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Accumulators and Batteries for Medical Equipment (Glossary) |
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In particular mobile deployments often take place under extremely difficult underlying conditions. For example, the power supply for vital systems in rescue services must also function in extreme temperatures and be generally insensitive to vibrations and soiling. Long working life Energy carriers for implanted devices must have a particularly long working life, so that operations to replace the batteries are required as seldom as possible. For instance, on average modern cardiac pacemakers function for a period of eight years.
It is self-evident that batteries for cardiac pacemakers or defibrillators must have the lowest possible failure probability. To be able to guarantee reliability this also means that it must be possible to store the secondary or primary cells under controlled conditions. For this purpose the manufacturer must provide reliable information for aging during storage (respectively also aging during use for secondary cells) and there must be a manufacturing date on the batteries. Biocompatibility Batteries which are intended for implantation or for permanent contact with the skin must be made of biocompatible material or at least have an appropriate encapsulation which is sealed, for instance, by a ceramic metal welding. In addition worth should be placed on components which are as non-toxic as possible.
Accumulators and batteries used in medical areas often have to be sterilisable. This requires them to be resistant against aggressive disinfectants or against heat and pressure (approximately 2 bar). In autoclaves the sterilisation typically lasts 15 minutes at 121 °C, and in extreme cases the sterilisation process has to last 18 minutes at 134 °C. Application areas Application areas for batteries and rechargeable batteries in medical equipment are, for instance:
 Defibrillators Cardiac pacemakers Wheelchairs Patient lifters Injection and infusion equipment Monitors Scales and thermometers Suction pumps Nutrition pumps Surgical saws and drills Blood sugar and blood pressure measuring instruments Respiratory devices for mobile rescue services Emergency power for operating theatres and life-sustaining systemsLegal basis In Germany and in Austria the requirements for the medical sector are stipulated in the Medical Device Law [Medizinproduktegesetz] (D, AU), respectively the Regulation on the installation, operation and use of medical devices [Medical Devices Operator Ordinance, MPBetreibV] (D) and the EU Medical Product Directive (CE mark). In Switzerland medical products must by licensed by Swissmed. However, on the basis of bilateral agreements the system of conformity evaluation, respectively certification of the European Union (EU) is also taken over there. The following shows examples of pertinent EU regulations for the CE mark for accumulators in the medical sector: Electrical equipment: 2006/95/EC Electromagnetic compatibility: 89/336/EEC, 2004/108/EC Active implantable medical devices: 90/385/EEC, 2007/47/EC Medical devices: 93/42/EEC, 2007/47/EC In-vitro diagnostic medical devices: 98/79/EC Measuring devices: 2004/22/ECAdditional sources of information In the following you will find links to other sources of information. Please note that these are external websites for which we accept no responsibility. EU EU Commission: Homepage for medical devicesEU: so-called Blue Guide ("New Concept CE")Amendment 2007 to the Medical Device Directive 93/42/EECDIMDI: Medical Devices Law OverviewGermany Federal Ministry of Justice: Medical Device LawFederal Ministry of Justice: Medical Devices Operator OrdinanceFederal Ministry of Health: Laws and Ordinances: Medical DevicesDIMDI: Medical Devices Law OverviewCentral Authority for Health Protection Regarding Medicinal Products and Medical DevicesAustria Austrian Register for Medical DevicesAustrian Agency for Health and Food Safety (AGES)Switzerland Swiss Agency for therapeutic products (Swissmedic)© Marc Stenzel Important note The above text is the result of careful research by a lay jurist. This text is possibly imperfect, incomplete or not up to date. You should therefore never use the information provided here as the sole basis for legal-related decisions. Instead, you should also consult qualified sources of information, such as a lawyer.
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