1、July 2015 Translation by DIN-Sprachendienst.English price group 16No 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 1
2、1.140!%CoX“2327653www.din.deDDIN EN 455-3Medical gloves for single use Part 3: Requirements and testing for biological evaluation;English version EN 455-3:2015,English translation of DIN EN 455-3:2015-07Medizinische Handschuhe zum einmaligen Gebrauch Teil 3: Anforderungen und Prfung fr die biologisc
3、he Bewertung;Englische Fassung EN 455-3:2015,Englische bersetzung von DIN EN 455-3:2015-07Gants mdicaux non rutilisables Partie 3: Exigences et essais pour valuation biologique;Version anglaise EN 455-3:2015,Traduction anglaise de DIN EN 455-3:2015-07SupersedesDIN EN 455-3:2007-03www.beuth.deIn case
4、 of doubt, the German-language original shall be considered authoritative.Document comprises 36 pages 06.15 DIN EN 455-3:2015-07 2 A comma is used as the decimal marker. National foreword This document (EN 455-3:2015) 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. Amendments This standard differs from DIN EN 455-3:2007-03 as follows: a) the
6、standard has been brought in line with relevant parts of EN ISO 10993 concerning the biological evaluation of medical devices; b) normative references have been revised; c) EN 980 has been replaced by EN ISO 15223-1; d) Subclause 4.2 “Chemicals” has been updated; e) Subclause 4.4 “Powder” has been r
7、enamed “Powder-free gloves”; f) the level “As Low As Reasonably Practicable (ALARP)” has been deleted throughout the document; g) Subclause 4.6 “Labelling” has been updated; h) the symbol for products containing natural latex (Figure 1) has been deleted; i) references in Annex B have been revised; j
8、) information is given on the relationship between this European Standard and Directive 89/686/EEC on Personal Protective Equipment (see Annex ZA). Previous editions DIN EN 455-3: 2000-02, 2007-03 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 455-3 April 2015 ICS 11.140 Supersedes EN 455-3:20
9、06English Version Medical gloves for single use - Part 3: Requirements and testing for biological 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
10、 Bewertung 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 the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliogr
11、aphical references concerning such national standards may be obtained on application 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 responsibi
12、lity 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 national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic
13、 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 United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISA
14、TION 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 reserved worldwide for CEN national Members. Ref. No. EN 455-3:2015 EEN 455-3:2015 (E) 2 Contents Page Foreword 3 Introduction .5 1 Sc
15、ope 6 2 Normative references 6 3 Terms and definitions .6 4 Requirements .7 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 (normativ
16、e) Method for the determination of aqueous extractable proteins in natural rubber 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 chr
17、omatography (HPLC) 26 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC Medical Devices 34 DIN EN 455-3:2015-07 EN 455-3:2015(E)3 Foreword This document (EN 455-3:2015) has been prepared by Technical Committee CEN/TC 205 “Non-
18、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 conflicting national standards shall be withdrawn at the latest b
19、y 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 supersedes EN 455-3:2006. This document has been prepare
20、d 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 integral part of this document. With respect to EN 455-3:2006 the fol
21、lowing changes are: a) standard was specified to relevant parts of EN ISO 10993 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)
22、level “As Low As Reasonably Practicable“ (ALARP) removed in the whole standard; 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
23、on Personal Protective Equipment made (see Annex ZA). 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 fo
24、r 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
25、 Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, DIN EN 455-3:2015-07 EN 455-3:2015 (E) 4 Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Sw
26、itzerland, Turkey and the United Kingdom. DIN EN 455-3:2015-07 EN 455-3:2015 (E) 5 Introduction 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,
27、 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 test methods
28、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 contribute to th
29、e 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 of
30、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 10993. DIN EN 455-3:2015-07 EN 455-3:2015 (E) 6 1 Scope This part of EN 455 specifies requirements for the evaluation of biological saf
31、ety for medical gloves for single use. It gives requirements for labelling and the disclosure 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.
32、For dated references, only the edition cited applies. For undated references, the latest edition 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 devi
33、ces - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009) EN ISO 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 irrit
34、ation and skin sensitization (ISO 10993-10:2010) EN ISO 14971:2012, Medical devices - Application 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
35、 supplied - Part 1: General requirements (ISO 15223-1:2012) EN ISO 21171:2006, Medical gloves - 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 Strasb
36、ourg; France http:/www.edqm.eu/ 3 Terms and definitions For the purposes of this document, the 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
37、 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 endotoxins
38、lipo-polysaccharides originating from the outer cell-membrane of Gram-negative bacteria Note 1 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 t
39、he gloves. 3.3 powder all water insoluble material on the surface of a glove that is removed by washing under the conditions of the test DIN EN 455-3:2015-07 EN 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 ma
40、terials accidentally present which may be readily detached from 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.). 3.4 process limit highest value likel
41、y to be encountered for a validated manufacturing process 3.5 proteins, allergenic proteins capable 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
42、 fever and other adverse reactions in humans 4 Requirements 4.1 General EN ISO 10993-1:2009 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. Based on EN ISO 10993-1:200
43、9 medical gloves are classified as limited contact duration surface devices and require compliance 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 directi
44、ves for these products. A risk management process in accordance with EN ISO 14971:2012 shall be established. 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 manufactur
45、ing 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. Upon request the manufacturer shall provide evidence of the steps taken to reduce the risk to the end-user of exposure to chemicals
46、used in the manufacturing process which, based on current data, are known to cause adverse health 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 tha
47、t is known to form a substance that is subject of such a declaration. DIN EN 455-3:2015-07 EN 455-3:2015 (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
48、 such labelled gloves the endotoxin content shall not exceed the limit of 20 endotoxin units per pair 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 minimize the leachable protein level. The manufacturer shall monitor the process limit of leachable protein in the finished gloves containi
