CEN TR 16953-2017 Medical gloves for single use - Guidance for selection.pdf

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1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Medical gloves for single use - Guidance for selectionPD CEN/TR 16953:2017National forewordThis Published Document is the UK implementation of CEN/TR 16953:2017. The UK participation in its preparation was entrusted to

2、Technical Committee CH/205/3, Medical gloves.A list of organizations represented on this committee can be 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. The British Stand

3、ards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 98604 8ICS 11.140Compliance with a British Standard cannot confer immunity from legal obligations.This Published Document was published under the authority of the Standards Policy and Strategy Committee on 31 December 2017.A

4、mendments/corrigenda issued since publicationDate Text affectedPUBLISHED DOCUMENTPD CEN/TR 16953:2017TECHNICAL REPORTRAPPORT TECHNIQUETECHNISCHER BERICHTCEN/TR 16953November 2017ICS 11.140EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Ma

5、nagement Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN Ref. No. CEN/TR 16953:2017: EAll rights of exploitation in any form and by any means reserved worldwide for CEN national MembersMedical gloves for single use - Guidance for selectionGants mdicaux non rutilisables - Lignes directrices pour s

6、lectionner des gants mdicaux non rutilisablesMedizinische Einmalhandschuhe - Leitlinien fr die AuswahlThis Technical Report was approved by CEN on 22 October 2017. It has been drawn up by the Technical Committee CEN/TC 205.CEN members are the national standards bodies of Austria, Belgium, Bulgaria,

7、Croatia, Cyprus, Czech 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

8、Turkey and United Kingdom.English VersionCEN/TR 16953:2017 (E)European forewordThis document (CEN/TR 16953:2017) has been prepared by Technical Committee CEN/TC 205 “Non-active medical devices”, the secretariat of which is held by DIN.Attention is drawn to the possibility that some of the elements o

9、f this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association.This Technical Report gives information

10、 for use in the EN 455 series of standards. EN 455, Medical gloves for single use, which consists of the following parts: 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

11、: Requirements and testing for shelf life determination 2PD CEN/TR 16953:2017CEN/TR 16953:2017 (E)IntroductionThis Technical Report sets out guidance for users and choosers for selection, storage and use of gloves for medical applications.Glove selection is technically complex and should be undertak

12、en by suitably qualified professionals.Medical gloves have been shown to be a barrier to agents responsible for the transmission of infections. In order to help ensure effectiveness, it is essential that the gloves fit properly, are free from holes, and have adequate physical properties over their e

13、ntire shelf life to resist barrier failure during use. In addition it is important that adequate information is provided on any risks to the health of glove users or patients that use of the gloves can cause, e.g. allergic reactions. These issues are addressed in the EN 455 series.EN Standards once

14、mandated by the EU Commission are referred to as harmonized and are binding on CEN Member States. Products which comply with harmonized standards are assumed to comply with relevant Essential Requirements. Horizontal standards apply across a range of different types of product (e.g. sterility or lab

15、elling). Vertical standards apply to a specific type of product e.g. medical gloves.CE marking is a key indicator of a products compliance with EU legislation and enables the free movement of products within the European market. By affixing the CE marking on a product, a manufacturer is declaring co

16、nformity with all legal requirements to achieve CE marking and therefore ensuring validity for that product to be sold throughout the EEA, the member states of the EU and European Free Trade Association countries - Iceland, Norway, Liechtenstein and Turkey. Further information regarding CE marking c

17、an be found in Annex C.Single-use medical gloves fall into two main device classifications depending on degree of invasiveness of their use.Non sterile Examination gloves are class I medical devices and are CE marked by the manufacturer without third party regulatory approval. They are usually, but

18、not necessarily, ambidextrous and bulk-packed. Sterile examination gloves are class I sterile medical devices designed for short non-invasive aseptic procedures (generally less than 60 min) in patient care. They require regulatory approval for their sterility. Because they are intended for short pro

