Active implantable medical devices - Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) Ingestion-build-115288 The primary audience for this

The primary audience for this Guide is laboratory staff who are required to prepare and use materials for specific in-house quality control applications

The wedge tensile test and hardness test have been improved

and expression of results with a test report that ensures the testing performance of separation of oil in filling compounds

2  Management of impartiality

Active implantable medical devices - Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) Ingestion-build-115288 The primary audience for this1 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