Standards Compliance Product Specifications
10 - 2 Operator’s Manual of Anesthesia System
10.1 Standards Compliance
The Anesthesia System is in compliance with the following industry standards.
ANSI/AAMI 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 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance -
Collateral Standard: Electromagnetic disturbances -
Requirements and tests
IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance -
Collateral standard: Usability
IEC 60601-1-8 Edition 2.1 2012-11 Medical electrical equipment - Part 1-8: General
requirements for basic safety and essential performance -
Collateral standard: General requirements, tests and
guidance for alarm systems in medical electrical equipment
and medical electrical systems
IEC 62304 Edition 1.1 2015-06 Medical device software - Software life cycle processes
IEC 62366-1 Edition 1.0 2015-02 Medical devices - Part 1: Application of usability
engineering to medical devices
ISO 10993-1 Fifth edition 2018-08 Biological Evaluation of Medical Devices - Part 1: Evaluation
and testing within a risk management process
ISO 10993-5 Third edition 2009-06-01 Biological Evaluation of Medical Devices -- Part 5: Tests for in
vitro cytotoxicity
ISO 10993-10 Third edition 2010-08-01 Biological Evaluation Of Medical Devices -- Part 10: Tests for
irritation and skin sensitization
ISO 10993-18 First edition 2005-07-01 Biological evaluation of medical devices -- Part 18: Chemical
characterization of materials
ISO 14971 Second edition 2007-03-01 Medical Devices - Application of Risk Management to
Medical Devices
ISO 15223-1 Third edition 2016-11-01 Medical Devices - Symbols to be used with Medical Device
Labels, labeling and Information to be supplied - Part 1:
General Requirements
ISO 80601-2-13 First edition 2011-08-01 Medical electrical equipment - Part 2-13: Particular
requirements for basic safety and essential performance of
an anaesthetic workstation [including: Amendment 1 2015-
03-01 and Amendment 2 2018-07]
ISO 80601-2-55 Second edition 2018-02 Medical electrical equipment - Part 2-55: Particular
requirements for the basic safety and essential performance
of respiratory gas monitors
ISO 5356-1 Fourth edition 2015-03-15 Anaesthetic and respiratory equipment - Conical
connectors - Part 1: cones and sockets
CGA V-1:2013 Standard for Compressed Gas Cylinder Valves Outlet and
Inlet Connections
CGA V-5:2008 (Reaffirmed 2013) Diameter index safety system (Noninterchangeable low
pressure connections for medical gas applications)
ASTM F1101-90 (Reapproved 2003) Standard Specification for Ventilators Intended for Use
During Anesthesia
ISO 10993-12 Fourth edition 2012-07-01 Biological evaluation of medical devices - Part 12: Sample
preparation and reference materials
TABLE 10-1
Standards Compliance
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