EN ISO 21171-2006 en Medical gloves Determination of removable surface powder《医疗专用手套 可移动表面粉末的测定 ISO 21171-2006》.pdf

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1、BRITISH STANDARDBS EN ISO 21171:2006Medical gloves Determination of removable surface powderThe European Standard EN ISO 21171:2006 has the status of a British StandardICS 11.140g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g5

2、4g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN ISO 21171:2006This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2006 BSI 2006ISBN 0 580 48375 4National forewordThis British Standard is the official En

3、glish language version of EN ISO 21171:2006. It is identical with ISO 21171:2006.The UK participation in its preparation was entrusted by Technical Committee CH/205, Non-active medical devices, to Subcommittee CH/205/3, Medical gloves, which has the responsibility to: A list of organizations represe

4、nted on this subcommittee can be obtained on request to its secretary.Cross-referencesThe British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”,

5、 or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer i

6、mmunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related international and European developments and promulgate them

7、in the UK.Summary of pagesThis document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to v, a blank page, pages 1 to 10, an inside back cover and a back cover.The BSI copyright notice displayed in this document indicates

8、 when the document was last issued.Amendments issued since publicationAmd. No. Date CommentsEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 21171May 2006ICS 11.140English VersionMedical gloves - Determination of removable surface powder(ISO 21171:2006)Gants usage mdical - Dtermination de la po

9、udre desurface amovible (ISO 21171:2006)Medizinische Handschuhe - Bestimmung des entfernbarenOberflchenpuders (ISO 21171:2006)This European Standard was approved by CEN on 3 April 2006.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving

10、 this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (

11、English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, C

12、zech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROP

13、EN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 21171:2006: EForeword This document (EN ISO 21171:2006) has been prepare

14、d by Technical Committee ISO/TC 45 “Rubber and rubber products“ in collaboration with 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 t

15、ext or by endorsement, at the latest by November 2006, and conflicting national standards shall be withdrawn at the latest by November 2006. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential require

16、ments of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Aus

17、tria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The

18、 text of ISO 21171:2006 has been approved by CEN as EN ISO 21171:2006 without any modifications. EN ISO 21171:2006Reference numberISO 21171:2006(E)INTERNATIONAL STANDARD ISO21171First edition2006-05-01Medical gloves Determination of removable surface powder Gants usage mdical Dtermination de la poud

19、re de surface amovible EN ISO 21171:2006ii iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Principle. 1 3 Terms and definitions. 1 4 Apparatus 2 5 Reagents 2 6 Sampling 2 7 Method A Procedure for powdered gloves 2 8 Calculation of the result (method A). 3 9 Methods B and C Procedure for “p

20、owder-free” gloves . 3 10 Precision 6 11 Test report . 8 Bibliography . 9 EN ISO 21171:2006iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carrie

21、d out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. IS

22、O collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare Internatio

23、nal Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the ele

24、ments of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 21171 was prepared by Technical Committee ISO/TC 45, Rubber and rubber products, Subcommittee SC 3, Raw materials (including latex) for use in the rubber i

25、ndustry. This International Standard is based on ASTM D 6124-01, Standard Test Method for Residual Powder on Medical Gloves, copyright ASTM, used with permission of ASTM. For the purposes of this International Standard, the CEN annex regarding fulfilment of European Council Directives has been remov

26、ed. EN ISO 21171:2006vIntroduction Depending on their method of manufacture, some medical gloves can have on their surface a small amount of powder, normally modified corn-starch, which is intended to assist donning. Current thinking is that the presence of excessive amounts of such powder can prese

27、nt a health hazard. The methods for the determination of removable surface powder in this International Standard are based on those given in ASTM D 6124-01, from which they differ in the method for determining removable powder from powder-free surgeons gloves and in the precision data. EN ISO 21171:

28、2006blank1Medical gloves Determination of removable surface powder WARNING Persons using this International Standard should be familiar with normal laboratory practice. This standard does not purport to address all of the safety problems, if any, associated with its use. It is the responsibility of

29、the user to establish appropriate safety and health practices and to ensure compliance with any national regulatory conditions. 1 Scope This International Standard specifies methods for the determination of readily removable powder on the surface of gloves for medical use. Three methods are specifie

30、d: method A for powdered gloves and methods B and C for powder-free gloves. This International Standard does not address safety issues that may be associated with the presence of powder on gloves nor does it prescribe limits on the amounts that may be present. The applicability of this International

31、 Standard to medical gloves not made from rubber has not been established. 2 Principle The surfaces of a glove are washed with water to remove the water-insoluble powder which is then determined by filtration followed by weighing. The number of gloves used for the procedure depends on whether the gl

32、oves are nominally powder-free or powdered. 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 powder all water-insoluble material on the surface of a glove that is removed by washing under the conditions of the test 3.2 powdered gloves gloves f

33、or which a powder has been used as a part of the manufacturing process, generally to facilitate donning, and described by the manufacturer as “powdered” 3.3 powder-free gloves gloves which are described by the manufacturer as “powder-free” NOTE Gloves should always be clearly labelled as to whether

