메뉴 건너뛰기




Volumn 43, Issue 3, 2007, Pages 268-276

Electromagnetic immunity of medical devices: The European regulatory framework

Author keywords

Directives; Electromagnetic compatibility; Equipment and supplies; Medical devices; Reference standards

Indexed keywords

APPARATUS, EQUIPMENT AND SUPPLIES; ARTIFICIAL HEART PACEMAKER; DEFIBRILLATOR; ELECTROMAGNETIC FIELD; EQUIPMENT; EQUIPMENT DESIGN; EUROPEAN UNION; HEALTH CARE FACILITY; HUMAN; INTERNATIONAL COOPERATION; MAXIMUM ALLOWABLE CONCENTRATION; MOBILE PHONE; OCCUPATIONAL HEALTH; PRACTICE GUIDELINE; REVIEW; STANDARD;

EID: 35348960507     PISSN: 00212571     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review
Times cited : (15)

References (28)
  • 1
    • 35349018810 scopus 로고    scopus 로고
    • Council Directive of 14 June 1993, 93/42/EEC
    • Council of the European Communities, Bruxelles
    • Council of the European Communities. Council Directive of 14 June 1993, 93/42/EEC. Medical Device. Bruxelles.
    • Medical Device
  • 2
    • 35348940983 scopus 로고    scopus 로고
    • Council of the European Communities. Council Directive of 20 June 1990, 90/385/EEC. Active implantable medical devices. Official Journal of the European Community L189, 20/07/1990.
    • Council of the European Communities. Council Directive of 20 June 1990, 90/385/EEC. Active implantable medical devices. Official Journal of the European Community L189, 20/07/1990.
  • 3
    • 35348946171 scopus 로고    scopus 로고
    • Council of the European Communities. Council Directive of 27 October 1998 on in vitro diagnostic medical devices, 98/79/EEC. Official Journal of the European Community L169, 12/07/1993.
    • Council of the European Communities. Council Directive of 27 October 1998 on in vitro diagnostic medical devices, 98/79/EEC. Official Journal of the European Community L169, 12/07/1993.
  • 4
    • 0002587509 scopus 로고
    • Performance degradation of electronic medical devices due to electromagnetic interferences
    • Silberberg JL. Performance degradation of electronic medical devices due to electromagnetic interferences. Compliance Engineering 1993:25-39.
    • (1993) Compliance Engineering , pp. 25-39
    • Silberberg, J.L.1
  • 5
    • 0029045473 scopus 로고    scopus 로고
    • Barbaro V, Bartolini P, Donato A, Militello C, Altamura G, Ammirati F, Santini M. Do European GSM mobile cellular phones pose a potential risk to pacemaker patients? Pacing Clin Electrophysiol 1995;18:1218-24.
    • Barbaro V, Bartolini P, Donato A, Militello C, Altamura G, Ammirati F, Santini M. Do European GSM mobile cellular phones pose a potential risk to pacemaker patients? Pacing Clin Electrophysiol 1995;18:1218-24.
  • 7
    • 0030254253 scopus 로고    scopus 로고
    • Wireless phones and pacemaker interaction
    • Hayes DL. Wireless phones and pacemaker interaction. Pacing Clin Electrophysiol 1996;19:1405-6.
    • (1996) Pacing Clin Electrophysiol , vol.19 , pp. 1405-1406
    • Hayes, D.L.1
  • 8
    • 0029837925 scopus 로고    scopus 로고
    • Electromagnetic interference of pacemakers by mobile phones
    • Irnich W, Batz L, Muller R, et al. Electromagnetic interference of pacemakers by mobile phones. Pacing Clin Electrophysiol 1996;19:1431-46.
    • (1996) Pacing Clin Electrophysiol , vol.19 , pp. 1431-1446
    • Irnich, W.1    Batz, L.2    Muller, R.3
  • 10
    • 0029816916 scopus 로고    scopus 로고
    • The safety of digital mobile cellular telephones with minute ventilation rate adaptive pacemakers
    • Sparks PB, Mond HG, Joyner KH, Wood MP. The safety of digital mobile cellular telephones with minute ventilation rate adaptive pacemakers. Pacing Clin Electrophysiol 1996;19:1451-5.
    • (1996) Pacing Clin Electrophysiol , vol.19 , pp. 1451-1455
    • Sparks, P.B.1    Mond, H.G.2    Joyner, K.H.3    Wood, M.P.4
  • 11
    • 0029820870 scopus 로고    scopus 로고
