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Replacement of mercury thermometers and sphygmomanometers in health care
Replacement of mercury
thermometers and
sphygmomanometers
in health care
Technical guidance
Edited by: Jo Anna M Shimek,

Jorge Emmanuel, Peter Orris
and Yves Chartier
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C o n t e n ts
Foreword!...........................................................................................................!v!
Acknowledgements!.....................................................................................!vii!
I.! WHO!policy!........................................................................................!1!
II.! Purpose!of!this!guide!......................................................................!3!
III.! Background!.......................................................................................!5!
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IV.! Thermometers!.................................................................................!9!
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V.! Sphygmomanometers!..................................................................!17!
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VI.! Conclusion!.......................................................................................!25!
Annex!1!............................................................................................................!27!
Annex!2!............................................................................................................!39!
References!......................................................................................................!45!
!
Tables
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iv Replacement of mercury themometers and sphygmomanometers in health care

Foreword
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3
III. Background
a. Chemistry
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4.1F0>7(!)18!&180F,(&)-!E(.804,F!\6_C!
b. Exposure
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,=),! )EE(.Q&>),7-*! .172,=&(8! .L! ,=7! >7(40(*! 4&(40-),&1/! &1! ,=7! /-.')-!
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5
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87F&/1),78!,=7!'0(1&1/!.L!>78&4)-!`)F,7!)F!,=7!L.0(,=2-)(/7F,!>7(40(*!
7>&FF&.1!F.0(47!&1!,=7!l1&,78!<,),7F!\10_C!!
c. Human exposure
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.(!FE74&)-!7804),&.1!\12_C
6 Replacement of mercury themometers and sphygmomanometers in health care

d. Costs
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<,),7F! +71,7(F! L.(! 5&F7)F7! +.1,(.-! )18! 3(7K71,&.1N! 7F,&>),78! ,=),! ,=7!
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FE=*/>.>)1.>7,7(FC
Background 7
I V. T h e r m o m e t e r s
a. History
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,=7!8)*!\15_C!
b. Operation of mercury thermometers

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9
c. Accuracy of mercury thermometers
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d. Mercury-free thermometers
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e. Accuracy of mercury-free thermometers

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(7E.(,78! )F! L.--.`F]! >7(40(*2&12/-)FFN! >7)1! JRCZYO!q+N! F,)18)(8!
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-&g0&8!4(*F,)-!L.(7=7)8N!>7)1!JRCZD[!q+N!F,)18)(8!87K&),&.1!aCZHJd!)18!
8&/&,)-! ,*>E)1&4! &1L()(78N! >7)1! JRCZ[!q+N! F,)18)(8! 87K&),&.1! aCZDZC!
:-,=.0/=! )--! ,=(77! )-,7(1),7F! `7(7! 4.>E)()'-7! ,.! ,=7! >7(40(*!
,=7(>.>7,7(N! ,=7! )0,=.(F! L)K.0(78! ,=7! 8&/&,)-! ,=7(>.>7,7(! L.(!
/717()-! 0F7N! ,=7! ,*>E)1&4! >.87-! L.(! 014..E7(),&K7! E),&71,F! )18! ,=7!
-&g0&8!4(*F,)-!L.(7=7)8!>7,=.8!L.(!=.>7!0F7!\13_C!;)1*!.,=7(!F4&71,&L&4!
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,=7(>.>7,7(FN!)18!,=7!4.14-0F&.1F!)(7!F.>7,&>7F!4.1,()8&4,.(*!\19_C!!
f. Cost considerations
I=7! E0(4=)F7! E(&47! .L! 87K&47FN! `=&4=! K)(&7F! L(.>! 4.01,(*! ,.! 4.01,(*N!
(7>)&1F! )! ?7*! E.&1,! ,.! '7! 4.1F&87(78C! $,=7(! L)4,.(F! &1! )88&,&.1! ,.!
E0(4=)F7! E(&47! 1778! ,.! '7! 4.1F&87(78! F04=! )FN! ,=7! (),7! .L! 0F7! .L!
4.1F0>)'-7! &,7>F! -&?7! )-4.=.-! `&E7FN! '),,7(&7FN! 40LLF! )18! .,=7(! E)(,FN!
)18!(7E)&(!)18!4)-&'(),&.1!4.F,F!)--!1778!,.!'7!4.1F&87(78C!I`.!L)4,.(F!
.L,71! .K7(-..?78! )(7! ,=7! 4.F,F! .L! 8&FE.F)-! .L! ,=7! >7(40(*24.1,)&1&1/!
01&,F!)18!,=7!7804),&.1!.L!F,)LL!.1!,=7!E(.E7(!.E7(),&.1!.L!,=7!01&,FC!
S1! HaaON! +()`L.(8! 7,! )-C! \20_! >.87--78! 4.>E)()'-7! 4.F,F! &1! )! -)(/7!
,7)4=&1/! =.FE&,)-! .L! HHaO! '78F! &1! ,=7!l1&,78! n&1/8.>! .K7(! )! Da2*7)(!
E7(&.8C! I=7*! 7F,&>),78! ,=),! ,=7! >7(40(*! ,=7(>.>7,7(! `)F! ,=7!
Thermometers 11
4=7)E7F,! ,=7(>.>7,7(! )-,7(1),&K7! )F! 1.! '),,7(&7FN! 4.K7(FN! (7E)&(F! .(!
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)'.K7N! ,=7! (),7! .L! '(7)?)/7! &F! >04=! =&/=7(C! SL! ,=7! ,=7(>.>7,7(!
'(7)?)/7!(),7!L.(!,=7!;7Q&4)1!E78&),(&4!=.FE&,)-!\F77!)'.K7_!`&,=!HDH!
'78F!&F!7Q,()E.-),78!,.!,=&F!HHaO2'78!F7,,&1/N!,=7!(),7!`.0-8!'7!4-.F7(!
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'(7)?)/7!(),7!.L!.1-*!JJv!.(!)'.K7!`.0-8!>)?7!,=7!4.1,)4,N!4.>E)4,!
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\O]D! 8&LL7(71,&)-_! (7>)&178! ,=7! F)>7C! +7(,)&1-*N! 7Q)4,! 4.F,F! `&--! K)(*!
`&,=! -.4),&.1N! >.87-! )18! 10>'7(! .L! 01&,F! E0(4=)F78C! #.`7K7(N!
=.FE&,)-F!,=),!=)K7!F0'F,&,0,78!>7(40(*!,=7(>.>7,7(F!&1!)!10>'7(!.L!
4.01,(&7FG&14-08&1/! :(/71,&1)N! ;7Q&4.! )18! ,=7! 3=&-&EE&17FG(7E.(,!
4.F,!F)K&1/F!`&,=!,=7!8&/&,)-!87K&47FC!
g. Mercury thermometer replacement

S1!/717()-N!F0447FFL0-!>7(40(*!(7E-)47>71,!E(./()>>7F!71,)&-]!
w &1K.-K&1/!E)(,&4&E),.(*!F,)?7=.-87(Fd!!
w 4.1804,&1/! )1! &1K71,.(*! ,.! &871,&L*! ,=7! 10>'7(F! )18! 0F7F! .L!
>7(40(*24.1,)&1&1/! 87K&47F! )18! >),7(&)-F! &1! ,=7! =7)-,=24)(7!
L)4&-&,*d!
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w 87K7-.E&1/!)!'08/7,!)18!E(.40(7>71,!E(.47FFd!!
w F)L7-*!(7>.K&1/!.(!8&FE.F&1/!>7(40(*2>7)F0(&1/!87K&47Fd!!
w E(7E)(&1/!E(./()>F!F04=!)F!F,)LL!7804),&.1d!!
w E7(&.8&4)--*!>)&1,)&1&1/!)18!4)-&'(),&1/!,=7!7g0&E>71,N!)F!177878d!!
w >.1&,.(&1/! ,=7! 0F7! .L! ,=7! 1.12>7(40(*! )-,7(1),&K7F! ,.! 71F0(7! ,=7!
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:1! 7Q)>E-7! .L! ,=&F! )EE(.)4=! &F! .0,-&178! &1! ,=7! F,7EF! '7-.`C!
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)EE(.E(&),7C!
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>)(?78!)18!K71,78!,.!,=7!.0,F&87!\21_C!
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Thermometers 13
!
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,*E7C!SL!87F&(78N!)F?!,=7!K718.(\F_!L.(!F7K7()-!,(&)-!01&,F!)18!
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87F&(78!,*E7!L.(!E0(4=)F7C!
Mercury-free product listings1

S1! 9)10)(*! HaaON! ,=7! (7E.(,! MHRA! 04144! Thermometer! review:! UK!
market! survey! 2005! .L! ,=7! ;78&4&17F! )18! #7)-,=4)(7! E(.804,F!
f7/0-),.(*! :/714*! `)F! (7-7)F78! )18! 4.1,)&178! )! -&F,&1/! .L! E(.804,F!
)K)&-)'-7!),!,=),!,&>7!.1!,=7!>)(?7,!&1!,=7!l1&,78!n&1/8.>]!
=,,E]66```C`)-7FC1=FC0?6F&,7FJ68.4>7,)8),)C4L>x.(/&8yMMJz&8yOM
DZJ!!
:!E)(,&)-!-&F,&1/!.L!E(.804,F!)K)&-)'-7!&1!,=7!3=&-&EE&17F!&F!4.1,)&178!&1!
Guide! to! alternatives! for! healthcare! personnelN! #7)-,=! +)(7! "&,=.0,!
#)(>N!<.0,=7)F,!:F&)N!E0'-&F=78!&1!HaaZ]!
=,,E]66```C1.=)(>C.(/6-&'68.`1-.)8F6>7(40(*6;7(40(*2
k(77ib0&87i,.i:-,7(1),&K7FCE8L!
k.(! E(.804,F! F.-8! &1! ,=7! l1&,78! <,),7FN! ,=7! k..8! )18! 5(0/!
:8>&1&F,(),&.1! \k5:_! >)&1,)&1F! )! -&F,&1/! .L! )--! )EE(.K78! >78&4)-!
87K&47F! &14-08&1/! ,=7(>.>7,7(FC! I=7F7! 4)1! '7! F7)(4=78! '*!
>)10L)4,0(7(jF!1)>7N!E(.804,!1)>7!.(!ODa?!10>'7(!\k5:!)EE-&4),&.1!
4.87_C!I=7!F7)(4=!L.(>!&F!L.018!),]!
=,,E]66```C)447FF8),)CL8)C/.K6F4(&E,F648(=64L8.4F64LE>16E>1C4L>!!
Step!6! 57,7(>&17! ,=7! E=)F72&1! F4=780-7! L.(! ,=7! 17`! 01&,FC!

+.1F&87(),&.1!F=.0-8!'7!/&K71!,.!,=7!,&>7!177878!,.!&1F,)--!
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F,)LL!7804),&.1)-!E(./()>>7C!
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,=7! E0(4=)F7! .L! ,=7! 01&,F! )18! )447FF.(&7F! \F04=! )F! E(.'7!
4.K7(F!.(!F=7),=F_N!&1F,)--),&.1!)F!177878N!F,)LL!7804),&.1!.1!
,=7! 0F7! .L! ,=7! 17`! 87K&47FN! 4)-&'(),&.1! )18! >)&1,71)147!
F4=780-7FN! (7>.K)-! )18! F,.()/7! .L! ,=7! >7(40(*24.1,)&1&1/!
01&,F! )18! E0(4=)F7! .L! )1*! 4.1F0>)'-7F! 177878! .1! )1!
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!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! !!!!!!!!!!!!!!!!!!!!!!!
1
These product listings are examples. Other listings are also available.

