EN 455-3-2015 en Medical gloves for single use - Part 3 Requirements and testing for biological evaluation《一次性医用手套 第3部分 生物评价的要求和试验》.pdf

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1、BSI Standards PublicationBS EN 455-3:2015Medical gloves for single usePart 3: Requirements and testing forbiological evaluationBS EN 455-3:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 455-3:2015. Itsupersedes BS EN 455-3:2006 which is withdrawn.The UK pa

2、rticipation 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 responsible f

3、or its correctapplication. The British Standards Institution 2015. Published by BSI StandardsLimited 2015ISBN 978 0 580 82689 4ICS 11.140Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and

4、Strategy Committee on 30 April 2015.Amendments issued since publicationDate Text affectedBS EN 455-3:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 455-3 April 2015 ICS 11.140 Supersedes EN 455-3:2006English Version Medical gloves for single use - Part 3: Requirements and testing for biolo

5、gical evaluation Gants mdicaux non rutilisables - Partie 3 : Exigences et essais pour valuation biologique Medizinische Handschuhe zum einmaligen Gebrauch - Teil 3: Anforderungen und Prfung fr die biologische Bewertung This European Standard was approved by CEN on 24 January 2015. CEN members are bo

6、und 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 application to the

7、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 Management Centre

8、 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, Lithuania,

9、 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, B-1000

10、Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 455-3:2015 EBS EN 455-3:2015EN 455-3:2015 (E) 2 Contents Page Foreword 3 Introduction .5 1 Scope 6 2 Normative references 6 3 Terms and definitions .6 4 Requirements .7

11、4.1 General 7 4.2 Chemicals .7 4.3 Endotoxins .8 4.4 Powder-free gloves 8 4.5 Proteins, leachable 8 4.6 Labelling .8 5 Test methods 9 5.1 Endotoxins .9 5.2 Powder 9 5.3 Proteins, leachable 9 6 Test report 9 Annex A (normative) Method for the determination of aqueous extractable proteins in natural r

12、ubber gloves using the modified Lowry assay 10 Annex B (informative) Immunological methods for the measurements of natural rubber latex allergens 20 Annex C (informative) Amino acid analysis (AAA) by high pressure liquid chromatography (HPLC) 26 Annex ZA (informative) Relationship between this Europ

13、ean Standard and the Essential Requirements of EU Directive 93/42/EEC Medical Devices 34 BS EN 455-3:2015EN 455-3:2015 (E) 3 Foreword This document (EN 455-3:2015) has been prepared by Technical Committee CEN/TC 205 “Non-active medical devices”, the secretariat of which is held by DIN. This European

14、 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 conflicting national standards shall be withdrawn at the latest by October 2015. Attention is drawn to the possibility that some of the elements

15、 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 supersedes EN 455-3:2006. This document has been prepared under a mandate given to CEN by the European Commission and the European Free

16、 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 document. With respect to EN 455-3:2006 the following changes are: a) standard was specified to relevant parts of EN ISO 10993

17、 for Biological evaluation of medical devices; b) normative references revised; c) EN 980 was replaced by EN ISO 15223-1; d) subclause 4.2 “chemicals“ was specified; e) subclause 4.4 specified as “powder-free gloves“; f) level “As Low As Reasonably Practicable“ (ALARP) removed in the whole standard;

18、 g) subclause 4.6 “labelling“ specified; h) symbol for products containing natural latex (Figure 1) removed; i) the references in Annex B revised; j) Correspondence between this European Standard and Directive 89/686/EEC on Personal Protective Equipment made (see Annex ZA). EN 455 consists of the fo

19、llowing 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 evaluation; Part 4: Requirements and testing for shelf life determ

20、ination. 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 Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, Fr

21、ance, Germany, Greece, BS EN 455-3:2015EN 455-3:2015 (E) 4 Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 455-3:2015EN 455-3:2015 (E) 5 Introd

22、uction Adverse reactions to proteins in latex products have been reported over several years in variable rates of prevalence. Additionally, adverse reactions due to chemicals, lubricants, sterilization residues, pyrogens or other residues are described in the scientific literature. Adverse reactions

23、 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 test methods for biological evaluation of medical devices. However it does not specifically address ad

24、verse 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 contribute to the risk of reaction: a) the duration and frequency of skin contact with gloves; b) the exp

25、osure 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 of EN 455 gives requirements and test methods for evaluation of the biological safety of med

26、ical gloves as part of a risk management process, in accordance with EN ISO 10993. BS EN 455-3:2015EN 455-3:2015 (E) 6 1 Scope This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labelling and the disclosure

27、of information relevant to the test methods used. 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 editi

