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

Status
Published
Public Enquiry End Date
19-Sep-2019
Publication Date
15-Jul-2020
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
25-May-2020
Due Date
30-Jul-2020
Completion Date
16-Jul-2020

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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

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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
...

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