BS PD CEN TR 12401-2009 Dentistry - Guidance on the Classification of Dental Devices and Accessories.pdf
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1、 - - - - - - - - - - - - - - - * - - - - - - - - - - W W D - w - - - - 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 Invasiv
2、e 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 CEN/TR 12401:2009 (E) 3 Foreword This document (CEN/TR 12401:2009) has been prepared by Technical Committee CEN/TC 55 “
3、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 document supersedes CEN/TR 1
4、2401:2003. 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. CEN/TR 12401:2009 (E) 4 Introduction Dental products are marketed for long term, short term and transient use in the
5、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 implanted devices in the oral cavity with a minimu
6、m 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. Many dental materials, instruments, equipm
7、ent 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 to classify the product according to the r
8、ules 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 Authorities. The European Commission has devel
9、oped 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 also have been taken into consideration. It
10、 will, therefore, be of value to manufacturers in making decisions with regard to the likely classification of particular devices. CEN/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 June 1993
11、, 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 classification is
12、 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 device are in
13、cluded 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 Directive
14、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 by the Comm
15、ission (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 30 days)
16、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 CEN/TR 12401:2009 (E) 6 Table 1 (continued) En
17、dodontic 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 for removable prostheses and
18、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 Orthodontic materials and devic
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