MDA DB 9801 Supplement 1.
December 1999 Checks and tests for newly delivered medical devices.
Key points: Replaces HEI 95 and HEI 140 part ll along with extending the scope of pre-user checks and tests to non-electrical medical devices. It emphasises the requirement to check the safety and function of newly-delivered medical devices. Checking that the correct product, manuals and accessories have been supplied and are in good condition and working order. Ensuring that risks associated with using a particular model for the first time are minimised e.g. training needs, recording device on PPM database. Highlights that many tests previously specified in standards are type tests which pose a challenge to the device, and should only be carried out by the manufacturer or a test house. "Product items subjected to type tests are never put into service, in case the test has caused some damage. Type tests must never be used as pre-use tests. Tests are designed to test equipment in normal working order, not to subject equipment to currents or voltages exceeding those experienced in normal operating conditions. No test should involve shorting electrodes together, or applying high voltages to electrodes." Like HEI 95, DB9801 Supplement 1. includes a good example of a comprehensive acceptance test log form which bioengineering departments can utilise or slightly modify to suit their own requirements. Modules B to E of the form could also be utilised or slightly modified for use as the basis of routine test regimes.
As follow up to todays other subject:-
Some of the main points that may affect our current working environments and practice!!
EN50191 Electrical Test Installations
When more than one person is working within the controlled area dual controls are required to energies supplies.
An isolation transformer is required under certain circumstances.
Emergency switch off with at least one outside the test area.
Prevention of automatic on unintentional switching on.
Barriers. At least 1800mm high for voltages over 1Kv.
Signal lights.
RCD rated at 30mA.
Insulated bench tops.
One other person must be present in visual and audible contact. :rolleyes
Bill