Through its worldwide network of Laboratories, Prism Computer Solutions, Inc. helps its customers to certify their products according to international standards, regulations and industry requirements, ensuring that products comply with the quality and safety needs demanded by the global market and end users
Prism Computer Solutions, offers the industry testing and technical consultancy services covering the whole product life cycle, and provides the product with added value before its market launch.
Our Capability also covers in country testing requires by various country during worldwide certification.
In additions we work with the agencies and test labs during and after testing as well as reviews all test results for finalization of the test reports
| Essential Requirement | Standard Number / Revision | Standard Title | |
|---|---|---|---|
| Health & Safety (Art. 3(1)(a)) | IEC 60601-1 2005 + CORR1 (2006) + CORR 2 (2007) | Active Implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer. | |
| Health & Safety (Art. 3(1)(a)) | EN 62311 2008 | Assessment of Electronic and Electrical Equipment Related to Human Exposure Restrictions for Electromagnetic Fields ( 0 Hz - 300 GHz) | |
| EMC (Art. 3(1)(b)) | EN 301 489-1 V1.9.2 2011-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 1: Common technical requirements. | |
| EMC (Art. 3(1)(b)) | EN 301 489-31 V1.1.1 2005-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 31:Specific conditions for equipment in the 9kHz to 315 kHz band for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices(ULP-AMI-P) | |
| Spectrum (Art. 3(2)) | EN 302 195-2 V1.1.1 2004-03 | 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; Part2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE directive. |
| Essential Requirement | Standard Number / Revision | Standard Title | |
|---|---|---|---|
| Health & Safety (Art. 3(1)(a)) | IEC 60601-1 2005 + CORR1 (2006) + CORR 2 (2007) | Active Implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer. | |
| Health & Safety (Art. 3(1)(a)) | EN 62311 2008 | Assessment of Electronic and Electrical Equipment Related to Human Exposure Restrictions for Electromagnetic Fields ( 0 Hz - 300 GHz) | |
| EMC (Art. 3(1)(b)) | EN 301 489-1 V1.9.2 2011-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 1: Common technical requirements. | |
| EMC (Art. 3(1)(b)) | EN 301 489-17 V2.2.1 2012-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment; Part 17:Specific conditions for Broadband Data Transmission Systems | |
| Spectrum (Art. 3(2)) | EN 300 328 V1.8.1 2012-06 | 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. | |
| Spectrum (Art.3(2)) | EN 301 893 V1.7.1 2012-06 | Broadband Radio Access Networks (BRAN); 5 GHz high performance RLAN; Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive |
| Essential Requirement | Standard Number / Revision | Standard Title | |
|---|---|---|---|
| Health & Safety (Art. 3(1)(a)) | IEC 60601-1 2005 + CORR1 (2006) + CORR 2 (2007) | Active Implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer. | |
| Health & Safety (Art. 3(1)(a)) | EN 62311 2008 | Assessment of Electronic and Electrical Equipment Related to Human Exposure Restrictions for Electromagnetic Fields ( 0 Hz - 300 GHz) | |
| EMC (Art. 3(1)(b)) | EN 301 489-1 V1.9.2 2011-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 1: Common technical requirements. | |
| EMC (Art. 3(1)(b)) | EN 301 489-17 V2.2.1 2012-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment; Part 17:Specific conditions for Broadband Data Transmission Systems | |
| Spectrum (Art. 3(2)) | EN 300 328 V1.8.1 2012-06 | 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. | |
| Spectrum (Art.3(2)) | EN 301 893 V1.7.1 2012-06 | Broadband Radio Access Networks (BRAN); 5 GHz high performance RLAN; Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive |
| Essential Requirement | Standard Number / Revision | Standard Title | |
|---|---|---|---|
