1、July 2015 Translation by DIN-Sprachendienst.English price group 9No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11
2、.140!%CoW“2327652www.din.deDDIN EN 455-2Medical gloves for single use Part 2: Requirements and testing for physical properties;English version EN 455-2:2015,English translation of DIN EN 455-2:2015-07Medizinische Handschuhe zum einmaligen Gebrauch Teil 2: Anforderungen und Prfung der physikalischen
3、Eigenschaften;Englische Fassung EN 455-2:2015,Englische bersetzung von DIN EN 455-2:2015-07Gants mdicaux non rutilisables Partie 2: Exigences et essais pour proprits physiques;Version anglaise EN 455-2:2015,Traduction anglaise de DIN EN 455-2:2015-07SupersedesDIN EN 455-2:2011-05www.beuth.deIn case
4、of doubt, the German-language original shall be considered authoritative.Document comprises 13 pages 06.15 DIN EN 455-2:2015-07 2 A comma is used as the decimal marker. National foreword This document (EN 455-2:2015) has been prepared by Technical Committee CEN/TC 205 “Non-active medical devices”, (
5、Secretariat: DIN, Germany). The responsible German body involved in its preparation was the DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-01-05 AA Medizinische Einmalhandschuhe. The DIN Standards corresponding to the International Standards referred to in t
6、his document are as follows: ISO 23529:2010 DIN ISO 23529:2012-10 Amendments This standard differs from DIN EN 455-2:2011-05 as follows: a) normative references have been updated; b) Clause 7 “Labelling” has been added; c) in Table 3 “Median values of force at break”, the exception for nitrile has b
7、een deleted; d) Annex ZA (informative) has been updated. Previous editions DIN EN 455-2: 1995-04, 1998-07, 2001-01, 2010-04, 2011-05 DIN EN 455-2 Corrigendum 1: 1996-12 National Annex NA (informative) Bibliography DIN ISO 23529, Rubber General procedures for preparing and conditioning test pieces fo
8、r physical test methods EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 455-2 April 2015 ICS 11.140 Supersedes EN 455-2:2009+A2:2013English Version Medical gloves for single use - Part 2: Requirements and testing for physical properties Gants mdicaux non rutilisables - Partie 2 : Exigences et e
9、ssais pour proprits physiques Medizinische Handschuhe zum einmaligen Gebrauch - Teil 2: Anforderungen und Prfung der physikalischen Eigenschaften This European Standard was approved by CEN on 24 January 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate t
10、he conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standar
11、d 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 nation
12、al standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slova
13、kia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means
14、 reserved worldwide for CEN national Members. Ref. No. EN 455-2:2015 EEN 455-2:2015 (E) 2 Contents Page Foreword 3 1 Scope 4 2 Normative references 4 3 Terms and definitions .4 4 Dimensions .5 4.1 General 5 4.2 Length .5 4.3 Width .5 5 Strength 7 5.1 General 7 5.2 Force at break 7 5.3 Force at break
15、 after challenge testing .9 6 Test report . 10 7 Labelling 10 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC concerning medical devices . 11 DIN EN 455-2:2015-07 EN 455-2:2015 (E) 3 Foreword This document (EN 455-2:2015) ha
16、s 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 October 2015 and conflictin
17、g national standards shall be withdrawn at the latest by October 2015. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document s
18、upersedes EN 455-2:2009+A2:2013. This document 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 integr
19、al part of this document. With respect to EN 455-2:2009+A2:2013 the following changes are: a) normative references revised; b) new Clause 7 “labelling“ introduced; c) exception for nitrile in Table 3 for median values of force of break deleted; d) Annex ZA updated. EN 455 consists of the following p
20、arts, 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 Accor
21、ding to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany,
22、 Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. DIN EN 455-2:2015-07 EN 455-2:2015 (E) 4 1 Scope This European Standard specifies requiremen
23、ts and gives test methods for physical properties of single-use medical gloves (i.e. surgical gloves and examination/procedure gloves) in order to ensure that they provide and maintain in use an adequate level of protection from cross contamination for both patient and user. This European Standard d
24、oes not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000. 2 Normative references The following documents, in whole or in part, are norma
25、tively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 455-4:2009, Medical gloves for single use Part 4: Requireme
26、nts and testing for shelf life determination EN 1041:2008+A1:2013, Information supplied by the manufacturer of medical devices EN ISO 15223-1:2012, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements (ISO 15223-1:2012)
27、ISO 188:2007, Rubber, vulcanized or thermoplastic Accelerated ageing and heat resistance tests ISO 23529:2010, Rubber General procedures for preparing and conditioning test pieces for physical test methods 3 Terms and definitions For the purposes of this document, the following terms and definitions
28、 apply. 3.1 medical gloves for single use gloves intended for use in the medical field to protect patient and user from cross-contamination 3.2 surgical gloves sterile, anatomically shaped medical gloves with the thumb positioned towards the palmar surface of the index finger rather than lying flat,
29、 and intended for use in invasive surgery 3.3 examination gloves procedure gloves sterile or non-sterile medical gloves, which may or may not be anatomically shaped, intended for conducting medical examinations, diagnostic and therapeutic procedures and for handling contaminated medical material 3.4
