ANSI AAMI IEC 60601-2-16-2012 pdf download.
ANSI AAMI IEC 60601-2-16-2012 pdf download.Medical electrical equipment
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 IEC 60601-1. 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 IEC 60601-1-2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the IEC 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 201.101. 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. Subclauses, figures or tables 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.
Addition: The instructions for use shall additionally include the following, if applicable: – a description of the method(s) by which sanitization or disinfection is achieved; – * a statement that the test procedure by which the effectiveness of sanitization or disinfection has been verified is available on request; – a warning stating to follow the MANUFACTURER’S instructions to disinfect the HEMODIALYSIS EQUIPMENT. If other procedures are used it is the responsibility of the RESPONSIBLE ORGANIZATION to validate the disinfection procedure for efficacy and safety. This warning shall specifically list HAZARDS including the failure mode that may result from other procedures; – a warning that the RESPONSIBLE ORGANIZATION is responsible for the hygienic quality of any delivery system(s)， e.g. central water supply system， CENTRAL DELIVERY SYSTEMS, HEMODIALYSIS EQUIPMENT connecting devices, including the fluid lines from connection points to the HEMODIALYSIS EQUIPMENT.
