【BS英国标准】BS EN 4553 Medical gloves for single use Part 3 Requirements and testing for bi

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1、国内外标准大全豆丁网国内外标准下载地址 BRITISH STANDARDBS EN455-3:2006Medical gloves for single use Part 3: Requirements and testing for biological evaluationThe European Standard EN 455-3:2006 has the status of aBritish StandardICS 11.140 BS EN 455-3:2006National forewordThis British Standard was published by BSI. It

2、 is the UK implementation ofEN 455-3:2006. It supersedes BS EN 455-3:2000 which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/205, Non-active medical devices, to Subcommittee CH/205/3, Medical gloves.A list of organizations represented on CH/205/3 can b

3、e obtained on request to its secretary.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 cannot confer immunity from legal obligations.Amd. No.DateCommentsThis British Standard

4、 was published under the authority of the Standards Policy and Strategy Committeeon 31 January 2007 BSI 2007ISBN 978 0 580 49995 1Amendments issued since publicationEUROPEAN STANDARD NORME EUROPENNEEUROPISCHE NORMEN 455-3December 2006ICS 11.140Supersedes EN 455-3:1999English VersionMedical gloves fo

5、r single use - Part 3: Requirements and testing for biological evaluationGants mdicaux non rutilisables - Partie 3: Exigences et essais pour valuation biologiqueMedizinische Handschuhe zum einmaligen Gebrauch - Teil3: Anforderungen und Prfung fr die biologischeBewertungThis European Standard was app

6、roved by CEN on 13 October 2006.CEN members 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 nationa

7、l standards may be obtained on application to the Central Secretariat 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 notifi

8、ed to the Central Secretariat has the same status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherland

9、s, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONC OM I T EUR OP EN DE NOR M AL I S ATI ON EUR OP I S C HES KOM I TEE F R NOR M UNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2006 CENAll rights o

10、f exploitation in any form and by any means reserved worldwide for CEN national Members.Ref. No. EN 455-3:2006: EEN 455-3:2006 (E)ContentsPageForeword.3Introduction .41Scope .52Normative references .53Terms and definitions .64Requirements .65Test methods.86Test report .9Annex A (normative) Method fo

11、r the determination of aqueous extractable proteins in naturalrubber gloves using the modified Lowry assay .10Annex B (informative) Immunological methods for the measurement of natural rubber latexallergens .20Annex C (informative) Amino acid analysis (AAA) by high pressure liquid chromatography(HPL

12、C) .27Annex ZA (informative) Relationship between this European Standard and the EssentialRequirements of EU Directive 93/42/EEC Medical Devices.3635ForewordThis document (EN 455-3:2006) has been prepared by Technical Committee CEN/TC 205 “Non-active medical devices”, the secretariat of which is hel

13、d 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 June 2007, and conflicting national standards shall be withdrawn at the latest by June 2007.This document supersedes EN 455-3:1999.This doc

14、ument has been prepared under a mandate given to CEN by the European Commission and theEuropean Free Trade Association, and supports essential requirements of EU Directive 93/42/EEC.For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. EN 455 consi

15、sts 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 for biological evaluationAccording to the CEN/CENELEC Internal Regulatio

16、ns, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway

17、, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.IntroductionAdverse reactions to proteins in latex products have been reported over several years in variable rates of prevalence. Additionally, adverse reactions due to chemicals, lubricants, sterilizatio

18、n residues, pyrogens or other residues are described in the scientific literature. Adverse reactions are most often reported due to gloves made from natural rubber latex, but some of the reactions can also be seen due to gloves made from synthetic polymers.EN ISO 10993 specifies requirements and tes

19、t methods for biological evaluation of medical devices. However it does not specifically address adverse reactions that can result from the use of medical gloves (e.g, immediate type allergies). These adverse reactions occur to specific allergens that can be present in gloves. Several factors contri

20、bute to the risk of reaction:a)the duration and frequency of skin contact with gloves;b)the exposure to the allergens through direct contact to mucosa and skin (especially when not intact) and by inhalation of particles;c)the occlusive nature of the glove/skin interaction during glove use.This part

21、of EN 455 gives requirements and test methods for evaluation of the biological safety of medical gloves as part of a risk management process, in accordance with EN ISO 14971 and EN ISO 10993.1ScopeThis part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves f

22、or single use. It gives requirements for labelling and the disclosure of information relevant to the test methods used.2Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated ref

