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					                          “Challenges in Design and Certification”




                       “Challenges in design and certification of
                         new medical equipment in aircrafts –
                                The EU experience“

                                                          >>                               <<




Airmed Brighton, 25. Mai 2011, Rolf Kraus, Director MIC, Bucher Leichtbau AG, CH-8117 Fällanden   1
                          “Challenges in Design and Certification”

 Bucher Leichtbau in Fällanden




  Bucher Leichtbau AG
  Industriestr. 1
  CH-8117 Fällanden                                                                           Founded 1953
  Tel.: +41 44 806 2424                                                                              -
                                                                                            58 years of aircraft
  bucher@bucher-group.com
                                                                                           interiors experience
  www.bucher-group.com
Airmed Brighton, 25. Mai 2011, Rolf Kraus, Director MIC, Bucher Leichtbau AG, CH-8117 Fällanden                    2
                          “Challenges in Design and Certification”




Airmed Brighton, 25. Mai 2011, Rolf Kraus, Director MIC, Bucher Leichtbau AG, CH-8117 Fällanden   3
                          “Challenges in Design and Certification”

 Contents : CE marked product


          •Requirements - Trend
          •Medical regulations
          •Documentation for medical devices
          •CE-Certificates
          •Handling of material




Airmed Brighton, 25. Mai 2011, Rolf Kraus, Director MIC, Bucher Leichtbau AG, CH-8117 Fällanden   4
                          “Challenges in Design and Certification”

 Requirements - Trend


  EN/ISO ??

  93/42 EEC
                                  Past = Cargo
                                Today aviation law
  EN 1865                        and medical law
                                    approved
  EN 13718

  EASA
  Local Auth.
  (FOCA)

                       Past                                                                       Today   Future
Airmed Brighton, 25. Mai 2011, Rolf Kraus, Director MIC, Bucher Leichtbau AG, CH-8117 Fällanden                5
                          “Challenges in Design and Certification”

 Regulations:
 Directive 93/42/EEC: 14. June 1993:
       Medical Device Directive (MDD) => national law in every member state
 Medical Devices Operator Ordinance (MPBetreibV) since 29.06.1998
 DIN EN ISO 13718-1: since 2002
      Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical
     devices used in air ambulances
 DIN EN ISO 13718-2: since 2002
     Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical
     requirements of air ambulances.
 DIN EN 1865: Last revision 2010
     "Specifications for stretchers and other patient handling equipment used in road ambulances"
 EASA since 15. 07. 2002

 http://ec.europa.eu/consumers/sectors/medical-devices/documents/guidelines
                                                     /
Airmed Brighton, 25. Mai 2011, Rolf Kraus, Director MIC, Bucher Leichtbau AG, CH-8117 Fällanden   6
                          “Challenges in Design and Certification”

 Documentation for medical devices:
 Design :
 -    Risk analysis
 -    Classification
 -    Compliance of all regulations
 -    Design and calculations
 -    Tests and approvals
 -    Declaration of conformity

 Production / Logistics:
 -   Approved suppliers
 -   Handling of material
 -   Quality assurance

 Sales / After Sales
 -    Instructions from manufacturer
 -    User manuals
 -    Maintenance manuals
 -    Post market (observation)
                                                     /
Airmed Brighton, 25. Mai 2011, Rolf Kraus, Director MIC, Bucher Leichtbau AG, CH-8117 Fällanden   7
                          “Challenges in Design and Certification”

 Documentation – Risk analysis:




Airmed Brighton, 25. Mai 2011, Rolf Kraus, Director MIC, Bucher Leichtbau AG, CH-8117 Fällanden   8
                          “Challenges in Design and Certification”

 Classification regarding 93/42 EEC:




Airmed Brighton, 25. Mai 2011, Rolf Kraus, Director MIC, Bucher Leichtbau AG, CH-8117 Fällanden   9
                          “Challenges in Design and Certification”

 Compliance of all regulations:




Airmed Brighton, 25. Mai 2011, Rolf Kraus, Director MIC, Bucher Leichtbau AG, CH-8117 Fällanden   10
                          “Challenges in Design and Certification”

 Tests Stretcher:




Airmed Brighton, 25. Mai 2011, Rolf Kraus, Director MIC, Bucher Leichtbau AG, CH-8117 Fällanden   11
                          “Challenges in Design and Certification”

 CE-Certificate Class 1 Product




Airmed Brighton, 25. Mai 2011, Rolf Kraus, Director MIC, Bucher Leichtbau AG, CH-8117 Fällanden   12
                          “Challenges in Design and Certification”

CE-Certificate Class 2b Product




Airmed Brighton, 25. Mai 2011, Rolf Kraus, Director MIC, Bucher Leichtbau AG, CH-8117 Fällanden   13
                          “Challenges in Design and Certification”

 Documentation - Manuals:

 User Manual                                                                        Maintenance Manual




Airmed Brighton, 25. Mai 2011, Rolf Kraus, Director MIC, Bucher Leichtbau AG, CH-8117 Fällanden     14
                          “Challenges in Design and Certification”


 Handling of purchased material:
 Case 1 :
 CE marked part / product - no modification
 ⇒ Check if user and maintenance manual fulfills all requirements

 Case 2 :
 CE marked part / product – with modification
 ⇒ Agreement about change management with supplier
 ⇒ New tests under new situation
 ⇒ Classification of the new modified product

 Case 3 :
 Non approved part / product
 ⇒ Complete procedure
 ⇒ Documentation, Risk analysis, Tests, …


                                                     /
Airmed Brighton, 25. Mai 2011, Rolf Kraus, Director MIC, Bucher Leichtbau AG, CH-8117 Fällanden   15
                          “Challenges in Design and Certification”




         Thank you for your attention !




                                                       Questions ?



Airmed Brighton, 25. Mai 2011, Rolf Kraus, Director MIC, Bucher Leichtbau AG, CH-8117 Fällanden   16
                          “Challenges in Design and Certification”

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Airmed Brighton, 25. Mai 2011, Rolf Kraus, Director MIC, Bucher Leichtbau AG, CH-8117 Fällanden   17

				
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