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ETSI EN 302 195-1 V1.1.1 (2004-03)

Current

Current

The latest, up-to-date edition.

Electromagnetic compatibility and Radio spectrum Matters (ERM); Radio equipment in the frequency range 9 kHz to 315 kHz for Ultra Low Power Active Medical Implants (ULP-AMI) and accessories; Part 1: Technical characteristics and test methods

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-03-2004

Free

Intellectual Property Rights
Foreword
1 Scope
2 References
3 Definitions, symbols and abbreviations
  3.1 Definitions
  3.2 Symbols
  3.3 Abbreviations
4 Technical requirements specifications
  4.1 General requirements
  4.2 Presentation of equipment for testing purposes
  4.3 Mechanical and electrical design
  4.4 Declarations by the applicant
  4.5 Auxiliary test equipment
  4.6 Interpretation of the measurement results
5 Test conditions, power sources and ambient temperatures
  5.1 Normal and extreme test conditions
  5.2 Test power source
  5.3 Normal test conditions
  5.4 Extreme test conditions
6 General conditions
  6.1 Normal test signals and test modulation
  6.2 Antenna
  6.3 Test fixture
  6.4 Test sites and general arrangements for radiated measurements
  6.5 Modes of operation of the transmitter
  6.6 Measuring receiver
7 Transmitter requirements
  7.1 Transmitter definitions
  7.2 Transmitter carrier output levels
  7.3 Permitted frequency range of the modulation bandwidth
  7.4 Spurious emissions
  7.5 Duty cycle
8 Receiver requirement
  8.1 Blocking or desensitization
  8.2 Receiver spurious radiation
9 Measurement uncertainty
Annex A (normative): Radiated measurements
      A.1 Test sites and general arrangements for measurements
          involving the use of radiated fields
      A.2 Guidance on the use of radiation test sites
Annex B (normative): H-field limit correction factor for generated
        E-fields
Annex C (informative): E-fields in the near field at low frequencies
Annex D (normative): H-field measurements at other distances than
        10 m
Annex E (informative): Bibliography
History

Pertains to Ultra Low Power Active Medical Implant (ULP-AMI) transmitters and receivers operating in the range from 9 kHz to 315 kHz and any associated radio apparatus transmitting in the frequency range of 9 kHz to 315 kHz including external programmers and patient related telecommunication devices using digital modulation techniques such as, but not limited to, FSK or pulse position modulation.

DocumentType
Standard
Pages
37
PublisherName
European Telecommunications Standards Institute
Status
Current

Standards Relationship
NBN EN 302 195-1 : 2004 Identical
NEN EN 302195-1 : 2004 Identical
DIN EN 302195-1:2004-08 Identical
NF EN 302195-1 : 2004 Identical
PN EN 302 195-1 : 2005 Identical

NF EN 302195-2 : 2004 ELECTROMAGNETIC COMPATIBILITY AND RADIO SPECTRUM MATTERS (ERM) - RADIO EQUIPMENT IN THE FREQUENCY RANGE 9 KHZ TO 315 KHZ FOR ULTRA LOW POWER ACTIVE MEDICAL IMPLANTS (ULP-AMI) AND ACCESSORIES - PART 2: HARMONIZED EN COVERING ESSENTIAL REQUIREMENTS OF ARTICLE 3.2 OF THE R&TTE DIRECTIVE
AAMI TIR18:2010 GUIDANCE ON ELECTROMAGNETIC COMPATIBILITY OF MEDICAL DEVICES IN HEALTHCARE FACILITIES

ETSI EN 300 330-1 V1.8.1 (2015-03) Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Radio equipment in the frequency range 9 kHz to 25 MHz and inductive loop systems in the frequency range 9 kHz to 30 MHz; Part 1: Technical characteristics and test methods
ETSI EN 301 489-3 V1.6.1 (2013-08) Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 3: Specific conditions for Short-Range Devices (SRD) operating on frequencies between 9 kHz and 246 GHz
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
119999/5/EC : 1999 DIRECTIVE 1999/5/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 9 MARCH 1999 ON RADIO EQUIPMENT AND TELECOMMUNICATIONS TERMINAL EQUIPMENT AND THE MUTUAL RECOGNITION OF THEIR CONFORMITY
CISPR 16-1:1999+AMD1:2002 CSV Specification for radio disturbance and immunity measuring apparatus and methods - Part 1: Radio disturbance and immunity measuring apparatus

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