AS 60601.2.24:2018 pdf download.MEDICAL EL ECTRICAL EQUIPMENT – Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers.
201.1.2 Object
Replacement:
The object of this particular standard Is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for ENTERAL NUTRITION PUMPS, INFUSION PUMPS, INFUSION PUMPS
FOR AMBULATORY USE, SYRINGE OR CONTAINER PUMPS, VOLUMETRIC INFUSION CONTROLLERS and
VOLUMETRIC INFUSION PUMPS, as defined in 201.3.204, 201.3.206, 201.3.207, 201.3.220,
201.3.222 and 201.3.223.
201 .1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201 .2 of this particular standard.
IEC 60601-1-2:2007, IEC 60601-1-6:2010 and IEC 60601-1-8:2006 apply as modified in Clauses 202, 206 and 208 respectively. IEC 60601-1-3 does not apply. All other published collateral standards in the IEC 60601-1 series apply as published.
201.1.4 PartIcular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 6060 1-1 is referred to in this particular standard as the general standard. Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix “201 (e.g. 201.1 in this standard addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix 20x where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the 60601-1-2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words:
RepIacement means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this particular standard.
AddiLion” means that the text of this particular standard is additional to the requirements of the general standard or applicable collateral standard.
Amendmentw means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are numbered starting from 201.101. However, due to the fact that definitions in the general standard are numbered 3.1 through 3.139, additional definitions in this standard are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.AS 60601.2.24 pdf download.