| RSS 210 Issue 8:2010 | Bluetooth Device, WiFi Device, Local Area Network(LAN) Device, Low Power Transmitter. | ||
| FCC Part 15.209 | Part 15 class B 175 khz Wifi, Bluetooth | ||
| FCC Part 15 (c) | Part 15 class B 175 khz Wifi, Bluetooth. | ||
| FCC Part 15.247, 15.249 | Part 15 class B 175 khz Wifi, Bluetooth. | ||
| FCC Part 15.247:2010 OET 65 | |||
| RSS210:2007 | 175 khz RF Exposure | ||
| RSS102 | 175 khz RF Exposure |
| Essential Requirement | Standard Number / Revision | Standard Title | |
|---|---|---|---|
| Health & Safety (Art. 3(1)(a)) | EN 45502-1 1997 | Active Implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer. | |
| Health & Safety (Art. 3(1)(a)) | EN 45502-2 2008/AC:2009 | Active Implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia( included s implantable defibrillators) | |
| Health & Safety (Art. 3(1)(a)) | EN 62479 2010 | Assessment of the compliance of low power electronic and electrical equipment with the basic restrictions related to human exposure to electromagnetic field (10 MHz to 300 GHz) | |
| EMC (Art. 3(1)(b)) | EN 301 489-1 V1.9.2 2011-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 1: Common technical requirements. | |
| EMC (Art. 3(1)(b)) | EN 301 489-31 V1.1.1 2005-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 31:Specific conditions for equipment in the 9kHz to 315 kHz band for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices(ULP-AMI-P).. | |
| EMC (Art. 3(1)(b)) | EN 301 489-27 V1.1.1 2004-03 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 27:Specific conditions for Ultra Low Power Active Medical Implants(ULP-AMI) and related peripheral devices(ULP-AMI-P) | |
| Spectrum (Art. 3(2)) | EN 302 195-2 V1.1.1 2004-03 | 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; Part2: Harmonized EN covering essential requirements of article 3.2 of the R7TTE directive. | |
| Spectrum (Art.3(2)) | EN 301 839-2 V1.3.1 2009-10 | 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 Directives. |
| Essential Requirement | Standard Number / Revision | Standard Title | |
|---|---|---|---|
| Health & Safety (Art. 3(1)(a)) | IEC 60601-1 2005 + CORR1 (2006) + CORR 2 (2007) | Active Implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer. | |
| Health & Safety (Art. 3(1)(a)) | EN 62311 2008 | Assessment of Electronic and Electrical Equipment Related to Human Exposure Restrictions for Electromagnetic Fields ( 0 Hz - 300 GHz) | |
| EMC (Art. 3(1)(b)) | EN 301 489-1 V1.9.2 2011-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 1: Common technical requirements. | |
| EMC (Art. 3(1)(b)) | EN 301 489-31 V1.1.1 2005-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 31:Specific conditions for equipment in the 9kHz to 315 kHz band for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices(ULP-AMI-P) | |
| Spectrum (Art. 3(2)) | EN 302 195-2 V1.1.1 2004-03 | 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; Part2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE directive. |
| Essential Requirement | Standard Number / Revision | Standard Title | |
|---|---|---|---|
| Health & Safety (Art. 3(1)(a)) | IEC 60601-1 2005 + CORR1 (2006) + CORR 2 (2007) | Active Implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer. | |
| Health & Safety (Art. 3(1)(a)) | EN 62311 2008 | Assessment of Electronic and Electrical Equipment Related to Human Exposure Restrictions for Electromagnetic Fields ( 0 Hz - 300 GHz) | |
| EMC (Art. 3(1)(b)) | EN 301 489-1 V1.9.2 2011-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 1: Common technical requirements. | |
| EMC (Art. 3(1)(b)) | EN 301 489-17 V2.2.1 2012-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment; Part 17:Specific conditions for Broadband Data Transmission Systems | |
| Spectrum (Art. 3(2)) | EN 300 328 V1.8.1 2012-06 | 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. | |
| Spectrum (Art.3(2)) | EN 301 893 V1.7.1 2012-06 | Broadband Radio Access Networks (BRAN); 5 GHz high performance RLAN; Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive |
• What is EMC?