23、erences, the latest edition of the referenced document (including any amendments) applies.EN 980, Graphical symbols for use in the labelling of medical devicesEN 1041, Information supplied by the manufacturer with medical devicesEN ISO 10993 (all parts), Biological evaluation of medical devicesEN IS

24、O 14971, Medical devices Application of risk management to medical devices (ISO 14971:2000)EN ISO 21171:2006, Medical gloves Determination of removable surface powder (ISO 21171:2006) European Pharmacopoeia, Monograph 2.6.14 Bacterial Endotoxins: publisher EDQM Council of Europe; 226avenue de Colmar

25、 B.P. 907; F-67029 Strasbourg; France http:/www.pheur.org3Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1 chemicalssubstances added or formed during any step of the manufacturing process or in storage which may be available in the final productNO

26、TEThese can include lubricants, chemical coatings and sterilizing agents. Several chemical ingredients are commonly used during processing of gloves, some of them are known to cause type IV allergic reactions. The type and amount of residual chemicals added and finally present are variable.3.2 endot

27、oxinslipo-polysaccharides originating from the outer cell-membrane of Gram-negative bacteriaNOTEEndotoxins are one type of pyrogen. Sources of endotoxins can include bacterial contamination of the raw materials, especially the process water used during manufacturing and manual handling of the gloves

28、.3.3 powderall water insoluble material on the surface of a glove that is removed by washing under the conditions of the testEN ISO 21171:2006, definition 3.1NOTEThis includes both deliberately added powder and other processing aids or materials accidentally present which may be readily detached fro

29、m the surface of the glove. For the purpose of this European Standard any glove containing 2 mg or less powder is a powder-free glove and more than 2 mg is a powdered glove (for requirement see 4.4.).3.4process limithighest value likely to be encountered for a validated manufacturing process3.5prote

30、ins, allergenicproteins capable of causing a type I allergic reaction3.6proteins, leachableaqueous proteins and peptides extractable from the final product3.7 pyrogenssubstances creating fever in rabbits which can be related to fever and other adverse reactions in humans4Requirements4.1GeneralMedica

31、l gloves for single use shall be evaluated as described in the EN ISO 10993 series. Part 1 of this series describes the general principles governing the biological evaluation of medical devices and shall be used to select the appropriate tests as described in other parts of the series.A risk managem

32、ent process in accordance with EN ISO 14971 shall be established.4.2ChemicalsGloves shall not be dressed with talcum powder (magnesium silicate).Chemicals known to be allergenic shall be avoided if technical alternatives exist. Wherever possible allowable limits for leachable residual chemicals shal

33、l be established using EN ISO 10993-17 and these limits shall be complied with. Wherever this is not possible, the residual chemicals level shall be As Low As Reasonably Practicable (ALARP see EN ISO 14971).The manufacturer shall disclose, upon request, a list of chemical ingredients either added du

34、ring manufacturing or already known to be present in the product such as accelerators, antioxidants and biocides, that are known to cause adverse health effects based on current data.4.3EndotoxinsThe manufacturer shall monitor the endotoxin contamination of sterile gloves using the test method speci

35、fied in 5.1 if the gloves are labelled with low endotoxin content. For such labelled gloves the endotoxin content shall not exceed the limit of 20 endotoxin units per pair of gloves.4.4PowderFor powder free gloves the total quantity of powder residues determined according to the test method under5.2

36、 shall not exceed 2 mg per glove. Any glove containing more than 2 mg powder is a powdered glove.4.5Proteins, leachableThe manufacturer shall monitor the process limit of leachable protein in the finished gloves containing natural rubber latex by the method specified in 5.3 and described in Annex A.

37、 The documentation of these results shall be retained. The results of the test and applied test method shall be made available on request.The leachable protein level shall be As Low As Reasonably Practicable (ALARP).NOTEProteins, allergenic: This European Standard specifies a method measuring a broa

38、d approximation for the allergen content, e.g. leachable proteins. There is no direct correlation between leachable proteins and allergen content. Quantitative methods to measure allergenic proteins are under development, as described in Annex B.4.6LabellingIn addition to the labelling specified in

39、EN 1041 and the relevant symbols given in EN 980, the following requirements apply:a)medical gloves containing natural rubber latex shall be labelled at least on the packaging, of the smallest packaging unit with the following symbol (EN 980 general requirements for symbols apply);Figure 1 Symbol fo