30、 lot collection of gloves of the same design, colour, shape, size and formulation, manufactured at essentially the same time, using the same process, raw materials of the same specifications, common equipment and packed in the same type of individual container SOURCE: EN 455-4:2009, 3.4 DIN EN 455-2
31、:2015-07 EN 455-2:2015 (E) 5 4 Dimensions 4.1 General When measured as described in 4.2 and 4.3 taking 13 samples from each lot, the median value obtained for the dimensions shall be as given in Tables 1 and 2. Key w width l length Figure 1 Designation of length and width of gloves 4.2 Length Measur
32、e the length (dimension l, as designated in Figure 1) by freely suspending the glove with the middle finger on a vertical graduated rule having a rounded tip so as to fit the shape of the finger tip of the glove. Remove wrinkles and folds without stretching the glove. Record the median measured leng
33、th. For greater ease of measurement, the ruler may be angled backwards slightly so that the glove is in contact with the ruler. 4.3 Width Measure the width (dimension w, as designated in Figure 1), to the nearest mm, using a ruler, with the glove placed on a flat surface. Do not stretch the glove. D
34、INEN 455-2:2015-07EN 455-2:2015(E)6 Table 1 Dimensions of surgical gloves Size Median lengthaMedian widthb cl in mm w in mm 5 250 67 4 5,5 250 72 4 6 260 77 5 6,5 260 83 5 7 270 89 5 7,5 270 95 5 8 270 102 6 8,5 280 108 6 9 280 114 6 9,5 280 121 6 aDimension l as designated in Figure 1. bDimension w
35、 as designated in Figure 1. cThe width requirements are for gloves made from natural rubber latex and all other elastomeric materials. These dimensions may not be appropriate for gloves made from other materials. Table 2 Dimensions of examination/procedure gloves Size Median lengthal in mm Median wi
36、dthb cw in mm Extra Small 240 80 Small 80 10 Medium 95 10 Large 110 10 Extra Large 110 NOTE Manufacturers may optionally use the sizes and dimensions given in Table 1 in order to provide a wider range of glove sizes. aDimension l as designated in Figure 1. bDimension w as designated in Figure 1. cTh
37、e width requirements are for gloves made from natural rubber latex and all other elastomeric materials. These dimensions may not be appropriate for gloves made from other materials. DIN EN 455-2:2015-07 EN 455-2:2015(E)7 5 Strength 5.1 General Different glove materials require different force at bre
38、ak requirements to ensure an acceptable performance. Absolute force at break values do not directly correlate with the in use performance. Selection of appropriate glove materials for the intended application shall be part of the risk management process. When the strength of the glove is tested as d
39、escribed in 5.2 at a temperature of (23 2) C and a relative humidity of (50 5) % r.h. the force at break of gloves shall be as given in Table 3. 5.2 Force at break 5.2.1 Ageing and shelf life requirements are described in EN 455-4:2009. 5.2.2 Obtain one dumb-bell test piece from each of 13 gloves ta
40、ken from a single lot (from seven pairs of gloves where applicable) using a cutter as specified in Figure 2 from the palm, back of the hand or cuff areas of each glove in the test sample, avoiding textured areas if possible and taking the test pieces in the direction of the longitudinal axis of the
41、glove. DIN EN 455-2:2015-07 EN 455-2:2015(E)8 Dimensions in millimetres Key 1 grind 6 mm/min. 2 spacer 3 bolts Figure 2 Cutter for dumb bell specimens 5.2.3 Determine the force at break of the 13 test pieces after conditioning for a minimum of 16 h. The tensometer should be equipped with a load cell
42、 appropriate for the strength of the sample under test, with jaws that firmly grip but do not damage the test specimen and with a crosshead speed of 500 mm/min. If a test piece breaks at the shoulder, it is not necessary to repeat the test on another test piece. 5.2.4 a) Determine the single wall th
43、ickness (tf) of the same glove as in 5.2.2 at a point on the middle finger within (13 3) mm of the fingertip by measuring the double wall thickness as described in method A of ISO 23529:2010, Clause 7.1, using a gauge with a foot pressure of (22 5) kPa. Take the single wall thickness as one half of
44、the measured double wall thickness. DIN EN 455-2:2015-07 EN 455-2:2015(E)9 b) Measure the thickness of the dumb-bell test pieces (tx) as described in method A of ISO 23529:2010, Clause 7.1, using the gauge described in 5.2.4 a). c) Compare the values of tfand tx. If tf/tx 0,9, no correction to the m
45、easured force at break is necessary. If tf/tx 0,9, correct the measured value by multiplying the measured force at break (see 5.2.3) by a factor of tf/tx. Although there is no requirement for thickness in this standard, it is recognised that the fingers of a glove may, because of design or manufactu
46、ring processes, be significantly thinner and therefore weaker in terms of force to break than at the points from which the test pieces were taken. It is important to ensure that the minimum force at break requirements given in Table 3 is maintained at the fingertips. If the difference in thickness b
47、etween the fingertip and the point from which the test pieces were taken is small (less than 10 %), no correction is necessary. If this difference is greater than 10 %, a correction factor based on the relative thickness is applied to the measured force at break to obtain a true estimate of the stre
48、ngth of the glove at the fingertip. 5.2.5 Record the force at break, in N, for each of the 13 samples, corrected as described in 5.2.4 if necessary. The median of the recorded results shall comply with the values of Table 3. Table 3 Median values of force at break Force at break in Newton Surgical gloves a) Examination/procedure gloves b) c) Throughout shelf life tested according to 5.2 and within 12 months of manufacture tested according to 5.3 9,0 6
