AMATECH F-ASLWF, Инструкция по эксплуатации

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INSTRUCTIONS FOR USE
Document Number: 80028288
Page 15
Issue Date: 27 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
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.
ISTA
International Safe Transit Association standards
for package testing