EVS/TK 11

Meditsiiniseadmed

Käsitlusala: 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.

Peegelkomiteed
  • 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 - Medical equipment, software, and systems
  • 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
Komitee liikmed
  1. Radexpert OÜ
  2. Ravimiamet
  3. Celvia CC AS
  4. TorroSen OÜ
  5. Humal Elektroonika OÜ
  6. Tartu Ülikool

Loomiskuupäev: 09.01.2001

Tehnilise komitee tööprogramm

Esimees: Kalle Kepler

Koordinaator: Triin Teppand