28、on of the referenced document (including any amendments) applies. EN 1041:2008+A1:2013, Information supplied by the manufacturer of medical devices EN ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009) EN IS

29、O 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) EN ISO 10993-10:2013, Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010) EN ISO 14971:2012, Medical devices - Applicat

30、ion of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) 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) EN ISO 21171:2006, Medical gloves

31、- Determination of removable surface powder (ISO 21171:2006) European Pharmacopoeia, General chapter 2.6.14 Bacterial Endotoxins: publisher EDQM - Council of Europe; 7 alle Kastner, CS 30026, F-67081 Strasbourg; France http:/www.edqm.eu/ 3 Terms and definitions For the purposes of this document, the

32、 following terms and definitions apply. 3.1 chemicals substances added or formed during any step of the manufacturing process or in storage which may be available in the final product Note 1 to entry: These can include lubricants, chemical coatings and sterilizing agents. Several chemical ingredient

33、s 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 endotoxins lipo-polysaccharides originating from the outer cell-membrane of Gram-negative bacteria Note 1

34、 to entry: Endotoxins 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. 3.3 powder all water insoluble material on the surface of a glove that is removed b

35、y washing under the conditions of the test BS EN 455-3:2015EN 455-3:2015 (E) 7 SOURCE: EN ISO 21171:2006, 3.1 Note 1 to entry: This includes both deliberately added powder and other processing aids or materials accidentally present which may be readily detached from the surface of the glove. For the

36、 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.). 3.4 process limit highest value likely to be encountered for a validated manufacturing process 3.5 proteins, allergenic proteins capab

37、le of causing a type I allergic reaction 3.6 proteins, leachable aqueous proteins and peptides extractable from the final product 3.7 pyrogens substances creating fever in rabbits which can be related to fever and other adverse reactions in humans 4 Requirements 4.1 General EN ISO 10993-1:2009 descr

38、ibes 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. Based on EN ISO 10993-1:2009 medical gloves are classified as limited contact duration surface devices and require complianc

39、e to EN ISO 10993-5:2009 and EN ISO 10993-10:2013. The classification of medical gloves according to EN ISO 10993-1:2009 should not be confused with the definitions provided in the medical device directives for these products. A risk management process in accordance with EN ISO 14971:2012 shall be e

40、stablished. 4.2 Chemicals Gloves shall not be dressed with talcum powder (magnesium silicate). The manufacturer shall disclose, upon request, a list of chemical ingredients either added during manufacturing or already known to be present in the product such as accelerators, antioxidants and biocides

41、 that are known to cause adverse health effects based on current data. Upon request the manufacturer shall provide evidence of the steps taken to reduce the risk to the end-user of exposure to chemicals used in the manufacturing process which, based on current data, are known to cause adverse health

42、 effects. Manufacturers may only declare the absence of a substance if the substance is not used in any part of the manufacturing process. No compounds shall be used in the manufacture of the product that is known to form a substance that is subject of such a declaration. BS EN 455-3:2015EN 455-3:20

43、15 (E) 8 4.3 Endotoxins The manufacturer shall monitor the endotoxin contamination of sterile gloves using the test method specified 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

44、of gloves. 4.4 Powder-free gloves For powder-free gloves the total quantity of powder residues determined according to the test method under 5.2 shall not exceed 2 mg per glove. Any glove containing more than 2 mg powder is a powdered glove. 4.5 Proteins, leachable The manufacturer shall strive to m

45、inimize the leachable protein level. The 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. The documentation of these results shall be retained. The results of the test and

46、 applied test method shall be made available on request. NOTE Proteins, allergenic: This European Standard specifies a method measuring a broad approximation for the allergen content, e.g. leachable proteins. There is no direct correlation between leachable proteins and allergen content. Quantitativ

47、e methods to measure allergenic proteins are, described in Annex B. 4.6 Labelling In addition to the labelling specified in EN 1041:2008+A1:2013 and the relevant symbols given in EN ISO 15223-1:2012, the following requirements apply: a) medical gloves containing natural rubber latex shall be labelle

48、d on the packaging of at least the smallest packaging unit with the EN ISO 15223-1:2012 symbol for latex (reference number 5.4.5). The labelling shall include the following or equivalent warning statement together with the symbol (Product) contains natural rubber latex which may cause allergic react

49、ions, including anaphylactic responses; b) the labelling shall include a prominent indication of whether the glove is powdered or powder-free; c) sterile powdered gloves shall be labelled with the following or equivalent: CAUTION: Surface powder shall be removed aseptically prior to undertaking operative procedures in order to minimize the risk of adverse tissue reactions; NOTE 1 This caution statement can be given on the inner wrapping. d) for any medical glove containing natural rubber latex the product labelling shall not include: any term suggesting relativ