1、PD CEN/TR 12401:2009 ICS 11.060.01 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW PUBLISHED DOCUMENT Dentistry Guidance on the classification of dental devices and accessoriesThis Published Document was published under the authority of the Standards Policy and Strategy Commit
2、tee on 30 June 2009. BSI 2009 ISBN 978 0 580 64612 6 Amendments/corrigenda issued since publication Date Comments PD CEN/TR 12401:2009 National foreword This Published Document is the UK implementation of CEN/TR 12401:2009. It supersedes PD/CR 12401:2003 which is withdrawn. The UK participation in i
3、ts preparation was entrusted to Technical Committee CH/106, Dentistry. 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 app
4、lication. Compliance with a British Standard cannot confer immunity from legal obligations.PD CEN/TR 12401:2009 TECHNICAL REPORT RAPPORT TECHNIQUE TECHNISCHER BERICHT CEN/TR 12401 May 2009 ICS 11.060.01 Supersedes CEN/TR 12401:2003 English Version Dentistry - Guidance on the classification of dental
5、 devices and accessories Art dentaire - Lignes directrices pour la classification des dispositifs dentaires et accessoires Zahnheilkunde - Anleitung zur Klassifizierung von Dentalprodukten und Zubehr This Technical Report was approved by CEN on 5 April 2009. It has been drawn up by the Technical Com
6、mittee CEN/TC 55. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia,
7、 Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for
8、CEN national Members. Ref. No. CEN/TR 12401:2009: EPD CEN/TR 12401:2009 CEN/TR 12401:2009 (E) 2 Contents Foreword 3 Introduction . 4 1 Scope 5 2 Classification of dental devices and accessories 5 3 Proposals for classification of dental devices and accessories 5 Bibliography 10 Tables Table 1 Invasi
9、ve devices used in the oral cavity 5 Table 2 Invasive devices used in the oral cavity by the patient 8 Table 3 Non invasive devices . 8 Table 4 Instruments . 8 Table 5 Equipment . 9 PD CEN/TR 12401:2009 CEN/TR 12401:2009 (E) 3 Foreword This document (CEN/TR 12401:2009) has been prepared by Technical
10、 Committee CEN/TC 55 “Dentistry”, the secretariat of which is held by DIN. 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 docume
11、nt supersedes CEN/TR 12401:2003. The responsible working group is CEN/TC 55/WG 3 “Classification“ (secretariat: DIN), representing the dental trade and industry, the dental profession and notified bodies. PD CEN/TR 12401:2009 CEN/TR 12401:2009 (E) 4 Introduction Dental products are marketed for long
12、 term, short term and transient use in the mouth. A large number of items have been developed to assist in the treatment and prevention of oral diseases and the handling of dental materials. In contrast to pharmaceuticals (medicinal products), many dental materials are intended to perform as implant
13、ed devices in the oral cavity with a minimum of degradation and release of substances, i.e. their main action is to replace lost and defective teeth and oral tissue. Some materials contain elements that may initiate toxic or allergic responses. Other materials have additions of medicinal substances.
