User's Manual

User Manual
Manual No. AMSL/DMR/UM/FD 009
Rev. 00 Effective Date 12.07.2022 Page | 14
ISO 10993-10: Fourth
edition 2021-11
Biological evaluation of medical devices -- Part
10: Tests for irritation and skin sensitization
ISO 14971 Third Edition
2019-12
Medical devices - Application of risk
management to medical devices
ISO 15223-1 Third
edition 2016-11-01
Medical devices - Symbols to be used with
information to be supplied by the manufacturer -
Part 1: General requirements
ANSI AAMI HE75:2009/
(R)2013
Human factors engineering - Design of medical
devices
ISO 10993-5 Third
edition 2009-06-01
Biological evaluation of medical devices - Part 5:
Tests for in vitro cytotoxicity
IEC 62220-1-1 Edition
1.0 2015-03
Medical electrical equipment-Characteristics of
digital X-ray imaging devices Part 1-1:
Determination of the detective quantum
efficiency Detectors used in radiographic imaging
IEC 62133-2 Edition1.0
2017-02
Secondary cells and batteries containing alkaline
or other non-acid electrolytes - Safety
requirements for portable sealed secondary cells,
and for batteries made from them, for use in
portable applications - Part 2: Lithium systems
ISO 20417 First edition
2021-04 Corrected
version 2021-12
Medical devices -Information to be supplied by
the manufacturer
21 CFR 892.1680
FDA Standards for stationary x-ray system
3.1.2. Classification
Type of protection against electrical
shock
Class 1
Degree of protection against
electrical shock
Type B Equipment
Degree of protection against harmful
ingress of water:
IPX6 (An IPX6 rating does not indicate
compliance with, and the detectors
have not been tested for compliance
with, any other IPX_ ratings.)
Degree of safety of application in the presence of a flammable anesthetics