IEC Technical Report 60601-4-4
IEC TR 60601-4-4:2017
Medical electrical equipment - Part 4-4: Guidance and interpretation - Guidance for writers of particular standards when creating alarm system-related requirements
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.
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.
CHFÂ 155.-
Technical committee
TC 62/SC 62A Common aspects of medical equipment, software, and systemsCategory
Safety| Publication type | Technical Report |
| Publication date | 2017-08-17 |
| Edition | 1.0 |
| ICS | 11.040.01 |
| Stability date | 2028 |
| ISBN number | 9782832246856 |
| Pages | 22 |
| File size | 1023.28 KB |
Ensure healthy lives and promote well-being for all
Build resilient infrastructure, promote inclusive and sustainable industrialization and foster innovation
Reduce inequality within and among countries
Ensure sustainable consumption and production patterns
Take urgent action to combat climate change and its impacts