GB 16174.2-2024 Implants for surgery—Active implantable medical devices—Part 2:Cardiac pacemakers

Scope

This document specifies the special requirements for pacemakers.
This document applies to active implantable medical devices used to treat bradyarrhythmia, as well as devices providing cardiac resynchronization therapy, and certain non-implantable components and accessories of active implantable medical devices.
The tests specified in this document are type tests, which are used to confirm compliance through sample testing.
The electrical characteristics of implantable pulse generators or electrode leads are verified using the appropriate methods described in this document or other methods, provided that the accuracy of these other methods can be proven to be equal to or better than the specified methods. In case of disputes, the methods specified in this document shall prevail.
ISO 14708-6 covers all aspects of active implantable medical devices used to treat tachyarrhythmia.
Note: What are commonly referred to as "active implantable medical devices" may actually be a single device, a combination of multiple devices, or a combination of one or more devices with one or more accessories. Not all of these components are partially or fully implantable, but if non-implantable components or accessories may affect the safety and performance of the implantable device, requirements for non-implantable components and accessories must be specified.

Development Information

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