Medical electrical equipment – Part 4-4: Guidance and interpretation – Guidance for writers of particular standards when creating alarm system-related requirements (Edition 1.0)
This document is intended to assist writers when drafting ALARM SYSTEM-related requirements for particular standards in the IEC 60601 and IEC 80601 or ISO 80601 series of standards. Object The object of this document is to encourage consistent references to ALARM SYSTEM-related requirements when introducing those requirements to particular standards. This is accomplished by providing suggested model language@ with examples@ for common ALARM SYSTEM-related requirements. Each of the recommendations is based upon text that has been used in existing particular standards. The expectation is that this model language will be used when ALARM SYSTEM-related requirements are needed in particular standards. The collateral standard for ALARM SYSTEMS@ IEC 60601-1-8@ contains the horizontal ALARM SYSTEM-related requirements for ME EQUIPMENT and ME SYSTEMS. The recommendations in this document are intended to aid the writers of particular standards when referencing IEC 60601- 1-8:2006 and IEC 60601-1-8:2006/AMD1:2012