3101126 Rev A Vapotherm Oxygen Assist Module Instructions for Use
Page 21
Standards
IEC 60601-1:2005 (Third Edition)
+ CORR. 1:2006 + CORR. 2:2007
+ A1:2012 (or IEC 60601-1: 2012
reprint)
Medical Electrical Equipment – Part 1: General Requirements for Basic Safety
and Essential Performance
IEC 60601-1-10:2007, AMD1:2013
for use in conjunction with IEC
60601-1:2005, COR1:2006,
COR2:2007, AMD1:2012
Medical Electrical Equipment – Part 1-10: General requirements for basic safety
and essential performance – Collateral standard: Requirements for the
development of Physiologic Closed-loop Controllers (FDA Consensus Standard
FR Recognition Number 19-9)
IEC 60601-1-6:2010, AMD1:2013
for use in conjunction with IEC
62366:2007, AMD1:2014 and
IEC 60601-1:2005, COR1:2006,
COR2:2007, AMD1: 2012 or
equivalent consolidated version IEC
60601-1:2012 (Edition 3.1)
Medical Electrical Equipment – Part 1-6: General requirements for basic safety
and
essential performance – Collateral Standard: Usability
IEC 60601-1- 8: 2006 (Second
Edition) + Am.1: 2012 for use in
conjunction with IEC 60601-1: 2005
(Third Edition) + Am.1: 2012
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 60601-1-2. Ed. 4.0 (2014-02)
General requirements for safety – Collateral standard: Electromagnetic
Compatibility – Requirements and tests
ISO 80601-2-61:2017, COR1:2018
for use IEC 60601-1:2005,
COR1:2006, COR2:2007,
AMD1:2012
Medical electrical equipment – Part 2-61: Particular requirements for basic
safety and essential performance of pulse oximeter equipment
IEC 62304:2006 (First Edition) +
A1:2015
(or IEC 62304:2015 CSV)
Medical device software: Software Life cycle processes
IEC 62366-1:2015
Medical devices – Part 1: Application of usability engineering to medical devices
Section 19 Specifications
