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Active implantable medical devices - Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
Description
Active implantable medical devices - Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)1 Scope This Part 2 2 of EN 45502 specifies requirements that are applicable to implantable cardioverter defibrillators and the functions of active implantable medical devices intended to treat tachyarrhythmia. The tests that are specified in EN 45502 are type tests and are to be carried out on samples of a device to show compliance. This part of EN 45502 is also applicable to some non implantable parts and accessories of the devices (see Note 1). The
a) introduces the still image part of ISO/IEC 13249 (all parts)
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By adopting BS EN 4329
The management procedures are based on the application layer services
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