    • Influence of D-net (European GSM-standard) cellular phones on pacemaker function in 50 patients with permanent pacemakers
    • Wilke A, Grimm W, Funck R, Maisch B. Influence of D-net (European GSM-standard) cellular phones on pacemaker function in 50 patients with permanent pacemakers. Pacing Clin Electrophysiol 1996;19:1456-8.
    • (1996) Pacing Clin Electrophysiol , vol.19 , pp. 1456-1458
    • Wilke, A.1    Grimm, W.2    Funck, R.3    Maisch, B.4
  • 12
    • 0031193865 scopus 로고    scopus 로고
    • In vitro testing of pacemakers for digital cellular phone electromagnetic interference
    • Ruggera PS, Witters DM, Bassen HI. In vitro testing of pacemakers for digital cellular phone electromagnetic interference. Biomed Instrum Technol 1997;31:358-71.
    • (1997) Biomed Instrum Technol , vol.31 , pp. 358-371
    • Ruggera, P.S.1    Witters, D.M.2    Bassen, H.I.3
  • 14
    • 0037683318 scopus 로고    scopus 로고
    • Electromagnetic filters impede adverse interference of pacemakers by digital cellular telephones
    • Carillo R, Williams D, Traad E, Schor J. Electromagnetic filters impede adverse interference of pacemakers by digital cellular telephones. J Am Coll Cardiol 1996;27:901-22.
    • (1996) J Am Coll Cardiol , vol.27 , pp. 901-922
    • Carillo, R.1    Williams, D.2    Traad, E.3    Schor, J.4
  • 15
    • 0031294426 scopus 로고    scopus 로고
    • and application of broadband ceramic feedthrough capacitor EMI filters to cardiac pacemakers and implantable defibrillators, Chicago, USA: 30 October-2 November
    • Stevenson R. Design and application of broadband ceramic feedthrough capacitor EMI filters to cardiac pacemakers and implantable defibrillators. In: Proceedings Annual International Conference IEEE Engineering in Medicine and Biology Society. Chicago, USA: 30 October-2 November 1997. p. 2558-62.
    • (1997) Proceedings Annual International Conference IEEE Engineering in Medicine and Biology Society , pp. 2558-2562
    • Design, S.R.1
  • 17
    • 35349028679 scopus 로고    scopus 로고
    • International Electrotechnical Commission. IEC EN 60601-1. Medical electrical equipment. Part 1: General requirements for basic safety and essential performance. Geneva: IEC; 2006.
    • International Electrotechnical Commission. IEC EN 60601-1. Medical electrical equipment. Part 1: General requirements for basic safety and essential performance. Geneva: IEC; 2006.
  • 18
    • 35349010884 scopus 로고    scopus 로고
    • International Electrotechnical Commission. IEC EN 60601-1-2. Medical electrical equipment. Part I: General requirements for safety. 2. Collateral standard: electromagnetic compatibility. Requirements and tests. Geneva: IEC; 2003.
    • International Electrotechnical Commission. IEC EN 60601-1-2. Medical electrical equipment. Part I: General requirements for safety. 2. Collateral standard: electromagnetic compatibility. Requirements and tests. Geneva: IEC; 2003.
  • 19
    • 35349026469 scopus 로고    scopus 로고
    • ANSI/AAMI PC69. American active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemaker and implantable cardioverter defibrillators. Washington, DC: National Standard Institute / Association for the Advancement of Medical Instrumentation; 2000.
    • ANSI/AAMI PC69. American active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemaker and implantable cardioverter defibrillators. Washington, DC: National Standard Institute / Association for the Advancement of Medical Instrumentation; 2000.
  • 20
    • 35349005551 scopus 로고    scopus 로고
    • CEN/CLC/JWG AIMD EN 45502-1. Active implantable medical devices. Part 1: General requirements for safety, marking and information to be provided by the manufacturer. Bruxelles: Comité Européen de Normalisation Electrotechnique (CENELEC); 1997.
