1 / 9

SEKILAS TENTANG IEC TECHNICAL COMMITTEE 62 : ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

SEKILAS TENTANG IEC TECHNICAL COMMITTEE 62 : ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE. PRESENTED BY: Beluh Mabasa Ginting.ST 006/BSN/TAS-QC Tenaga Ahli Standardisasi : Health Care Technology(ICS 11) 09-10 Juli 2008. I. Pendahuluan.

kory
Download Presentation

SEKILAS TENTANG IEC TECHNICAL COMMITTEE 62 : ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. SEKILAS TENTANG IEC TECHNICAL COMMITTEE 62 :ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE PRESENTED BY: BeluhMabasa Ginting.ST 006/BSN/TAS-QC TenagaAhliStandardisasi :Health Care Technology(ICS 11) 09-10 Juli 2008

  2. I. Pendahuluan International Electronical Commission (IEC) adalah organisasi internasional untuk standardisasi yang anggotanya mencakup semua panitia teknik kelistrikan yang ada di dunia (IEC National Committee). Tujuan dan sasaran IEC adalah untuk mempromosikan kerjasama internasional tentang semua pertanyaan mengenai standardisasi dalam bidang kelistrikan, elektronik dan teknologi terkait (dari power generation, transmission and distribution to home appliances and office equipment, medical electrical equipment, semiconductors, fibre optics, batteries, solar energy, nanotechnology and marine energy), publikasi IEC mencakup standar internasional, spesifikasi teknis (TS), laporan teknis (TR), publicly available specification (PAS) Perumusan yang terkait dengan standardisasi peralatan listrik medik/medical electrical equipment oleh International Electronical Commission (IEC) dipercayakan kepada Technical Committee/TC 62: Electrical equipment in medical practice. Dikarenakan begitu luasnya ruang lingkup teknologi pelayanan kesehatan /health care technology (ICS 11) khususnya bidang peralatan listrik medik/medical electrical equipment maka technical committee/TC 62 membentuk beberapa subpanitia teknis/subcommittee sebagai berikut:

  3. Subcommittee pada TC 62: Electrical Equipment in medical practice adalah : Subcommittee 62A: Common aspects of electrical equipment used in medical practice Subcommittee 62B: Diagnostic imaging Equipment Subcommittee 62C: Equipment for radiotherapy, nuclear medicine and radiation dosimetry Subcommittee 62D: Electromedical Equipment yang masing-masing mempunyai tugas untuk merumuskan standar yang terkait dengan standardisasi peralatan listrik medik/medical electrical equipment

  4. HISTORIS IEC 60601-1 Edisi pertama subpanitia teknis 62A yang dipublikasikan tahun 1976, yaitu IEC/TR 60513, Basic aspects of the safety philosophy for electrical equipments use in medical practice menjadi dasar untuk pengembangan : edisi pertama IEC 601-1: 1977, Safety of medical elecrical equipment, Part 1: General requirements, standar yang memuat persyaratan umum untuk keselamatan peralatan listrik medik); edisi kedua IEC 601-1: 1988, Medical elecrical equipment, Part 1: General requirements for safety, IEC 60601-1: 2005, Medical electrical equipment-Part 1- General requirement for basic safety and essential performance seri IEC 60601-1-xx standar kolateral untuk peralatan listrik medik; seri IEC 60601-2-xx standar yang memuat persyaratan khusus untuk keselamatan peralatan listrik medik tertentu ; dan seri IEC 60601-3-xx sebagai standar kinerja untuk tipe khusus peralatan listrik medik.

  5. Publication numbering of IEC As from 1 Januari 2007 all IEC publication edition are issued with a designation in the 60000 series. For example , IEC 34-1 is now refered to as 60034-1

  6. IEC 60601-1: (2005-12) Third edition, Medical electrical equipment-Part 1- General requirement for basic safety and essential performance tidak berlaku untuk : Chemical technology. Laboratory equipment/Peralatan laboratorium yang perumusannya dipercayakan kepada Technical Committee 66 - Safety of measuring, control and laboratory equipment masuk ICS 71.040.10Chemical laboratories. Laboratory equipment dan 19.080Electrical and electronic testing Including testing equipment, contoh : - IEC 61010-2-020 (2006-05) Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-020: Particular requirements for laboratory centrifuges In vitro diagnostic (IVD) medical equipment yang perumusannya dipercakan kepada Technical Committee 66 - Safety of measuring, control and laboratory equipment masuk ICS 11.040.55Diagnostic equipment Including medical monitoring equipment, medical thermometers and related materials dan 19.080Electrical and electronic testing Including testing equipment.Equipment for measuring electrical and magnetic quantities, see 17.220.20, contoh: - IEC 61010-2-101 (2002-01) Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

  7. (lanjutan) Peralatan implan aktif (active implantable medical devices) ISO 14780-1, Implant for surgery – Active implantble medical devices – Part 1: General requirement for safety, marking and for information to be provided by the manufactures, kecuali ISO 14780-1 mensyaratkan harus sesuai dengan IEC 60601-1. Sistem pemipaan gas medik ISO 7396-1, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum. CATATAN: Subpasal 6.3 ISO 7396-1 menggunakan persyaratan IEC 60601-1-8 untuk monitoring and sinyal alarm tertentu.

  8. CISPR 11 CISPR singkatan dari Comite International Special des Perturbations Radioelectriques atau dalam bahasa ingris the International special committee on Radio Interference dikenal dengan singkagtan CISPR, merupakan panitia khusus dibawah sponsorship International Electrotechnical Commissions (IEC). Anggotanya berasal dari panitia nasional/ national committees IEC, dan dari anggota organisasi internasional negara lain yang tertarik dalam bidang pengurangan interferensi radio. CISPR dibentuk tahun 1934. Salah satu dari publikasi CISPR yang paling terkenal yang terkait dengan peralatan kesehatan adalah CISRP 11. Industrial, Scientific, and Medical (ISM) Radio-Frequency Equipment-Electromagnetic Disturbance Characteristics-Limits and Methods of Measurement. CISPR 11 ini masuk dalam kelompok : CISPR Subcommittee B – Interference relating to industrial, scientific, and medical (ISM) radio frequency apparatus, to other (heavy) industrial equipment, to overhead power lines, to high voltage equipment, and to electric traction.

  9. STANDARD IS NOTHING WITHOUT UNDERSTANDING …!

More Related