EN 455-2-2015 en Medical gloves for single use - Part 2 Requirements and testing for physical properties《一次性医用手套 第2部分 物理性能的要求和试验》.pdf

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1、BSI Standards PublicationBS EN 455-2:2015Medical gloves for single usePart 2: Requirements and testing for physical propertiesBS EN 455-2:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 455-2:2015. Itsupersedes BS EN 455-2:2009+A2:2013 which is withdrawn.Th

2、e UK participation in its preparation was entrusted to TechnicalCommittee CH/205/3, Medical gloves.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are respon

3、sible for its correctapplication. The British Standards Institution 2015. Published by BSI StandardsLimited 2015ISBN 978 0 580 82688 7ICS 11.140Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Poli

4、cy and Strategy Committee on 30 April 2015.Amendments issued since publicationDate T e x t a f f e c t e dEUROPEAN 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

5、for physical properties Gants mdicaux non rutilisables - Partie 2 : Exigences et essais 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 membe

6、rs 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 such national standards may be obtained on applicatio

7、n to the CEN-CENELEC Management Centre or to any 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 Manageme

8、nt 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, L

9、ithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, 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

10、, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 455-2:2015 EBS EN 455-2:2015EN 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 Gener

11、al 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 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 medic

12、al devices . 11 BS EN 455-2:2015EN 455-2:2015 (E) 3 Foreword This document (EN 455-2:2015) 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 pub

13、lication of an identical text or by endorsement, at the latest by October 2015 and conflicting 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

14、 shall not be held responsible for identifying any or all such patent rights. This document supersedes 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 Dir

15、ective(s). For relationship with EU Directive(s), see informative Annex ZA which is an integral 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 med

16、ian values of force of break deleted; d) Annex ZA updated. 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

17、for biological evaluation Part 4: Requirements and testing for shelf life determination According 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

18、 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

19、 BS EN 455-2:2015EN 455-2:2015 (E) 4 1 Scope This European Standard specifies requirements 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

20、 protection from cross contamination for both patient and user. This European Standard does 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

21、 500 000. 2 Normative references The following documents, in whole or in part, are normatively 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

22、 any amendments) applies. EN 455-4:2009, Medical gloves for single use Part 4: Requirements 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, l

23、abelling and information to be supplied Part 1: General requirements (ISO 15223-1:2012) 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 Term

24、s and definitions For the purposes of this document, the following terms and definitions 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

25、 thumb positioned towards the palmar surface of the index finger rather than lying flat, 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,

26、diagnostic and therapeutic procedures and for handling contaminated medical material 3.4 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

27、 packed in the same type of individual container SOURCE: EN 455-4:2009, 3.4 BS EN 455-2:2015EN 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

28、width l length Figure 1 Designation of length and width of gloves 4.2 Length Measure 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. Remo

29、ve wrinkles and folds without stretching the glove. Record the median measured length. 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,

30、using a ruler, with the glove placed on a flat surface. Do not stretch the glove. BS EN 455-2:2015EN 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 10

31、8 6 9 280 114 6 9,5 280 121 6 aDimension l as designated in Figure 1. bDimension w 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

32、 2 Dimensions of examination/procedure gloves Size Median lengthal in mm Median widthb 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. a

33、Dimension l as designated in Figure 1. bDimension w 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. BS EN 455-2:2015EN 455-2:2015 (E) 7

34、5 Strength 5.1 General Different glove materials require different force at break 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 par

35、t of the risk management process. When the strength of the glove is tested as described 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

36、 EN 455-4:2009. 5.2.2 Obtain one dumb-bell test piece from each of 13 gloves taken 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 possib

37、le and taking the test pieces in the direction of the longitudinal axis of the glove. BS EN 455-2:2015EN 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 conditioni

38、ng for a minimum of 16 h. The tensometer should be equipped with a load cell 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

39、repeat the test on another test piece. 5.2.4 a) Determine the single wall thickness (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

40、 foot pressure of (22 5) kPa. Take the single wall thickness as one half of the measured double wall thickness. BS EN 455-2:2015EN 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)

41、. c) Compare the values of tfand tx. If tf/tx 0,9, no correction to the measured 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 r

42、ecognised that the fingers of a glove may, because of design or manufacturing 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

43、Table 3 is maintained at the fingertips. If the difference in thickness between 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 app

44、lied to the measured force at break to obtain a true estimate of the strength 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. Ta

45、ble 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 6,0 3,6 a) Requirements for all surgical gloves. b) Requirements for all

46、examination gloves, except gloves made from thermoplastic materials (e.g. polyvinylchloride, polyethylene) c) Requirements for gloves made from thermoplastic materials (e.g. polyvinylchloride, polyethylene). 5.3 Force at break after challenge testing 5.3.1 Gloves packaged in unit packages or gloves

47、taken from bulk packages shall be placed for a period of seven days at a temperature of (70 2) C in an oven as specified in ISO 188:2007, clause 4. 5.3.2 Measure the force at break as described in 5.2. BS EN 455-2:2015EN 455-2:2015 (E) 10 6 Test report Any test report shall include at least the foll

48、owing information: a) reference to this part of EN 455; b) the type of glove and the manufacturing batch code; c) the name and address of the manufacturer or distributor and test laboratory, if different; d) the date of testing performed; e) the test results. 7 Labelling In addition to labelling req

49、uirements defined in other parts of EN 455 manufacturers shall label the glove and/or the packaging with the date of manufacture in accordance with EN ISO 15223-1:2012 and EN 1041:2008+A1:2013. Date of manufacture is defined as the packaging date. BS EN 455-2:2015EN 455-2:2015 (E) 11 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC concerning medical devices This European Standard has been prepared under a