EVS/TK 11

Meditsiiniseadmed

Scope: Meditsiinilised süstimisvahendid, anesteesia- ja hingamisaparatuur, kirurgilised implantaadid, kirurgiariistad, meditsiiniliste vahendite bioloogiline hinnang, tervisehooldetoodete steriliseerimine, meditsiiniliste vahendite kvaliteet, kliinilised laboratoorsed katsetused ja in vitro diagnostilised katsetussüsteemid, mehaanilised rasestumisvastased vahendid, mitteaktiivsed kirurgilised implantaadid, hingamis- ja anesteesiaaparatuur, mitteaktiivsed meditsiiniseadmed, meditsiiniseadmete steriliseerimine, oftalmoloogiline optika, in vitro diagnoosimissüsteemid, meditsiinilised sterilisaatorid.

Mirror Committees
  • CEN/CLC/JTC 3 - Quality management and corresponding general aspects for medical devices
  • CEN/TC 102 - Sterilizers and associated equipment for processing of medical devices
  • CEN/TC 140 - In vitro diagnostic medical devices
  • CEN/TC 170 - Ophthalmic optics
  • CEN/TC 204 - Sterilization of medical devices
  • CEN/TC 205 - Non-active medical devices
  • CEN/TC 206 - Biological and clinical evaluation of medical devices
  • CEN/TC 215 - Respiratory and anaesthetic equipment
  • CEN/TC 285 - Non-active surgical implants
  • CEN/TC 293 - Assistive products and accessibility
  • CEN/TC 55 - Dentistry
  • CLC/TC 62 - Electrical equipment in medical practice
  • IEC/TC 62 - Electrical equipment in medical practice
  • ISO/TC 106 - Dentistry
  • ISO/TC 121 - Anaesthetic and respiratory equipment
  • ISO/TC 150 - Implants for surgery
  • ISO/TC 157 - Non-systemic contraceptives and STI barrier prophylactics
  • ISO/TC 170 - Surgical instruments
  • ISO/TC 173 - Assistive products
  • ISO/TC 194 - Biological and clinical evaluation of medical devices
  • ISO/TC 198 - Sterilization of health care products
  • ISO/TC 210 - Quality management and corresponding general aspects for medical devices
  • ISO/TC 212 - Clinical laboratory testing and in vitro diagnostic test systems
  • ISO/TC 215 - Health informatics
  • ISO/TC 84 - Devices for administration of medicinal products and catheters
Committee members
  1. Radexpert OÜ
  2. Terviseamet
  3. Sotsiaalministeerium
  4. Tervisetehnoloogiate Arenduskeskus AS
  5. TorroSen OÜ
  6. Humal Elektroonika OÜ
  7. Tartu Ülikool

Establishment Date: 09.01.2001

Work Programme for Technical Committee

Chairman: Kalle Kepler

Coordinator: Anna-Maria Hütt