19、cedures only, examination gloves are generally thinner, and less robust than surgical grade gloves. They are usually sold in a limited number of sizes. The force at break requirements for such gloves are specified at levels which are lower than for surgical gloves but are based on many years cumulat

20、ive experience of minimum requirements needed to ensure acceptable performance in use. Values differ for different materials and are reflected in the requirements of EN 455-2. They are sold either powdered with donning powder or as powder free. Powder free gloves may have surface treatments or added

21、 chemical agents to assist in easy donning.Surgical gloves are class IIa medical devices and are designed for invasive procedures. CE marking requires approval of a Notified Body. They are sold sterile in a range of full and half sizes and packed in pairs of handed gloves. Packaging is normally in a

22、n easy peel pack that can deliver sterile inner wrapped gloves onto the sterile surgical field. Sterility is achieved by e.g. gamma or electron beam irradiation or by ethylene oxide treatment. Surgical gloves are sterilized to a sterility assurance level (SAL) of 106(according to EN 556-1) which giv

23、es a one in a million probability of finding a non sterile device. Force at break requirements are more rigorous than for examination gloves and reflect the levels that can be achieved for the materials concerned balanced against other in-use factors such as comfort, dexterity and sensitivity of tou

24、ch.3PD CEN/TR 16953:2017CEN/TR 16953:2017 (E)European foreword 2Introduction . 3European foreword 5Introduction . 61 Scope . 72 Normative references 73 Terms and definitions . 74 Considerations in glove selection . 94.1 General . 94.2 Cross contamination risk 104.2.1 General. 104.2.2 Freedom from ho

25、les .104.2.3 Physical properties .114.2.4 Storage stability .114.3 Biocompatibility . 124.3.1 General. 124.3.2 Allergenic potential 124.3.3 Plasticisers . 144.4 Potential contaminants . 144.4.1 General. 144.4.2 Glove Powder . 144.4.3 Sterilization residues (Endotoxins) 144.4.4 Surface additives .155

26、 Raw materials .155.1 Specific glove raw materials . 155.1.1 Natural rubber 155.1.2 Synthetic rubber155.1.3 Thermoplastics .155.2 Glove coating 156 Glove disinfection .167 Labelling .16Annex A (informative) Glove materials and their use17Annex B (informative) Additional information 19Annex C (inform

27、ative) CE-Marking 22Bibliography .234Contents PagePD CEN/TR 16953:2017CEN/TR 16953:2017 (E)European forewordThis document (CEN/TR 16953:2017) has been prepared by Technical Committee CEN/TC 205 “Non-active medical devices”, the secretariat of which is held by DIN.Attention is drawn to the possibilit

28、y that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association.This Techn

29、ical Report gives information for use in the EN 455 series of standards. EN 455, Medical gloves for single use, which consists of the following parts: Part 1: Requirements and testing for freedom from holes Part 2: Requirements and testing for physical properties Part 3: Requirements and testing for

30、 biological evaluation Part 4: Requirements and testing for shelf life determination 5PD CEN/TR 16953:2017CEN/TR 16953:2017 (E)IntroductionThis Technical Report sets out guidance for users and choosers for selection, storage and use of gloves for medical applications.Glove selection is technically c

31、omplex and should be undertaken by suitably qualified professionals.Medical gloves have been shown to be a barrier to agents responsible for the transmission of infections. In order to help ensure effectiveness, it is essential that the gloves fit properly, are free from holes, and have adequate phy

32、sical properties over their entire shelf life to resist barrier failure during use. In addition it is important that adequate information is provided on any risks to the health of glove users or patients that use of the gloves can cause, e.g. allergic reactions. These issues are addressed in the EN

33、455 series.EN Standards once mandated by the EU Commission are referred to as harmonized and are binding on CEN Member States. Products which comply with harmonized standards are assumed to comply with relevant Essential Requirements. Horizontal standards apply across a range of different types of p

