DIN EN 455-1-2001 Medical gloves for single use - Part 1 Requirements and testing for freedom from holes German version EN 455-1 2000《一次性医用手套 第1部分 密封性要求和检验》.pdf

1、DEUTSCHE NORM Januarv 2001 Medical gloves for single use Part 1 : Requirements and testing for freedom from holes English version of DIN EN 455-1 DIN - EN 455-1 ICs 11.140 Supersedes July 1998 edition. Medizinische Handschuhe zum einmaligen Gebrauch - Teil 1 : Anforderungen und Prfung auf Dichtheit

2、European Standard EN 455-1 : 2000 has the status of a DIN Standard. National foreword This standard has been prepared by CEN/TC 205 Non-active medical devices (Secretariat: United King- dom). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards C

3、ommittee), Technical Committee Medizinische finmalhandschuhe. Amendments This standard differs from DIN EN 455-1, July 1998 edition, in that clause 6 has been specified in more detail. Previous edition DIN EN 455-1 : 1998-07 EN comprises 5 pages. No pari of this standard may be reproduced without th

4、e prior permission of Ref. No. DIN EN 455-1 : 2001 -0 Y Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany, s the exclusive right of sale for German Standards (DIN-Normen). English price group O7 Sales No. 1107 05.01 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NOR

5、M 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 : Dtection des trous - Prescriptions et essais Medizinische Handschuhe zum einmaligen Gebrau

6、ch -Teil 1 : Anfor- derungen und Prfung auf Dichtheit This European Standard was approved by CEN on 2000-09-1 6. CEN members are bound to comply with the CENKENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alt

7、eration. Up-to-date lists and bibliographical references concerning such national stand- ards may be obtained on application to the Central Secretariat or to any CEN member. The European Standards exist in three official versions (English, French, German). A version in any other language made by tra

8、nslation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, the Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ire

9、land, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and the United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels O 2000. CEN - All rights o

10、f exploitation in any form and by any means reserved worldwide for CEN national members. Ref. No. EN 455-1 : 2000 E Page 2 EN 455-1 : 2000 Foreword This European Standard has been prepared by Technical Committee CENTC 205 “Non-active medical devices“, the secretariat of which is held by BSI. This Eu

11、ropean Standard supersedes EN 455-1 :1993 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 April 2001, and conflicting national standards shall be withdrawn at the latest by April 2001. This Europe

12、an 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(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this standard. This Eur

13、opean 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 addresses requirements and testing for biological evaluation. According to the CENKENELEC Internal Regulations, the na

14、tional standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.

15、 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 to EN 374-1 “Protective gloves against chemicals and micro-organisms - Part 1 : Terminology and performance require

16、ments“. 2 Normative reference This European Standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or

17、 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 publication referred to applies (including amendments). IS0 2859-1 Sampling procedures for inspection by attributes - Part 1

18、 : Sampling plans indexed by acceptable quality level (AQL) for lot-by-lot inspection. 3 Term and definition For the purposes of this standard the following term and definition apply: 3.1 medical gloves for single use gloves intended for use in the medical field to protect patient and user from cros

19、s-contamination. Page 3 EN 455-1 : 2000 4 Requirement Medical gloves for single use shall not leak when tested in accordance with clause 5. 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

20、glove and such that the tube is capable of holding any of the 1000 ml of water that may exceed the natural fill volume of 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 w

21、ithout damaging the glove (see figure 1). Add 1000 ml f 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. NOTE Some of the water may remain in the filling tube depending on the glove being tested Immediately insp

22、ect the glove visually for water leakage. Allow the glove to hang and visually inspect the glove for water leakage again 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

23、 suitable means until the water level reaches 40 mm from the cuff end. Inspect visually the previously untested portion 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 g

24、iven in 5.1 or by another test which is validated against this test. 6 Sampling, inspection level and AQL Each lot shall be sampled in accordance with IS0 2859-1 general inspection level 1, but utilising a minimum sample size and corresponding acceptancehejection numbers equivalent to sample size co

25、de letter L. When tested by the method described in 5.1 for referee purpose, the compliance level for freedom from holes 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 si

26、zes which would impact on manufacturing and testing costs. A minimum sample size equivalent to sample size code letter 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 Test report Any test report shall include at leas

27、t the following information: - a reference to this part of EN 455; -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 n

28、on-conforming gloves). Page 4 EN 455-1 : 2000 a)Cuff end of glove b)Locking device c)Fill tube overlapping Dimensions in millimeters A-A Figure 1 - Watertightness test - Filling tube Page 5 EN 455-1 : 2000 Clauselsub-clause of this Corresponding essential European Standard requirement of Directive 9

29、3142lEEC Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives Comments This European standard has been prepared under a mandate given to CENKENELEC by the European commission and the European Free Trade Association and suppor

30、ts essential requirements of EU Directive 93142lEEC. 4 5 5.2 6 7 WARNING Other requirements and other EU Directives mav be applicable to the product(s) falling within the scope of this standard. 1, 2, 3, 7.2, 8.1 1, 2, 3, 7.2 8.1 1, 2, 7.2, 8.1 1. 2. 8.1 The following clauses of this standard, as de

31、tailed in table ZA.1, are likely to support requirements of Directive 93142lEEC. 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.l - Correspondence between this European Standard and EU Directives