List Of Applicable Standards - AMATECH Skytron Manual Del Usuario

INSTRUCTIONS FOR USE
5

List of Applicable Standards:

Sl. no Standards
1. EN 62366-1
2. EN ISO 14971
3. EN 1041
4. EN ISO 15223-1
5. EN ISO 10993-1
6. IEC 60601-2-46
7. ISTA
Document Number: D-720340
Version: C
Medical devices - Part 1: Application of usability
engineering to medical devices
Medical devices- Application of risk management to
medical devices.
Information supplied by the manufacturer of medical
devices
Medical devices - Symbols to be used with medical
device labels, labelling and information to be supplied
- Part 1: General requirements
Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management
process
Medical electrical equipment - Part 2-46: Particular
requirements for the basic safety and essential
performance of operating tables
International Safe Transit Association standards for
package testing
Page 16
Description
Issue Date: 18 MAR 2020
Ref Blank Template: 80025118 Ver. E