Standards applied for the ABC Electronic Gizmo

Published Standards used and/or referenced in the Technical File are listed below with the
rationale given. Harmonised Standards are used where available.

Standard Rationale
ISO EN ISO 9001:2008 Quality Management System.
ISO EN ISO 13485:2012 Quality Management System.
BS EN ISO 8359:2009 To comply with the technical requirements of
an Oxygen Concentrator.
BS EN (IEC) 60601-1:2006 To comply with the requirements for medical
electrical equipment – basic safety and
essential performance.
BS EN ISO 60601-1-2:2007 Because of the environment the unit is used in
it should meet the requirements of
electromagnetic compatibility (EMC).
BS EN 62366:2008 To comply with the requirements of usability.
BS EN ISO 14971:2009 To comply with the requirements of Risk
Management.
BS EN 60529:1992 Due to the device type and the environment it
is used in it should be assessed to establish
an IP rating.
BS EN 980:2008 Symbols used on labels and IFU.
BS EN 1041:2008 IFU guidance.

Issue 1