Specifications and bibliography
Operator’s Manual V1.1 • EasyOne Air • EasyOne Connect
© ndd Medizintechnik AG • Technoparkstrasse 1, 8005 Zurich, Switzerland • www.ndd.ch
133
List of tests and parameters, 36
Application Note
Reference Predicted Normal Values
Application Notes for further information, 3
Certifications and
standards
International
standards
IEC 60601-1 Medical electrical equipment. General requirements for
basic safety and essential performance
IEC 60601-1-2 Medical electrical equipment. General requirements for
basic safety and essential performance. Collateral standard.
Electromagnetic compatibility. Requirements and tests
IEC 62304 Medical device software – Software life cycle processes
IEC 62366 Medical devices. Application of usability engineering to
medical devices
ISO 13485 Medical devices — Quality management systems —
Requirements for regulatory purposes
ISO 14971 Medical devices. Application of risk management to medical
devices
ISO 26782 Anesthetic and respiratory equipment. Spirometers intended
for the measurement of time forced expired volumes in humans
ISO 23747 Anesthetic and respiratory equipment. Peak expiratory flow
meters for the assessment of pulmonary function in spontaneously
breathing humans
EU
CE marked, EC declaration of conformity, see on the
ndd
website under
“Certificates”
US
FDA 510(k) market clearance
Associations and
institutes
ATS/ERS 2005, NIOSH, OSHA
Life time
7 years
Specifications for
EasyOne Air
