SIST EN 455-1:2020+A1:2022/kFprA2:2024

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 - Partie1 : 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
• Public Enquiry End Date: 30-Mar-2023
• ICS: 11.140 - Hospital equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 98 - Abandoned project (Adopted Project)
• Start Date: 04-Oct-2024
• Due Date: 09-Oct-2024
• Completion Date: 04-Oct-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
• Mandate: M/575 AMD 2 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medicial devices in support of Regulation (EU) 2017746
• Ref Project: EN 455-1:2020+A1:2022/FprA2 - Medical gloves for single use - Part 1: Requirements and testing for freedom of holes

Relations

• Merged Into: SIST EN 455-1:2020+A2:2024 - Medical gloves for single use - Part 1: Requirements and testing for freedom of holes
• Effective Date: 01-Dec-2024
• Amends: SIST EN 455-1:2020+A1:2022 - Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
• Effective Date: 01-Mar-2023

Overview

SIST EN 455-1:2020+A1:2022/kFprA2:2024 is a European standard developed by CEN that specifies the requirements and testing methods for medical gloves for single use to ensure freedom from holes. This standard forms part 1 of the EN 455 series, which comprehensively addresses the quality and safety of disposable medical gloves. Its purpose is to guarantee the integrity of gloves as a barrier against contaminants, protecting both healthcare personnel and patients during medical procedures.

The standard has been updated with amendments to align it with EU Regulation 2017/745 on medical devices, reinforcing compliance with health and safety requirements and providing manufacturers with a clear framework for product design, testing, and risk management.

Key Topics

• Freedom from holes testing: Specifies precise methods to detect pinholes and defects in gloves to ensure no compromise in barrier protection.
• Acceptance Quality Level (AQL): Defines limits on allowable holes to maintain a high safety standard.
• Relationship with EU regulations: The standard supports conformity with essential EU regulatory requirements, such as clinical evaluation, risk management, and post-market surveillance.
• Design and manufacturing safety: Emphasizes risk reduction through design and manufacturing processes to limit microbial leakage and infection risks.
• Amendments and updates: Incorporates latest revisions to better align with changes in European legislation and technical advancements.

Applications

SIST EN 455-1:2020+A1:2022/kFprA2:2024 is crucial for:

• Manufacturers of single-use medical gloves seeking to certify product quality and compliance with European legislation.
• Healthcare providers and hospitals requiring gloves that guarantee high barrier protection against pathogens and contaminants.
• Regulatory bodies and certification organizations involved in the conformity assessment of disposable medical gloves.
• Supply chain and quality assurance professionals ensuring the delivery of safe, defect-free gloves.

By adhering to this standard, stakeholders can minimize infection risks during medical and surgical procedures, enhancing patient safety and occupational health.

Related Standards

EN 455 series includes complementary parts that collectively ensure the full lifecycle management and safety of medical gloves:

• EN 455-2: Requirements and testing for physical properties (strength, elongation, etc.)
• EN 455-3: Requirements and testing for biological evaluation (biocompatibility)
• EN 455-4: Requirements and testing for shelf life determination (durability over time)
• Part 5 (under development): Extractable chemical residues (chemical safety aspects)

These standards together form a comprehensive framework supporting the design, manufacture, testing, and post-market evaluation of single-use medical gloves.

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Keywords: EN 455-1, medical gloves standard, single-use gloves, freedom from holes, AQL testing, medical device compliance, EU Regulation 2017/745, glove integrity, infection control, disposable medical gloves.

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
...