! !
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(7E-)47>71,!01&,F!)18!&14-087!,=7!10>'7(!.L!01&,F!,=),!`&--!
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<7-74,!,=7!K718.(!L.(!,=7!E(.m74,C!
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(7>.K)-!)18!,()1FL7(C!
Step!11! 30(4=)F7!,=7!01&,F!)44.(8&1/!,.!,=7!E=)F72&1!F4=780-7C!!
Step!12! 37(L.(>! )1*! &1&,&)-! ,7F,F! .(! 4)-&'(),&.1! )F! E7(! ,=7!
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.E7(),&.1!)18!>)&1,71)147!.L!,=7!17`!87K&47FC!
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8&FE.F)-!F&,7!)44.(8&1/!,.!-.4)-!=)V)(8.0F!`)F,7!(7/0-),&.1FC!
Thermometers 15
! !
Step!15! ;.1&,.(!)18!71F0(7!,=),!,=7!1.12>7(40(*!,=7(>.>7,7(F!)(7!
E(.E7(-*!0F78!)18!>)&1,)&178N!)18!,=),!)1*!`)F,7N!&14-08&1/!
7182.L2-&L7! `)F,7N! &F! >)1)/78! &1! )1! 71K&(.1>71,)--*! F.018!
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V. Sp h y g m o m a n o m e t e r s
a. History
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(74.(878! )(,7(&)-! E0-F),&.1F! .1! )1! 7Q,7(1)-! /()E=N! `)F! 87K7-.E78! &1!
D[OO! '*! n)(-! T&7(.(8,C! :! =.F,! .L! .,=7(! FE=*/>.>7,7(FN! 87K&47F! ,=),!
7Q,7(1)--*! >7)F0(78! )(,7(&)-! E(7FF0(7! '*! 8&(74,-*! 4.>E(7FF&1/! ,=7!
()8&)-!)(,7(*N!L.--.`78!,=(.0/=!,=7!718!.L!,=7!471,0(*!)18!'7*.18C!<f!
K.1! W)F4=! &1,(.80478! ,=7! (0''7(N! =.--.`! ')--! L&--78! `&,=! `),7(! .(!
>7(40(*! ,.! .'F,(04,! ,=7! )(,7(*N! )18! 4.>'&178! ,=&F! `&,=! )1! )17(.&8!
>)1.>7,7(! &1! D[[aC! I=7! >7(40(*! FE=*/>.>)1.>7,7(N! )!
FE=*/>.>7,7(! `&,=! )! F7E)(),7! 4.>E(7FF&.1! 87K&47! L.(! ,=7! )(>N! `)F!
&1,(.80478!'*!<4&E&.17!f&K)2f.44&!&1!D[YRC!S187E71871,-*N!&1!D[YZN!#&--!
)18! W)(1)(8! &1,(.80478! )! F&>&-)(! 87K&47! `&,=! )1! )17(.&8! >)1.>7,7(!
\35_C!
S1! DYaON! X&?.-&! n.(.,?.LL! `)F! ,=7! L&(F,! ,.! F0//7F,! -&F,71&1/! ,.! )(,7(*!
F.018F!`=&-7!0F&1/!)!F,7,=.F4.E7N!`=&4=!'*!,=71!`)F!17)(-*!)!471,0(*!
.-8C! I=&F! )0F40-,),.(*! >7,=.8! `)F! >.(7! (7-&)'-7! ,=)1! E)-E),&.1! &1!
&871,&L*&1/!,=7!8&)F,.-&4!E(7FF0(7!\27_C!!
b. Operation of a manual sphygmomanometer

:! >)10)-! FE=*/>.>)1.>7,7(jF! ')F&4! 4.>E.171,F! &14-087! )1!
&1L-),)'-7! 40LL! ,.! E-)47! E(7FF0(7! .1! ,=7! )(,7(*N! )! E(7FF0(72>7)F0(&1/!
F4)-7!)18!)1!&1L-),&.1!'0-'!,.!&1L-),7!,=7!40LLC!<E=*/>.>)1.>7,7(F!)(7!
0F78! `&,=! )! F,7,=.F4.E7! ,.! >7)F0(7! ,=7! F*F,.-&4! )18! 8&)F,.-&4! '-..8!
E(7FF0(7C! I.! >7)F0(7! '-..8! E(7FF0(7N! ,=7! &1L-),)'-7! 40LL! &F! E-)478!
)(.018!,=7!0EE7(!)(>!)18!&1L-),78!,.!)!E.&1,!`=7(7!,=7!'-..8!L-.`!&F!
40,! .LLC! :F! ,=7! 40LL! &F! &1L-),78N! ,=7! 1778-7! .1! ,=7! )17(.&8! F4)-7! .(!
>7(40(*!&1!,=7!>)1.>7,7(!(&F7F!,=(.0/=!,=7!4.-0>1N!)18!,=7!(7F0-,&1/!
E(7FF0(7!&F!8&FE-)*78!.1!,=7!F4)-7C!I=7!F,7,=.F4.E7!&F!E-)478!.K7(!,=7!
'()4=&)-! )(,7(*! ),! ,=7! 7-'.`C! I=7! E(7FF0(7! &F! F-.`-*! (7-&7K78! '*!
87L-),&1/! ,=7! 40LL! )18N! )F! ,=7! '-..8! F,)(,F! L-.`&1/! )/)&1N! )! E.018&1/!
F.018! `&--! '7! =7)(8! ,=(.0/=! ,=7! F,7,=.F4.E7C! I=&F! 10>'7(! 8&FE-)*78!
.1! ,=7! F4)-7! ),! ,=&F! E.&1,! &F! ,=7! F*F,.-&4! '-..8! E(7FF0(7N! `=&4=!
(7E(7F71,F!,=7!>)Q&>0>!.0,E0,!E(7FF0(7!.L!,=7!=7)(,C!:F!,=7!E(7FF0(7!
4.1,&107F! ,.! '7! (780478N! )! E.&1,! &F! (7)4=78! `=7(7! ,=7(7! &F! 1.! F.018!
&18&4),&1/! ,=),! ,=7! =7)(,! &F! ),! (7F,C! I=&F! 10>'7(! )F! 8&FE-)*78! .1! ,=7!
F4)-7! &F! ?1.`1! )F! ,=7! 8&)F,.-&4! E(7FF0(7C! 57FE&,7! >)m.(! E(./(7FF! &1!
>78&4)-!87K&47F!.K7(!,=7!E)F,!471,0(*N!>.F,!.L!,=&F!>7,=.8.-./*!&F!F,&--!
,=7!F)>7!)F!&1!,=7!7)(-*!Ha,=!471,0(*C!!
17
c. Accuracy of mercury sphygmomanometers
:-,=.0/=! ,=7! >7(40(*! ,=7(>.>7,7(! &F! )! (7-),&K7-*! F&>E-7! 87K&47N! ,=7!
>)10)-! >7(40(*! FE=*/>.>)1.>7,7(! &F! )! >.(7! 4.>E-&4),78! E&747! .L!
7g0&E>71,C!#.`7K7(N!&L!E(.E7(-*!K)-&8),78N!4)-&'(),78!)18!>)&1,)&178N!
&,! `&--! E(.K&87! )440(),7! '-..8! E(7FF0(7! (7)8&1/FC! :440()4*! &F!
87E71871,! .1! F7K7()-! =0>)1! L)4,.(FN! F04=! )F! E(.E7(! 40LL! F&V7N! E(.E7(!
E-)47>71,! .L! ,=7! 40LL! .1! ,=7! )(>N! (74./1&,&.1! .L! 7>7(/7147! )18!
8&F)EE7)()147!.L!,=7!)(,7(&)-!F.018FN!)440(),7!(74.(8&1/!.L!,=7!F*F,.-&4!
)18!8&)F,.-&4!718!E.&1,FN!)18!,=7!E),&71,jF!-7K7-!.L!)1Q&7,*C!!
3(.E7(! >)&1,71)147! &14-087F! )! K&F0)-! &1FE74,&.1! .L! ,=7! 01&,! )18!

(7/0-)(!4)-&'(),&.1!.L!)!K)-&8),78!01&,C!:!F,08*!'*!;)(?)180!7,!)-C!\36_!
),! )! -)(/7! ,7)4=&1/! =.FE&,)-! &1! %.18.1! ,7F,78! MRY! >7(40(*!
FE=*/>.>)1.>7,7(FN! .'F7(K78! >78&4)-! E(.L7FF&.1)-F! ,)?&1/! '-..8!
E(7FF0(7! (7)8&1/F! )18! (7K&7`78! (7F0-,F! .L! )! g07F,&.11)&(7! 4.>E-7,78!
'*! ,=7! >78&4)-! F,)LLC! I`71,*2L&K7! 01&,F! `7(7! 7Q4-0878! L(.>!
7Q)>&1),&.1!)F!,=7*!=)8!>&FF&1/!4.>E.171,FC!I=7!E=*F&4)-!&1FE74,&.1!
.L! ,=7! 01&,F! L.018! .'F40(7! >7(40(*! 4.-0>1F! 807! ,.! 8&(,! .(! >7(40(*!
.Q&8),&.1! \J[v_d! F4)-7F! ,=),! =)8! L)878! .(! 4.-0>1F! ,=),! =)8! ,0(178N!
=&187(&1/! (7)8&1/F! .L! ,=7! >7(40(*! >71&F40F! \D[v_d! &14.((74,!
.(&71,),&.1! .L! ,=7! >7(40(*! 4.-0>1! &1! E.(,)'-7! 01&,F! \Hav_d! )18! K7(*!
L7`! `&,=! .'F7(K78! >7(40(*! -7)?F! \aCZv_C! +0LLF! )18! ,0'&1/! =)8! )-F.!
87,7(&.(),78!&1!>)1*!01&,FC!T)-&8),&.1!(74.(8F!`7(7!1.,!(7K&7`78!)18!
>)&1,71)147!(74.(8F!`7(7!)K)&-)'-7!L.(!.1-*!HJ!.L!MMM!01&,F!\29_C!
d. Mercury-free sphygmomanometers
I=7(7! )(7! ,`.! 4.>>.1! )-,7(1),&K7F! ,.! ,=7! >7(40(*!
FE=*/>.>)1.>7,7(]! )17(.&8! )18! .F4&--.>7,(&4! 87K&47FC! :17(.&8!
87K&47F! )(7! -&g0&82L(77! 87K&47F! ,=),! 0F7! >74=)1&4)-! E)(,F! ,.! (7-)*! ,=7!
'-..8! E(7FF0(7! ,.! ,=7! /)0/7C! I=&F! 87K&47! 0F7F! ,=7! 1.(>)-! '-..8!
E(7FF0(7! 40LL! )18! F,7,=.F4.E7! ,.! 87,7(>&17! ,=7! F*F,.-&4! )18! 8&)F,.-&4!
E(7FF0(7FC!
I=7! .F4&--.>7,(&4! 87K&47F! )(7! .E7(),78! )0,.>),&4)--*! .147! ,=7! 40LL! &F!
E-)478! .1! ,=7! 0EE7(! )(>C! S1L-),&.1! )18! 87L-),&.1! .L! ,=7! 40LL! )(7!
.',)&178!'*!7-74,(.1&4!>7)1FC!3(7FF0(72`)K7!4=)1/7F!)(7!,()1F>&,,78!
,.!,=7!.F4&--),&1/!87K&47!)18!)1!)-/.(&,=>N!.L,71!E(.E(&7,)(*N!&F!0F78!,.!
4)-40-),7!,=7!F*F,.-&4!)18!8&)F,.-&4!E(7FF0(7FN!`=&4=!)(7!8&FE-)*78!.1!)!
8&/&,)-! (7)8.0,C! b&K71! ,=7! &1)440()4*! .L! ,=7! )0F40-,),.(*! ,74=1&g07N!
K)-&8),78! )18! )LL.(8)'-7! 7-74,(.1&4! 87K&47F! ,=),! =)K7! ,=7! .E,&.1! ,.!
F7-74,! >)10)-! (7)8&1/F! )(7! E(7L7((78! .E,&.1F! L.(! -.`2(7F.0(47!!
F7,,&1/F!\37_C!!

