Active implantable medical devices - Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) Ingestion-build-115288 BS EN ISO 50001 is

BS EN ISO 50001 is similar to BS EN 16001

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Active implantable medical devices - Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) Ingestion-build-115288 BS EN ISO 50001 is1 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