4 General requirements

ü        If the MANUFACTURER chooses as a means of RISK CONTROL to have the ME EQUIPMENT or ME SYSTEM notify the OPERATOR that a HAZARDOUS SITUATION can exist, then the ME EQUIPMENT or ME SYSTEM shall include an ALARM SYSTEM complying with this collateral standard for that purpose. See also 12.3 of the general standard (מעניין איזה דברים רואים משם שלא רואים מכאן).

אני מניח כי ה general standard  – הוא 60601-1

?       The RISK ASSESSMENT shall also consider HAZARDS to PATIENTS, OPERATORS, and other persons arising from the ALARM SYSTEM (see 6.8.3).

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