• Radiated Emissions
• Conducted Emissions
• Harmonic Current Testing
• Voltage Flicker Testing
• Immunity Testing Overview
• ESD
• Radiated Immunity
• EFT
• Surge
• Conducted Immunity
• Magnetic Field
• Voltage Dips, Drops & Interruptions
• Our partnership with local and overseas agencies and test labs cover the following applicable standards
| Essential Requirement | Standard Number / Revision | Standard Title | |
|---|---|---|---|
| Health & Safety (Art. 3(1)(a)) | EN 45502-1 1997 | Active Implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer. | |
| Health & Safety (Art. 3(1)(a)) | EN 45502-2 2008/AC:2009 | Active Implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia( included s implantable defibrillators) | |
| Health & Safety (Art. 3(1)(a)) | EN 62479 2010 | Assessment of the compliance of low power electronic and electrical equipment with the basic restrictions related to human exposure to electromagnetic field (10 MHz to 300 GHz) | |
| EMC (Art. 3(1)(b)) | EN 301 489-1 V1.9.2 2011-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 1: Common technical requirements. | |
| EMC (Art. 3(1)(b)) | EN 301 489-31 V1.1.1 2005-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 31:Specific conditions for equipment in the 9kHz to 315 kHz band for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices(ULP-AMI-P).. | |
| EMC (Art. 3(1)(b)) | EN 301 489-27 V1.1.1 2004-03 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 27:Specific conditions for Ultra Low Power Active Medical Implants(ULP-AMI) and related peripheral devices(ULP-AMI-P) | |
| Spectrum (Art. 3(2)) | EN 302 195-2 V1.1.1 2004-03 | 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; Part2: Harmonized EN covering essential requirements of article 3.2 of the R7TTE directive. | |
| Spectrum (Art.3(2)) | EN 301 839-2 V1.3.1 2009-10 | 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 Directives. |
| Essential Requirement | Standard Number / Revision | Standard Title | |
|---|---|---|---|
| Health & Safety (Art. 3(1)(a)) | IEC 60601-1 2005 + CORR1 (2006) + CORR 2 (2007) | Active Implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer. | |
| Health & Safety (Art. 3(1)(a)) | EN 62311 2008 | Assessment of Electronic and Electrical Equipment Related to Human Exposure Restrictions for Electromagnetic Fields ( 0 Hz - 300 GHz) | |
| EMC (Art. 3(1)(b)) | EN 301 489-1 V1.9.2 2011-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 1: Common technical requirements. | |
| EMC (Art. 3(1)(b)) | EN 301 489-31 V1.1.1 2005-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 31:Specific conditions for equipment in the 9kHz to 315 kHz band for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices(ULP-AMI-P) | |
| Spectrum (Art. 3(2)) | EN 302 195-2 V1.1.1 2004-03 | 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; Part2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE directive. |
| Essential Requirement | Standard Number / Revision | Standard Title | |
|---|---|---|---|
| Health & Safety (Art. 3(1)(a)) | IEC 60601-1 2005 + CORR1 (2006) + CORR 2 (2007) | Active Implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer. | |
| Health & Safety (Art. 3(1)(a)) | EN 62311 2008 | Assessment of Electronic and Electrical Equipment Related to Human Exposure Restrictions for Electromagnetic Fields ( 0 Hz - 300 GHz) | |
| EMC (Art. 3(1)(b)) | EN 301 489-1 V1.9.2 2011-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 1: Common technical requirements. | |
| EMC (Art. 3(1)(b)) | EN 301 489-17 V2.2.1 2012-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment; Part 17:Specific conditions for Broadband Data Transmission Systems | |
| Spectrum (Art. 3(2)) | EN 300 328 V1.8.1 2012-06 | 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. | |
| Spectrum (Art.3(2)) | EN 301 893 V1.7.1 2012-06 | Broadband Radio Access Networks (BRAN); 5 GHz high performance RLAN; Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive |
| Essential Requirement | Standard Number / Revision | Standard Title | |
|---|---|---|---|
| Health & Safety (Art. 3(1)(a)) | EN 45502-1 1997 | Active Implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer. | |
| Health & Safety (Art. 3(1)(a)) | EN 45502-2 2008/AC:2009 | Active Implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia( included s implantable defibrillators) | |
| Health & Safety (Art. 3(1)(a)) | EN 62479 2010 | Assessment of the compliance of low power electronic and electrical equipment with the basic restrictions related to human exposure to electromagnetic field (10 MHz to 300 GHz) | |
| EMC (Art. 3(1)(b)) | EN 301 489-1 V1.9.2 2011-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 1: Common technical requirements. | |
| EMC (Art. 3(1)(b)) | EN 301 489-31 V1.1.1 2005-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 31:Specific conditions for equipment in the 9kHz to 315 kHz band for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices(ULP-AMI-P).. | |
