IEC 60601-2-50:2009 pdf free download

IEC 60601-2-50:2009 pdf free download

IEC 60601-2-50:2009 pdf free download Medical electrical equipment – Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
2u1.1scope, opject ana relatea stanaaras
Clause 1 of the general standard 1) applies, except as follows:
201.1.1 * scope
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANTPHOTOTHERAPY EQUIPMENT, as defined in 201.3.203 of this standard,also referred to asME EQUIPMENT.
lf a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or toME SYSTEMs only, the title and content of that clause or subclause will say so. lf that is not thecase, 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 SYSTEMSwithin the scope of this standard are not covered by specific requirements in this standardexcept in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This particular standard specifies safety requirements for INFANT PHOTOTHERAPY EQUIPMENT,but alternate methods of compliance with a specific clause by demonstrating equivalent safetywill not be judged as non-compliant if the MANUFACTURER has demonstrated in his RISKMANAGEMENT’ FlILE that the RISK presented by the HAZARD has been found to be of anacceptable level when weighed against the benefit of treatment from the device.
This particular standard does not apply to:
devices supplying heat via BLANKETS,PADs or MATTRESSEs in medical use, for informationsee lEC 80601-2-35;
INFANT INCUBATORs; for information see lEC 60601-2-19;
-INFANT TRANSPORT INCUBATORS; for information, see lEC 60601-2-20;-INFANTRADIANT WARMERS; for information see lEC 60601-2-21.
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIALPERFORMANCE requirements for INFANT PHOTOTHERAPY EQUIPMENT (as defined in 201.3.203),which reduce the safety HAZARDS to PATIENTs and oPERATORS as much as possible and tospecify tests for demonstrating compliance with these requirements.
201.1.3Collateral standardsAddition:
This particular standard refers to those applicable collateral standards that are listed inClause 2 of the general standard and Clause 2 of this particular standard.
IEC 60601-1-2 applies as modified in Clause 202.IEC 60601-1-3 and lEC 60601-1-102) donot apply. All other published collateral standards in the IEC 60601-1 series apply aspublished.
201.1.4Particular standardsReplacement:
ln the IEC 60601 series,particular standards may modify,replace or delete requirementscontained in the general standard and collateral standards as appropriate for the particularME EQUIPMENT under consideration,and may add other BASiC SAFETY and ESSENTIALPERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity,IEC 60601-1 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 ofthe general standard with the prefix “201″(e.g. 201.1 in this standard addresses the contentof 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 thisparticular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateralstandard,203.4 in this particular standard addresses the content of Clause 4 of theIEC 60601-1-3 collateral standard,etc.). The changes to the text of the general standard arespecified by the use of the following words: