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求救各位大佬
ISO 81060-2:2018/amd 1:2020里面新增的这个定义
total limb circumference range
range, from the smallest limb circumference to the largest limb circumference, intended by the manufacturer for use with the automated sphygmomanometer
这个total limb circumference range，到底指的啥意思啊？
就是比如我有三个尺寸的袖带：20-26，,25-34，32-43，那这个total limb circumference range是不是就是20-43？
以此为基础，关于受试者肢体周长的要求
1) at least 20 % of the subjects shall have a limb circumference which lies within each quarter of the total limb circumference range;
2) at least 10 % of the subjects shall have a limb circumference which lies within the highest octile of the total limb circumference range; and
3) at least 10 % of the subjects shall have a limb circumference within the lowest octile of the total limb circumference range
是不是意思就是，20-43要分成八份
至少10%的受试者肢体周长在20-22.9范围内
至少20%的受试者肢体周长在20-25.8范围内
至少20%的受试者肢体周长在25.8-31.6范围内
至少20%的受试者肢体周长在31.6-37.4范围内
至少20%的受试者肢体周长在37.4-43.2范围内
至少10%的受试者肢体周长在40.3-43.2范围内
是这样理解的不？
还有一个就是
Additionally, for a sphygmomanometer intended for use with multiple cuff sizes, each cuff shall be tested on at least N (cuff) subjects as calculated according to Formula (1).
N (cuff) =[ r (cuff)/2*r (total) ]*N (total)
where
N (total) is the total number of subjects in the study;
r (cuff) is the size of the limb circumference range for the individual cuff;
r (total) is the size of the total limb circumference range.
这里头的r (total)和r (cuff)，到底咋个计算啊，如上面举例，
三个袖带尺寸：20-26，,25-34，32-43，
是不是对应的r (cuff) 就分别是6、9、11，然后r (total)就是23，
这样算出三个袖带尺寸分别至少需要在11、16、20个受试者上进行测试？
求求各路大佬现身解答，感激不尽！！！！
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发表于 2023-11-24 16:27:20
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