34、roduct (e.g. sterility or labelling). Vertical standards apply to a specific type of product e.g. medical gloves.CE marking is a key indicator of a products compliance with EU legislation and enables the free movement of products within the European market. By affixing the CE marking on a product, a

35、 manufacturer is declaring conformity with all legal requirements to achieve CE marking and therefore ensuring validity for that product to be sold throughout the EEA, the member states of the EU and European Free Trade Association countries - Iceland, Norway, Liechtenstein and Turkey. Further infor

36、mation regarding CE marking can be found in Annex C.Single-use medical gloves fall into two main device classifications depending on degree of invasiveness of their use.Non sterile Examination gloves are class I medical devices and are CE marked by the manufacturer without third party regulatory app

37、roval. They are usually, but not necessarily, ambidextrous and bulk-packed. Sterile examination gloves are class I sterile medical devices designed for short non-invasive aseptic procedures (generally less than 60 min) in patient care. They require regulatory approval for their sterility. Because th

38、ey are intended for short procedures only, examination gloves are generally thinner, and less robust than surgical grade gloves. They are usually sold in a limited number of sizes. The force at break requirements for such gloves are specified at levels which are lower than for surgical gloves but ar

39、e based on many years cumulative experience of minimum requirements needed to ensure acceptable performance in use. Values differ for different materials and are reflected in the requirements of EN 455-2. They are sold either powdered with donning powder or as powder free. Powder free gloves may hav

40、e surface treatments or added chemical agents to assist in easy donning.Surgical gloves are class IIa medical devices and are designed for invasive procedures. CE marking requires approval of a Notified Body. They are sold sterile in a range of full and half sizes and packed in pairs of handed glove

41、s. Packaging is normally in an easy peel pack that can deliver sterile inner wrapped gloves onto the sterile surgical field. Sterility is achieved by e.g. gamma or electron beam irradiation or by ethylene oxide treatment. Surgical gloves are sterilized to a sterility assurance level (SAL) of 106(acc

42、ording to EN 556-1) which gives a one in a million probability of finding a non sterile device. Force at break requirements are more rigorous than for examination gloves and reflect the levels that can be achieved for the materials concerned balanced against other in-use factors such as comfort, dex

43、terity and sensitivity of touch.6PD CEN/TR 16953:2017CEN/TR 16953:2017 (E)1 ScopeThis Technical Report provides information for those choosing or using sterile and non-sterile gloves for medical applications based on a risk assessment. It deals with gloves worn primarily for the protection of the pa

44、tient and glove user from biological cross contamination.NOTE Gloves worn specifically for the protection of the glove user from e.g. chemical and biological hazards are covered by the EU-Directive on Personal Protective Equipment (PPE) and the related standards e.g. EN 16523-1, EN 374-2, EN 374-4,

45、EN ISO 374-1 and EN ISO 374-5.This document describes the rationale behind the requirements of the EN 455 series and explores the possible trade-offs in glove selection between the various factors which affect glove, physical properties, biocompatibility, comfort and sensitivity. The strengths and w

46、eaknesses of various alternative glove materials and the potential biological hazards presented by their use are also explored.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated referenc

47、es, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.EN 455 (series), Medical gloves for single useEN ISO 374-5, Protective gloves against dangerous chemicals and micro-organisms Part 5: Terminology and performan

48、ce requirements for micro-organisms risks (ISO 374-5)EN ISO 10993-10, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization (ISO 10993-10)ISO 2859-1, Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit

49、(AQL) for lot-by-lot inspection3 Terms and definitionsFor the purposes of this document, the terms and definitions given in the EN 455 series and the following apply.3.1EU Directives3.1.1MDDMD Directive(Medical Device Directive)legal act of the European Union covering the requirements that apply to medical devices including gloves with a medical purpose in the patient environmentNote 1 to entry: Protection against chemicals such as disinfectants, chemotherapy drugs etc. or against mechanical risks is not considered to be a medical purpose.N