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CEN

EN 455-1:2020+A1:2022/FprA2

(Amendment)

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

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

Gants médicaux non réutilisables - Partie 1 : Exigences et essais pour la détection de l'absence de trous

Medicinske rokavice za enkratno uporabo - 1. del: Zahteve in preskusi za ugotavljanje odsotnosti lukenj - Dopolnilo A2

General Information

Status
Not Published
Publication Date
04-Sep-2024
ICS
11.140 - Hospital equipment
Technical Committee
CEN/TC 205 - Non-active medical devices
Drafting Committee
CEN/TC 205/WG 3 - Medical gloves
Current Stage
5060 - Closure of Vote - Formal Approval
Start Date
11-Jul-2024
Due Date
19-Jun-2024
Completion Date
11-Jul-2024
Directive
2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Mandate
M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
Ref Project
SIST EN 455-1:2020+A1:2022/kFprA2:2024 - Medical gloves for single use - Part 1: Requirements and testing for freedom of holes

Relations

Merged Into
EN 455-1:2020+A2:2024 - Medical gloves for single use - Part 1: Requirements and testing for freedom of holes
Effective Date
17-Jul-2024
Amends
EN 455-1:2020+A1:2022 - Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
Effective Date
11-May-2022

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EN 455-1:2020+A1:2022/oprA2:2023EN 455-1:2020+A1:2022/oprA2:2023
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EN 455-1:2020+A1:2022/oprA2:2023
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Standards Content (Sample)


SLOVENSKI STANDARD
SIST EN 455-1:2020+A1:2022/oprA2:2023
01-marec-2023
Medicinske rokavice za enkratno uporabo - 1. del: Zahteve in preskusi za
ugotavljanje odsotnosti lukenj - Dopolnilo A2
Medical gloves for single use - Part 1: Requirements and testing for freedom of 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/prA2:2023
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN 455- en,fr,de
1:2020+A1:2022/oprA2:2023
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

SIST EN 455-1:2020+A1:2022/oprA2:2023

SIST EN 455-1:2020+A1:2022/oprA2:2023

DRAFT
EUROPEAN STANDARD
EN 455-1:2020+A1:2022
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA2
January 2023
ICS 11.140
English Version
Medical gloves for single use - Part 1: Requirements and
testing for freedom of 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 draft amendment is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 205.

This draft amendment A2, if approved, will modify the European Standard EN 455-1:2020+A1:2022. If this draft becomes an
amendment, CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
inclusion of this amendment into the relevant national standard without any alteration.

This draft amendment 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. EN 455-
worldwide for CEN national Members. 1:2020+A1:2022/prA2:2023:2023 E

SIST EN 455-1:2020+A1:2022/oprA2:2023
EN 455-1:2020+A1:2022/prA2:2023 (E)
Contents Page
European foreword . 3
1 Modifications to the European foreword . 4
2 Modification to Annex A, 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 . 4
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered . 5
SIST EN 455-1:2020+A1:2022/oprA2:2023
EN 455-1:2020+A1:2022/prA2:2023 (E)
European foreword
This document (EN 455-1:2020+A1:2022/prA2:2023) 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 has been prepared under a Standardization Request given to CEN and CENELEC by the
European Commission and the European Free Trade Association, and supports essential requirements
of EU Directive(s) / Regulation(s).
For the relationship with EU Directive(s) / 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.

SIST EN 455-1:2020+A1:2022/oprA2:2023
EN 455-1:2020+A1:2022/prA2:2023 (E)
1 Modifications to the European foreword
Besides of the formal update of the existing European foreword of EN 455-1:2020+A1:2022 to include
EN 455-1:2020+prA2:2023, due to the intended integration of an Annex ZA add the following text at the
appropriate place:
“This document has been prepared under a Standardization Request given to CEN and CENELEC by the
European Commission and the European Free Trade Association, and supports essential requirements
of EU Directive(s) / Regulation(s).
For the relationship with EU Directive(s) / Regulation(s), see in
...

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