Medical electrical equipment - Part 4-4: Guidance and interpretation - Guidance for writers of particular standards when creating alarm system-related requirements
医用电气设备第4-4部分:指南和解释创建报警系统相关要求时特殊标准编写者指南
IEC TR 60601-4-4:2017(E) 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.
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.