Terms of Reference for TC ERM Working Group (WG) 30: Medical devices

Approved at ERM #87b

1           Tasks:

The tasks of TC ERM WG 30 are as follows:

• 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 the application;


• Prepare System Reference documents (SRdocs) addressing frequency allocation matters in relation with radiocommunications applications for medical devices;


• Cover all aspects specific to medical telemetry transmitting devices and all medical implant telemetry device specifications/standards.

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

A liaison with CENELEC TC 62 will be established to monitor the standardisation activity in teh field of medical devices.

2           Remarks:

TC ERM WG 30 will provide the expertise to TC ERM, TC ERM WG RM and CEPT ECC Working Groups and Project Teams, as required, for radiocommunications issues in connection with medical devices.

It is necessary to work closely with other TC ERM WGs dealing with Short Range Device applications (e.g. WG 11, WG 17, WG 28) to achieve cooperation in order to ensure consistency and technical harmony for ETSI standards in the most cost-efficient way.

Horizontal aspects related to EMC and radio spectrum matters will be deferred to TC ERM WG EMC and TC ERM WG RM respectively.