S1! )88&,&.1N! ,=7(7! )(7! 5.EE-7(2')F78! E-7,=*F>./()E=&4! >.1&,.(FN!
E=.,.47--2')F78! >.1&,.(F! )18! F,()&12/)0/72')F78! >.1&,.(FC! I=7F7!
87K&47F!)(7!L.(!FE74&)-,*!E0(E.F7F!)18!)(7!1.,!&1!/717()-!0F7C!I=7*!`&--!
1.,! '7! 4.K7(78! &1! ,=&F! 8.40>71,N! '0,! ,=7! F)>7! /717()-! )EE(.)4=7F!
)EE-*!,.!,=7&(!&1,(.804,&.1!)F!,.!,=7!)17(.&8!)18!.F4&--.>7,(&4!87K&47FC!
e. Accuracy of mercury-free sphygmomanometers

3(.E7(-*! >)&1,)&178N! 4)-&'(),78! )18! K)-&8),78! >7(40(*2L(77!
FE=*/>.>)1.>7,7(F! `&--! E(.K&87! 4.>E)()'-7! )440()4*! ,.! 87K&47F!
4.1,)&1&1/! >7(40(*C! I=7! )440()4*! .L! ,=7F7! )-,7(1),&K7!
FE=*/>.>)1.>7,7(F! 4)1! '7! >7)F0(78! '*! ,=7! )'&-&,*! .L! ,=7! 87K&47! ,.!
F),&FL)4,.(&-*!4.>E-7,7!,=7!K)-&8),&.1!E(.,.4.-C!3(.E7(-*!4)-&'(),78!)18!
>)&1,)&178!87K&47F!.E7(),78!)44.(8&1/!,.!>)10L)4,0(7(!FE74&L&4),&.1F!
F=.0-8! '7! )'-7! >77,! ,=7! (7g0&(7>71,F! \38_C! :! F7>&2)0,.>),78! 87K&47!
,=),! =)F! '771! 87F&/178! ,.! >7)F0(7! '-..8! E(7FF0(7! &1! (7F.0(472
4.1F,()&178! F7,,&1/FN! F),&FL&7F! ,=7! 4(&,7(&)! 8()`1! 0E! '*! ,=7! ".(-8!
#7)-,=! $(/)1&V),&.1! \"#$_! )18! &F! (7)F.1)'-*! E(&478! =)F! 0187(/.17!
,74=1&4)-!)18!L&7-8!K)-&8),&.1!&1!4.--)'.(),&.1!`&,=!"#$!\11_.!
f. Calibration
+)-&'(),&.1!&F!)!4.>E)(&F.1!'7,`771!,=7!(7L7(7147!K)-07!)18!,=7!K)-07!
L(.>! ,=7! 87K&47! '7&1/! ,7F,78C! :F! E)(,! .L! &,F! /0&87-&17F! .1! ,=7!
>)1)/7>71,! .L! =*E7(,71F&.1! \39_N! ,=7! W(&,&F=! #*E7(,71F&.1! <.4&7,*!
\W#<_! =)F! E0'-&F=78! /0&87-&17F! .1! ,=7! E(.E7(! 0F7! .L! 1.12&1K)F&K7N!
F7>&2)0,.>),78!FE=*/>.>)1.>7,7(FC!I=7!E(.,.4.-F!L.(!both!>7(40(*!
)18! 1.12>7(40(*! >7)F0(&1/! 87K&47F! &14-087! E(.E7(! >)&1,71)147N!
4)-&'(),&.1!)18!K)-&8),&.1C!!
I=7! :>7(&4)1! #7)(,! :FF.4&),&.1N! &1! &,F! (74.>>718),&.1F! \40_N! 1.,7F!

,=),!)--!>)10)-!87K&47FG>7(40(*!)18!)17(.&8!FE=*/>.>)1.>7,7(FG
F=.0-8!'7!4=74?78!L.(!)440()4*!.L!,=7!E(7FF0(7!(7/&F,(),&.1!>74=)1&F>!
.1!)!(7/0-)(!')F&FC!
I=7!)17(.&8!87K&47F!F=.0-8!'7!4=74?78!'*!4.1174,&1/!,=7!>)1.>7,7(!
,.!)!>7(40(*!4.-0>1!.(!)1!7-74,(.1&4!,7F,&1/!87K&47!`&,=!)!U2,0'7C!I=7!
1778-7! F=.0-8! (7F,! ),! ,=7! V7(.! E.&1,! '7L.(7! ,=7! 40LL! &F! &1L-),78! )18!
F=.0-8!(7/&F,7(!)!(7)8&1/!,=),!&F!`&,=&1!M!>>#/!.L!,=7!>7(40(*!4.-0>1!
`=71! ,=7! 40LL! &F! &1L-),78! ,.! E(7FF0(7F! .L! Daa! )18! Haa! >>#/C! I=7!
1778-7!F=.0-8!(7,0(1!,.!V7(.!)L,7(!87L-),&.1C!!
:-,=.0/=! 1.,! &14-0878! &1! ,=7F7! (74.>>718),&.1FN! &,! F=.0-8! '7! 1.,78!
,=),! 0F&1/! )1! 7-74,(.1&4! E(7FF0(72/717(),&1/! 87K&47! L.(! 4.>E)(&F.1!
E(.K&87F!)1!)440()4*!,=),!&F!)1!.(87(!.L!>)/1&,087!'7,,7(!,=)1!,=),!.L!)!
Sphygmomanometers 19
>7(40(*!4.-0>1!807!,.!,=7!K)(&)'&-&,*!(7-),78!,.!>7(40(*!>)1.>7,(*!
\41_C!
+)-&'(),&.1!E(.4780(7F!71F0(7!,=),!,=7!01&,!&F!E7(L.(>&1/!)44.(8&1/!,.!
,=7!>)10L)4,0(7(jF!FE74&L&4),&.1FC!!
g. Validation
T)-&8),&.1! &F! )! E(.47FF! ,.! 87,7(>&17! `=7,=7(! )! >7)F0(7>71,!
,74=1.-./*! &F! )'-7! ,.! E(.8047! )1! )440(),7! K)-07! `=71! ,7F,78! .1! )!
=0>)1! E.E0-),&.1C! k.(! FE=*/>.>)1.>7,7(FN! ,=7! E(.,.4.-F! .L! ,=7!
:FF.4&),&.1! L.(! ,=7! :8K)147>71,! .L! ;78&4)-! S1F,(0>71,),&.1! \::;S_!
)18! ,=7! W#<! )(7! ,=7! >.F,! `&87-*! )447E,78N! )-,=.0/=! ,=7! P0(.E7)1!
<.4&7,*!.L!#*E7(,71F&.1!".(?&1/!b(.0E!.1!W-..8!3(7FF0(7!;.1&,.(&1/!
=)F!87K7-.E78!)1!&1,7(1),&.1)-!E(.,.4.-!,=),!&F!7)F&7(!,.!E7(L.(>!\42_C!
57K&47F!,=),!E)FF!,=7!4(&,7(&)!.L!,=7F7!E(.,.4.-F!)(7!m08/78!,.!'7!F,),7!
.L!,=7!)(,!`&,=!(7FE74,!,.!)440()4*!&1!)!4-&1&4)-!F7,,&1/C!57K&47F!=)K&1/!
E)FF78!,=7F7!E(.,.4.-F!&14-087!>7(40(*N!)17(.&8!)18!)0,.>),78!'-..8!
E(7FF0(7! 87K&47F! L.(! 4-&1&4)-! 0F7! &1! =.FE&,)-Fd! .F4&--),.(*! )0,.>),78!
'-..8! E(7FF0(7! 87K&47Fd! .F4&--),.(*! )0,.>),78! '-..8! E(7FF0(7! 87K&47F!
L.(! F7-L2>7)F0(7>71,! ),! ,=7! 0EE7(! )(>! )18! ),! ,=7! `(&F,d! )18!
)>'0-),.(*!'-..8!E(7FF0(7!>.1&,.(&1/!87K&47FC!!
I=7! W#<jF! 87K&472/()8&1/! 4(&,7(&)! \F77! I)'-7! OCD_! )(7! ')F78! .1! )!
4.>E)(&F.1! .L! '-..8! E(7FF0(7! >7)F0(78! '*! ,=7! 87K&47! '7&1/! ,7F,78!
`&,=! >7)F0(7>71,F! >)87! '*! ,()&178! .'F7(K7(F! 0F&1/! )! >7(40(*!
FE=*/>.>)1.>7,7(! )18! F,7,=.F4.E7! \43_C! I=7! /()87! &F! -&1?78! ,.! ,=7!
E7(471,)/7F! .L! (7)8&1/F! L)--&1/! `&,=&1! O!>>#/N! Da!>>#/! )18!
DO!>>#/! .L! ,=7! >7(40(*! F,)18)(8C! :--! ,=(77! E7(471,)/7F! >0F,! '7!
/(7),7(! ,=)1! .(! 7g0)-! ,.! ,=7! K)-07F! F=.`1! &1! ,=7! ,)'-7! L.(! )! FE74&L&4!
/()87! ,.! '7! )`)(878C! 57K&47F! ,=),! )4=&7K7! b()87! :! .(! W! L.(! '.,=!
F*F,.-&4! )18! 8&)F,.-&4! '-..8! E(7FF0(7! )(7! 4.1F&87(78! )447E,)'-7! L.(!
4-&1&4)-!0F7C!
Table 5.1 British Hypertension Society grading criteria

Absolute difference between standard and test device
Grade !5 mmHg !10 mmHg !15 mmHg
A 60% 85% 95%
B 50% 75% 90%
C 40% 65% 85%
D worse than C

T)-&8),&.1! E(.,.4.-F! )(7! 4.>E-7,78! '*! ,=7! >)10L)4,0(7(! .(! )1!
&187E71871,!)/714*!,.!87>.1F,(),7!4.>E-&)147!`&,=!,=7!E7(L.(>)147!
F,)18)(8FC! :F! -.1/! )F! ,=7! 01&,! &F! E(.E7(-*! 4)-&'(),78! )44.(8&1/! ,.! ,=7!
>)10L)4,0(7(jF! .E7(),&1/! &1F,(04,&.1F! )18! ,=7! 01&,! =)F! 87>.1F,(),78!
4.>E-&)147! `&,=! ,=7! E7(L.(>)147! F,)18)(8FN! ,=7! 01&,! `&--! E(.8047!
(7-&)'-7! (7F0-,FC! f7F0-,F! .L! ,=7! 7Q740,78! K)-&8),&.1! E(.,.4.-! F=.0-8! '7!
>)87!)K)&-)'-7!,.!,=7!E0(4=)F7(!)18!)1*!4)-&'(),&.1!E(.4780(7F!F=.0-8!
'7!E(.K&878!'*!,=7!>)10L)4,0(7(C!!
")1! 7,! )-C! \44_! 4.1804,78! )! (7K&7`! .L! E0'-&F=78! F,08&7F! .L! )0,.>),&4!
8&/&,)-! 87K&47FC! I=7! (7K&7`! &14-0878! DDJ! F,08&7F! L(.>! HH! 8&LL7(71,!
4.01,(&7FC! I=7! 87K&47F! =)8! '771! K)-&8),78! )/)&1F,! ),! -7)F,! .17!
(74./1&V78!E(.,.4.-]!W#<!E(.,.4.-N!DYYJd!::;S!E(.,.4.-N!HaaHd!.(!,=7!
P0(.E7)1! <.4&7,*! .L! #*E7(,71F&.1! S1,7(1),&.1)-! 3(.,.4.-! \P#<2S3_N!
HaaHC!"=71!,=7!W#<!E(.,.4.-!`)F!0F78!L.(!K)-&8),&.1N!HO!.L!JD!87K&47F!
\[Dv_! E)FF78! F),&FL)4,.(&-*d! `=71! ,=7! ::;S! E(.,.4.-! `)F! 0F78N! JZ! .L!
MD!87K&47F!\Yav_!E)FF78d!)18!`=71!,=7!P#<2S3!E(.,.4.-!`)F!0F78N!JM!
.L!JO!87K&47F!\YZv_!E)FF78C!!
S,! F=.0-8! '7! 1.,78! ,=),! ,=7! P#<2S3! E(.,.4.-! (7g0&(7F! JJ! ,7F,! F0'm74,FN!
`=7(7)F! ,=7! W#<! )18! ::;S! E(.,.4.-F! (7g0&(7! [O! F0'm74,F! \32_C! S1!
)88&,&.1! ,.! E)FF&1/! ,=7! K)-&8),&.1! E(.,.4.-N! (7/0-)(! 4)-&'(),&.1! )18!
>)&1,71)147! )(7! 1747FF)(*! ,.! 71F0(7! ,=7! )440()4*! .L! ,=7!
FE=*/>.>)1.>7,7(C!!
h. Cost considerations
I=7!4.F,F!.L!>7(40(*!)18!)17(.&8!FE=*/>.>)1.>7,7(F!)(7!7FF71,&)--*!
7g0)-N! `&,=! '.,=! 87K&47F! .L,71! '7&1/! >)10L)4,0(78! '*! ,=7! F)>7!
4.>E)1*C!$F4&--.F4.E&4N!)0,.>),&4!87K&47F!)(7!>.(7!7QE71F&K7!\45_C!!
i. Replacement of mercury-containing
sphygmomanometers
Step!1! k.--.`! F,7EF! D! ,.! J! &1! ,=7! F74,&.1! .1! >7(40(*! ,=7(>.>7,7(!
(7E-)47>71,C!
Step!2! W)F78! .1! ,=7! &1L.(>),&.1! E(.K&878! )'.K7N! 87,7(>&17! `=&4=!

