SSH EN 301 839-2 V1.1.1:2002

Çështjet e pajtueshmërisë Elektromagnetike dhe të spektrit të Radios (ERM); Pajisje radio në diapazonin e frekuencave 402 MHz deri në 405 MHz për Implantet Mjekësore Aktive me Fuqi Ultra të Ulët dhe Aksesorët; Pjesa 2: EN i harmonizuar që mbulon kërkesat thelbësore të artikullit 3.2 të Direktivës R&TTE

Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 402 MHz to 405 MHz for Ultra Low Power Active Medical Implants and Accessories; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive

Scope

The present document applies to Ultra Low Power-Active Medical Implants (ULP-AMI) and accessories as described in
Directive 90/385/EEC [4], operating in a Medical Implant Communications System (MICS) in the frequency band
402 MHz to 405 MHz.
NOTE 1: The present document applies to operation in the band 402 MHz to 405 MHz only; devices that can also
operate in spectrum outside this band should also meet any applicable requirements for operation in such
bands.
The present document is intended to cover the provisions of Directive 1999/5/EC [1] (R&TTE Directive) article 3.2,
which states that "….. radio equipment shall be so constructed that it effectively uses the spectrum allocated to
terrestrial/space radio communications and orbital resources so as to avoid harmful interference".
In addition to the present document, other ENs that specify technical requirements in respect of essential requirements
under other parts of article 3 of the R&TTE Directive [1] will apply to equipment within the scope of the present
document.
NOTE 2: A list of such ENs is included on the web site http://www.newapproach.org/.