The present document covers Ultra Low Power Active Medical Implant (ULP-AMI) and any associated nonimplantablePeripherals (ULP-AMI-P) equipment incorporating low frequency technology, which is designed to operatein the frequency range of 9 kHz to 315 kHz for the purpose of providing a digital communication link.
The present document includes methods of measurement for ULP-AMI and ULP-AMI-P incorporatingattachable/detachable antenna connector(s) and/or integral antenna(s). Equipment designed for use with an integralantenna may use a temporary or permanent internal connector for the purpose of testing, provided the characteristicsbeing measured are representative of the final product placed on the market.
If equipment already placed on the market is required to be inspected it should be tested in accordance with the methodsof measurement specified in the present document.
Clauses 1 through 3 provide a general description on the types of equipment covered by the present document and thedefinitions, symbols and abbreviations used.
Clause 4 provides the technical requirements specifications, limits and conformance relative to transmitter and receiverfunction.
Clauses 5.1 and 5.2 specify the conditions for testing of the equipment and interpretation of the measurement resultswith the maximum measurement uncertainty values.
Clause 5.3 specifies the required measurement methods.
Annex A (normative) provides the relationship between the present document and the essential requirements ofDirective 2014/53/EU [i.2].
Annex B (normative) provides specifications concerning radiated measurements.
Annex C (normative) provides procedures for H-field measurements at other distances than 10 m.
Annex D (informative) bibliography; provides additional information.
- Edition:
- 2.1.1
- Published:
- 06/01/2016
- Number of Pages:
- 36
- File Size:
- 1 file , 190 KB
- Note:
- This product is unavailable in Russia, Ukraine, Belarus
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