,*E7! .L! FE=*/>.>)1.>7,7(! `&--! >77,! ,=7! 1778F! .L! *.0(!
L)4&-&,&7F!\F77!:117Q!H_C!
Step!3! S871,&L*! ,=7! K718.(F! ,=),! )(7! )'-7! ,.! E(.K&87! ,=7!
FE=*/>.>)1.>7,7(! .L! 4=.&47C! :F! E)(,! .L! ,=7! 01&,! F7-74,&.1!
E(.47FFN! &,! >)*! '7! 87F&()'-7! ,.! (01! )! ,(&)-! &1! ,=7! L)4&-&,*!
`=7(7! ,=7! 01&,F! `&--! '7! 7K)-0),78! ,.! 87,7(>&17! 7)F7! .L! 0F7N!
(7g0&(7>71,F! L.(! 4)-&'(),&.1! )18! >)&1,71)147! .L! ,=7! 01&,N!
)18! ,=7! ,&>7! 7F,&>),7F! 177878! ,.! &1F,)--N! 4)-&'(),7! )18!
>)&1,)&1! ,=7! 01&,F! )18! 7804),7! ,=7! F,)LLC! :L,7(! (747&K&1/!
L778')4?!L(.>!,=7!0F7(F!.L!,=7!01&,N!&871,&L*!,=7!87F&(78!,*E7!
)18!>.87-!.L!,=7!01&,C!
Mercury-free product listings

;)1*!K)-&8),&.1!E(.,.4.-F!=)K7!'771!4.>E-7,78!L.(!7Q&F,&1/!E(.804,FN!
`&,=! ,=7! (7F0-,F! E0'-&F=78! &1! ,=7! F4&71,&L&4! -&,7(),0(7C! <7K7()-!
&187E71871,! /(.0EF! =)K7! 4),)-./078! K)-&8),&.1! (7E.(,F! )18! E(.K&878!
,=7!(7F0-,F!L.(!K)(&.0F!>.87-F!&1!,)'0-)(!L.(>C!
I=7! W#<! >)&1,)&1F! )! `7'! E)/7! -&F,&1/! 87K&47F! ,=),! =)K7! E)FF78! ,=7&(!
K)-&8),&.1!,7F,FN!`&,=!E(&47F!)18!.,=7(!&1L.(>),&.1]!
=,,E]66```C'=F.4C.(/6'-..8iE(7FF0(7i-&F,CF,>C!!
I=7! 8)'-! P804),&.1)-! I(0F,! =)F! )! `7'! F&,7! ,=),! -&F,F! E(.804,F! )18! ,=7!
(7F0-,FN!.(!-)4?!.L!(7F0-,FN!L.(!)--!,=(77!K)-&8),&.1!E(.,.4.-F]!
=,,E]66```C8)'-7804),&.1)-C.(/6FE=*/>.>)1.>7,7(FC=,>-!
Step!4! 57,7(>&17! ,=7! E=)F72&1! F4=780-7! L.(! ,=7! 17`! 01&,FC!

+.1F&87(),&.1!F=.0-8!'7!/&K71!,.!,=7!,&>7!177878!,.!&1F,)--!
.(! (7E-)47! ,=7! 01&,FN! )18! 4)-&'(),&.1! .L! ,=7! 01&,FN! &L! 177878C!
57K7-.E! F,)18)(8! .E7(),&1/! E(.4780(7F! L.(! ,=7! 17`! 01&,F!
)18! )1! 7804),&.1)-! E(./()>>7! L.(! '.,=! 4-&1&4)-! 0F7(F! )18!
>)&1,71)147! E7(F.117-C! k.(! >)Q&>0>! 7LL74,&K717FFN! '.,=!
,=7! E(.4780(7F! )18! ,=7! 7804),&.1)-! E(./()>>7! F=.0-8! '7!
87K7-.E78!&1!4.1m014,&.1!`&,=!E7(F.117-!`=.!`&--!'7!0F&1/!
,=7!17`!87K&47FC!
Step!5! 57K7-.E!)!'08/7,!L.(!,=7!(7E-)47>71,!E(./()>>7N!&14-08&1/!
,=7! E0(4=)F7! .L! ,=7! 01&,FN! &1F,)--),&.1! )F! 177878N! F,)LL!
7804),&.1! .1! ,=7! 0F7! .L! ,=7! 17`! 87K&47FN! 4)-&'(),&.1! )18!
>)&1,71)147! F4=780-7FN! (7>.K)-! )18! F,.()/7! .L! ,=7!
>7(40(*24.1,)&1&1/! 01&,FN! )18! E0(4=)F7! .L! )1*! F0EE-&7F!
177878!L.(!>)&1,71)147!.1!)1!.1/.&1/!')F&FC!
Step!6! 57K7-.E! )! '&8! FE74&L&4),&.1! L.(! ,=7! E0(4=)F7! .L! ,=7!

(7E-)47>71,!01&,F!)18!&14-087!,=7!10>'7(!.L!01&,F!,=),!`&--!
'7! (7g0&(78C! <E74&L*! 4.1L.(>&,*! `&,=! ,=7! )EE(.E(&),7!
F,)18)(8N! `)(()1,*! (7g0&(7>71,F! )18! )1*! .,=7(! -.4)-!
4.1F&87(),&.1FC! k.--.`! ,=7! F,)18)(8! E(.4780(7F! L.(!
4.>E7,&,&K7! '&88&1/! .(! .,=7(! E(.40(7>71,! >7,=.8C!
+.>E)(7! ,=7! K718.(! E)4?)/7F! L.(! 4.>E-&)147! `&,=! ,=7!
)EE(.E(&),7! F,)18)(8! )18! .,=7(! FE74&L&4),&.1FC! f7g0&(7!

47(,&L&4),&.1! .(! E(..L! .L! 4.>E-&)147! `&,=! ,=7! F,)18)(8N!
7FE74&)--*! L(.>! 17`! K718.(F! .(! K718.(F! 1.,! -&F,78! &1!
1),&.1)-!.(!&1,7(1),&.1)-!47(,&L&78!E(.804,!-&F,&1/FC!+.1F&87(!
,=7!)'&-&,*!.L!,=7!K718.(!,.!E(.K&87!,=7!(7g0&(78!10>'7(!.L!
01&,F! &1! )! ,&>7-*! L)F=&.1! F.! )F! ,.! L&,! ,=7! E=)F72&1! F4=780-7C!
<7-74,!,=7!K718.(!L.(!,=7!E(.m74,C!
Step!7! f7K&7`! ,=7! F7-74,78! K718.(jF! (7g0&(7>71,F! L.(! 4)-&'(),&.1!

)18!>)&1,71)147!.L!,=7!FE=*/>.>)1.>7,7(N!)18!.',)&1!)1*!
177878!7g0&E>71,C!57,7(>&17!`=.!`&--!'7!)FF&/178!,=7!,)F?!
.L!4.1804,&1/!,=7!(7g0&(78!4)-&'(),&.1!)18!>)&1,71)147N!)18!
.1! `=),! F4=780-7C! <.-&4&,! ,=7! K718.(jF! )&8! &1! E-)11&1/! L.(!
7804),&.1!)18!4.1,&10&1/!7804),&.1N!&L!1747FF)(*C!
Step!8! 3(7E)(7! ,=7! &1,7(&>! F,.()/7! F&,7! L.(! E=)F782.0,! >7(40(*!

>7)F0(&1/! 87K&47FC! SL! )EE(.K78! >7(40(*28&FE.F)-! L)4&-&,&7F!
)(7!)K)&-)'-7!&1!,=7!4.01,(*N!&871,&L*!,=7!`)F,7!K718.(!`=.!
`&--! '7! (7FE.1F&'-7! L.(! 8&FE.F)-! .L! ,=7! >7(40(*24.1,)&1&1/!
01&,F!)18!87K7-.E!E(.4780(7F!,=),!`&--!'7!L.--.`78!L.(!,=7&(!
(7>.K)-!)18!,()1FL7(C!
Step!9! 30(4=)F7!,=7!01&,F!)44.(8&1/!,.!,=7!E=)F72&1!F4=780-7C!
Step!10! 37(L.(>! )1*! &1&,&)-! ,7F,F! .(! 4)-&'(),&.1! )F! E7(! ,=7!
>)10L)4,0(7(jF!FE74&L&4),&.1FC!:1!7-74,(.1&4!E(7FF0(7!/)0/7!
F=.0-8!'7!)K)&-)'-7!L.(!4)-&'(),&.1!E0(E.F7FC!
Step!11! +.1804,!,=7!E-)1178!F,)LL!7804),&.1)-!)4,&K&,*!(7-),78!,.!,=7!
.E7(),&.1! )18! >)&1,71)147! .L! ,=7! 17`! 87K&47FC! f7g07F,!
K718.(!)FF&F,)147!)18!E)(,&4&E),&.1!&1!,=&F!E(.47FFC!
Step!12! 5&F,(&'0,7! .(! &1F,)--! 17`! 87K&47F! &1! 7Q4=)1/7! L.(! .-8!
>7(40(*! FE=*/>.>)1.>7,7(FC! f7>.K7! )18! ,()1FL7(! ,=7!
>7(40(*24.1,)&1&1/!01&,F!,.!)!87F&/1),78!F,.()/7!)(7)C!SL!,=7!
4.01,(*!=)F! )EE(.K78!>7(40(*28&FE.F)-!L)4&-&,&7FN!,()1FE.(,!
)18!8&FE.F7!.L!,=7!>7(40(*24.1,)&1&1/!01&,F!),!)1!)EE(.K78!
8&FE.F)-!F&,7!)44.(8&1/!,.!-.4)-!=)V)(8.0F!`)F,7!(7/0-),&.1FC!
Step!13! ;.1&,.(! )18! 71F0(7! ,=),! ,=7! 1.12>7(40(*!

FE=*/>.>)1.>7,7(F! )(7! E(.E7(-*! 0F78! )18! >)&1,)&178N!
)18!,=),!)1*!`)F,7N!&14-08&1/!7182.L2-&L7!`)F,7N!&F!>)1)/78!
&1!)1!71K&(.1>71,)--*!F.018!>)117(C!
VI. Conclusion
:-,7(1),&K7F! ,.! >7(40(*24.1,)&1&1/! ,=7(>.>7,7(F! )18! FE=*/>.2!

