EMC Technologies Sydney and Melbourne laboratories are NATA accredited to Medical Safety standard IEC/EN 60601-1 and EMC Safety standard IEC/EN 60601-1-2.
EMC Technologies has been working with Australia’s major Electro Medical Equipment designers and manufacturers since 1992. Think of a major Australian medical equipment manufacturer and there is a high probability we are their test lab of choice. Our unmatched experience and NATA accreditation/world recognition has been instrumental in the successful approval and launch of many products in the lucrative overseas markets including:
–Europe: Medical Devices Directive 93/42/EC as amended by 2007/47/EC
–United States: Food and Drug Administration (FDA)
–Australia: Therapeutic Goods Administration (TGA)
– Japan and others.
In Australia devices that fall under TGA jurisdiction must be tested to IEC 60601-1 and IEC 60601-1-2. RCM testing, certification and labelling requirements as governed by ACMA do not apply.
The base safety standard is IEC 60601-1. There may also be a device standard and you need to consider these when looking at the safety requirements. Presently EMC Technologies Pty Ltd Sydney is accredited to edition III with Please check with us for the current status of our accreditation.
EMC Technologies also have a proven track record in the investigation and solving of on-site interference problems associated with Medical Imaging (MRI, Ultrasound) and other electro-medical equipment.