14、 Many dental materials, instruments, equipment and disposables are covered by the Council Directive 93/42 EEC of 14 June 1993 concerning medical devices. The Directive also provides rules for the classification of medical devices based on risk and intended use. It is the manufacturers responsibility
15、 to classify the product according to the rules of the Directive. The classification should be acceptable to Notified Bodies (NB) and Competent Authorities (CA). The Directive describes procedures for resolving any disputes over classification between manufacturers, Notified Bodies and Competent Aut
16、horities. The European Commission has developed a document ”Guidelines for the Classification of Medical Devices”. This CEN Technical Report is intended to complement that guidance. In addition, NB-MED, European Co-ordination of Notified Bodies, have developed a series of consensus statements which
17、also have been taken into consideration. It will, therefore, be of value to manufacturers in making decisions with regard to the likely classification of particular devices. PD CEN/TR 12401:2009 CEN/TR 12401:2009 (E) 5 1 Scope This CEN Technical Report provides guidance on the application of the cla
18、ssification rules in Council Directive 93/42 EEC of 14 June 1993, amended by Directive 2007/47/EC, concerning medical devices as they pertain to dental devices and accessories. 2 Classification of dental devices and accessories The list of dental devices and accessories given in Tables 1 to 5 should
19、 not necessarily be considered exhaustive. The classification is based on the most commonly accepted form and intended use of the devices and accessories listed. If a manufacturer proposes another intended use, the classification of the product may need to be reconsidered. Materials and other prefab
20、ricated devices that will be part of a custom made device are included in this guidance document. Custom made devices are not. Some materials can be used both for long term and short term custom made devices. The intended purpose claimed by the manufacturer will then be decisive for the classificati
21、on. In this document the implementing rule 2.5 of the Directive has been used for the proposed classification, i.e. ”the strictest rules.shall apply”. It is recommended that this list be considered in conjunction with the Directive 93/42 EEC 1 and the ”Guidelines to the classification of medical dev
22、ices” (MEDDEV 2.4.1, latest revision) 2, as prepared by the Commission (see Bibliography). 3 Proposals for classification of dental devices and accessories Proposals for classification of dental devices and accessories are given in Tables 1 to 5. Table 1 Invasive devices used in the oral cavity Inte
23、nded use Rule Suggested Class Long term use (more than 30 days) Plastic materials for direct insertion metals polymers cements 8 II A Cavity lining materials 8 II A Dentine adhesives 8 II A Pit and fissure sealants 5 II A Protective film (long term) 5 II A Pulp capping materials non medicated medica
24、ted 8 13 II A III PD CEN/TR 12401:2009 CEN/TR 12401:2009 (E) 6 Table 1 (continued) Endodontic filling materials sealers points retrograde root canal filling materials 8 II A Luting materials water based cements eugenol based cements polymer based cements 8 II A Materials for fixed prostheses and inl
25、ays metals ceramics and glass polymers 8 II A Materials for removable prostheses and other intraorale appliances including maxillofacial prostheses metals ceramics polymers 5 II A Endostabilizers / Transendodontic implants 8 II B Prefabricated parts, surgically invasive, transient, short term or lon
26、g term use (e.g. pins, posts, attachments) 6,7,8 II A Orthodontic materials and devices, intraorale use metals ceramics polymers 5 II A Dental implants metals ceramics and glass polymers carbon based calcium based 8 II B Dental implants, biologically active coating 8 III Bone substitutes non resorba
27、ble resorbable 8 8 II B III Materials for guided tissue regeneration non resorbable resorbable 8 8 II B III Osteo-synthesis devices 8 III Short term use (max. 30 days) Protective films (varnish) 5 I PD CEN/TR 12401:2009 CEN/TR 12401:2009 (E) 7 Table 1 (concluded) Protective films, medicated NOTE Fil
28、ms with a primary function of slow release of medicines are a medicinal product 13 III Temporary filling materials 7 II A Temporary crowns and bridges prefabricated materials for custom made temporary devices 7 II A Short term relining and tissue conditioning materials non medicated medicated 5 13 I
29、 III Surgical packs (dressings) Surgical packs, medicated 7 13 II A III Suture material, non absorbable Suture material, absorbable/medicated 7 13 II A III Transient use (less than 60 min) Syringe tips for delivery of dental materials 5 I Materials for surface preparation (etch, prime) 6 II A Bleach
