 1: Anforderungen und PrÃ1/4fung auf Dichtheit
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey 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
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 455-1:2019 E
worldwide for CEN national Members.
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oSIST prEN 455-1:2019
prEN 455-1:2019 (E)
Contents Page
European foreword . 3
1 Scope . 4
2 Normative references . 4
3 Terms and definitions . 4
4 Requirement . 4
5 Water tightness test for detection of holes . 4
5.1 Referee testing . 4
5.2 Routine testing . 5
6 Sampling, inspection level and AQL. 5
7 Test report . 5
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 [OJ L 117]
aimed to be covered . 7
Bibliography . 8
2
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oSIST prEN 455-1:2019
prEN 455-1:2019 (E)
European foreword
This document (prEN 455-1:2019) 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 455-1:2000.
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).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
Compared to the previous edition the following main changes have been introduced:
a) The term 3.1 “medical gloves for single-use” has been amended by a Note;
b) The term 3.2 “hole” has been added;
c) In 5.1 the referee testing has been enhanced to cover the issue on extension of the glove when it is
filled with water;
d) In Clause 6 the first paragraph has been slightly changed to accommodate the EC rules for
referencing ISO standards which are not available as EN standards;
e) The Annex ZA has been updated in alignment to the Medical Device Regulation (MDR).
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.
3
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oSIST prEN 455-1:2019
prEN 455-1:2019 (E)
1 Scope
This document specifies requirements and gives the test method for medical gloves for single use in
order to determine freedom from holes.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of
...
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