| EMC (Art. 3(1)(b)) | EN 301 489-27 V1.1.1 2004-03 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 27:Specific conditions for Ultra Low Power Active Medical Implants(ULP-AMI) and related peripheral devices(ULP-AMI-P) | |
| Spectrum (Art. 3(2)) | EN 302 195-2 V1.1.1 2004-03 | 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; Part2: Harmonized EN covering essential requirements of article 3.2 of the R7TTE directive. | |
| Spectrum (Art.3(2)) | EN 301 839-2 V1.3.1 2009-10 | 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 Directives. |
| Essential Requirement | Standard Number / Revision | Standard Title | |
|---|---|---|---|
| Health & Safety (Art. 3(1)(a)) | IEC 60601-1 2005 + CORR1 (2006) + CORR 2 (2007) | Active Implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer. | |
| Health & Safety (Art. 3(1)(a)) | EN 62311 2008 | Assessment of Electronic and Electrical Equipment Related to Human Exposure Restrictions for Electromagnetic Fields ( 0 Hz - 300 GHz) | |
| EMC (Art. 3(1)(b)) | EN 301 489-1 V1.9.2 2011-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 1: Common technical requirements. | |
| EMC (Art. 3(1)(b)) | EN 301 489-31 V1.1.1 2005-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 31:Specific conditions for equipment in the 9kHz to 315 kHz band for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices(ULP-AMI-P) | |
| Spectrum (Art. 3(2)) | EN 302 195-2 V1.1.1 2004-03 | 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; Part2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE directive. |
| Essential Requirement | Standard Number / Revision | Standard Title | |
|---|---|---|---|
| Health & Safety (Art. 3(1)(a)) | IEC 60601-1 2005 + CORR1 (2006) + CORR 2 (2007) | Active Implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer. | |
| Health & Safety (Art. 3(1)(a)) | EN 62311 2008 | Assessment of Electronic and Electrical Equipment Related to Human Exposure Restrictions for Electromagnetic Fields ( 0 Hz - 300 GHz) | |
| EMC (Art. 3(1)(b)) | EN 301 489-1 V1.9.2 2011-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 1: Common technical requirements. | |
| EMC (Art. 3(1)(b)) | EN 301 489-17 V2.2.1 2012-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment; Part 17:Specific conditions for Broadband Data Transmission Systems | |
| Spectrum (Art. 3(2)) | EN 300 328 V1.8.1 2012-06 | 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. | |
| Spectrum (Art.3(2)) | EN 301 893 V1.7.1 2012-06 | Broadband Radio Access Networks (BRAN); 5 GHz high performance RLAN; Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive |
| Essential Requirement | Standard Number / Revision | Standard Title | |
|---|---|---|---|
| Health & Safety (Art. 3(1)(a)) | EN 45502-1 1997 | Active Implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer. | |
| Health & Safety (Art. 3(1)(a)) | EN 45502-2 2008/AC:2009 | Active Implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia( included s implantable defibrillators) | |
| Health & Safety (Art. 3(1)(a)) | EN 62479 2010 | Assessment of the compliance of low power electronic and electrical equipment with the basic restrictions related to human exposure to electromagnetic field (10 MHz to 300 GHz) | |
| EMC (Art. 3(1)(b)) | EN 301 489-1 V1.9.2 2011-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 1: Common technical requirements. | |
| EMC (Art. 3(1)(b)) | EN 301 489-31 V1.1.1 2005-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 31:Specific conditions for equipment in the 9kHz to 315 kHz band for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices(ULP-AMI-P).. | |
| EMC (Art. 3(1)(b)) | EN 301 489-27 V1.1.1 2004-03 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 27:Specific conditions for Ultra Low Power Active Medical Implants(ULP-AMI) and related peripheral devices(ULP-AMI-P) | |
| Spectrum (Art. 3(2)) | EN 302 195-2 V1.1.1 2004-03 | 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; Part2: Harmonized EN covering essential requirements of article 3.2 of the R7TTE directive. | |
| Spectrum (Art.3(2)) | EN 301 839-2 V1.3.1 2009-10 | 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 Directives. |
| Essential Requirement | Standard Number / Revision | Standard Title | |
|---|---|---|---|
| Health & Safety (Art. 3(1)(a)) | IEC 60601-1 2005 + CORR1 (2006) + CORR 2 (2007) | Active Implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer. | |
| Health & Safety (Art. 3(1)(a)) | EN 62311 2008 | Assessment of Electronic and Electrical Equipment Related to Human Exposure Restrictions for Electromagnetic Fields ( 0 Hz - 300 GHz) | |
| EMC (Art. 3(1)(b)) | EN 301 489-1 V1.9.2 2011-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 1: Common technical requirements. | |
| EMC (Art. 3(1)(b)) | EN 301 489-31 V1.1.1 2005-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 31:Specific conditions for equipment in the 9kHz to 315 kHz band for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices(ULP-AMI-P) | |