34、they are powdered or powder-free (unlabelled gloves would normally be unacceptable to consumers). Nevertheless, if a sample of gloves does not carry the designation “powdered” or “powder-free”, the gloves should be analysed as if they were powdered. EN ISO 21171:20062 4 Apparatus Normal laboratory g

35、lassware and tweezers, together with the following: 4.1 Balance, accurate to 0,1 mg. 4.2 Mechanical shaker, capable of a minimum oscillation frequency of 1,7 Hz (102 cycles/min). 4.3 Drying oven, capable of maintaining 100 C 5 C. 4.4 Filters, 90 mm and 47 mm glass microfibre filters of 2,7 m pore si

36、ze, together with suction filtration apparatus. 4.5 Desiccator. 5 Reagents 5.1 Wherever water is called for, distilled or deionized water shall be used. 6 Sampling Randomly select an appropriate number of gloves from each lot to be evaluated. For determinations on powdered gloves, use two gloves and

37、 for determinations on powder-free gloves use five gloves except in the case of surgeons gloves for which use three pairs (i.e. six gloves). 7 Method A Procedure for powdered gloves 7.1 Before use, rinse all glassware and tweezers with water. 7.2 The test shall be carried out at 25 C 5 C on two glov

38、es randomly selected. 7.3 Take a 90 mm, 2,7 m pore size filter and place it in the desiccator for not less than 30 min. Remove the filter and immediately weigh it on the balance, determining the mass to the nearest 0,1 mg. Record the mass in grams (m0). NOTE The use of a PTFE (polytetrafluoroethylen

39、e) base is suggested if experience shows that there is a risk of tearing the filter on removal from a glass surface. 7.4 Place the filter in the suction apparatus. 7.5 Carefully remove a glove from its packaging and insert it into a 1 l capacity conical flask, or other suitable container, containing

40、 500 cm3of water so that 1 cm to 3 cm of the cuff projects out round the rim of the flask. Pour approximately 250 cm3of water into the glove while holding a small portion of the cuff away from the rim of the flask to allow air to be vented from the flask. While pouring the water into the glove ensur

41、e that the projecting part of the cuff is rinsed. Tightly seal the flask with a rubber stopper covered by a small piece of polypropylene sheet so that the flask does not leak. Place the sealed flask in the mechanical shaker and oscillate for 30 s at a speed of not less than 1,7 Hz. Ensure that all t

42、he surfaces of the glove are well washed. 7.6 Take the flask from the shaker and remove the stopper. Pour the water from inside the glove through the filter in the suction filtration unit. Remove the glove from the flask and pour any remaining water from inside the glove through the filter, followed

43、 by the water in the flask. 7.7 Using the same glove repeat the procedure of 7.5 and 7.6 with a further 500 cm3of fresh water in the flask and 250 cm3in the glove. EN ISO 21171:200637.8 Repeat the procedure of 7.7 twice more, to make a total of four fresh water rinses for a single glove. Finally, ri

44、nse the flask and stopper covering with fresh water, to ensure that all material on them has been transferred to the filter. 7.9 Using a second glove repeat the procedure of 7.5 to 7.8 (in the case of surgeons gloves, use the other one of the pair). 7.10 Remove as much water from the filter as possi

45、ble by suction. Discard the filtrate. Carefully remove the filter and transfer it to a washed and dried watch glass or Petri dish. Dry in an oven at 100 C 5 C for 1 h then transfer to the desiccator to cool for not less than 30 min. Weigh the filter immediately after removal from the desiccator to m

46、inimize re-adsorption of moisture. Record the mass, in grams, to the nearest 0,1 mg (m1). 8 Calculation of the result (method A) The mass of powder, in milligrams, on the two gloves is given by (m1 m0) 1 000 The average mass (mA) of powder per glove, in milligrams, is given by mmm=10A1 00029 Methods

47、 B and C Procedure for “powder-free” gloves 9.1 General The procedure to be used for “powder-free” gloves is generally similar to that described above (see Clause 7). However, it employs a smaller filter and five gloves, except in the case of surgeons gloves when six are used (see the Note) and the

48、same water is used for rinsing each of them. Because only a small amount of powder should be present, it is also necessary to run a blank. NOTE Surgeons gloves are packaged in pairs. As the right hand and the left hand are not normally produced at the same time, it is important to test the same numb

49、er of each hand. 9.2 Method B Procedure for “powder-free” gloves other than surgeons gloves 9.2.1 Before use, rinse all glassware and tweezers with water. 9.2.2 The test shall be carried out at 25 C 5 C on five gloves randomly selected. 9.2.3 Take a 47 mm, 2,7 m pore size filter. Transfer it to the suction apparatus, rinse it with three portions of 50 cm3of water and suck free of water. Place the filter on a watch glass or Petri dish and dry it in an oven at 100 C 5 C for 1 h. Transfer the filter to a desiccator to cool