30、ing agents for intra dental bleaching professional use only 6 II A Impression materials 5 I Rubber dam and accessories 5 I Cotton rolls, gaze, etc. 5 I Wedges 5 I Waxes 5 I Gingival retraction device Gingival retraction device, medicated NOTE Astringents and haemostatic solutions are medicinal produ
31、cts 5 13 I III Matrix bands 5 I Impression trays 5 I Endodontic absorbant points 6 II A Polishing paste Polishing paste, medicated 5 13 I III Polishing strips 5 I Articulating, occlusion and bite registration devices 5 I Radiographic devices 16 II A PD CEN/TR 12401:2009 CEN/TR 12401:2009 (E) 8 Table
32、 2 Invasive devices used in the oral cavity by the patient Intended use Rule Suggested Class Long term use (more than 30 days) Cushions and relining materials 5 II A Short term use (max. 30 days) Trays for gels 5 I Temporary filling 6 II A Denture adhesives, cushions and relining materials 5 I Table
33、 3 Non invasive devices Intended use Rule Suggested Class Denture cleansers with a disinfecting function 15 II A Orthodontic materials and devices, extra oral parts 1 I Table 4 Instruments Intended use Rule Suggested Class Power operated instruments Diagnostic probe with a measuring function invasiv
34、e and energy driven surgically invasive and energy driven 10 6 II A II A Dental handpieces for rotary instruments 9 II A Rotary instruments for connection to dental handpieces surgically invasive invasive (polishing and prophylactic devices) non invasive 6 5 1 II A II A I Powered devices for surgica
35、l treatment, non rotary 9 IIA Energy driven injection devices 6 IIA Hand operated instruments Diagnostic probe with a measuring function, not energy driven NOTE (M) means approval of the measuring system 5 I (M) Reusable hand instruments 6 I Single use hand instruments 6 II A PD CEN/TR 12401:2009 CE
36、N/TR 12401:2009 (E) 9 Table 5 Equipment Intended use Rule Suggested Class Multifunctional air and water syringes connected to a dental unit 11 II A Single use tips for multifunctional syringes for suction equipment 5 5 II A II A High and medium volume suction equipment 11 II A Dental unit incorporat
37、ing, controlling or monitoring active devices in class II B active devices in class II A 9 9 II B II A Amalgam separator used as an integral part of the dental unit 1 I Dental operating light 12 I Devices for cleaning and disinfection of : Non invasive devices Invasive devices 15 15 II A IIB Cautery
38、 9 II B High frequency electrosurgery unit 9 II B Diagnostic fiberoptic handpieces 12 I Laser unit, dental non surgical surgical 9 9 II A II B Low voltage motor drive for handpieces 9 II A Air motor drive for handpieces 9 II A Dental patient chair 1 I Dental curing light with handpieces 9 II A Pulp
39、tester 10 II A Dental radiographic equipment 10 II B Ultrasonic scaler including handpiece 9 II A Dental radiographic imaging systems with a part applied to the patient Note: Stand alone software is considered to be an active device 16 II A Chair side CAD-CAM systems with or without intra oral regis
40、tration 1 I Lubricants for invasive devices (such as dental handpieces) 1 I Powered mixing devices used in the dental surgery, accessory to dental materials 1 I PD CEN/TR 12401:2009 CEN/TR 12401:2009 (E) 10 Bibliography Legal documents 1 Council Directive 93/42 EEC of 14 June 1993 concerning medical
41、 devices, Official Journal of the European Union (OJEU) No. L. 169/1 of 1993-07-12, page 1 43; amended by Council Directive 2007/47/EC, OJEU No. L 247/21 of 2007-09-21 2 MedDev 2.4.1, European Commission, Guidelines for the classification of Medical Devices (MedDev), Version 2.4.1, Rev. 8, July 2001
42、 3 Co-ordination of Notified Bodies Medical Devices (NB-MED) on Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC, Issue 05/00 Level 1 Basic standards for medical devices 4 EN ISO 13485, Medical devices Quality management systems Requirements for regulatory purposes 5 CEN ISO/TR 14969, Medical d
43、evices Quality management systems Guidance on the application of ISO 13485 6 EN ISO 14971, Medical devices Application of risk management to medical devices Level 2 Group standards for medical devices for dentistry 7 EN 1639, Dentistry Medical devices for dentistry Instruments 8 EN 1640, Dentistry M
44、edical devices for dentistry Equipment 9 EN 1641, Dentistry Medical devices for dentistry Materials 10 EN 1642, Dentistry Medical devices used for dentistry Dental implants 11 EN ISO 7405, Dentistry Evaluation of biocompatibility of medical devices used in dentistry 12 EN 21942, (Parts 1 to 4), Dent
45、al vocabulary 13 EN ISO 1942-5, Dental vocabulary Part 5: Terms associated with testing (ISO 1942-5:1989) PD CEN/TR 12401:2009 This page has been intentionally left blankPD CEN/TR 12401:2009 BSI Group Headquarters 389 Chiswick High Road, London, W4 4AL, UK Tel +44 (0)20 8996 9001 Fax +44 (0)20 8996
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