NOTE: The International Standard corresponding to this Standard and the symbol of degree of correspondence are as follows.

IEC 60601-1-2: 2001 Medical electrical equipment-Part 1-2: General requirements for safety-Collateral standard: Electromagnetic compatibility- Requirements and tests and Amendment 1: 2004 (lDT)

In addition, symbols which denote the degree of correspondence in the contents between the relevant International Standard and JIS are IDT (identical), MOD (modified), and NEQ (not equivalent) according to ISO/IEC Guide 21-1.

As well as methods for installation, it establishes methods for minimizing the possibility of electromagnetic interference (EMI) between the installed equipment and the vehicle electrical and electronic systems.

ISO 7176-21:2009 also specifies requirements and test methods for the electromagnetic compatibility of battery chargers intended for use with electrically powered wheelchairs and scooters.

NOTE This document was designed for pulse generators used with endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of technologies that do not use endocardial leads or epicardial leads for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies.

It specifies performance limits of these devices, which are subject to interactions with EM emitters operating across the EM spectrum in the two following ranges:

— 0 Hz = ? < 385 MHz;

— 385 MHz = ? = 3 000 MHz

This document also specifies requirements for the protection of these devices from EM fields encountered in a therapeutic environment and defines their required accompanying documentation, providing manufacturers of EM emitters with information about their expected level of immunity.