For those of you in the medical device industry, it can sometimes be difficult to keep up with new releases in your sector. Here at Document Center Inc., we have a service called Standards Informer that was developed to solve this problem for you. It monitors new releases and revisions that may affect you and provides you with a quarterly report of these new items.
One new item we’d like to bring to your attention is ISO 14117, “Active implantable medical devices – Electromagnetic compatibility – EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices.” This new release is based on ANSI/AAMI PC69:2007. The relationship between the documents is addressed in Section A.2.4 of the ISO Edition.
ISO 14117:2012 addresses the EM compatibility of pacemakers and ICDs up to 3 000 MHz and is divided in several sections. They include
- 0 Hz ≤ ƒ < 450 MHz, the lower-frequency bands
- 450 MHz ≤ ƒ < 3 000 MHz, the frequencies, ƒ, that are typically associated with personal hand-held communication devices
- ƒ ≥ 3,000 MHz, testing of devices above 3 GHz is not required.
Technical Committee 150 Subcommittee 6 (Implants for surgery, Active implants) believes it is reasonable to expect that patients with pacemakers and ICDs will be exposed to increasingly complex EM environments. Also, the rapid evolution of new technologies and their acceptance by patients will lead to growing expectations for unrestricted use. Due to the changing EM environment and customer expectations, the subcommittee developed this standard to assist manufacturers with the evaluation process of their product designs to assess compatibility with the complex fields, broad range of frequencies, and variety of modulation schemes associated with existing and future applications.
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