User Manual

9. CONFORMANCE TO STANDARDS
9. CONFORMANCE TO STANDARDS
This device was developed in conformance with all or parts of the following standards:
─ EN 45502-1: 1998 – Active implantable medical devices. General requirements for
safety, marking and information to be provided by the manufacturer.
─ EN 45502-2-1: 2003 – Active implantable medical devices. Part 2-1: Particular
requirements for active implantable medical devices intended to treat bradyarrhythmia
(cardiac pacemakers).
─ EN 45502-2-2: 2008 – Active implantable medical devices. Part 2-2: Particular
requirements for active implantable medical devices intended to treat tachyarrhythmia
(includes implantable defibrillators).
─ ISO 5841-3: 2013 Low profile connectors (IS1) for implantable pacemakers.
─ ISO27186:2010 (DF-4): Active implantable medical devices - Four-pole connector
system for implantable cardiac rhythm management devices — Dimensional and test
requirements.
─ ANSI/AAMI PC69: 2007 Active implantable Medical Devices - Electromagnetic
compatibility - EMC test protocols for implantable cardiac pacemakers and implantable
Cardioverter Defibrillators.
─ 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 301 839-1 (v1.3.1) & EN 301 839-2 (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.
SORIN – INTENSIA SonR CRT-D 184 – U150A
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