Electrical medical devices imported into Australia must comply with additional safety requirements to ensure they connect safely to the electrical mains network in hospitals or at home (230 V single phase voltage or 400 V (L-L) three-phase voltage, 50 Hz).
Healthcare facilities require full compliance with the Australian medical device regulations and safety standard. We can check the test reports and accompanying documentation supplied by overseas manufacturers and certify compliance of your medical devices.
Certification Body Australia is officially accredited by the Joint Accreditation System of Australia & New Zealand (JAS-ANZ) to issue safety certificates under AS/NZS IEC 60601.1 replacing (AS/NZS 3200.1) standard.
If you would like to discuss your safety certification needs, please contact Gunther Theisz at gtheisz@certificationbody.com.au or use our general enquiries email: contact@certificationbody.com.au.