CEI EN 60601-1-6/A1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Collateral standard: Usability
Данный раздел/документ содержится в продуктах:
- Техэксперт: Машиностроительный комплекс
- Картотека зарубежных и международных стандартов
- CEI EN 60601-2-33/A1/A2 Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
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- CEI EN 60601-2-33/A1/A2 Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
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- CEI EN 60601-2-33/A1/A2 Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
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- CEI EN 60601-2-24 Medical electrical equipment Part 2: Particular requirements for basic safety and essential performance of infusion pumps and controllers
- CEI EN 60601-1-6/A1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Collateral standard: Usability
- CEI EN 60601-1-10/A1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
- Картотека зарубежных и международных стандартов
Comitato Elettrotecnico Italiano
Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Collateral standard: Usability
N EN 60601-1-6/A1
Annotation
INTRODUCTION TO THE AMENDMENT
The third edition of IEC 60601-1-6 was published in 2010. The third edition created a bridge that enables a MANUFACTURER to conform to the requirements in IEC 60601-1 that make normative reference to IEC 60601-1-6 by employing a USABILITY ENGINEERING PROCESS complying with IEC 62366:2007. However, IEC 62366 contains certain life-cycle process elements that are inconsistent with a TYPE TEST. This amendment is intended to clarify the elements of the USABILITY ENGINEERING PROCESS that are required for compliance with the IEC 60601 series.
Автоматический перевод:
Медицинская Часть 1 электрооборудования: Общие требования для основной безопасности и существенной производительности - Коллатеральный стандарт: Удобство пользования
ВВЕДЕНИЕ В ПОПРАВКУ
Третий выпуск IEC 60601-1-6 был опубликован в 2010. Третий выпуск создал мост, который позволяет MANUFACTURER соответствовать требованиям в IEC 60601-1, которые делают нормативную ссылку на IEC 60601-1-6 путем использования USABILITY ENGINEERING PROCESS, выполняющий IEC 62366:2007. Однако IEC 62366 содержит определенные элементы процесса жизненного цикла, которые противоречивы с TYPE TEST. Эта поправка предназначается для разъяснения элементов USABILITY ENGINEERING PROCESS, которые требуются для соответствия с рядом IEC 60601.
