OES Medical is pleased to confirm that the Cygnus ventilator is now fully compliant to IEC 60601-1 (Edition 3.1). This joins the Astra 3i anaesthesia machine range in meeting the latest safety standard.
IEC 60601 is a series of technical standards that ensure the safety of medical electrical equipment. IEC 60601-1 (Edition 3.1) deals with the basic safety and essential requirements of medical electrical equipment and serves to ensure that no single electrical, mechanical or functional failure shall pose an unacceptable risk to patients and operators. It is an essential safety standard for any medical device manufacturer and is harmonised under the Medical Devices Directive (MDD) 93 / 42 / EEC.
IEC 60601-1 (Edition 3.1) is a widely accepted standard in the US, Canada, EU, Japan, Brazil Russia and Australia. Since January 2014 many countries have started to enforce the implementation of IEC 60601-1 (Edition 3.1) as a mandatory requirement for medical equipment being imported. To avoid being denied entry into these markets manufacturers should ensure their products comply with Edition 3.1 of this standard now rather than waiting until the 31 December 2017 final deadline. Note – for some new devices (including the OES Cygnus ventilator – as defined in Annex ZZ of the standard) this compliance date is set even earlier – on 1st January 2016.
Managing Director Richard Fiedorowicz comments as follows :
“In line with our company vision and history of innovative design development in the field of anaesthesia I am delighted we have designed and are now manufacturing a ventilator today, in July 2015 that meets future regulatory requirements, well before the January 2016 deadline. We have in effect future-proofed our customers with regards to regulatory issues for the next generation of our products.”
Please contact us for further information regarding compliance with IEC 60601 (Edition 3.1) and to obtain copies of our Declaration of Conformity.
7th June 2015