YY 0989.6-2025 Implants for surgery—Active implantable medical devices—Part 6:Particular requirements for active implantable medical devices intended to treat tachyarrhythmia(including implantable defibrillators)

Scope

This document specifies the requirements for active implantable medical devices (including implantable defibrillators) used in the treatment of tachyarrhythmia.
This document applies to implantable cardioverter-defibrillators, implantable cardiac resynchronization therapy/defibrillators, active implantable medical devices with the function of treating tachyarrhythmia, and certain non-implantable components and accessories of active implantable medical devices (see note).
This document does not apply to active implantable medical devices used in the treatment of bradyarrhythmia or cardiac resynchronization. GB 16174.2-2024 specifies such requirements.
Note 1: The tests specified in this document are type tests, and conformity is confirmed through testing of samples.
Note 2: The characteristics of implantable pulse generators or electrode leads are verified using 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 superior to the specified methods. In case of dispute, the methods specified in this document shall prevail.
Note 3: What is 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.

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