Medical gloves for single use - Part 1: Requirements and testing for freedom from holes

This document specifies requirements and gives the test method for medical gloves for single use in order to determine freedom from holes.

Medizinische Handschuhe zum einmaligen Gebrauch - Teil 1: 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 gants médicaux non réutilisables.

Medicinske rokavice za enkratno uporabo - 1. del: Zahteve in preskusi za ugotavljanje odsotnosti lukenj (vključuje dopolnilo A1)

General Information

Status
Published
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
23-Feb-2022
Completion Date
23-Feb-2022

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SLOVENSKI STANDARD
SIST EN 455-1:2020+A1:2022
01-maj-2022
Nadomešča:
SIST EN 455-1:2020
Medicinske rokavice za enkratno uporabo - 1. del: Zahteve in preskusi za
ugotavljanje odsotnosti lukenj (vključuje dopolnilo A1)

Medical gloves for single use - Part 1: Requirements and testing for freedom from holes

Medizinische Handschuhe zum einmaligen Gebrauch - Teil 1: 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+A1:2022
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN 455-1:2020+A1:2022 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+A1:2022
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SIST EN 455-1:2020+A1:2022
EN 455-1:2020+A1
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2022
EUROPÄISCHE NORM
ICS 11.140 Supersedes EN 455-1:2020
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 and includes Amendment 1 approved by CEN on 16 December

2021.

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

© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 455-1:2020+A1:2022 E

worldwide for CEN national Members.
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SIST EN 455-1:2020+A1:2022
EN 455-1:2020+A1 :2022 (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+A1:2022
EN 455-1:2020+A1:2022 (E)
European foreword

This document (EN 455-1:2020+A1:2022) 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 August 2022, and conflicting national standards shall

be withdrawn at the latest by August 2022.

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 455-1:2020".
This document includes Amendment 1 approved by CEN on 23 February 2022.

The start and finish of text introduced or altered by amendment is indicated in the text by tags !".

In comparison with the previous 2000 edition, the following main changes have been introduced to the

2020 edition:

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 standard
...

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