DIN EN ISO 14708-2 VDE 0750-20-2:2022-12

Implants for surgery – Active implantable medical devices

Part 2: Cardiac pacemakers

(ISO 14708-2:2019); German version EN ISO 14708-2:2022
Class/Status: Standard, valid
Released: 2022-12
VDE Art. No.: 0701201

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This document specifies requirements that are applicable to those active impaltable devices intended to treat bradyarrhythmias and devices that provide therapies for cardiac resynchronization. The tests that are specified in this document are type tests, and are to be carried out on samples of a device to show compliance. This document was designed for Bradyarrhythmia pulse generators used with endocardial or epicardial leads. At the time of this edition, the authors recognized the emergence of leadless technologies for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies

Replacement for:
DIN EN 45502-2-1 VDE 0750-10-1:2004-08

This Document is related to the following Topics (in bold):

11	HEALTH CARE TECHNOLOGY
11.020	Medical sciences and health care facilities in general
11.040	Medical equipment
11.060	Dentistry
11.080	Sterilization and disinfection
11.100	Laboratory medicine
11.140	Hospital equipment
11.180	Aids for disabled or handicapped persons

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Title		Format
	Prinz, Thorsten (Hrsg.) Entwicklung und Herstellung medizinischer Software Normen in der Medizintechnik VDE-Schriftenreihe – Normen verständlich, Band 171 2017, 219 pages, Din A5, Broschur Dieser Buchtitel ist auch als E-Book (PDF) erhältlich » More Information