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Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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SAFETY OF IMPLANTABLE CARDIAC PACEMAKERS

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Superseded date: 01-03-2008

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Published date: 12-01-2013

Publisher: European Committee for Standards - Electrical

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Abstract - (Show below) - (Hide below)

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.

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Committee	TC 62
Document Type	Standard
ISBN
Pages
Published
Publisher	European Committee for Standards - Electrical
Status	Superseded
Superseded By	EN 45502-2-2 : 2008 COR 2009 EN 45502-2-2:2008 EN 45502-2-1:2003 EN 45502-2-2 : 2008 COR 2009 EN 45502-2-2 : 2008

National Adoptions - (Show below) - (Hide below)

Equivalent Standard(s)	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

Standards Referenced By This Book - (Show below) - (Hide below)

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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