Active implantable medical devices - Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) Ingestion-build-264231 a) providing interpretation of the

a) providing interpretation of the requirements in the EN ISO 9000 series of standards

This standard also establishes interfaces between the user (purchaser) and the designer

swabbing technique

Requirements for associated platforms and safety hoops are also given

Active implantable medical devices - Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) Ingestion-build-264231 a) providing interpretation of the1 Scope This Part 2 1 specifies requirements that are applicable to those active implantable medical devices intended to treat bradyarrhythmias. 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 2 1 is also applicable to some non implantable parts and accessories of the devices (see Note 1). The characteristics of the implantable pulse generator or lead shall be