AAMI IEC-60601-2-39-2018 pdf download.Medical electrical equipment—Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment.
201.1 Scope, object and related standards
Clause I of the general stwidardt applies, except as follows:
201,1.1 Scope
Replacement:
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFOR1.IANCF of PER’ToNEAL DIALYSIS ME E0uIPMEN1’ as defined in 201.3.208. hereafter referred to as PD EQuIPMENt. It applies to PD E0UIPMENT intended for use either by medical staff or under the supervision of medical experts, including PD EQUIPMENT operated by the PATIENT, regardless of whether the PD EQUIPMENT is used in a hospital or domestic environment.
If a clause or subclause IS specifically Intended to be applicable to ME EQUIPMENT only. or to liE SYSTEMS only, the title and content of that clause or subclause will say so. It that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.41 of the general standard
NOTE See aiso 4.2 of the general standard
This document can also be applied to PD EQUIPMENT used for compensation or alleviation of disease, injury or disabIlity.
These parlicular requirements do not apply to the DIALY5IND SOLUTION, or the DIALYSINO SOLUTION CIRCUIT.
201.1.2 Object
Replacement.
The object of this particular stand is to establish particular 5A5C sAFsTr and EssENTIAl. PSRFORtWICE reqiements for o EOUIPWNT defined in 201.3.208.
201.1.3 Coltaterat standards
Addition,’
This perlicutar 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 60601-1-2:2014. IEC 60601-1-8:2006 and IEC 60601-1-8:2006lAhtDl:20t2, and IEC 60601-1-11:2015 apply as modified in Clauses 202, 208 and 211- 1EC606.01-1-3 and IEC6O6O1-1-12 do not apply. IEC 60601-1-9:2007 and IEC 60601-1-9:20071Ak1D1:2013 do not apply as noted in Clause 209. 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 prionty over the general standard.
For brevity. IEC 60601-1:2005 and IEC 60601-1:200StAMDI:2012 are referred to In this parlicular 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 document addresses the content of Ctause I 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 test of the general standard are specified by the use of the following words:
•Replacernenr means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this particular standard
Addifion means that the text of this particular standard is additional to the requirements of the general standard or applicable collateral standard,
Amendrnenr 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 3.147. additional definitions in this document are numbered beginning from 201.3.201. Additional annexes are lettered AA B8, etc.. and additional Items as), bb), etc.
Subelauses, figures or tables whicfi are additional to those of a collateral standard are numbered starting from 20x. where x is the number of the collateral standard, for example 202 for IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term this ctocumenr is used to make reterence to the general standard, any applicable collateral standards and this particular standard taken together
Where there is no corresponding clause or subclause in this particular standard, the clause or subclause of the general standard or applicable ooltataral standard, aithough possibly not relevant, applies without modification, where it is Intended that any part of the general standard or applicable collateral standard. although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard,
20t2 Normative references
NOTE Informative references are lislea in the bibliography.
Ctause 2 of the general standard applies, except as follows
Replacement:
IEC 60601-1-2:2014. Medical alecfrical equipment — Part 1-2: General requirements for basic safety and essentIAl performance — Collateral Standard. Electromagnetic disturbances — Requirements and test.AAMI IEC-60601-2-39 pdf download.