EN 455-1-2000 en Medical Gloves for Single Use - Part 1 Requirements and Testing for Freedom from Holes《一次性用医用手套 第1部分 防洞要求和试验 代替EN 455-1-1993》.pdf

1、STD-BSI BS EN 455-3-ENGL 2000 W Lb24bb9 0885563 TTO = BRITISH STANDARD BS EN 455-1:2000 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes The European Standard EN 4551:2000 has the status of a British Standard ICs 11.140 NO COPYING WITHOUT BSI PERMISSION EXCEPT

2、AS PERMIITED BY COPYRIGHT LAW STD.BSI BS EN 455-1-ENGL 2000 = Lb24bb 0885562 937 m BS EN 455-1:2000 direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 December 2000 Amd. No. National foreword Date Comment

3、s This British Standard is the officiai English language version of EN 4551:2000. It supersedes BS EN 4551:1994 which is withdrawn The UK participation in its preparation was entrusted to Technical Committee CW6, Rubber products for hospital use, which has the responsibility to: - aid enquirers to u

4、nderstand the tea - present to the responsible European committee any enquiries on the - monitor related internatiod and European developments and promulgate interpretation, or proposals for change, and keep the UK interests informed them in the UK A list of organizations represented on this committ

5、ee can be obtained on request to its secrem. Cross-references The British Standards which implement intemational or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using th

6、e “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from

7、 legal obligations. Summary of pages This document comprises a front cover, am inside front cover, the EN titie page, pages 2 to 5 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. O BSI 122000 I I ISBN O 580 36697 9 STD-BSI BS EN 4SS-

8、L-ENGL 2000 Lb24bb7 0885563 873 9 EUROPEAN STANDARD NORME EUROPEENNE EUROPAISCHE NORM EN 455-1 October 2000 ICs 13.340 Supersedes EN 455-1 :1993 English version Medical gloves for single use - Part 1: Requirements and testing for freedom from holes Gants mdicaux non rutilisables - Partie 1 : Dtectio

9、n des trous - Prescriptions et essais Medizinische Handschuhe zum einmaligen Gebrauch - Teil 1: Anforderungen und Prifung auf Dichtheit This European Standard was approved by CEN on 16 September 2000. CEN members are bound to comply with the CENICENELEC Intemal Regulations which stipulate the condit

10、ions for giving this Europsan Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning sich national standards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three o

11、fficial versions (English, French, German). A version in any other language made by traislation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as he official versions. CEN members are the national standards bodies of Austria

12、, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMIEE FOR STANDARDIZATION EUROPAISCHES KOMITEE FR NORMUNG COMITE EUROPEN DE NORMALISATION Central Secret

13、ariat: rue de Stassart, 36 81050 Brussels O 2000 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 455-1 :2000 E STD-BSI BS EN 455-II-ENGL 2000 = Lb24bb9 OBB55b4 70T = Page 2 EN 455-1 i2000 Foreword This European Standard has been pr

14、epared by Technical Committee CEN/TC 205, Non-active medical devices, the Secretariat of which is held by BSI. This European Standard supersedes EN 455-1 ;I 993 This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at t

15、he latest by April 2001, and conflicting national standards shall be withdrawn at the latest by April 2001. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive).

16、For relationship with EU Directive), see informative Annex ZA, which is an integral part of this standard. This European Standard applies to medical gloves for single use and has been prepared in three parts. This part addresses freedom from holes; Part 2 addresses physical properties and Part 3 add

17、resses requirements and testing for biological evaluation. According to the CENICENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Ic

18、eland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. 1 Scope This part of this standard specifies requirements and gives the test method for medical gloves for single use in order to determine freedom from holes. NOTE Attention is drawn

19、 to EN 374-1 “Protective gloves against chemicals and micro-organisms - Part 1: Terminology and performance requirements“. 2 Normative Reference This European Standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropri

20、ate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publicati

21、on referred to applies (including amendments). IS0 2859-1, Sampling procedures for inspection by attributes - Part 1: Sampling plans indexed by acceptable quality level (AQL) for lot-by-lot inspection 3 Tenn and definition For the purposes of this standard the following term and definition apply: 3.