>)1.>7,7(F! )(7! )K)&-)'-7N! )18! )(7! )440(),7! )18! E()4,&4)-! &1! 4-&1&4)-!
F7,,&1/FC! I=7F7! )-,7(1),&K7F! F=.0-8! '7! 4.1F&87(78! `=71! (7E-)4&1/! .(!
E=)F&1/! .0,! >7(40(*! 01&,F! &1! =7)-,=24)(7! F7,,&1/FC! I=7! 7-&>&1),&.1! .L!
>7(40(*N!)!E.,71,!170(.,.Q&1N!L(.>!,=7F7!87K&47F!E(.,74,F!=7)-,=24)(7!
E(.K&87(F!)18!,=7&(!4.>>01&,&7FC!S1!,=&F!`)*N!&,!E(.>.,7F!/..8!=7)-,=!
L.(! E),&71,F! )F! `7--C! I=&F! /0&87! E(.K&87F! )! F,7E2'*2F,7E! )EE(.)4=! ,.!
E=)F&1/! .0,! >7(40(*! ,=7(>.>7,7(F! )18! FE=*/>.>)1.>7,7(FC! S,!
7>E=)F&V7F! ,=7! )K)&-)'&-&,*! )18! 4.F,! 4.1F&87(),&.1F! .L! )-,7(1),&K7!
7g0&E>71,N!)18!,=7&(!4.1L.(>&,*!`&,=!7Q&F,&1/!&1,7(1),&.1)-!.(!1),&.1)-!
F,)18)(8F!`&,=!,=7!0187(F,)18&1/!,=),!,=7*!>0F,!'7!E(.E7(-*!K)-&8),78!
'*!,=7!>)10L)4,0(7(!)18!4)-&'(),78!'*!,=7!0F7(C!SL!,=&F!&F!?7E,!&1!>&18!
)18! &L! (7E-)47>71,! 7g0&E>71,! &F! E=)F782&1! )F! F0//7F,78! &1! ,=&F!
8.40>71,N! ,=7! 17`! 87K&47F! `&--! E(.K&87! 7g0&K)-71,! )440()4*! )18!
4.>E)()'-7!4-&1&4)-!0,&-&,*C!
25
Annex 1
Table A1.1 Requirements for digital thermometers

n7*!E)()>7,7(F!&1!P0(.E7)1!F,)18)(8!PX!DHMZa2J]Haaac:D]HaaY]!
Parameter Summary of the specification Test procedure

Maximum 0.1 °C Measuring Method in 7.3 of
permissible error temperature range: EN 12470-3:2000
over the specified 35.5–42.0 °C
temperature range Ambient temperature
range: 18–28 °C
0.2 °C Outside the above
measuring range or
ambient temperature
range
Minimum measuring 35.5–40.0 °C Method in 7.2 of
range EN 12470-3:2000
Resolution (digital 0.1 °C or less Visual inspection
increment)
Ambient temperature 10–35 °C Method in 7.7 of
operating range EN 12470-3:2000
Note: If the digital thermometer uses a single-use protective probe cover, the thermometer together with the
probe cover must meet the above requirements.
27
Table A1.1 Requirements for digital thermometers continued
n7*!E)()>7,7(F!&1!:<I;!PDDDH2aa!\(7)EE(.K78!HaaR_]!

Maximum ±0.3 °C Measuring temperature Method in 5.4 of ASTM
permissible error range: <35.8 °C E1112-00
over the specified Ambient temperature
temperature range range: see below
±0.2 °C Measuring temperature
range: 35.8–<37 °C
Ambient temperature
range: see below
range: 37–39 °C
Ambient temperature
range: see below
range: >39–41 °C
Ambient temperature
range: see below
range: >41 °C
Ambient temperature
range: see below
Precision and bias Test results should have an expanded See 5.6 in ASTM E1112-00
uncertainty (k = 3) not exceeding
0.045 °C
Measuring range 35.5–41.0 °C (Digital display)
Resolution (digital <0.1 °C (Digital display)
increment)
Ambient temperature 16–40 °C at a relative humidity of Method in 5.5.1 of
operating range 15–95% (non-condensing) ASTM E1112-00
!

$,=7(!&>E.(,)1,!/717()-! E)()>7,7(F!&1!,=7!PX! )18! :<I;!F,)18)(8Fd! (7-7K)1,!
F74,&.1F!&1!,=7!(7FE74,&K7!F,)18)(8F!)(7!(7L7(71478!&1!'()4?7,F!A!B]!
Summary of the
Summary of the specification in specification in
Parameter EN 12470-3:2000 ASTM E1112-00
Warning when The device should give a visual or n/a
out of range auditory warning when the measured
temperature is not within the specified
measuring range [see sections 6.2.1 and
7.2]
Time response 60 seconds under specified conditions n/a
[see sections 6.2.4 and 7.4]
Effect of storage The device should meet the EN accuracy The device should meet the
requirement after being stored in its ASTM accuracy requirement
unopened primary package at five after being stored and/or
different temperatures for 24 hours each transported in an environment
in sequence [see sections 6.3.2 and 7.8] of –20 °C to 50 °C and a
relative humidity of 15–95%
non-condensing for one
month [see test method in
section 5.5.2]
Long-term The device should meet the EN accuracy n/a
stability requirement after exposure to either
55 °C or 80 °C for a specified number of
days [see section 6.2.6]
Readability Numerals should appear at least 4 mm Numerals should appear at
high [see section 6.4.1.2] least 2.5 mm high and
1.5 mm wide, with at least
0.7 mm in between [see
section 4.4.2.2]
Ability to The device should meet the EN accuracy n/a
withstand thermal requirement after being exposed to five
shock cycles of 0 °C and 55 °C for an hour
each [see sections 6.3.3 and 7.9]
Effect of humidity The device should meet the EN accuracy The device should meet the
requirement after being exposed to a ASTM accuracy requirement
temperature of 45 °C and a relative after being exposed to at
humidity of 85% for 48 hours [see least four test conditions
sections 6.3.4 and 7.10] involving two temperatures
and four relative humidities
[see section 5.5.1]
Annex 1 29
Summary of the
Summary of the specification in specification in ASTM
Parameter EN 12470-3:2000 E1112-00
Resistance to The device should meet the EN accuracy The instruction manual
mechanical shock requirement after being dropped onto a should inform the user if
hard surface from a height of 1 metre [see the performance is
sections 6.3.6 and 7.11] degraded by
mechanical shock such
as from a drop test; the
device should withstand
dropping without
presenting an electrical
hazard [see sections
4.3.3.3 and 4.6.2.1]
Water resistance The device should meet the EN accuracy n/a
requirement after being immersed in water
for 30 minutes [see sections 6.3.7 and 7.12]
Maximum energy The energy dissipated by the probe should n/a
dissipation not cause a temperature rise in the
indicated temperature of more than 0.01 °C
[see sections 6.2.5 and 7.5]
n/a, not available,
Note: See the list of available features of digital thermometers, below.

S>E.(,)1,!E)()>7,7(F!(7-),78!,.!F)L7,*!&1!,=7!PX!.(!:<I;!F,)18)(8Fd!(7-7K)1,!
F74,&.1F!&1!,=7!(7FE74,&K7!F,)18)(8F!)(7!(7L7(71478!&1!'()4?7,F!A!B]!
Summary of the specification in Summary of the specification

Parameter EN 12470-3:2000 in ASTM E1112-00
Electrical safety The device should comply with EN The device and its accessories
60601-1 (28) [see section 6.5] (such as battery chargers)
should meet general electrical
safety requirements found in UL
544 (29) [see section 4.6.1]
Electromagnetic The device should conform to EN n/a
compatibility 60601-1-2 (27) [see section 6.3.5]
Voltage limit The device should provide a visual n/a
indication or auditory warning when the
supply voltage is not within
specified limits [see section 6.4.1.1]
Battery condition n/a The accuracy and condition of
the device should not be
affected by the battery condition
unless a continuous automatic
indication of unreliable condition
is provided [see section 4.5]
Mechanical safety The device should not have sharp n/a
ends or angles, and the probe
should be smoothly rounded to
prevent injuries to the user or
patient [see section 6.6]
Material of The device should be free from The case and any non-
construction biological hazards disposable accessories should
[see section 6.4.2] withstand biological and
physical cleaning without
degrading performance; the
parts of the device intended for
contact with the patient should
be non-toxic [see section 4.6.2
and test methods in sections
5.2 and 5.3]
Functional safe test The device should have a self- n/a
testing routine [see section 4.4.1.3]
n/a, not available.
Note: See the list of available features of digital thermometers, below.
Annex 1 31
3)()>7,7(F! (7-),78! ,.! >)(?&1/! )18! 8.40>71,),&.1! &1! ,=7! PX! .(! :<I;!
F,)18)(8Fd! (7-7K)1,! F74,&.1F! &1! ,=7! (7FE74,&K7! F,)18)(8F! )(7! (7L7(71478! &1!
'()4?7,F!A!B]!
Summary of the
Summary of the specification in specification in
Parameter EN 12470-3:2000 ASTM E1112-00
Marking Information from the manufacturer should Identification markings
comply with EN 1041 (30); marking should should not deteriorate
include the symbol “C” adjacent to the when the device is
numerals, the body site (if applicable), etc. cleaned [see cleaning
[see sections 8.1 and 8.2] test in section 5.2];
markings should include
model, serial or lot
number, temperature
scale, etc. [see
section 4.7]
Instructions for use The information in the instructions should Instructions should
include environmental conditions of use, include operation, care
storage and transport; cleaning and and use, biological and
disinfection; selection, replacement and physical cleaning,
disposal of batteries, if applicable; probe service and repair if
cover use, if applicable; measuring time; permitted, determination
maintenance and calibration; etc. [see of accuracy,
section 8.3] recalibration, detailed
specifications, etc. [see
sections 4.3.3, 4.7 and
4.8]
Identification Compliance with EN 1041 and EN 980 (31) “Conforms to ASTM
[see section 8.1] E1112 (name and
address of producer or
distributor)” [see section
4.7.6.1 for the full
statement of
identification]

X.,7!,=),!,=7!)'.K7!FE74&L&4),&.1F!8.!1.,!)EE-*!,.!FE74&)-&V78!,7>E7(),0(72
>7)F0(&1/! 87K&47FN! F04=! )F! E0->.1)(*! )(,7(*! 4),=7,7(F! )18! ,7>E7(),0(7!
E(.'7F!L.(!=*E.,=7(>&4!E),&71,FC!W)F)-!,7>E7(),0(7!,=7(>.>7,7(F!(7g0&(7!
=&/=7(!)440()4*N!,*E&4)--*!aCaO!q+N!,=)1!,=7!F,)18)(8!L7K7(!,=7(>.>7,7(C!!
PX! DHMZa2J]Haaa! (7g0&(7F! ,=),! 7)4=! &18&K&80)-! -.,! F=)--! '7! F0'm74,78! ,.!
&18&K&80)-! .(! F,),&F,&4)-! ,7F,&1/N! )F! 7QE-)&178! &1! F74,&.1! ZCDCD! )18! &1!
S<$!H[OY2H]DY[O! \32_C! :<I;! S1,7(1),&.1)-! =)F! )1! )88&,&.1)-! F,)18)(8!
FE74&L&4),&.1N! :<I;! PDDaM2Y[! \33_N! L.(! 4-&1&4)-! ,=7(>.>7,7(! E(.'7! 4.K7(F!
)18!F=7),=FC!!
Available features of digital thermometers

