ISO 5841-1 Cardiac Pacemakers - Part 1: Implantable Pacemakers - Second Edition
Данный раздел/документ содержится в продуктах:
- Техэксперт: Машиностроительный комплекс
- Картотека зарубежных и международных стандартов
- CEN EN 13855-1 Manufactured articles solely filled with feathers and down - Measurement of thickness and compressibility of cushions - Part 1: Test method by rotation
- 59
- CEN EN 13855-1 Manufactured articles solely filled with feathers and down - Measurement of thickness and compressibility of cushions - Part 1: Test method by rotation
- 59.040
- CEN EN 13855-1 Manufactured articles solely filled with feathers and down - Measurement of thickness and compressibility of cushions - Part 1: Test method by rotation
- CEN EN 13855-2 Manufactured articles solely filled with feathers and down - Measurement of thickness and compressibility of cushions - Part 2: Test method by oscillation
- 97
- CEN EN 13855-1 Manufactured articles solely filled with feathers and down - Measurement of thickness and compressibility of cushions - Part 1: Test method by rotation
- 97.140
- CEN EN 13855-1 Manufactured articles solely filled with feathers and down - Measurement of thickness and compressibility of cushions - Part 1: Test method by rotation
- CEN EN 13855-2 Manufactured articles solely filled with feathers and down - Measurement of thickness and compressibility of cushions - Part 2: Test method by oscillation
- CEI EN 61496-2 Safety of machinery - Electro-sensitive protective equipment Part 2: Particular requirements for equipment using active opto-electronic protective devices (AOPDs)
- ISO 16142-1 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non?IVD medical devices and guidance on the selection of standards - First Edition
- Картотека зарубежных и международных стандартов
International Organization for Standardization
Cardiac Pacemakers - Part 1: Implantable Pacemakers - Second Edition
N 5841-1
Annotation
Scope and field of application
This part of ISO 5841 establishes basic terminology and definitions, and specifies requirements for marking implantable cardiac pacemakers and their packaging.
Minimum requirements for the ability of pacemaker pulse generators to withstand environmental stress conditions are also specified along with appropriate test methods.
Annex A explains the coding system for identifying the mode of operation of pulse generators. Test methods to assess the basic electrical parameters for conformance with claims are included in annex B; annex C describes the estimation and expression of the nominal service life of a pulse generator; annex D provides an example of a technical information sheet; annex E provides a rationale for certain of the provisions of this part of ISO 5841 and annex F provides optional symbols to be used in place of written words.
This part of ISO 5841 applies to all types of wholly implantable cardiac pacemakers; it does not cover anti-tachyarrythmia and defibrillation functions of pacemakers, nor pacemakers powered by isotopic cells (nuclear-powered pacemakers).
Автоматический перевод:
Кардиостимуляторы - Часть 1: Имплантируемые Электрокардиостимуляторы - Второе Издание
Сфера охвата и области применения
Эта часть ISO 5841 устанавливает основные термины и определения, и устанавливает требования к маркировке имплантируемых кардиостимуляторов и их упаковки.
