Mindray A7 Operating Instructions

Standards Compliance Product Specifications
9 - 2 046-004667-00 A7™ Operating Instructions
9.1 Standards Compliance
The A7 Anesthesia System is in compliance with the following industry standards.
The anesthesia workstation shall be used together with the monitoring devices, alarm system and
protective devices below:
ANSI / AAMI ES60601-1:2005/(R)2012 and
C1:2009/(R)2012 and, A2:2010/(R)2012
(consolidated text)
Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance
IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance -
Collateral standard: Electromagnetic compatibility -
Requirements and tests
IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance -
collateral standard: usability
IEC 60601-1-8:2006 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 system
IEC 62304:2006 Medical device software - Software life cycle processes
IEC 62366 Edition 1.1 2014-01 Medical Devices - Application of Usability Engineering to
Medical Devices
ISO10993-1:2009 Biological Evaluation of Medical Devices - Part 1: Evaluation
and Testing Within A Risk Management Process
ANSI/AAMI/ ISO 10993-5:2009 Biological Evaluation of Medical Devices -- Part 5: Tests for in
Vitro Cytotoxicity
ISO 10993-10:2010 Biological Evaluation Of Medical Devices -- Part 10: Tests for
irritation and skin sensitization
ISO10993-18:2005 Biological evaluation of medical devices -- Part 18:
Chemical characterization of materials
ISO14971:2007 Medical Devices - Application of Risk Management to
Medical Devices
ISO 15223-1:2012 Medical Devices - Symbols to be used with Medical Device
Labels, Labelling, and Information to be supplied - Part 1:
General Requirements
ISO 80601-2-13:2011 Medical electrical equipment —Part 2-13: Particular
requirements for basic safety and essential performance of
an anaesthetic workstation
ISO 80601-2-55:2011 Medical electrical equipment - Part 2-55: Particular
requirements for the basic safety and essential performance
of respiratory gas monitors
ISO 5356-1:2004 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
TABLE 9-1
Standards Compliance

Mindray A7 Specifications

General

Brand	Mindray
Model	A7
Category	Medical Equipment
Language	English