I=7!L.--.`&1/!FE74&L&4),&.1FN!1.,!(7g0&(78!'*!,=7!P0(.E7)1!X.(>!1.(!'*!,=7!
:<I;! F,)18)(8N! E7(,)&1! ,.! L7),0(7F! )K)&-)'-7! L(.>! 8&LL7(71,! F0EE-&7(F! ,=),!
>)*!'7!)8878!)44.(8&1/!,.!,=7!1778F!)18!87F&(7F!.L!,=7!=7)-,=24)(7!L)4&-&,*C!
<.>7!.L!,=7F7!.E,&.1)-!L7),0(7F!>)*!71,)&-!)88&,&.1)-!4.F,FC!I=7*!)(7]!
w ()E&8!(7FE.1F7!,&>7!\7C/C!Da!F74.18F!.(!-7FF_d!
w 7Q,()2-)(/7!8&FE-)*!.(!8&FE-)*!`&,=!>)/1&L*&1/!-71Fd!
w )08&'-7!)-)(>!`=71!,=7!E7)?!,7>E7(),0(7!&F!(7)4=78d!
w 8&FE-)*!.L!F7-L24=74?!(7F0-,F!80(&1/!F,)(,20Ed!
w >7>.(*! L014,&.1! ,=),! F,.(7F! ,=7! -)F,! ,7>E7(),0(7! (7)8&1/! .(! >)1*!
,7>E7(),0(7!(7)8&1/Fd!
w )0,.>),&4!F=0,2.LLd!
w >7(40(*2L(77!.(!o1.!)8878!>7(40(*p!'),,7(*!\34_d!
w -.1/!'),,7(*!-&L7d!L.(!7Q)>E-7N!Maaa!,7>E7(),0(7!(7)8&1/F!.(!Jaa!=.0(Fd!
w 7)F&-*!(7E-)47)'-7!.(!(74=)(/7)'-7!'),,7(*d!
w &L!F.-)(!E.`7(78N!0E!,.!ZH!=.0(F!E7(!F.-)(!4=)(/7d!
w L-7Q&'-7!E(.'7!,&Ed!
w 80)-!F4)-7!\'.,=!q+!)18!qk_d!
w F,)18)(8!8&FE.F)'-7!F,7(&-7!E(.'7!4.K7(Fd!
w >7,=.8!.L!(7>.K)-!.L!E(.'7!4.K7(F]!>)10)-!.(!7m74,!'0,,.1d!
w 40F,.>&V78!4.-.0(F!,.!8&F,&1/0&F=!'7,`771!.()-N!(74,)-!)18!)Q&--)(*!0F7d!
w (7F&F,)147!,.!FE74&L&4!8&F&1L74,)1,F!)18!4-7)17(F!0F78!&1!,=7!=7)-,=24)(7!
L)4&-&,*d!
w >&1&>)-!E)4?)/&1/!`)F,7d!
w ),!-7)F,!.17!*7)(!`)(()1,*d!
Annex 1 33
w E(..L!.L!47(,&L&4),&.1!.L!4.1L.(>&,*!,.!&1,7(1),&.1)-!F,)18)(8FN!&14-08&1/!
PX! DHMZa2J]Haaa! .(! :<I;! PDDDHd! SP+6PX! RaRaD! .(! l%! RaRaDd!
PX!DaMD!)18!PX!Y[ad!:I<;!PDDaMN!&L!)EE-&4)'-7d!
w S<$! YaaD! \g0)-&,*! >)1)/7>71,_! 47(,&L&4),&.1! .L! ,=7! >)10L)4,0(&1/!
L)4&-&,*d!
w S<$! DJM[O! .(! S<$! DJM[[! \>78&4)-! 87K&47! g0)-&,*! >)1)/7>71,_!
47(,&L&4),&.1!.L!,=7!>78&4)-!87K&47!>)10L)4,0(7(d!
w S<$! DMaaa! \71K&(.1>71,)-! >)1)/7>71,_! 47(,&L&4),&.1! .L! ,=7!
>)10L)4,0(7C!

Table A1.2 Requirements for phase-change thermometers
<0>>)(*!.L!(7g0&(7>71,F!&1!:<I;!P[HO2Y[!\24_]!
Parameter Summary of the specification Section

Maximum error ±0.3 °C <35.8 °C 5.3 (see test method in 6.2.1)
over the specified ±0.2 °C 35.8–36.9 °C
temperature ±0.1 °C 37.0–39.0 °C
range
±0.2 °C 39.1–41.0 °C
±0.3 °C >41.0 °C
Minimum 35–40.4 °C unless otherwise labelled 5.2
measuring range
Measurement !1 minute 5.4 (see test method in 6.2.4)
retention
Resolution "0.1 °C 5.6
(graduation)
Operating The device should meet the ASTM accuracy 5.5 (see test method in 6.3)
environment requirement in the range of 18–33 °C unless
otherwise marked
Workmanship No constructional defects to prevent meeting 5.7
the ASTM accuracy requirement
Stability All requirements should be met over the shelf 5.8
life; if the shelf life is less than 5 years, the
expiration date should be displayed
Storage The device should meet the ASTM accuracy 5.9 (see test method in 6.4)
environment requirement after storage for 1 day at
temperatures from –18 °C to 38 °C and
relative humidities from 15% to 90%, and for
1 month at temperatures from 15.5 °C to
32 °C and relative humidities from 30% to
75%
Marking and Markings should include the name and/or 5.10
labelling trademark of the manufacturer or distributor,
serial number or code to indicate
manufacturing lot, etc.; operating instructions
should be provided
Toxicity Parts intended for contact and chemicals 5.11 (see test method in 6.5)
should be non-toxic
Precision and bias Test results should have an expanded 6.6
uncertainty (k = 3) not exceeding 0.045 °C
Identification “Conforms to ASTM E825 (name and 7
address of producer or distributor)”—see
section 7 for the full statement of
identification
Annex 1 35
Table A1.3 Requirements for tympanic infrared thermometers
n7*!E)()>7,7(F!&1!P0(.E7)1!F,)18)(8!PX!DHMZa2O]HaaJ!\25_]!

Maximum ±0.2 °C Measuring temperature Method in 7.4 and 7.5 of
permissible error range: 35.5–42.0 °C EN 12470-5:2003
over the specified Ambient temperature
temperature range: 18–28 °C
range ±0.3 °C Outside the above
measuring range or
ambient temperature
range
Minimum 35.5–40.0 °C Method in 7.3 of EN 12470-
measuring range 5:2003
Maximum ±0.3 °C for every patient age group Method in 7.7 of EN 12470-
permissible (newborn, children, adults) for which the 5:2003
clinical infrared ear thermometer is intended for use
repeatability
Resolution 0.1 °C or less Visual inspection
(digital
increment)
Ambient 16–35 °C Method in 7.4 of EN 12470-
temperature 5:2003
operating range
Note: If the infrared ear thermometer uses a protective probe cover, the thermometer together with the probe cover
must meet the requirements above. If the probe cover is intended for multiple use, the above requirements must be
met after the probe cover has been cleaned, disinfected and/or sterilized according to the manufacturer’s
specifications.

Table A1.3 Requirements for tympanic infrared thermometers continued
n7*!(7g0&(7>71,F!&1!:<I;!PD[RO2Y[!\(7)EE(.K78!HaaY_!\26_]!

Maximum 0.3 °C <36 °C 5.3
permissible 0.2 °C 36–39 °C (see test method in 6.1.4)
laboratory error 0.3 °C >39 °C
for given black-
body temperature
range
Minimum 34.4–42.2 °C unless otherwise labelled 5.2
measuring range
Clinical accuracy To be determined and disclosed upon 5.5.1
request for each device model, adjustable (see also 6.2)
display mode and age group intended for use
Display 0.1 °C 5.8.1
resolution
Operating The device should meet the laboratory error 5.6.1.1
temperature requirement operating in the range of 16–
40°C unless otherwise marked
Operating Up to 95% for the specified operating 5.7
humidity range temperature range
Annex 1 37
Table A1.4 Requirements for temporal artery infrared thermometers
n7*!(7g0&(7>71,F!&1!:<I;!PD[RO2Y[!\(7)EE(.K78!HaaY_!\26_]

Maximum 0.3 °C 5.4
permissible (see test method in 6.1.5)
laboratory error
for given black-
body temperature
range
Minimum 22–40.0 °C 5.2
measuring range
Display 0.1 °C 5.8.1
resolution
Operating The device should meet the laboratory error 5.6.1.1
temperature requirement operating in the range of 16–
40 °C unless otherwise marked
Operating Up to 95% for the specified operating 5.7
humidity range temperature range

Annex 2
Table A2.1 Requirements for aneroid sphygmomanometers

X.12)0,.>),78! 1.12&1K)F&K7! FE=*/>.>)1.>7,7(F! 0F&1/! )1! )17(.&8!
>)1.>7,7(! F=.0-8! >77,! ,=7! (7g0&(7>71,F! .L! :X<S6::;S6S<$! [DaRa2D]HaaZ!
\47_C!!

Identification and marking
Unit of mmHg or kPa 4.1
measurement
Legibility of Should be clearly legible; see compliance test 4.2
markings
Durability of Should be sufficiently durable to remain clearly legible during 4.3
markings the expected service life; see compliance test
Marking Should include the name or trademark and address of 4.4
manufacturer, model, serial or batch number if appropriate,
proper disposal, etc.
Usability of reading Should have an indication when the reading error due to 4.5
parallax exceeds ±2 mmHg (0.3 kPa)
Cuff marking Should indicate the correct positioning and appropriate limb 4.6
circumference
Marking on the Should include contents; special storage or handling, if any; 4.7
packaging intended use of the cuff; and appropriate symbols or label for
equipment or components that are sterile, have an expiration
date, or are for single use
General requirements
Test requirements (Type tests, samples, environmental conditions, etc.) 5
Electrical safety Compliance with IEC 60601-1 if electricity is used 6.2
Mechanical safety Should avoid rough surfaces, sharp corners and edges that 6.3
could cause injury or damage
Mechanical Should function properly after falling 25 cm (or 1 m for 6.4.1
strength “shock-resistant” sphygmomanometers), except for stationary
devices; see compliance test
Should function properly after shock and vibration; see 6.4.2
compliance tests
39
Table A2.1 Requirements for aneroid sphygmomanometers continued
Accuracy and other key requirements
Maximum error for " ±3 mmHg (±0.4 kPa) for the following conditions: 7.1.1
the cuff pressure temperature range of 15–25 °C, relative humidity range of
measurement over 15–85% (non-condensing) and decreasing pressure; see
the nominal range compliance test
" ±3 mmHg (±0.4 kPa) or 2%, whichever is greater, for the
following conditions: temperature range of 10–40 °C, relative
humidity range of 15–85% (non-condensing) and decreasing
pressure; see compliance test
Nominal range and 0 mmHg (0 kPa) to at least 260 mmHg (35 kPa) 7.1.2
measuring range
Air leakage Should not cause a pressure drop that exceeds 4 mmHg/min 7.2.1
(0.5 kPa/min); see compliance test
Pressure reduction Should be adjustable to a deflation rate of 2 mmHg/s 7.2.2
rate (0.3 kPa/s) to 3 mmHg/s (0.4 kPa/s); see compliance test
Rapid exhaust Should not exceed 10 seconds from 260 mmHg (35 kPa) to 7.2.3
15 mmHg (2 kPa); see compliance test
Dimensions of cuff Dimensions based on the limb circumference at the midpoint 7.2.4
of the intended range of the cuff
Cuff, bladder and Should be able to withstand the maximum pressure; should 7.2.5
tubing connectors have a means to prevent accidental disconnection; see and
compliance tests 7.2.6
Tamper proofing or Should prevent tampering with, or unauthorized access to, 7.3
unauthorized adjustments and functions that affect accuracy
access
Dynamic response <1.5 seconds in cuff pressure indication for a specified drop 7.4
in pressure; see compliance test
Additional requirements
Scale mark and Requirements for a tolerance zone and movement of the 9.1 and 9.2
zero elastic sensing element
Hysteresis error <4 mmHg (0.5 kPa) throughout the pressure range; see 9.3
compliance test
Construction and Not more than 3 mmHg (0.4 kPa) difference in pressure 9.4
materials indication after 10 000 full-scale cycles; see compliance
test
Cleaning, Reusable parts that come in contact with the patient 10
sterilization, should be capable of being cleaned, and disinfected or
disinfection sterilized

Table A2.1 Requirements for aneroid sphygmomanometers continued
Additional requirements continued
Information Should include identification; instructions for use; 12
supplied by the instructions for cleaning, and sterilization or disinfection;
manufacturer instructions for routine maintenance, as well as
inspection and preventive maintenance by service
personnel; instructions for end-of-life disposal; and
technical description
Annex 2 41
Table A2.2 Requirements for automated sphygmomanometers
:0,.>),78! 1.12&1K)F&K7! \>78&4)-! 7-74,(&4)-_! FE=*/>.>)1.>7,7(F! F=.0-8!
>77,! ,=7! (7g0&(7>71,F! .L! :X<S6::;S6S<$! [DaRa2H]HaaY! \47_! )18!
:X<S6::;S6P+![aRaD2H2Ja]HaaY!\48_C!!

