European Standards Benefits and challenges. Per Kr Andersen Convenor CEN TC 239 WG 1 and 5 Senior adviser Norwegian Directorate of Health

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Muriel Hampton
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1 European Standards Benefits and challenges Per Kr Andersen Convenor CEN TC 239 WG 1 and 5 Senior adviser Norwegian Directorate of Health 1

2 European standards Benefits and challenges Standards is an important tool for quality enhancement Standards can be understood in different ways: Requirements in directives, national law and regulations JAR/EASA requirements CEN and ISO standards National standards (National standardization Bodies) Business sector/industry standards Operational handbooks others 2

national law and regulations JAR/EASA requirements CEN and ISO standards National

3 STANDARD: Definition by CEN document, established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context 3

use, rules, guidelines or characteristics for activities or their

4 Relevant standards from CEN TC 239 Rescue systems EN 1789 Medical vehicles and their equipment - Road Ambulances EN 1865 Stretchers and other patient handling equipment (5 parts) EN Medical vehicles and their equipment Air ambulances Part 1: Medical device interface requirements EN Medical vehicles and their equipment Air ambulances - Part 2: Operational and technical requirements of air ambulances EN Rescue systems - Transportation of incubators - Part 1: Interface conditions EN 13976/AC 2004 Rescue systems - Transportation of incubators - Part 2: System requirements Medical device related standards (MDD 93/42 EEC) 4

their equipment Air ambulances - Part 2: Operational and technical requirements of air ambulances EN 13976 Rescue systems - Transportation of incubators - Part

5 CEN TC 239 standards Developement of European standards are proposed by: - a CEN/ISO member country or - by the EU commission Goal for air ambulances: To create a safe working platform for monitoring, treatment and transport of patients and staff, without interference between aircraft and patient environment 5

create a safe working platform for monitoring, treatment and transport of

6 CEN TC 239 standards All member bodies of CEN (Europe) can participate. In addition, liaison members from ISO can participate in the working group Participants: Specialists i.e. Physicians Government/governing bodies Operators Manufacturers of aircrafts and medical devices End users (i e: operators, medical staff) 6

7 Standardization procedure elements Standards are voluntary to use The work are based on consensus The work should be user lead Based on TC decision PrEN are send on enquiry and later to Final Vote Final decision from weighted votes based on country population 7

Based on TC decision PrEN are send on enquiry and later to Final

8 Working Groups under CEN TC 239 WG 1: Road Ambulances and equipmet WG 4: Transport of incubators WG 5: Air Ambulances 8

9 Air Ambulance Standards Committee Europeenne Normalisation (CEN Standard) (European Standardization Organization) Important for Air ambulances FW and RW EN Medical vehicles and their equipment Air ambulances Part 1: Medical device interface requirements EN Medical vehicles and their equipment Air ambulances - Part 2: Operational and technical requirements of air ambulances Per Kr Andersen - Convenor CEN TC 239 Rescue Systems WG 5 Air Ambulances 9

Medical device interface requirements EN 13718-2 Medical vehicles and their equipment Air ambulances - Part 2:

10 Air Ambulance standards Part 1: Medical device interface requirements EN :2008 has been technically revised. The following points represent the most important changes in the revision: the standard was revised according to pren :2014. clarification of unclear issues in this part of the standard and between the two parts of the standard the standard was modified/integrated to meet the Medical Devices Directive 93/42/EEC requirements IEC/FDIS Medical Electrical Equipment -- Part 1-12: General requirements for basic safety and essential performance - Requirements for medical electrical equipment and medical electrical systems used in the emergency medical services environment 10

clarification of unclear issues in this part of the standard and between the two parts of the standard the standard was modified/integrated to meet the Medical Devices

11 Air Ambulance standards Part 2: Operational and technical requirements of air ambulances EN :2008 has been technically revised. The following points represent the most important changes in the revision: clarified unclear issues in this part of the standard and between the two parts of the standard (for example requirements for patient's compartment illumination); changed text related to enhancing safety related to the risk from rotors on helicopters; clarified the requirements for the patient treatment area the standard has been modified/integrated to meet the Medical Devices Directive 93/42/EEC requirements 11

of the standard (for example requirements for patient's compartment illumination); changed text related to enhancing safety related to the risk from rotors

12 Air Ambulance standards FprEN :2013 as agreed by CEN/TC 239/WG 5 is on Formal Vote. FprEN :2013 has been treated in a CEN Technical Board conciliation meeting after complaint from one National body waiting for BT desicion A common proposal to BT is worked out We are waiting for a go for Final Vote 12

FprEN 13718-2:2013 has been treated in a CEN Technical Board conciliation

13 Standardization benefits Enhance safety, interfaces and interoperability Safe use of Medical Devices in aircrafts The Medical Devices works according to intentions The aircraft is not influenced by use of Medical Devices Standards give statement of quality and safety level and end results Standards support specifications of service and equipment Standards support compatibility to requirements 13

influenced by use of Medical Devices Standards give statement of quality and safety level and end

14 Safe use of Medical Devices in aircrafts The standard focus on general requirements for medical devices within air ambulances - specific and environmental conditions and performance - electrical power driven medical devices electromagnetic interference of medical devices gas- supply fixation of medical devices in air ambulances systems for the devices and their mechanical strength 14

electrical power driven medical devices electromagnetic interference of medical devices gas-

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16 Challenges in use of standards The use of standards are volontary Does not need to be used (i e related to MDD) Take time to develop Still lack of interface elements, i. e. connectors Still not one common strecher fixation system Development of standards is based on consensus may weaken the requirements 16

17 Successful Business area standards Norwegian standard for Physicians in RW Air Ambulance Norwegian standard for FW Flight Nurses Norwegian standard for Rescuemen Appliccable for rescuemen in: Air Ambulance operations SAR operations (national) SAR operations (offshore oil industry) (applicable to Coast guard helicopters) 17

Rescuemen Appliccable for rescuemen in: Air Ambulance operations SAR operations

18 Thank you 18

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20 Air Ambulance standards FprEN :2013 is dispatched to CEN/CCMC for Formal Vote. The member bodies will be informed when the voting for Formal Vote starts. The Italian national standardization body has filed a complaint on the content claiming restriction on free market access This has been treated in CEN and an a solution is recommended to the Technical board 20

The Italian national standardization body has filed a complaint on the content claiming

ICS 11.040.01; 11.160; 49.020 Pakeičia LST EN 13718-2:2008

LIETUVOS STANDARTAS LST EN 13718-2 ANGLIŠKOJI VERSIJA 2015 m. liepa ICS 11.040.01; 11.160; 49.020 Pakeičia LST EN 13718-2:2008 Medicinos transporto priemon s ir jų įranga. Medicinos pagalbos orlaiviai.