BS PD CEN TR 15133-2005 Nomenclature - Collective terms and codes for groups of medical devices《术语 医疗装置类的综合术语和代码》.pdf

1、PUBLISHED DOCUMENT PD CEN/TR 15133:2005 Nomenclature Collective terms and codes for groups of medical devices ICS 01.040.11; 11.040.01 PD CEN/TR 15133:2005 This Published Document was published under the authority of the Standards Policy and Strategy Committee on 12 December 2005 BSI 12 December 200

2、5 ISBN 0 580 46535 7 National foreword This Published Document is the official English language version of CEN/TR 15133:2005. The UK participation in its preparation was entrusted by Technical Committee CH/210, Quality management and corresponding general aspects for medical devices, to Subcommittee

3、 CH/210/3, General terminology and symbols, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related international a

4、nd European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BS

5、I Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for

6、its correct application. Compliance with a Published Document does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, the CEN/TR title page, pages 2 to 15 and a back cover. The BSI copyright notice displayed in this do

7、cument indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsTECHNICALREPORT RAPPORTTECHNIQUE TECHNISCHERBERICHT CEN/TR15133 June2005 ICS01.040.11;11.040.01 Englishversion NomenclatureCollectivetermsandcodesforgroupsof medicaldevices NomenclatureTerme

8、setcodescollectifspourles groupesdedispositifsmdicaux NomenklaturSammelbegriffeundKodesfrGruppenvon Medizinprodukten ThisTechnicalReportwasapprovedbyCENon6May2005.IthasbeendrawnupbytheTechnicalCommitteeCEN/TC257. CENmembersarethenationalstandardsbodiesofAustria,Belgium,Cyprus,CzechRepublic,Denmark,E

9、stonia,Finland,France, Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal, Slovakia, Slovenia,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG Managemen

10、tCentre:ruedeStassart,36B1050Brussels 2005CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.CEN/TR15133:2005:E2 Contents Page Foreword 3 Introduction4 1 Scope .5 2 Lists of collective terms .5 2.1 Application of Common Technology.5 2.2 Using similar man

11、ufacturing procedures .11 2.3 For similar medical procedures .12 2.4 Using common materials13 2.5 Specific risk-associated considerations .14 Bibliography.15 CEN/TR 15133:20053 Foreword This document (CEN/TR 15133:2005) has been prepared by Technical Committee CEN/TC 257 “Symbols and information pro

12、vided with medical devices and nomenclature for regulatory data exchange”, the secretariat of which is held by SFS. This CEN report has been prepared under the mandate (M321) given to CEN by the European Commission and the European Free Trade Association. This CEN Report is intended to complement th

13、e specific requirements of the EU regulations on medical devices relating to information exchanged between parties communicating in conformity with requirements of the Directives. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are b

14、ound to announce this CEN Technical Report: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and

15、United Kingdom. CEN/TR 15133:20054 Introduction This Technical Report contains collective terms for those medical devices which share common features and are identified in the Global Medical device Nomenclature (GMDN), published as CR 14230:2001 Global medical device nomenclature for the purpose of

16、regulatory data exchange (identical to ISO/TS 20225:2001 Whereas the GMDN is designed and was developed for regulatory data exchange in areas such as vigilance reporting and tracking of medical device safety, there is a need for a set of terms that are more refined than the GMDN category terms, yet

17、broader than the GMDN generic device group terms, to be used in the application of the medical device directives where the use of collective terms provides adequate identification. These collective terms are intended to be used for example: to illustrate the scope of certificates issued by Notified

18、Bodies when assessing which groups, families or types of medical devices are covered within a manufacturers quality system, to be used to identify the range of skills and general technological abilities for which a Notified Body has been approved, and is so appointed by the relevant Competent Author

19、ity, for the exchanges of information between Competent Authorities when general information on individual manufacturers capabilities is notified for inclusion in the European Database for Medical Devices (EUDAMED). These terms, named “collective terms“, are appropriate for providing general groupin

20、gs to meet, in particular, the above identified requirements. In the preparation of this CEN REPORT a number of principles were identified which were used in grouping together generic device group terms of the GMDN within the proposed “collective terms”. These were: Devices covered by the applicatio

21、n of common technology Devices manufactured using similar manufacturing procedures, and with common technical features. Devices manufactured for the application of similar Medical Procedures Devices manufactured using common materials requiring special skills. Devices developed to meet specific risk

22、-associated considerations. For ease of electronic transmission of data, and to eliminate the possibility of confusion with other coding systems having a three-digit code used for information concerning Medical Devices, each collective term is assigned a three-digit random code with the prefix “CT”

