User's Manual

26 – US-ENGLISH
 IEC 60601-1-2 (2007): Electromagnetic compatibility - Medical
electrical equipment. General requirements for basic safety and
essential performance - Collateral standard
 EN 50371 (2002) : Generic standard to demonstrate the
compliance of low power electronic and electrical apparatus with
the basic restrictions related to human exposure to
electromagnetic fields (10 MHz - 300 GHz)
 EN 301 489-1 (v1.8.1) & EN 301 489-27 (v1.1.1): Electromagnetic
compatibility and Radio spectrum Matters (ERM);
Electromagnetic Compatibility (EMC) standard for radio
equipment and services - Part 1 : Technical Requirements and
Part 27: Specific conditions for Ultra Low Power Active Medical
Implants (ULP-AMI) and related peripheral devices (ULP-AMI-P)
 EN 301839-1 (v1.3.1) & EN 301839-2 (v1.2.1): Electromagnetic
compatibility and Radio spectrum Matters (ERM); Short Range
Devices (SRD); Ultra Low Power Active Medical Implants (ULP-
AMI) and Peripherals (ULP-AMI-P) operating in the frequency
range 402 MHz to 405 MHz; Part 1: Technical characteristics and
test methods and Part 2: Harmonized EN covering essential
requirements of Article 3.2 of the R&TTE Directive
 EN 62311 (2008) : Assessment of electronic and electrical
equipment related to human exposure restrictions for
electromagnetic fields (0Hz to 300 GHz)
 EN 62209-2 (2010) : Human exposure to radio frequency fields
from hand-held and body-mounted wireless communication
devices – Human models, instrumentation and procedures – Part
2: Procedure to determine the specific absorption rate (SAR) for
wireless communication devices used in close proximity to the
human body (frequency range of 30MHz to 6 GHz)
This information should not be used as a basis of comparisons
among devices since different parts of the standards mentioned may
have been used.