| Spectrum (Art. 3(2)) | EN 302 195-2 V1.1.1 2004-03 | 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; Part2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE directive. |
| Essential Requirement | Standard Number / Revision | Standard Title | |
|---|---|---|---|
| Health & Safety (Art. 3(1)(a)) | IEC 60601-1 2005 + CORR1 (2006) + CORR 2 (2007) | Active Implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer. | |
| Health & Safety (Art. 3(1)(a)) | EN 62311 2008 | Assessment of Electronic and Electrical Equipment Related to Human Exposure Restrictions for Electromagnetic Fields ( 0 Hz - 300 GHz) | |
| EMC (Art. 3(1)(b)) | EN 301 489-1 V1.9.2 2011-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 1: Common technical requirements. | |
| EMC (Art. 3(1)(b)) | EN 301 489-17 V2.2.1 2012-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment; Part 17:Specific conditions for Broadband Data Transmission Systems | |
| Spectrum (Art. 3(2)) | EN 300 328 V1.8.1 2012-06 | 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. | |
| Spectrum (Art.3(2)) | EN 301 893 V1.7.1 2012-06 | Broadband Radio Access Networks (BRAN); 5 GHz high performance RLAN; Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive |
| Essential Requirement | Standard Number / Revision | Standard Title | |
|---|---|---|---|
| Health & Safety (Art. 3(1)(a)) | EN 45502-1 1997 | Active Implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer. | |
| Health & Safety (Art. 3(1)(a)) | EN 45502-2 2008/AC:2009 | Active Implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia( included s implantable defibrillators) | |
| Health & Safety (Art. 3(1)(a)) | EN 62479 2010 | Assessment of the compliance of low power electronic and electrical equipment with the basic restrictions related to human exposure to electromagnetic field (10 MHz to 300 GHz) | |
| EMC (Art. 3(1)(b)) | EN 301 489-1 V1.9.2 2011-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 1: Common technical requirements. | |
| EMC (Art. 3(1)(b)) | EN 301 489-31 V1.1.1 2005-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 31:Specific conditions for equipment in the 9kHz to 315 kHz band for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices(ULP-AMI-P).. | |
| EMC (Art. 3(1)(b)) | EN 301 489-27 V1.1.1 2004-03 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 27:Specific conditions for Ultra Low Power Active Medical Implants(ULP-AMI) and related peripheral devices(ULP-AMI-P) | |
| Spectrum (Art. 3(2)) | EN 302 195-2 V1.1.1 2004-03 | 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; Part2: Harmonized EN covering essential requirements of article 3.2 of the R7TTE directive. | |
| Spectrum (Art.3(2)) | EN 301 839-2 V1.3.1 2009-10 | 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 Directives. |
| Essential Requirement | Standard Number / Revision | Standard Title | |
|---|---|---|---|
| Health & Safety (Art. 3(1)(a)) | IEC 60601-1 2005 + CORR1 (2006) + CORR 2 (2007) | Active Implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer. | |
| Health & Safety (Art. 3(1)(a)) | EN 62311 2008 | Assessment of Electronic and Electrical Equipment Related to Human Exposure Restrictions for Electromagnetic Fields ( 0 Hz - 300 GHz) | |
| EMC (Art. 3(1)(b)) | EN 301 489-1 V1.9.2 2011-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 1: Common technical requirements. | |
| EMC (Art. 3(1)(b)) | EN 301 489-31 V1.1.1 2005-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 31:Specific conditions for equipment in the 9kHz to 315 kHz band for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices(ULP-AMI-P) | |
| Spectrum (Art. 3(2)) | EN 302 195-2 V1.1.1 2004-03 | 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; Part2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE directive. |
| Essential Requirement | Standard Number / Revision | Standard Title | |
|---|---|---|---|
| Health & Safety (Art. 3(1)(a)) | IEC 60601-1 2005 + CORR1 (2006) + CORR 2 (2007) | Active Implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer. | |
| Health & Safety (Art. 3(1)(a)) | EN 62311 2008 | Assessment of Electronic and Electrical Equipment Related to Human Exposure Restrictions for Electromagnetic Fields ( 0 Hz - 300 GHz) | |
| EMC (Art. 3(1)(b)) | EN 301 489-1 V1.9.2 2011-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment and services; Part 1: Common technical requirements. | |
| EMC (Art. 3(1)(b)) | EN 301 489-17 V2.2.1 2012-09 | Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility(EMC) standard for radio equipment; Part 17:Specific conditions for Broadband Data Transmission Systems | |
| Spectrum (Art. 3(2)) | EN 300 328 V1.8.1 2012-06 | 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. | |
| Spectrum (Art.3(2)) | EN 301 893 V1.7.1 2012-06 | Broadband Radio Access Networks (BRAN); 5 GHz high performance RLAN; Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive |
