Terms of Reference (ToR) for ETSI TC ERM Working Group (WG) MEDICAL: Medical Devices

Scope

The main objectives of TC ERM WG MEDICAL  are:

• Propose and elaborate product specific standards for radiocommunications equipment in connection with medical devices under the direction of TC ERM, where the generic standards are not applicable or suitable for these applications;
• Prepare System Reference documents (SRdocs) addressing frequency allocation matters in relation with radiocommunications applications for medical devices;
• Cover all aspects specific to wireless medical  transmitting and receiving devices and all all specifications/standards specific to medical implant communication devices and their associated peripherals.
• Develop Harmonised Standards for medical devices under the Radio Equipment Directive (2014/53/EU) addressing European Commission mandates.

The deliverables include Harmonised Standards addressing European Commission mandates for medical devices and active implants.

Areas of activity          

The activities of TC ERM WG MEDICAL include but not limited to the following Medical Devices broad areas:

• Active Medial Implants and their associated peripherals;
• Low Power Hearing Implant (LP-HI) systems including Cochlear Implant systems;
• Medical Data acquisition;
• Medical Body Area Network Systems (MBANS);
• Wireless Medical Capsule Endoscopy (WMCE);
• Medical Implantable WPT.

TC ERM WG MEDICAL will set-up the appropriate communication channels to the following groups both within and outside of ETSI.

ETSI groups

• TC ERM WG11
• TC ERM WG28
• TC ERM WG17 WP3
• TC ERM EMC
• TC ERM RM
• TC SmartBAN

External groups

• CEPT ECC Working Groups and Project Teams
• CENELEC TC 62
• ISO TC150 SC6
• TC SAFETY