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Standards [CURRENT]

CSA C22.2 No. 60601-2-31

Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source (Adopted IEC 60601-2-31:2020, third edition, 2020-01, with Canadian deviations)
Edition 2020-06-01

Standards [CURRENT]

CSA ISO/IEC TR 20017

Information technology - Radio frequency identification for item management - Electromagnetic interference impact of ISO/IEC 18000 interrogator emitters on implantable pacemakers and implantable cardioverter defibrillators (Adopted ISO/IEC TR 20017:2011, first edition, 2011-12-15)
Edition 2014-03-01

Standards [CURRENT]

IEC 60601-2-31

Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
Edition 2020-01

Draft standard [New]

IEC/DIS 80601-2-31

Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
Edition 2024-06

Draft standard [New]

OVE EN IEC 80601-2-31

Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source (IEC 62D/2136/CDV) (english version)
Edition 2024-08-01

Draft standard

12/30264401 DC

BS ISO 5841-3. Implants for surgery. Cardiac pacemakers Part 3. Low-profile connectors (IS-1) for implantable pacemakers
Edition 2012-09-03

Draft standard

23/30472825 DC

BS IEC 80601-2-31. Medical electrical equipment. Part 2-31. Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
Edition 2023-04-12

Draft standard [New]

24/30495736 DC

BS EN IEC 80601-2-31 Medical electrical equipment. Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
Edition 2024-06-28

Standards [CURRENT]

BS ISO 5841-2

Implants for surgery. Cardiac pacemakers. Reporting of clinical performance of populations of pulse generators or leads
Edition 2014-08-31

Standards [CURRENT]

BS ISO 14117

Active implantable medical devices. Electromagnetic compatibility. EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
Edition 2019-09-04

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