1、PD CEN/TR12401:2009ICS 11.060.01NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWPUBLISHED DOCUMENTDentistry Guidanceon the classificationof dental devices andaccessoriesThis Published Documentwas published under theauthority of the StandardsPolicy and StrategyCommittee on 30 Ju
2、ne2009. BSI 2009ISBN 978 0 580 64612 6Amendments/corrigenda issued since publicationDate CommentsPD CEN/TR 12401:2009National forewordThis Published Document is the UK implementation of CEN/TR12401:2009. It supersedes PD/CR 12401:2003 which is withdrawn.The UK participation in its preparation was en
3、trusted to TechnicalCommittee CH/106, Dentistry.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a
4、 British Standard cannot confer immunityfrom legal obligations.PD CEN/TR 12401:2009TECHNICAL REPORTRAPPORT TECHNIQUETECHNISCHER BERICHTCEN/TR 12401May 2009ICS 11.060.01 Supersedes CEN/TR 12401:2003 English VersionDentistry - Guidance on the classification of dental devices andaccessoriesArt dentaire
5、 - Lignes directrices pour la classification desdispositifs dentaires et accessoiresZahnheilkunde - Anleitung zur Klassifizierung vonDentalprodukten und ZubehrThis Technical Report was approved by CEN on 5 April 2009. It has been drawn up by the Technical Committee CEN/TC 55.CEN members are the nati
6、onal 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, Slovenia, Spain, Sweden, Switzerland and Un
7、ited Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. CEN/TR 12401:2009:
8、EPD CEN/TR 12401:2009CEN/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 Invasive devices used in the oral cavity 5 Table 2 Invasi
9、ve 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 12401:2009CEN/TR 12401:2009 (E) 3 Foreword This document (CEN/TR 12401:2009) has been prepared by Technical Committee CEN/TC 55 “Dentistry”, the secretariat of
10、 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 document supersedes CEN/TR 12401:2003. The responsible wor
11、king 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 12401:2009CEN/TR 12401:2009 (E) 4 Introduction Dental products are marketed for long term, short term and transient use in the mouth. A l
12、arge 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 implanted devices in the oral cavity with a minimum of degra
13、dation 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. Many dental materials, instruments, equipment and di
14、sposables 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 to classify the product according to the rules of th
15、e 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 Authorities. The European Commission has developed a doc
16、ument ”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 also have been taken into consideration. It will, the
17、refore, be of value to manufacturers in making decisions with regard to the likely classification of particular devices. PD CEN/TR 12401:2009CEN/TR 12401:2009 (E) 5 1 Scope This CEN Technical Report provides guidance on the application of the classification rules in Council Directive 93/42 EEC of 14
18、 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 not necessarily be considered exhaustive. The classif
19、ication 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 prefabricated devices that will be part of a custom made dev
20、ice 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 classification. In this document the implementing rule 2.5 of the
21、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 devices” (MEDDEV 2.4.1, latest revision) 2, as prepared b
22、y 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 Intended use Rule Suggested Class Long term use (more than
23、 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 medicated 8 13 II A III PD CEN/TR 12401:2009CEN/TR 12401:200
24、9 (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 inlays metals ceramics and glass polymers 8 II A Materials
25、 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 long term use (e.g. pins, posts, attachments) 6,7,8 II A O
26、rthodontic 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 resorbable resorbable 8 8 II B III Materials for guided tissue
27、 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 12401:2009CEN/TR 12401:2009 (E) 7 Table 1 (concluded) Protective films, medicated NOTE Films with a primary function of slow release of medicines
28、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 III Surgical packs (dressings) Surgical packs, medicate
29、d 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 Bleaching agents for intra dental bleaching professional use o
30、nly 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 products 5 13 I III Matrix bands 5 I Impression trays 5 I End
31、odontic 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 12401:2009CEN/TR 12401:2009 (E) 8 Table 2 Invasive devices used in the oral cavity by the patien
32、t 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 3 Non invasive devices Intended use Rule Suggested Class
33、 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 invasive and energy driven surgically invasive and energy driven
34、 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 surgical treatment, non rotary 9 IIA Energy driven injection dev
35、ices 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 12401:2009CEN/TR 12401:2009 (E) 9 Table 5 Equipment Intended use Rule
36、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 incorporating, controlling or monitoring active devices in class II
37、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 9 II B High frequency electrosurgery unit 9 II B Diagnost
38、ic 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 tester 10 II A Dental radiographic equipment 10 II B Ultra
39、sonic 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 registration 1 I Lubricants for invasive devices (such as denta
40、l handpieces) 1 I Powered mixing devices used in the dental surgery, accessory to dental materials 1 I PD CEN/TR 12401:2009CEN/TR 12401:2009 (E) 10 Bibliography Legal documents 1 Council Directive 93/42 EEC of 14 June 1993 concerning medical devices, Official Journal of the European Union (OJEU) No.
41、 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 3 Co-ordination of Notified Bodies Medical Devices (NB-MED
42、) 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 devices Quality management systems Guidance on the applicati
43、on 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 Medical devices for dentistry Equipment 9 EN 1641, Dentistry
44、 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), Dental vocabulary 13 EN ISO 1942-5, Dental vocabulary Part 5: T
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