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Details of 'DEN/ERM-TG30-003-2' Work Item
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  DEN/ERM-TG30-003-2 EN 302 510-2   ERM TG30
  Current Status
(Click to View Full Schedule)
Latest
Version
Cover Date Standstill Creation Date
  Citation in the OJ (2017-06-08) 1.1.1 2007-07-25 View Standstill Information 2004-07-01
  Rapporteur Technical Officer Harmonised Standard
  Peter E. Chadwick Marcello Pagnozzi Yes View Transposition Data
 
Title Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 30 MHz to 37,5 MHz for Ultra Low Power Active Medical Membrane Implants and Accessories; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive
Membrane implants 
Scope and Field
of Application
EN xxx XXX -1 and -2 will be developed to address a new technology in the medical field that will enhance the quality of life for afflicted patients and, in many cases, potentially save their life. This technology is a radically new concept for providing highly accurate real time vascular blood pressure level information from an ULP-AMI membrane implant transmitter that is embedded in a patient undergoing vascular surgery. This type of information is not currently available with any type of non-invasive technology. These systems cannot be properly tested to show conformance with the applicable legislation under any existing ETSI standards owing to the frequency range, the method of energy coupling, tissue absorption, and other factors. 
Supporting
Organizations
FCTT - CardioMEMS ; DSI - EUR ; Cetecom ; Medronic ; LPRA ; FICORA ; JS Consulting ; Bolt Consult 

 

Keywords Projects Clusters Frequencies Mandates Directives
  RADIO
REGULATION
SRD
TESTING
  Better Living with ICT
ULP-AMI (30 MHz to 37,5 MHz)
M/536
2014/53/EU
Official Journal
2007-09-25 2007/C 225/02 Article 3.2
Remarks
2017-06-15 vantricht WI Revision. 1 WI created with Ref: DEN/ERM-TG30-003-2_R&TTE. Comments copied = No, Schedule copied = Default
 
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