22、1 medical gloves for single use gloves intended for use in the medical field to protect patient and user from cross-contamination 4 Requirement Medical gloves for single use shall not leak when tested in accordance with clause 5. O BSI 12-2000 STDOBSI BS EN 455-L-ENGL 2000 Lb24bb9 08855b5 b4b = Page

23、 3 EN 455-1 12000 5 Watertightness test for detection of holes 5.1 Referee testing Vertically position a filling tube of dimensions shown in Figure 1 or of dimensions to fit the glove and such that the tube is capable of holding any of the 1 O00 mi of water that may exceed the natural fill volume of

24、 the glove. Attach the glove to the filling tube, overlapping the cuff by a maximum of 40 mm over the end of the tube and secure it by suitable means to obtain a watertight seal without damaging the glove (see Figure 1). Add i O00 ml f 50 ml of water at a temperature of (1 5 to 35)OC into the open e

25、nd of the filling tube, allowing the water to pass freely into the glove. NOTE Some of the water may remain in the filling tube depending on the glove being tested. Immediately inspect the glove visually for water leakage. Allow the glove to hang and visually inspect the glove for water leakage agai

26、n after a period of 2 min to 3 min. If, because of distension of the glove, the water does not rise to within 40 mm of the cuff end, raise the glove after the second inspection by a suitable means until the water level reaches 40 mm from the cuff end. Inspect visually the previously untested portion

27、 of the glove after a further period of 2 min to 3 min. Disregard leakages within 40 mm of the cuff. 5.2 Routine testing Routine testing shall be either by the watertightness test given in 5.1 or by another test which is validated against this test. 6 Sampling, inspection level and AQL Each lot shal

28、l be sampled in accordance with IS0 2859-1 general inspection level 1, but utilizing a minimum sample size and corresponding acceptancehejection 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 hole

29、s shall be an AQL of 13. NOTE This inspection level meets the requirements of Annex IV point 6.3 of the Medical Devices Directive, 93/42/EEC, and does not entail excessive sample sizes which would impact on manufacturing and testing costs. A minimum sample size equivalent to sample size code letter

30、L is necessary to ensure that an adequate assessment of the quality of the lot is obtained when the lot size is small or unknown. 7 Testreport Any test report shall include at least the following information: - a reference to this part of EN 455; -the type of gloves and manufacturing batch code; - t

31、he 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). Q BSI 12-2000 Page 4 EN 455-1 :2000 Dimensions in millimetres Key a) Cuff end of glove b) Locking d

32、evice c) Fill tube overlapping A-A c. Figure I -Watertightness test - Filling tube O BSI 12-2000 STD-BSI BS EN 455-1-ENGL 2000 1624667 0885567 417 = Clauselsubtlause of this European Standard 4 5 5.2 6 Page 5 EN 455-1 :2000 Corresponding essential Comments requirement of Directive 931421EEC 1, 2, 3,

33、 7.2, 8.1 1, 2, 3, 7.2 8.1 1, 2, 7.2, 8.1 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives This European standard has been prepared under a mandate given to CENKENELEC by the European commission and the European Free Trad

34、e Association and supports essential requirements of EU Directive 93/42/EEC. WARNING Other requirements and other EU Directives may be applicable ta the product(s) falling within the scope of this standard. The following clauses of this standard, as detailed in table A.1, are likely to support requi

35、rements of Directive 93/42/EEC. Compliance with the clauses of this standard provides one means of conforming with the specific essential requirements of the Directive concerned and associated EFTA regulations. Table ZA.1 - Correspondence between this European Standard and EU Directives 7 I 1, 2, 8.

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