AS IEC 60601.1.8:2017 Medical electrical equipment
4 General requirements
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 MESYSTEM shall include an ALARM SYSTEM complying with this collateral standard for that purpose. See also 1 2.3 of the general standard.
The RISK ASSESSMENT shall also consider HAZARDS to PATIENTS , OPERATORS , and other persons arising from the ALARM SYSTEM (see 6.8.3).
5 MEEQUIPMENT
identification marking and documents
NOTE Additional requirements for the marking on controls and instruments are specified in this collateral standard, together with the technical requirements, giving rise to requirements on markings. These requirements are also listed in Annex B.
5.1 Indicator lights and controls
In addition to the requirements for colours of indicator lights and their meanings in 7.8.1 of the general standard, the requirements of 6.3.2.2 apply.
NOTE Dot matrix or other alphanumeric displays are not considered to be an alarm indicator light unless those displays are used to simulate an alarm indicator lights (see 6.3.2.2).
5.2 A CCOMPANYING DOCUMENTS
NOTE Additional requirements on ACCOMPANYING DOCUMENTS are specified in this collateral standard, together with the technical requirements, giving rise to requirements on ACCOMPANYING DOCUMENTS . These requirements are also listed in Table B.2.
5.2.1 Instructions for use
The instructions for use shall:
• provide an overview of the ALARM SYSTEM , including a listing and description of every possible ALARM CONDITION and, as appropriate for the intended OPERATOR , a summary of how it is determined;
• indicate any delay inherent in the determination of an ALARM CONDITION ;
• disclose the OPERATOR ‘ S POSITION ; and
• include how and when to verify the functionality of the ALARM SYSTEM .
As applicable, the instructions for use shall caution against setting ALARM LIMITS to extreme values that can render the ALARM SYSTEM useless.
NOTE Additional requirements on instructions for use are specified in this collateral standard, together with the technical requirements, giving rise to requirements on instructions for use. These requirements are also listed in Table B.3.