Recognized Consensus Standards
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IEC 60601-2-31 Edition 2.1 2011-09
Standard Organization:
| IEC 60601-2-31 Edition 2.1 2011-09 Medical electrical equipment, Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source |
| Recognition Date | 2012-08-20 |
| Recognition List | 029 |
| Recognition Number | 3-102 |
| Extent | Complete standard |
| Standards Orgs | IEC International Electrotechnical Commission http://www.iec.ch/ |
| STG | Cardiovascular |
| FDA Tech | Ingmar Viohl FDA/OMPT/CDRH/ODE/DCD/IEDB/ 240-402-0233 Ingmar.Viohl@fda.hhs.gov |
Rationale:
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Scope:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred
to as ME EQUIPMENT.
Code of Federal Regulations:
| Regulation Number | Device Name | Device Class | Product Code |
| §870.3600 | Pulse Generator, External Pacemaker, Dual Chamber | Class 2 | OVJ |
| §870.3600 | Pulse-Generator, Pacemaker, External | Class 3 | DTE |
| §870.2900 | Cable, Transducer And Electrode, Patient, (Including Connector) | Class 2 | DSA |
FDA Guidance:
U.S. Food & Drug Administration
