ČSN ETSI EN 302 536 V2.1.1 (875139)

Anotace obsahu normy

The present document specifies technical characteristics and methods of measurements for Ultra Low Power-Animal Implant Devices (ULP-AIDs) and Peripherals as used by industry to develop new drugs and surgical techniques that provide improved health care for the benefit of human patients. ULP-AIDs operate in a Communications System using inductive technology in the frequency band 315 kHz to 600 kHz.
The present document contains the technical requirements for characteristics of ULP-AID and ULP-AID-P radio equipment which are aligned with annex 12 sub-band (c) of CEPT/ERC Recommendation 70-03 [i.3].
The frequency usage conditions for the bands 315 kHz to 600 kHz are EU wide harmonised for the SRD category "active medical implant devices" according to 2013/752/EU [i.6] with the following usage restrictions:
"This set of usage conditions is only available to animal implantable devices".
The present document covers the essential requirements of article 3.2 of Directive 2014/53/EU [i.1] under the conditions identified in annex A for Ultra Low Power Animal Implants and peripherals used in an implant communications system that supports development of medically related treatments that provide improved health care for patients. It does not necessarily include all the characteristics, which may be required by a user, nor does it necessarily represent the optimum performance achievable.