23、(Collective Term), which identifies the code source. It is expected that as the collective terms are brought into use, they will be assigned to the generic device group terms of the GMDN. The Maintenance Agency (MA) of the GMDN will make these links available. Details of progress in this area will b

24、e posted on the MA web site at http:/www.gmdn.org. CEN/TR 15133:20055 1 Scope This Technical Report lists collective terms and codes for groups of medical devices having common features. The listing is structured so that the terms can be used for the purposes required in regulatory reporting and for

25、 communication relevant to the application of the medical device regulation. For certain purposes in the application of the Medical Devices Directives, there is an urgent need for the development of a list of collective terms based on the identified principles to be used, for examples, as follows: t

26、o illustrate the scope of certificates issued by Notified Bodies when assessing which groups, families or types of medical devices are covered within a manufacturers quality system, to be used to identify the range of skills and general technological abilities for which a Notified Body has been appr

27、oved, and is so appointed by the relevant Competent Authority, for the exchanges of information between Competent Authorities when general information on individual manufacturers capabilities is notified for inclusion in the European Database for Medical Devices (EUDAMED). For the purpose of develop

28、ing sets of collective terms, Accessories to medical devices are integrated de facto in the corresponding medical device collective term. 2 Lists of collective terms NOTE 1 Any specific Generic Device term from the GMDN may be assignable to more than one of the collective terms listed here. NOTE 2 W

29、hen assigning collective terms for any of the particular uses outlined in the Introduction, more than one collective term may be assigned, if required, to improve the definition of the specified circumstances under which the assignment is being made. NOTE 3 The collective term(s) selected for any se

30、t of circumstances should cover the broadest scope in the grouping for which a selection is required so that the smallest set of collective terms that will describe the situation will be the one used. NOTE 4 When using the collective term codes to communicate information, the “CT” prefix must be use

31、d to identify the code source. 2.1 Application of Common Technology Any specific Generic Device group term from the GMDN shall be assignable to at least one of the collective terms listed as “Common technology”. Applicable GMDNCategories ct code Collective Terms 1 2 3 CT: 231 Ablation devices 9 10 C

32、T: 005 Absorbable implants 7 3 CEN/TR 15133:20056 Applicable GMDNCategories ct code Collective Terms 1 2 3 CT: 192 Accelerator systems 12 CT: 006 Acoustic chambers 4 CT: 007 Airways/respiratory systems 10 CT: 008 Ambulances and ancillary devices 5 CT: 009 Anaesthesia units/work stations and ancillar

33、y devices 2 3 CT: 010 Analgesia devices 2 CT:413 Analyzers 5 6 CT: 011 Angioplasty systems/devices 10 CT: 012 Bandages 10 CT: 013 Bedding/mattresses/pillows 5 CT: 102 Beds for medical purposes 11 CT: 096 Blood collecting devices 10 CT: 071 Blood flow measurement devices 4 CT: 066 Blood gas analysers

34、 4 6 CT: 014 Blood pressure measuring devices invasive/non- invasive 4 CT: 097 Blood transfusion sets 10 CT: 162 Bone cements 10 CT: 163 Bone remineralisation devices 10 3 CT: 193 Brachytherapy devices 12 CT: 091 Breast implants 7 CT: 070 Cardiac output measuring devices 4 CT: 228 Cardiac resynchron

35、isation devices 1 CT: 145 Cardiovascular devices 7 CT: 015 Catheters 10 4 7 CT: 095 Cell and tissue collection devices 10 CT: 196 Centrifuges 6 CEN/TR 15133:20057 Applicable GMDNCategories ct code Collective Terms 1 2 3 CT: 314 Clinical Chemistry Instruments 6 CT: 400 Cochlear implants 1 CT: 016 Com

36、puterized Tomography (CT), and ancillary devices 12 CT: 017 Contact lenses, corrective and lens care products 8 CT: 018 Contraceptive devices 10 CT: 164 Corneal prostheses 8 CT: 126 Correcting spectacles 8 CT: 078 Cryosurgical, devices 4 CT: 074 Defibrillators external 4 CT: 062 Defibrillators, impl

37、antable 1 CT: 019 DentaI equipment - non-powered 3 CT: 020 DentaI equipment - powered 3 CT: 003 Dental implants 3 7 CT: 001 Dental instruments, non-powered 3 CT: 002 Dental instruments, powered 3 4 CT: 064 Dental materials 3 CT: 401 Dental orthodontic devices 3 CT: 004 Dental prostheses 3 CT: 100 Di

