![]() ![]() Immunity test requirements shall be applied to the ports of the device according to the use environment(s) specified in the intended use.Īlthough healthcare professionals are present in the emergency medical services environment, the electromagnetic environment is similar to that of the home healthcare environment. ![]() Deviations from the plan made during testing, shall be documented in the test report. Annex G provides guidance and lots of details about the content of such a test plan. With the earlier version of this collateral standard it was good practice to make such plans with the 4th edition it is now an explicit requirement. ISO 13485:2016 now has a general requirement that every verification/validation report shall have a matching plan. schools and vehicles (IEC 6) Ĭ) During immunity testing, the Basic Safety and Essential Performance shall be tested in the modes that are most likely to result in an unacceptable risk, requiring hazard analysis and defining pass/fail criteria prior testing ĭ) Test levels for the immunity requirements have been increased Į) New requirements for enclosure port immunity to RF wireless communications equipment have been added. ![]() military and heavy industrial areas and harmonization with home healthcare environment, e.g. However, after, for declarations of conformity, in support to premarket submissions, FDA will only accept the 4th edition, with recognition number: 19-8 (or ANSI AAMI IEC 6:2014, #19-12).Ī) A formal test plan shall be provided to the test laboratory ī) Environments outside the professional health care facility shall be addressed, including special environments, e.g. The US appears to be a bit more industry-friendly, as grandfathering is allowed, meaning that products that have FDA market clearance can be continued to be placed on the market after. ![]()
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