AMATECH I-ABSLFH, Инструкция по эксплуатации, Страница: 16 / 334

INSTRUCTIONS FOR USE
Document Number: 80028239
Page 16
Issue Date: 18 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
5 List of Applicable Standards:
Sl. no Standards Description
1. EN 62366-1
Medical devices - Part 1: Application of usability
engineering to medical devices
2. EN ISO 14971
Medical devices- Application of risk management to
medical devices.
3. EN 1041
Information supplied by the manufacturer of medical
devices
4. EN ISO 15223-1
Medical devices - Symbols to be used with medical
device labels, labelling and information to be supplied -
Part 1: General requirements
5. EN ISO 10993-1
Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management process
6. IEC 60601-2-46
Medical electrical equipment - Part 2-46: Particular
requirements for the basic safety and essential
performance of operating tables
7. ISTA
International Safe Transit Association standards for
package testing