videomed Truelink 4, Инструкция по эксплуатации

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System identification
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80028008_030_B – 773625 – 2021-04-29
1.2 Reference standards
VIDEOMED S.r.l. declares that the Truelink 4 Video Management System complies with the specific
standards of the medical sector.
Legislation and rules applicable to the United States of America (USA) countries:
Standard Description
21 CFR Part 820 Quality System Regulation
21 CFR Part 821 Medical Device Tracking Requirements
21 CFR Part 803, 806, 807 Medical Device Reporting,
Medical Device Reports of Corrections and Removals,
Establishment Registration and Device Listing for Manufacturers
and initial Importers of Devices
21 CFR Part 801 Labeling
19 CFR Part 134 Country of origin marking.
AAMI / ANSI / ISO 14971:
2007/(R)2010 Medical Devices - Application Of Risk Management To Medical
Devices
AAMI / ANSI / IEC 62304:2006 Medical Device Software - Software Life Cycle Processes
ANSI AAMI IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to
medical devices
AAMI / ANSI HE75: 2009 Human Factors Engineering - Design Of Medical Devices
AAMI / ANSI ES60601-1:
2005/(R)2012 and A1:2012,
C1:2009/(R)2012
and A2:2010/(R)2012 Medical electrical equipment - part 1: general requirements for
basic safety and essential performance (IEC 60601-1:2005, Mod).
(General II (ES/EMC))
(U.S. Identical Adoption of Standard IEC 60601-1-2 Edition 4.0
2014-02
AAMI / ANSI / IEC 60601-1-2:2014 Medical electrical equipment -- part 1-2: general requirements for
basic safety and essential performance -- Collateral standard:
Electromagnetic disturbances -- Requirements and tests.
(General II (ES/EMC))
AAMI / ANSI / ISO 15223-1:2016 Medical Devices - Symbols To Be Used With Medical Device
Labels, Labelling And Information To Be Supplied - Part 1: General
Requirements
ISO 7010: Second edition 2011-06-01,
including amendment 1 (2012)
through amendment 7 (2016) Safety Signs
California Proposition 65 Safe Drinking Water and Toxic Enforcement Act of 1986