38、alysis devices / Haemodialysis/ Haemofiltration 10 CT: 045 Dialysis devices, peritoneal 10 4 CT: 225 Dialysis systems/machines and ancillary devices 4 5 10 CT: 022 Distension units 9 CT: 068 Electrocardiographs (ECG equipment) 4 CT: 025 Electroconvulsive therapy units 4 CT: 026 Electrodes and biosen

39、sors 4 CT: 023 Electroencephalographs (EEG equipment) 4 CEN/TR 15133:20058 Applicable GMDNCategories ct code Collective Terms 1 2 3 CT: 024 Electro-therapy equipment 4 CT: 065 Endoscopes and endoscopic devices 4 CT: 027 Enteral feeding devices, including dedicated pumps 4 10 CT: 234 Fixation devices

40、 10 CT: 054 Gas supply systems and ancillary devices 2 5 CT: 049 Gloves 10 CT: 029 Gynaecological/obstetrical devices 9 CT: 030 Haemostatic materials 10 CT: 101 Hearing aids 11 1 CT: 088 Heart valves 7 CT: 031 Heart-Lung bypass systems 1 4 CT: 077 Hyperthermia systems and ancillaries for malignant t

41、umor:growth treatment 4 12 CT: 032 Hypothermia/hyperthermia devices for body temperature regulation 5 CT: 229 Image guided surgery devices 12 CT: 075 Incubators, infant 4 CT: 028 Incubators, laboratory 4 6 CT: 223 Information systems including picture archiving and communication systems (PACS) 4 12

42、CT: 073 Infusion pumps 4 CT: 063 Infusion pumps, implantable 1 CT: 033 Intraocular implants 7 CT: 034 Intravenous administration sets 10 CT: 035 Iontopheresis equipment 4 CT: 083 Irrigation and lavage equipment 5 CT: 036 Lasers for medical use 4 3 CT: 220 Leucodepletion devices 10 CT: 221 Lifts for

43、patient/person transfer 5 11 CEN/TR 15133:20059 Applicable GMDNCategories ct code Collective Terms 1 2 3 CT: 037 Lithotriptors 4 CT: 105 Magnetic Resonance Imaging equipment (MRI) 12 CT: 038 Magnetic therapy units 4 CT: 079 Massage equipment 4 CT: 039 Medical gas supply devices (portable) 2 CT: 092

44、Medical gas supply systems and ancillary devices 2 5 CT: 199 Microscopes 6 CT: 127 Microscopes, surgical 5 3 CT: 084 Nebulizers for liquid or powder dispersal, Inhalers 2 CT: 098 Needles 10 3 CT: 040 Neurological diagnostic equipment 4 CT: 106 Nuclear medicine equipment 12 CT: 165 Ocular prostheses

45、8 CT: 085 Operating theatre lighting 5 3 CT: 041 Operating theatre tables and other patient supporting systems for medical interventions 5 3 CT: 087 Ophthalmological measuring/testing equipments 8 4 CT: 042 Ophthalmological, measuring, testing, surgical, instruments 8 4 CT: 166 Oral surgical fixatio

46、n/distraction devices 3 CT: 125 Orthopaedic implants, joints 7 CT: 043 Osteotomy devices 10 CT: 076 Pacemakers, cardiac, external 4 CT: 061 Pacemakers, cardiac, implantable 1 CT: 050 Patient monitoring systems/devices, respiratory 2 4 CT: 046 Phototherapy devices 4 CT: 080 Physiotherapy diathermy eq

47、uipment 4 CT: 047 Pressure alleviation devices 5 CEN/TR 15133:200510 Applicable GMDNCategories ct code Collective Terms 1 2 3 CT: 048 Prostheses for augmentation/replacement of body parts 7 3 CT: 108 Radiation Protection devices 12 CT: 104 Radiological diagnostic equipment i.e. X-ray) 12 3 CT: 109 R

48、adiotherapy equipment 12 CT: 197 Scales 5 CT: 194 Simulators, radiotherapy 12 CT: 112 Software for medical purposes 4 6 12 CT: 169 Software, diagnostic 4 CT: 051 Speech therapy devices 4 CT: 052 Sponges/swabs 10 CT: 215 Staining devices 6 CT: 094 Stapling/Suturing devices 9 10 CT: 090 Stents 7 CT: 0

49、86 Sterilizer/Disinfection devices 5 3 CT: 072 Stethoscopes 4 CT: 053 Stimulators, - muscle/nerve 4 CT: 110 Stimulators, muscle/nerve, implantable 1 CT: 082 Suction units and drainage devices 5 7 3 CT: 021 Surgical diathermy devices 4 3 CT: 093 Surgical instruments 9 3 CT: 055 Surgical instruments - powered 4 CT: 056 Surgical inst