AS 60601.2.20 pdf download

AS 60601.2.20 pdf download.Medical electrical equipment
201 .1 .1 Scope
Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT TRANSPORT INCUBATOR equipment, as defined in 201 .3.21 1 of this standard, also referred to as ME EQUIPMENT . If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS , as relevant. H AZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.1 3 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 TRANSPORT INCUBATORS but alternate methods of compliance with a specific clause by demonstrating equivalent safety will not be judged as non compliant if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable 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 information see IEC 80601 -2-35 [1 ] 1 ) ; – INFANT INCUBATORS which are not INFANT TRANSPORT INCUBATOR ; for information see IEC 60601 -2-1 9 [2]; – INFANT RADIANT WARMERS ; for information, see IEC 60601 -2-21 [3]; – INFANT PHOTOTHERAPY ; for information, see IEC 60601 -2-50 [4].
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 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 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: “Replacement” means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this particular standard. “Addition” means that the text of this particular standard is additional to the requirements of the general standard or applicable collateral standard. “Amendment” 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 .1 01 . However, due to the fact that definitions in the general standard are numbered 3.1 through 3.1 39, 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. Subclauses or figures which are additional to those of a collateral standard are numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601 – 1 -2, 203 for IEC 60601 -1 -3, etc. The term “this standard” is used to make reference 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 collateral standard, although 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.