    • CEN/CLC/JWG AIMD EN 45502-1. Active implantable medical devices. Part 1: General requirements for safety, marking and information to be provided by the manufacturer. Bruxelles: Comité Européen de Normalisation Electrotechnique (CENELEC); 1997.
  • 21
    • 35348947733 scopus 로고    scopus 로고
    • Standard C63.18. Recommended practice for an on-site, ad hoc test method for estimating radiated electromagnetic immunity of medical devices to specific radiofrequency trasmitters. Washington, DC: American National Standard Institute; 1999.
    • Standard C63.18. Recommended practice for an on-site, ad hoc test method for estimating radiated electromagnetic immunity of medical devices to specific radiofrequency trasmitters. Washington, DC: American National Standard Institute; 1999.
  • 22
    • 35349006092 scopus 로고    scopus 로고
    • CEN/CLC/JWG AIMD EN 45502-2-1. Active implantable medical devices. Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers). Bruxelles: Comité Européen de Normalisation Electrotechnique (CENELEC); 2003.
    • CEN/CLC/JWG AIMD EN 45502-2-1. Active implantable medical devices. Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers). Bruxelles: Comité Européen de Normalisation Electrotechnique (CENELEC); 2003.
  • 23
    • 35349023476 scopus 로고    scopus 로고
    • CEN/CLC/JWG AIMD prEN 45502-2-2. Active implantable medical devices. Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators). Bruxelles: Comité Européen de Normalisation Electrotechnique (CENELEC); 2006.
    • CEN/CLC/JWG AIMD prEN 45502-2-2. Active implantable medical devices. Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators). Bruxelles: Comité Européen de Normalisation Electrotechnique (CENELEC); 2006.
  • 24
    • 35348934665 scopus 로고    scopus 로고
    • CEN/CLC/JWG AIMD prEN 45502-2-3. Active implantable medical devices. Part 2-3: Particular requirements for cochlear implant systems. Bruxelles: Comité Européen de Normalisation Electrotechnique (CENELEC); 2006.
    • CEN/CLC/JWG AIMD prEN 45502-2-3. Active implantable medical devices. Part 2-3: Particular requirements for cochlear implant systems. Bruxelles: Comité Européen de Normalisation Electrotechnique (CENELEC); 2006.
  • 25
    • 35348938306 scopus 로고    scopus 로고
    • th individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC. Official Journal of the European Union L159; 30/04/2004.
    • th individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC. Official Journal of the European Union L159; 30/04/2004.
  • 26
    • 0343375204 scopus 로고    scopus 로고
    • Guidelines for limiting exposure to time-varying electric, magnetic, and electromagnetic fields (up to 300 GHz)
    • International Commission on Non-Ionizing Radiation Protection
    • International Commission on Non-Ionizing Radiation Protection. Guidelines for limiting exposure to time-varying electric, magnetic, and electromagnetic fields (up to 300 GHz). Health Physics 1998;74:494-522.
    • (1998) Health Physics , vol.74 , pp. 494-522
  • 27
    • 35349014448 scopus 로고    scopus 로고
    • Application of risk management to medical devices. Bruxelles: Comité Européen de Normalisation Electrotechnique
    • EN ISO 14971, CENELEC
    • EN ISO 14971. Application of risk management to medical devices. Bruxelles: Comité Européen de Normalisation Electrotechnique (CENELEC); 2004.
    • (2004)
  • 28
    • 35348962383 scopus 로고    scopus 로고
    • European Council. Council Recommendation 1999/519/EC of 12 July 1999 on the limitation of exposure of the general public to electromagnetic fields (O Hz to 300 GHz). Official Journal of the European Community L199, 30/07/1999.
    • European Council. Council Recommendation 1999/519/EC of 12 July 1999 on the limitation of exposure of the general public to electromagnetic fields (O Hz to 300 GHz). Official Journal of the European Community L199, 30/07/1999.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.