Essential requirements
Maximum error for the " ±3 mmHg (±0.4 kPa) or 2% of the reading, 201.12.1.102
measurement of the whichever is greater
cuff pressure over the
nominal measurement
range
Nominal blood Diastolic blood pressure: at least 20 mmHg 201.12.1.103
pressure indication (2.7 kPa) to 60 mmHg (8.0 kPa) in neonatal mode (see
range and 40 mmHg (5.3 kPa) to 130 mmHg (17.3 kPa) compliance
otherwise test)
Systolic blood pressure: at least 40 mmHg
(5.3 kPa) to 110 mmHg (14.7 kPa) in neonatal
mode and 60 mmHg (8.0 kPa) to 230 mmHg
(30.7 kPa) otherwise
Maximum pressure in <150 mmHg (20 kPa) in neonatal mode and 201.12.1.104
normal condition <300 mmHg (40 kPa) otherwise
Maximum pressure in Should not exceed +10 % of the maximum rated 201.12.1.105
single fault condition pressure for more than 3 seconds; see
201.12.1.105 for the requirements of the protection
device to prevent this
Manometer test mode The device should have a test mode that can be 201.12.1.106
used to verify calibration
Laboratory limits of the Less than 3 mmHg (0.4 kPa); see compliance test 201.12.1.107
change in error of the
blood pressure
determination
Alarm systems See 201.12.3.101 201.12.3
Various other requirements
General requirements Requirements include performing risk 201.4
management, expected service life, equipment
safety, etc., as detailed in section 4 of IEC 60601-
1:2005 or ANSI/AAMI ES60601-1:2005 (28)
Requirements for Requirements for type testing, sampling, 201.5
testing environmental and other conditions, test sequence,
etc., as detailed in section 5 of IEC 60601-1:2005
or ANSI/AAMI ES60601-1:2005

Table A2.2 Requirements for automated sphygmomanometers continued
Various other requirements continued
Classification Requirements pertain to protection against electric 201.6
shock, protection against entry of water or dust,
etc., as detailed in section 6 of IEC 60601-1:2005
or ANSI/AAMI ES60601-1:2005
Identification and Requirements involve legibility and durability of 201.7
markings markings, markings on the outside and inside of the
equipment or parts, abbreviations, marking of
controls, markings for different uses (e.g. neonatal),
warning and safety notices, etc., as detailed in
section 201 and section 7 of IEC 60601-1:2005 or
ANSI/AAMI ES60601-1:2005
Protection from Requirements to protect against electrical and 201.8, 201.9,
hazards and fault mechanical hazards of the device, excessive 201.10,
conditions temperatures, interruption of power supply, etc., as 201.11
detailed in sections 201.8 to 201.11, section
201.13, and sections 8 to 11 and 13 of IEC 60601-
1:2005 or ANSI/AAMI ES60601-1:2005
Programmable devices Requirements related to programmable electrical 201.14
devices, as detailed in section 14 of IEC 60601-
1:2005 or ANSI/AAMI ES60601-1:2005
Construction Requirements related to serviceability, mechanical 201.15
strength, shock and vibration, etc., including
compliance tests, as detailed in section 201.15 and
section 15 of IEC 60601-1:2005 or ANSI/AAMI
ES60601-1:2005
Requirements for Various other requirements dealing with power 201.16
electrical systems supply, enclosure, leakage current, etc., as detailed
in section 16 of IEC 60601-1:2005 or ANSI/AAMI
ES60601-1:2005
Electromagnetic Requirements involve a risk management process, 201.17, 202,
compatibility detailed in section 17 of IEC 60601-1:2005 or and IEC
ANSI/AAMI ES60601-1:2005; should conform to 60601-1-2
IEC 60601-1-2 (27); test method in section 202
Cuff, tubing, cuff Requirements involving construction and 201.101 and
connectors pressurization 201.102
Unauthorized access Should prevent tampering with, or unauthorized 201.103
access to, controls that affect accuracy
Maximum inflating time Requirements related to a pressure-relief protection 201.104
device
Automatic cycling Requirements related to a protection device for 201.105
modes long-term and short-term automatic mode, if
applicable
Annex 2 43
Table A2.3 Summary of requirements in ANSI/AAMI/ISO 81060-2:2009 (47)
Validation studies
General requirements Automated sphygmomanometers should be clinically 4
validated using either a non-invasive (auscultatory)
reference sphygmomanometer or a reference
invasive blood pressure monitoring equipment in
each mode of operation
Validation with an Minimum of 85 subjects with three valid blood 5
auscultatory reference pressure determinations for each (see details about
sphygmomanometer the study procedure and data analysis in section 5)
Validation with See study procedure and data analysis in section 6; 6
reference invasive clinical validation studies should comply with ISO
blood pressure 14155 (49); validation with reference invasive blood
monitoring equipment pressure monitoring equipment should not be used
for patients or subjects solely for the purpose of
validating sphygmomanometer performance
Validation for pregnant A sphygmomanometer for use in pregnant, including 7
patients pre-eclamptic, patients should be clinically evaluated
in that patient population

References
DC! Mercury! in! health! care:! policy! paperC! b717K)N! ".(-8! #7)-,=! $(/)1&V),&.1!
\=,,E]66```C`=.C&1,6`),7(iF)1&,),&.1i=7)-,=6>78&4)-`)F,76>7(40(*671
6N!)447FF78!5747>'7(!HaDa_C!
HC! 3)(),&!b!7,!)-C!f74.>>718),&.1F!L.(!'-..8!E(7FF0(7!>7)F0(&1/!87K&47F!L.(!
.LL&4764-&1&4! 0F7! &1! -.`! (7F.0(47! F7,,&1/C! Blood! Pressure! MonitoringN! HaaON!
Da]JhDaC!
JC! 3)(),&! b! 7,! )-C! :! 17`! F.-)(2E.`7(78! '-..8! E(7FF0(7! >7)F0(&1/! 87K&47! L.(!
-.`2(7F.0(47!F7,,&1/FC!HypertensionN!HaDaN!OR\R_]DaMZhDaOJC!
MC! n)(-&17(! 9C! Toward! the! tipping! point:! WHO–HCWH! global! initiative! to!
substitute!mercury"based!medical!devices!in!health!care,!a!two"year!progress!
reportC! ".(-8! #7)-,=! $(/)1&V),&.1! )18! #7)-,=! +)(7! "&,=.0,! #)(>N! &1!
)FF.4&),&.1! `&,=! ,=7! l1&,78! X),&.1F! 57K7-.E>71,! 3(./()>>7! b-.')-!
P1K&(.1>71,! k)4&-&,*! b-.')-! #7)-,=! +)(7! ")F,7! 3(.m74,N! HaDa!
\=,,E]66```C>7(40(*L(77=7)-,=4)(7C.(/66I.`)(8i,=7iI&EE&1/i3.&1,CE8L_C!
OC! I=7! /-.')-! &1&,&),&K7N! )! 4.--)'.(),&.1! `&,=! #7)-,=! +)(7! "&,=.0,! #)(>N! &F! )!
4.>E.171,! .L! ,=7! l1&,78! X),&.1F! P1K&(.1>71,! 3(./()>>7! ;7(40(*!
3(.804,F! 3)(,17(F=&EN! -78! '*! ,=7! l1&,78! <,),7F! P1K&(.1>71,)-! 3(.,74,&.1!
:/714*!\=,,E]66```C>7(40(*L(77=7)-,=4)(7C.(/_C!
RC! Mercury—basic! informationC! l1&,78! <,),7F! P1K&(.1>71,)-! 3(.,74,&.1!
:/714*! \=,,E]66```C7E)C/.K6>7(40(*6)'.0,C=,>N! )447FF78! 5747>'7(!
HaDa_C!
ZC! Mercury! emissions—the! global! contextC! l1&,78! <,),7F! P1K&(.1>71,)-!
3(.,74,&.1!:/714*!
! \=,,E]66```C7E)C/.K6>7(40(*64.1,(.-i7>&FF&.1F6/-.')-C=,>N! )447FF78!
5747>'7(!HaDa_C!
[C! Mercury—your!health!and!the!environmentC!#7)-,=!+)1)8)!
\=,,E]66```C=42F4C/4C4)67`=2F7>,6E0'F64.1,)>&1)1,F6>7(40(6gD2
gRi7C=,>-N!)447FF78!5747>'7(!HaDa_C!
YC! n)(-&17(! 9! 7,! )-C! ;7(40(*! L(77! =7)-,=! 4)(7C! World! Medical! JournalN! Haa[N!
OM\H_]JYhMOC!
DaC! Treatment!technologies!for!mercury!in!soil,!waste,!and!waterC!")F=&1/,.1!
5+N!l1&,78!<,),7F!P1K&(.1>71,)-!3(.,74,&.1!:/714*!$LL&47!.L!<0E7(L018!
f7>78&),&.1!)18!I74=1.-./*!S11.K),&.1N!HaaZ!
\=,,E]66```C7E)C/.K6,&.68.`1-.)86(7>786OMH(aZaaJCE8L_C!
45
DDC! :/714*!L.(!I.Q&4!<0'F,)147F!)18!5&F7)F7!f7/&F,(*!
\=,,E]66```C),F8(C484C/.K6,.QE(.L&-7F6,EMR24HCE8LN!)447FF78!R!$4,.'7(!
HaDa_C!
DHC! l1&,78! <,),7F! X),&.1)-! f7F7)(4=! +.014&-C! Toxicological! effects! of!
methylmercuryN! ")F=&1/,.1! 5+N! X),&.1)-! :4)87>*! 3(7FFN! Haaa]M!
\=,,E]66```C1)EC78064),)-./CE=Ex(74.(8i&8yY[YY{,.4_C!
DJC! I()1F)187! %N! %)18(&/)1! 3N! <4=74=,7(! +C! 30'-&4! =7)-,=! )18! 74.1.>&4!
4.1F7g07147F! .L! >7,=*-! >7(40(*! ,.Q&4&,*! ,.! ,=7! 87K7-.E&1/! '()&1C!
Environmental!Health!PerspectivesN!HaaON!DDJ]OYahOYRC!
DMC! ".(-8!P14*4-.E78&)!
\=,,E]66```C17`.(-8714*4-.E78&)C.(/671,(*6I=7(>.>7,7(N!)447FF78!
$4,.'7(!HaDa_C!
DOC! #)--&8)*!<C!5(!9)>7F!+0((&7!\DZORhD[aO_]!%&K7(E..-!E=*F&4&)1N!4)>E)&/17(N!
=*8(.,=7()E&F,! )18! >)1! .L! -7,,7(FC! Journal! of! Medical! BiographyN! HaaRN!
DM\D_]JRC!
DRC! Selecting! non"mercury! thermometersC! <0F,)&1)'-7! #.FE&,)-F! 3(.m74,!
\=,,E]66```CF0F,)&1)'-7=.FE&,)-FC.(/6#I;%<(46S3i;7(4ikIX.1>7(4C=,>
-N!)447FF78!DM!$4,.'7(!HaDa_C!
DZC! P>>)107-! 9C! Guidance! on! technical! specifications! for! non"mercury! medical!
devicesC! b-.')-! P1K&(.1>71,! k)4&-&,*! 3(.m74,! .1! b-.')-! #7)-,=4)(7! ")F,7N!
l1&,78!X),&.1F!57K7-.E>71,!3(./()>>7N!HaDaC!
D[C! k)8V&-!k;N!+=..1!5N!:(0>0/)>!nC!:!4.>E)(),&K7!F,08*!.1!,=7!)440()4*!.L!
1.1&1K)F&K7!,=7(>.>7,7(FC! Australian! Family! PhysicianN!HaDaN!JY\M_]HJZh
HJYC!

