EN 50061 : 88 AMD 1 95
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
SAFETY OF IMPLANTABLE CARDIAC PACEMAKERS
Superseded date
01-03-2008
Superseded by
EN 45502-2-2 : 2008 COR 2009
EN 45502-2-2:2008
EN 45502-2-2 : 2008 COR 2009
EN 45502-2-2 : 2008
Published date
12-01-2013
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Defines safety and other requirements exclusively for all types of wholly implantable cardiac Pacemakers. And also establishes basic terminology and definitions and includes requirements for the marking of pacemakers and their packaging.
| Committee |
TC 62
|
| DocumentType |
Standard
|
| PublisherName |
European Committee for Standards - Electrical
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NFC 74 346 : AMD 83 | Identical |
| DIN VDE 0750-9 : 1992 | Identical |
| SN EN 50061 : 1988 AMD 1 1995 | Identical |
| BS 6902-1:1990 | Identical |
| CEI EN 50061 : 1989 AMD 1 1996 | Identical |
| NF EN 50061 : 1988 AMD 1 1996 | Identical |
| PN EN 50061 : 2000 | Identical |
| DIN EN 50061 : AMD 1 1996 | Identical |
| I.S. EN 50061:1991 | Identical |
| BS 6902-1:Supplement No. 1:1996 | Identical |
| NEN EN 50061 : 1991 AMD 1/C1 1995 | Identical |
| UNE-EN 50061:1993 | Identical |
| NBN EN 50061 : 1994 AMD 1 1996 | Identical |
| VDE 0750-9 : 1992 AMD 1 1996 | Identical |
| DIN VDE 0750-9 : 1992 | Corresponds |
| ISO 14708-1:2014 | Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer |
| ISO 14117:2012 | Active implantable medical devices Electromagnetic compatibility EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices |
| AAMI ISO 14117 : 2012 | ACTIVE IMPLANTABLE MEDICAL DEVICES - ELECTROMAGNETIC COMPATIBILITY - EMC TEST PROTOCOLS FOR IMPLANTABLE CARDIAC PACEMAKERS, IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND CARDIAC RESYNCHRONIZATION DEVICES |
| CSA ISO/IEC TR 20017:14 (R2019) | 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) |
| BS ISO 14117:2012 | Active implantable medical devices. Electromagnetic compatibility. EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices |
| EN 50077 : 93 AC 93 | LOW-PROFILE CONNECTOR FOR IMPLANTABLE PACEMAKERS |
| BS 5724-2.31(1995) : 1995 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE |
| BS EN 45502-2-3:2010 | Active implantable medical devices Particular requirements for cochlear and auditory brainstem implant systems |
| ISO 14708-2:2012 | Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers |
| BS EN 45502-1:2015 | Implants for surgery. Active implantable medical devices General requirements for safety, marking and for information to be provided by the manufacturer |
| I.S. EN 45502-1:2015 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| EN 45502-1:2015 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| UNI CEI EN 45502-2-3 : 2010 | ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS |
| 13/30233325 DC : 0 | BS EN 45502-1 - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| ISO/IEC TR 20017:2011 | Information technology Radio frequency identification for item management Electromagnetic interference impact of ISO/IEC 18000 interrogator emitters on implantable pacemakers and implantable cardioverter defibrillators |
| ANSI/AAMI/ISO 14708-1:2014 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| UNE-EN 45502-2-3:2010 | Active implantable medical devices -- Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems |
| EN 45502-2-3:2010 | Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems |
| PREN 45502-1 : DRAFT 2013 | ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| CEI EN 50077 : 1998 | LOW-PROFILE CONNECTOR FOR IMPLANTABLE CARDIAC PACEMAKERS |
| I.S. EN 45502-2-3:2010 | ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS |
| EN 45502-1 : 2015 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
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