YY/T 1874-2023Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices (English PDF)

1 Scope

This document specifies procedures for the evaluation of one or more of the bradycardia, tachycardia, and cardiac

Electromagnetic compatibility (EMC) test methods for active implantable cardiovascular devices for resynchronization and other treatments:

NOTE: This document is designed for pulse generators used with endocardial leads or epicardial leads: For those who do not use endocardial or epicardial electrocardiography

Pulse generators using polar lead technology, adjusted at the discretion of the manufacturer using these technologies:

This document specifies performance limits for such devices when interacting with EM transmitters that may operate in the following two EM spectral ranges:

---0Hz<=f< 385MHz;

---385MHz<=f<=3000MHz:

This document also specifies the requirements for the protection of such devices from EM fields in medical environments, defines the required accompanying documents, and provides information about EM transmitter manufacturers and expected immunity levels:

This document applies to transvenous lead systems that can provide one or more of bradycardia, tachycardia, and cardiac resynchronization, etc:

Therapeutic Active Implantable Cardiovascular Devices:

2 Normative references

The contents of the following documents constitute the essential provisions of this document through normative references in the text: Among them, dated references,

Only the version corresponding to the date applies to this document; for undated references, the latest version (including all amendments) applies to this document:

ISO 14708-1:2014 Surgical implants Active implantable medical devices Part 1: General requirements for safety, marking and information provided by the manufacturer

Note: GB 16174:1-2015 Surgical implants Active implantable medical devices Part 1: General requirements for safety, marking and information provided by the manufacturer (ISO 4708-1:2000, IDT)

ISO 14708-2:2019 Surgical implants Active implantable medical devices Part 2: Cardiac pacemakers

Note: GB 16174:2-2015 Surgical Implants Active Implantable Medical Devices Part 2: Cardiac Pacemakers (ISO 14708-2:2005, IDT)

ISO 14708-6:2019 Surgical implants Active implantable medical devices Part 6: Active devices for the treatment of tachyarrhythmias

Note: YY 0989:6-2016 Active implantable medical devices for surgical implants Part 6: Active implantable medical devices for the treatment of tachyarrhythmias (including implantable defibrillators) specific requirements (ISO 14708-6:2010, IDT) […]