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|  Electromedical Equipment Testing TCA’s Electromedical Laboratory is Australia’s only recognised and accredited laboratory for testing medical electrical devices to the AS3200 and IEC60601 series in safety standards.
Click here to see our complete Manufacturer’s Medical Equipment List. This list shows the classes of medical equipment that we’ve tested and certified. If you’re a manufacturer or distributor of electromedical equipment and you’d like your product included on our list, please contact us by phone or email. Click here to go to our contacts page. Click here to see the list of current IEC 60601 Series standards. Click here to see the list of current AS/NZS 3200 Series standards. Services TCA Certificate of Conformance The TCA Certificate of Conformance is used to bridge the gap between the IEC documentation from overseas and the Australian standard AS/NZS 3200.1.0. The Australian standard is a usually common requirement for tenders of electromedical equipment and/or hospital biomedical engineering departments. Some tender requirements state they do not accept just the IEC documentation. The reason usually is the body issuing the tender does not want the responsibility for accepting the IEC60601 documentation due to the lack of experience with the standards and overseas reports. Full Testing to AS/NZS 3200.1.0 and/or IEC 60601-1 For products imported into Australia where IEC documentation can not be provided and compliance to AS/NZS 3200.1.0 is still required, full testing to AS/NZS 3200.1.0 will be required. For products manufactured within Australia, testing to AS/NZS 3200.1.0 can be performed for the Australian market and if required a report to IEC 60601-1 for the international market. If a report to IEC 60601-1 is not required at the time of the AS/NZS 3200.1.0 testing, the IEC 60601-1 report can be generated at a later date using the results from the AS/NZS 3200.1.0 testing. Tip: If the overseas manufacturer has no IEC 60601-1 documentation, we can provide an IEC 60601-1 report (additional fee applicable) for the manufacturer as well as the AS/NZS 3200.1.0 report for the Australian supplier. As a result the manufacturer may pay some of the testing fees.
Quotations It is preferred to receive the equipment before a firm quotation is sent. If it is not practical to send the equipment prior to the quotation being issued, TCA reserves the right to adjust the quotation on receipt of the equipment if required. If a quotation is required before receipt of the equipment, circuit diagrams and pamphlets or photographs of the equipment are required in the determination of the quote. Additional labour charges may be applied for large equipment or equipment requiring extensive unpacking/repacking or setting-up/dismantling. Assembly/disassembly or packing/unpacking instructions will be required if the method is not obvious. See also “delivery of equipment” Quoted time frame is only indicative at the date of issue of the quotation. Time frame may change after that date depending on the workload at the time of delivery of the test samples. Acceptance of Quotations If TCA has performed any work for your company in the past and there are no outstanding TCA invoices, a signed TCA quotation, a purchase order or fax/letter of authorisation referencing the quotation is sufficient. If TCA has never performed any work for your company, either the following can be used:
Work will not commence until the above process has been completed. After acceptance, a confirmation will be sent to you confirming what service is being provided, e.g. testing required, fee and completion date. Booking In for Assessment If pre-booking is required, the acceptance of the quotation must be completed (e.g. signed quotation or purchase order received) and all required samples received at least 2 days prior to the agreed commencement date. Note: If either the acceptance or sample have not been received prior to the agreed acceptance date, the booking will be cancelled and the project will be reallocated. If deadlines still need to be made but our current testing time prevents it, using the express time fee may be necessary. Delivery of Equipment A detailed parts list including a brief description must accompany the equipment when delivered to TCA. If a quotation has been issued for the equipment, please reference the quotation number for easy traceability. Return of Equipment The quotation indicates possible options (collect or destroy).
Before receiving the equipment we would like to briefly assess the IEC documentation to determine if it will meet our requirements to be used for the TCA Certificate of Conformance. Some of the initial requirements we look for are as follows: IEC60601-1 Test Reports
IEC60601-1-2 Test Reports
Certificates Certificates or declarations can not be used without the supporting test reports. Also, required will be the User manuals and (if available) the Service Manual. Equivalent IEC60601-1 Standards Some equivalent standards to IEC60601-1 (1988) with Amendments 1 & 2 are:
Relationship between AS/NZS 3200.1.0 and IEC 60601-1
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