40、r products containing natural rubber latexb)the labelling shall include the following or equivalent warning statement together with the symbol:(Product) contains natural rubber latex which may cause allergic reactions, including anaphylactic responses;c)the labelling shall include a prominent indica

41、tion of whether the glove is powdered or powder-free;d)sterilepowderedglovesshallbelabelledwiththefollowingorequivalent:CAUTION: Surface powder shall be removed aseptically prior to undertaking operative procedures in order to minimize the risk of adverse tissue reactions;NOTE 2This caution statemen

42、t can be given on the inner wrapping.e)for any medical glove containing natural rubber latex the product labelling shall not include: any term suggesting relative safety, such as low allergenicity, hypoallergenicity or low protein; any unjustified indication of the presence of allergens;f)if the man

43、ufacturer labels the gloves with the protein content, the process limit, measured as specified in5.3 shall be given.NOTE 3This does not allow a protein labelling claim below 50 g/g. Lower claims are not considered to be reliable given the expected process variation in manufacture and inter-laborator

44、y testing.5Test methods5.1EndotoxinsExcept where non-removable interferences in the Limulus Amoebocyte Lysate (LAL) procedures are present, selection, validation and use of technique shall be as described in the European Pharmacopoeia, Monograph2.6.14, Bacterial Endotoxins. The results shall be expr

45、essed in endotoxin units (E.U.) per pair of gloves.NOTE 1Where non-removable interferences in the LAL procedure are present, the bacterial endotoxin level cannot be accurately measured.The minimum number of pairs of gloves recommended to be tested in relation to the number of items in the batch are

46、two pairs of gloves for a batch size under thirty, three pairs of gloves for a batch size thirty to one hundred, and 3 % of a batch above size one hundred, up to a maximum of ten pairs of gloves per batch.The outside surface of a pair of gloves is extracted with 40 ml of endotoxin-free water (Water

47、LAL, EuropeanPharmacopoeia, for not less than 40 min and not more than 60 min at a temperature between 37 C and40 C in a way to ensure that all surfaces come into contact with the extraction medium. The extract is centrifuged, if necessary, for 15 min at 2000 g to remove particles after which the li

48、quid component is decanted and tested for endotoxin immediately afterwards.NOTE 2Other methods for the analysis of endotoxins exist and these can be used for routine quality control purposes provided they have been validated and a correlation established against the reference method specified in thi

49、s European Standard.5.2PowderThe test method for the determination of powder residues described in EN ISO 21171 shall be used.5.3Proteins, leachableThe test method for the analytical determination of leachable protein shall be the modified Lowry method given in Annex A or a suitably validated method

50、 which has been correlated against the modified Lowry method.NOTE 1An example of a validated analytical method is given in Annex C.NOTE 2The immunological methods in Annex B are currently not validated against the modified Lowry method but may be correlated to clinical response data.6Test reportThe

51、test report shall include at least the following information: a reference to this European Standard, i.e. EN 455-3; the type of gloves and manufacturing batch code; the name and address of the manufacturer or distributor and of the test laboratory if different; the date of the test; the description

52、of the test method applied; the test results.Annex A(normative)Method for the determination of aqueous extractable proteins in natural rubber gloves using the modified Lowry assayA.1 ScopeThis method is for the determination of the amount of aqueous extractable proteins in gloves for medical use mad

53、e from natural rubber (NR). It has been validated during inter-laboratory round-robin tests. The lower quantification limit is approximately 10 mg protein per g of glove (i.e. 2 mg protein per ml of extract) depending on the glove weight.Chemicals such as surfactants, accelerators and antioxidants a

54、dded to the NR latex during the manufacture of the gloves can interfere with the colour development during the determination, some materials may reduce colour development while others can increase it. If the test method yields results that appear erroneous due to interferants, then any validated ami

55、no acid analysis method can be used (as an example see the method given in Annex C).NOTEPersons using this method should be familiar with normal laboratory practice. This method does not purport to address all of the safety problems, if any, associated with its use. It is the responsibility of the u

56、ser to establish appropriate safety and health practices and to ensure compliance with any national regulatory conditions.A.2 PrincipleWater soluble proteins are extracted into a buffer solution and then precipitated with acids in the presence of sodium deoxycholate to concentrate them and to separate them from water soluble substances which may interfere with the determination. The precipitated proteins are redissolved in alkali and quantified colorimetrically by a modified Lowry method. The assay is based on the reaction of proteins wi