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Standards [CURRENT]

UNE-EN 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 (Endorsed by Asociación Española de Normalización in May of 2020.)
Edition 2020-05-01

Standards [CURRENT]

UNE-EN ISO 14708-2

Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO 14708-2:2019)
Edition 2023-04-12

Standards [CURRENT]

UNE-EN 45502-2-1

Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
Edition 2005-07-20

Standards [CURRENT]

UNE-EN 50527-2-1

Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-1: Specific assessment for workers with cardiac pacemakers (Endorsed by Asociación Española de Normalización in January of 2017.)
Edition 2017-01-01

Standards [CURRENT]

AS/NZS IEC 60601.2.31

Medical electrical equipment Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
Edition 2016

Standards [CURRENT]

DIN EN 50077

Low-profile connector for implantable cardiac pacemaker; German version EN 50077:1993
Edition 1994-03

Standards [CURRENT]

DIN EN 1064

Health informatics - Standard communication protocol - Computer-assisted electrocardiography; English version EN 1064:2020
Edition 2020-10

Standards [CURRENT]

DIN EN ISO 11073-10102

Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG (ISO/IEEE 11073-10102:2014); English version EN ISO 11073-10102:2014
Edition 2014-06

Standards [CURRENT]

DIN ISO 22468

Value stream management (VSM) (ISO 22468:2020)
Edition 2022-07

Standards [CURRENT]

DIN EN ISO 11073-10103

Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac (ISO/IEEE 11073-10103:2014); English version EN ISO 11073-10103:2013
Edition 2014-06

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