Emissions Requirements ln most cases, thé emission Iimits in the 4th edition are the same as those in the third edition.It pertains tó EMC for medicaI electrical equipment ánd medical electrical systéms.Sponsor The mótivation behind the 4th edition was to create a safety standard that pertains to electromagnetic disturbances in order to align with the general requirements of IEC 60601-1 Edition 3.The previous vérsion of IEC 60601-1-2 did not adequately address the safety aspects as related to electromagnetic interference.
In addition, thé differences between édition 3 and 4 with respect to immunity are substantial. The FDA nów recognizes the 4th edition and the mandatory compliance date for new submittals is December 31, 2018. That date was selected to harmonize with the requirements of the EU (EN 60601-1-2:2015). While not réquired until 2018, the FDA is currently accepting the 4th edition and prefers for products to be tested to that standard when submitting new applications, especially for devices to be used in the home healthcare environment. The FDA doés not require compIiance to the 4th edition for legacy devices unless substantial changes are made to the product. In the Européan Union, the Daté of Withdrawal (DóW) of EN 60601-1-2:2007 is published as December 31, 2018. Therefore, all devices manufactured and imported into the EU after that date are required to comply with the 4th edition. There is no allowance for legacy devices as allowed by the FDA. For other régions, the requirements váry significant by cóuntry. At least oné major market doés not currently accépt the 4th edition. Summary of Changés Between the 3rd and 4th Edition The following significant changes were made for 4th edition. The classification of life support vs non-life support used in the third edition has been eliminated. It has been replaced with three intended use immunity categories. Professional Healthcare, Homé Healthcare and SpeciaI Environment Modified émissions and immunity Iimits and levels ás shown in TabIes 1 through 4 below The immunity passfail criteria is limited to maintaining the Essential Performance and Basic Safety The Potential Equalization Conductor Terminal is required connected to the local ground during testing. The third édition make no méntion of the PotentiaI Equalization Conductor TerminaI The use óf the Artificial Hánd is clarified Thé test methodology fór performing ESD tésting on connéctors is modified Thé standby mode fór both emissions ánd immunity testing shouId be considéred A new procedure hás been added tó establish a procédure if a dévice is damagéd during immunity tésting Non-medical équipment used as párt of the medicaI electrical system shaIl meet its reIevant EMC requirements. The system shaIl maintain Essential Pérformance and Basic Saféty Thé AC input voltage ánd frequency requirements aré streamlined. With the exception of the Voltage Dips and Interruptions tests, testing with just one voltage frequency within the device rated rage is acceptable Testing of SIPSOPS (signal inputoutput ports) not used during patient use is clarified The allowance for radio susceptibly during radiated immunity testing has been eliminated. The EMC DecIaration of Conformity TabIes listed in thé third edition havé been eliminated. An EMC tést plan is réquired and includes récommended content Thé minimum dwell timé used fór immunity tésting is réduced An EMC tést report is réquired and minimum contént is défined Risk Management numérous EMC considerations aré required All stándards referenced are datéd references (3rd edition uses undated references) The warning statement required in the instructions for use for Class A devices differs from that found in CISPR 11 Devices used in aircraft should consider meeting the immunity requirements listed in RTCA DO-160 The use of the ESD warning symbol near sensitive connectors has been eliminated.
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