BS EN 455-1:2020 BSI Standards Publication Medical gloves for single use Part 1: Requirements and testing for freedom from holes bsi.BS EN 455-1:2020 BRITISH STANDARD National foreword This British Standard is the UK implementation of EN 455-1:2020. It supersedes BS EN 455-1:2000, which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/205/3, Medical gloves. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions ofa contract. Users are responsible for its correct application. © The British Standards Institution 2020 Published by BSI Standards Limited 2020 ISBN 978 0 539 04502 4 ICS 11.140; 13.340 Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 May 2020. Amendments/corrigenda issued since publication Date Text affectedEUROPEAN STANDARD EN 455-1 NORME EUROPEENNE EUROPAISCHE NORM May 2020 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 - Medizinische Handschuhe zum einmaligen Gebrauch Partie 1: Exigences et essais pour la + Teil 1: Anforderungen und Prifung auf Dichtheit détection de Fabsence de trous ‘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 stich national standards may be obtained on application to the CEN-CENELEC Management Centre or toany 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 ‘COMITE EUROPEEN DE NORMALISATION EUROPAISCHES KOMITEE POR NORMUNG, CCEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels (©2020 CEN _Allrights of exploitation in any form and by any means reserved Ref. No, EN 455-1:2020:E ‘worldwide for CEN national MembersBS 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 e ion 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; ©) In5.1 the referee testing has been enhanced to cover the issue on exten: filled with water; n of the glove when d)_InClause 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; ¢) 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 organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Icelan Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. iitBS EN 455-1:2020 EN 455-1:2020 (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 this document, the following terms and definitions apply. 180 and IEC maintain terminological databases for use in standardization at the following addresse: —_1SO Online browsing platform: available at https://www.iso.org/obp/ — IEC Electropedia: available at http://wwwelectropedia.org/ 34 medical gloves for single use gloves intended for use in the medical field to protect patient and user from cross-contamination, intended to be used on one individual during a single procedure NOTE Medical gloves labelled as single use are medical devices for single use according to the Medical Device Regulation (MDR). A single use medical device means a device that is intended to be used on one individual during single procedure. 3.2 hole defect of the glove which allows leakage of water 4 Requirement Medical gloves for single use shall not leak when tested in accordance with Clause 5. 5 Water tightness test for detection of holes 5.1 Referee testing Vertically position a filling tube of suitable dimensions to fit the glove such that the tube and the glove is capable of holding 1 000 ml of water. If, due to extension of the glove, the 1000 ml does not completely fill the glove, a means of ensuring thatall parts of the glove are tested shall be devised and implemented. Any modified process should not influence the viability of detection of holes. NOTE1 — For example, the glove can be clamped to restrict the flow of water sequentially until all parts of the glove have been tested for the required time interval. NOTE2 Suggested dimensions of the filling tube are shown in Figure 1. Attach the glove to the filling tube, overlapping the cuff by a maximum of 40 mm over the end ofthe tube and secure it by suitable means to obtain a watertight seal without damaging the glove (see Figure 1). Add (1.000 + 50) ml of water at a temperature of (15 to 35) °C into the open end of the filling tube, allowing the water to pass freely into the glove to ensure an equal distribution into each finger. Some of the water may remain in the filling tube depending on the glove being tested.BS EN 455-1:2020 EN 455-1:2020 (E) Immediately inspect the glove visually for water leakage. Repeat the inspection after a period of 2 min to 3 min. Leakages within 40 mm of the cuff are not relevant. 5.2 Routine testing Routine testing shall be either by the water tightness test given in 5.1 or by another test which is validated against this test. 6 Sampling, inspection level and AQL Each lot shall be sampled statistically in accordance with standardized AQL (acceptance quality level) tables for single sampling plans using general inspection level |, but utilizing a minimum sample size and corresponding acceptance/rejection numbers equivalent to sample size code letter L.. When tested by the method described in 5.1 for referee purpose, the compliance level for freedom from holes shall bean AQL of 0,65 for surgical gloves and 1,5 for examination gloves. NOTE1 Examples of standardized AQL tables can be found in [SO 2859-1 and ANSI/ASQ Z1.4. NOTE2 _Aminimum sample size equivalent to sample size code letter L ensures that an adequate assessment of the quality ofthe lot is obtained when the lot size is small or unknown, 7 Testreport Any test report shall include at least the following information: — areference to this document (EN 455-1); — the type of gloves and manufacturing batch code; — the name and address of the manufacturer or distributor and test laboratory, if different; — the date of the test performed; — the test results (batch size, sample size, number of non-conforming gloves).BS EN 455-1:2020 EN 455-1:2020 (E) Dimensions in milimeters A-A 3) 1 2 =050 SS Gf =#69 3 Key 1 cuffend ofglove 2 locking device 3 endoffill tube glove/fill tube overlap Figure 1 — Water tightness test — Filling tubeBS EN 455-1:2020 EN 455-1:2020 (E) 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 This European Standard has been prepared to support the corresponding General Safety and Performance Requirements and to provide one voluntary means of conforming to Regulation (EU) 2017/745 of 5 April 2017 concerning medical devices [0} L 117], the so called Medical Device Regulation (MDR). ‘This European Standard is suitable for conformity assessment purposes. Other means are possible, NOTE1 Currently for this European Standard there is no standardization request by the EU commission which is necessary to apply the harmonization procedure. An Annex ZA providing the presumption of conformity to the Medical Device Regulation (MDR) can therefore not be included in this document. Instead, this informative Annex has been included in order to provide at least the Table A.1 which conforms to the Table ZA.1 of the Annex ZA in both structure and content} NOTE2 The manufacturer's policy for determining acceptable risk must be in compliance with General Safety and Performance Requirements 1, 2,3, 4,5,8,9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation. NOTE3 When a General Safety and Performance Requirement does not appear in Table A.1, it means that itis not addressed by this European Standard. ‘Table A.1 — Correspondence between this European Standard and Annex | of Regulation (EU) 2017/745 [OJ L 117] ‘General Safety and Performance Requirements of | Clause(s)/subclause(s) of | _ Remarks/Notes Regulation (EU) 2017/745 this EN (Chapter I, Clause 1 4,6 ‘Safe design and high level of performance lachieved by defining 'AQL limits of freedom from holes [Chapter I, Clause 4. (a) 4,6 ‘safe design and man- uufacture through AQ. limits of freedom from holesBS EN 455-1:2020 EN 455-1:2020 (E) Bibliography [1] 180.2859-1, Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection [2] ANSI/ASQ 21.4, Sampling procedures and tables for inspection by attributesThis page deliberately left blankNO COPYING \WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW British Standards Institution (BSI) BSI is the national body responsible for preparing British Standar ls and other standards-related publications, information and service: BSI is incorporated by Royal Charter. British Standards and other standardization products are published by BSI Standards Limited. 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