User Manual

14. DECLARATION OF CONFORMITY
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SORIN - ORCHESTRA PLUS LINK – U386A
14. DECLARATION OF CONFORMITY
Sorin declares that this device conforms to the following Product Specifications:
Safety - IEC 60601-1: 2005 (Ed. 3) - Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance.
EMC - IEC 60601-1-2: 2012 (Ed. 3) - Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance - Collateral standard:
Electromagnetic compatibility - Requirements and Tests.
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 50385: 2002 - Product standard to demonstrate the compliance of radio base stations
and fixed terminal stations for wireless telecommunication systems with the basic
restrictions or the reference levels related.
EN 60950-1:2006/A12:2011 - Information technology equipment - Safety -- Part 1: General
requirements.
EN 62311: 2008 - Assessment of electronic and electrical equipment related to human
exposure restrictions for electromagnetic fields (0 Hz to 300 GHz)
EN 301 489-1 v1.8.1 - Electromagnetic compatibility and Radio spectrum Matters (ERM);
Electromagnetic Compatibility (EMC) standard for radio equipment and services - Part 1:
Common technical requirements.
EN 301 489-1 V1.9.2 - Electromagnetic compatibility and Radio spectrum Matters (ERM);
ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1:
Common technical requirements
EN 301 489-7 V1.3.1 - Electromagnetic compatibility and Radio spectrum Matters (ERM);
ElectroMagnetic Compatibility (EMC) standard for radio equipment; Part 17: Specific
conditions for Broadband Data Transmission Systems
EN 301 489-17 v2.1.1 - Specific conditions for Broadband Data Transmission Systems.
EN 301 489-27 v1.1.1 - Specific conditions for Ultra Low Power Active Medical Implants
(ULP-AMI) and related peripheral devices (ULP-AMI-P).
EN 300 328 v1.7.1 - Electromagnetic compatibility and Radio spectrum Matters (ERM);
Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz
ISM band and using wide band modulation techniques; Harmonized EN covering essential
requirements under article 3.2 of the R&TTE Directive.
ETSI EN 301 839-1 v1.3.1 - 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.
ETSI EN 301 839-2 v1.3.1 - 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
2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive.
Federal Communication Commission Interference Statement 47 CFR Section 15 and
105(b)