The manufacturer must prove that the level of residual risk is equivalent (comparable when using amendment 1). Also of important note, “different” does not mean “equivalent” simply providing an alternate method of compliance or risk control than that specified in the standard does not guarantee that the level of residual risk is equivalent to complying with the standard, even where the level of residual risk is acceptable. (This is not an allowance to freely deviate from stated requirements.) A heavy burden of proof is placed on the manufacturer as part of this allowance. Caution is recommended when using this allowance in the standard. To address this, the standard allows for deviations from requirements provided it can be shown that the level of residual risk (ISO 14971:2007, definition 2.15) is equivalent to the residual risk resulting from compliance with the requirement of IEC 60601-1. This creates situations where the requirements of the standard may not be suitable for all devices falling within the scope of the standard. The standard also recognizes that the development technology and/or medical practice will outpace the development of the standard. IEC 60601-1 is a device standard it contains requirements for construction, markings, labeling, and testing of medical devices.
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