DYC! <77N!L.(!7Q)>E-7]!%.`7!9+C!Thyroid!ScienceN!HaaYN!M\J_]+%<D2Yd!b&)1,&1!T!7,!
)-C! Journal! of! Clinical! NursingN! Haa[N! DZ\DD_]DOD[hDOHOd! ;.*)! T&--)7F40F)!
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Cirugía! BucalN! Haa[N! DJ\R_]PJ[OhJ[Yd! <E&,V7(! $3C! Dimensions! of! Critical!
Care! NursingN! Haa[N! HZ\D_]HMhHYd! ;.()1! 9%! 7,! )-C! Critical! Care! MedicineN!
HaaZN! JO\D_]JDHhJDJd! +()`L.(8! 5+N! #&4?F! WN! I=.>EF.1! ;9C! Journal! of!
Medical!Engineering!&!TechnologyN!HaaRN!Ja\M_]DYYhHDDd!5.88!<fC!Journal!
of! Clinical! EpidemiologyN! HaaRN! OY\M_]JOMhJOZd! f.F71,=)-! #;N! %7F-&7! :C!
Journal!of!Neonatal!NursingN!HaaRN!DH\M_]!DHOhDHYd!+()`L.(8!5N!b(7717!XN!
"71,`.(,=! <C! Thermometer! review:! UK! survey! 2005C! ;#f:! aMDMMN!
;78&4&17F! )18! #7)-,=4)(7! E(.804,F! f7/0-),.(*! :/714*N! 57E)(,>71,! .L!
#7)-,=N! l1&,78! n&1/8.>N! 9)10)(*! HaaOd! k)(17--! <! 7,! )-C! Journal! of! Clinical!
NursingN!HaaON!DM\O_]RJHhRJYd!n=.(F=&8!%!7,!)-C!Journal!of!Clinical!NursingN!
HaaON!DM\M_]MYRhOaad!<7(>7,2b)087-0F!SN!+=)87-),! SN!%71.&(!bC!Archives!of!
Pediatrics! and! Adolescent! MedicineN! HaaON! DH\[_]DHYHhDJaad! ;4n71V&7! XC!
Pediatric!NursingN!HaaJN!HY\H_]DDZhDHOd!^0(7F=&!k!7,!)-C!Pakistan!Journal!of!
Medical!SciencesN!HaaJN!DY\H_]DDDhDDJd!<>&,=!%<C!BMC!NursingN!HaaJN!H]Dd!
5.`8&1/!5N!Professional!NurseN!HaaHN!D[\J_]DRRhDR[d!;)4g0771!<C!British!
Journal! of! NursingN! HaaDN! Da\D_]OOhO[d! 971F71! WX! 7,! )-C! Acta! chirurgicaN!
HaaaN!DRR\DD_][M[h[ODd!</)1/)!:!7,!)-C!American!Journal!of!Maternal!and!
Child! NursingN! HaaaN! HO\H_]ZRhZYd! T)--7! 3+N! n&-8)=-2:187(F71! $N! <,7&1K.--!
nC!Tidsskr!Nor!LaegeforenN!HaaaN!DHa\D_]DOhDZd!:>.),71/2:8m7E.1/!UN!57-!
;018.!9N!;)1,=.0F!+:C!ChestN!DYYYN!DDO]DaaHhDaaOd!3(71,&47!5N!;.(7-)18!
9C! Geriatric! NursingN! DYYYN! Ha\R_]JDMhJDZd! %7&4?2f087! ;nN! W-..>! %kC!
Neonatal!NetworkN!DYY[N!DZ\O_]HDhJZd!;),F0?)`)!I!7,!)-C!Canadian!Journal!
of! AnaesthesiaN! DYYRN! MJ\DH_]DHHMhDHH[d! ~71/7*)! <IN! W-0>71,=)-! SC!
European! Journal! of! PediatricsN! DYYZN! DOO\DH_]DaaOhDaa[d! ;)4?71V&7! fN!
:F='0(*!:9C!British!Journal!of!AnaesthesiaN!DYYMN!ZH\H_]HMRhHMYd!5)K&7F!<3!
7,!)-C!Journal!of!Advanced!NursingN!DY[RN!DD\O_]OJOhOMJC!
HaC! +()`L.(8! 5N! #&4?F! WN! I=.>EF.1! ;C! "=&4=! ,=7(>.>7,7(x! k)4,.(F!
&1L-0714&1/! '7F,! 4=.&47! L.(! &1,7(>&,,71,! 4-&1&4)-! ,7>E7(),0(7! )FF7FF>71,C!
Journal!of!Medical!Engineering!&!TechnologyN!HaaRN!Ja\M_]DYYhHDDC!
HDC! <77N! L.(! 7Q)>E-7N! Guidance! on! the! cleanup,! temporary! or! intermediate!
storage,! and! transport! of! mercury! waste! from! healthcare! facilitiesC! l1&,78!
X),&.1F! 57K7-.E>71,! 3(./()>>7N! b-.')-! P1K&(.1>71,! k)4&-&,*! b-.')-!
#7)-,=4)(7!")F,7!3(.m74,N!HaDaC!
HHC! Clinical! thermometers—Part! 3:! Performance! of! compact! electrical!
thermometers! (non"predictive! and! predictive)! with! maximum! deviceC!
P0(.E7)1!<,)18)(8!PX!DHMZa2J]Haaac:DN!9017!HaaYC!
HJC! Standard! specification! for! electronic! thermometer! for! intermittent!
determination! of! patient! temperatureC! :<I;! PDDDH2aaN! (7)EE(.K78! HaaRC!
<77! )-F.! :<I;! PDDaM! (7-),78! ,.! 4-&1&4)-! ,=7(>.>7,7(! E(.'7! 4.K7(F! )18!
F=7),=FC!
References 47
HMC! Standard! specification! for! phase! change"type! disposable! fever! thermometer!
for! intermittent! determination! of! human! temperatureC! :<I;! P[HO2Y[!
\(7)EE(.K78!HaaY_C!
HOC! Clinical! thermometers—Part! 5:! Performance! of! infra"red! ear! thermometers!
(with!maximum!device)C!P0(.E7)1!X.(>!PX!DHMZa2O]HaaJC!
HRC! Standard! specification! for! infrared! thermometers! for! intermittent!
determination!of!patient!temperatureC!:<I;!PDYRO2Y[!\(7)EE(.K78!HaaY_C!
HZC! Medical! electrical! equipment—Part! 1"2:! General! requirements! for! basic!
safety! and! essential! performance;! Collateral! standard:! Electromagnetic!
compatibility—requirements!and!testsC!P0(.E7)1!X.(>!PX!RaRaD2DC!
H[C! Medical!electrical!equipment—Part!1:!General!requirements!for!basic!safety!
and! essential! performanceC! :X<S6::;S! P<RaRaD2D]HaaON! HaaRd! .(! SP+!
RaRaD2D]HaaOC!
HYC! Standards!for!safety,!medical!and!dental!equipmentN!l%!OMMC!X.(,='(..?N!S%N!
l187(`(&,7(F!%)'.(),.(&7FC!I=&F!l%!F,)18)(8!=)F!F&147!'771!F0E7(F7878!'*!
Medical! electrical! equipment—Part! 1:! General! requirements! for! safetyN! l%!
RaRaD2DN!)18!&,F!F0'F7g071,!(7K&F&.1FN!l187(`(&,7(F!%)'.(),.(&7FN!HO!:E(&-!
HaaJC!
JaC! Information! supplied! by! the! manufacturer! of! medical! devicesC! P0(.E7)1!
X.(>!PX!DaMDN!:0/0F,!Haa[C!
JDC! Symbols!for!use!in!the!labelling!of!medical!devicesC!P0(.E7)1!X.(>!PX!Y[aN!
Haa[C!
JHC! Sampling! procedures! for! inspection! by! attributes—Part! 2:! Sampling! plans!
indexed!by!limiting!quality!(LQ)!for!isolated!lot!inspectionC!S<$!H[OY2H]DY[OC!
JJC! Standard! specification! for! clinical! thermometer! probe! covers! and! sheathsC!
:<I;!PDDaM2Y[!\(7)EE(.K78!HaaY_C!
JMC! ;)1*! 8&/&,)-! ,=7(>.>7,7(F! 0F7! >&1&),0(7! \'0,,.1N! 4.&12F=)E78! )18!
'0,,.12F,)4?78_! '),,7(&7FC! %&,=&0>! >&1&),0(7! '),,7(&7F! =)K7! 1.! )8878!
>7(40(*C! <&-K7(! .Q&87N! V&14! )&(! )18! )-?)-&17! >)1/)17F7! 8&.Q&87! >&1&),0(7!
'),,7(&7F!=)K7!)1!)K7()/7!.L!HCON![CO!)18!DaC[!>/!.L!>7(40(*!E7(!'),,7(*N!
(7FE74,&K7-*C!;7(40(*2L(77!K7(F&.1F!.L!)--!.L!,=7F7!>&1&),0(7!'),,7(&7F!=)K7!
'771! 87K7-.E78C! X.12>&1&),0(7! 4*-&18(&4)-! )-?)-&17! '),,7(&7F! \::N! :::N!
::::! )18! X! F&V7Fd! .(! fRN! faJ! )18! fD! F&V7F_! 8.! 1.,! =)K7! )8878! >7(40(*C!
\f7L7(7147]! b)--&/)1! +N! ;.(.F7! bC! An! investigation! of! alternatives! to!
miniature! batteries! containing! mercuryC! f7E.(,! '*! ,=7! %.`7--! +71,7(! L.(!
<0F,)&1)'-7! 3(.804,&.1! L.(! ,=7! ;)&17! 57E)(,>71,! .L! P1K&(.1>71,)-!
3(.,74,&.1N!5747>'7(!DZN!HaaMC_!!
JOC! X)gK&!X#N!W-)0L.Q!;5C!Blood!pressure!measurement:!an!illustrated!historyN!
EEC!OhR!LLC!X7`!U.(?N!3)(,=71.1!30'-&F=&1/N!DYY[C!

JRC! ;)(?)180! XN! "=&,4=7(! kN! :(1.-8! :N! +)(17*! +C! I=7! >7(40(*!
FE=*/>.>)1.>7,7(!F=.0-8!'7!)')18.178!'7L.(7!&,!&F!E(.F4(&'78C!Journal!
of!Human!HypertensionN!HaaaN!DM\D_]JDhJRC!
JZC! Affordable! technology:! blood! pressure! measuring! devices! for! low"resource!
settingsC!b717K)N!".(-8!#7)-,=!$(/)1&V),&.1N!HaaOC!
J[C! Mercury! sphygmomanometers! in! healthcare! and! the! feasibility! of!
alternativesC!<4&71,&L&4!+.>>&,,77!.1!P>7(/&1/!)18!X7`-*!S871,&L&78!#7)-,=!
f&F?FN! 5&(74,.(),7! b717()-! L.(! #7)-,=! )18! +.1F0>7(FN! P0(.E7)1!
+.>>&FF&.1N!HJ!<7E,7>'7(N!HaaY!
\=,,E]6674C70(.E)C706=7)-,=6E=i(&F?64.>>&,,77F6aMiF471&=(68.4F6F471&=
(i.iaHOCE8L_C!
JYC! "&--&)>F!W!7,!)-C!b0&87-&17F!L.(!>)1)/7>71,!.L!=*E7(,71F&.1]!(7E.(,!.L!,=7!
L.0(,=! `.(?&1/! E)(,*! .L! ,=7! W(&,&F=! #*E7(,71F&.1! <.4&7,*N! HaaMGW#<! STC!
Journal!of!Human!HypertensionN!HaaMN!D[]DJYhD[OC!
MaC! 3&4?7(&1/! Ib! 7,! )-C! f74.>>718),&.1F! L.(! '-..8! E(7FF0(7! >7)F0(7>71,! &1!
=0>)1F!)18!7QE7(&>71,)-!)1&>)-FN!E)(,!D]!'-..8!E(7FF0(7!>7)F0(7>71,!&1!
=0>)1F]! )! F,),7>71,! L.(! E(.L7FF&.1)-F! L(.>! ,=7! <0'4.>>&,,77! .L!
3(.L7FF&.1)-! )18! 30'-&4! P804),&.1! .L! ,=7! :>7(&4)1! #7)(,! :FF.4&),&.1!
+.014&-! .1! #&/=! W-..8! 3(7FF0(7! f7F7)(4=N! :#:! <4&71,&L&4! <,),7>71,C!
HypertensionN!HaaON!MO]DMHC!
MDC! +.-7>)1! :9<N! <,7E=71! 5N! :F=`.(,=! ;N! T.`-7(! <%N! <=711)1! :C! :440()4*! .L!
,=7! E(7FF0(7! F4)-7! .L! FE=*/>.>)1.>7,7(F! &1! 4-&1&4)-! 0F7! `&,=&1! E(&>)(*!
4)(7C!Blood!Pressure!MonitoringN!HaaON!Da\M_]D[DhD[[C!
MHC! $jW(&71!P!7,!)-C!W-..8!E(7FF0(7!>7)F0(&1/!87K&47F]!(74.>>718),&.1F!.L!,=7!
P0(.E7)1!<.4&7,*!.L!#*E7(,71F&.1C!British!Medical!JournalN!HaaDN!JHH]OJDh
OJRC!
MJC! $jW(&71! P! 7,! )-C! ".(?&1/! b(.0E! .1! W-..8! 3(7FF0(7! ;.1&,.(&1/! .L! ,=7!
P0(.E7)1! <.4&7,*! .L! #*E7(,71F&.1! S1,7(1),&.1)-! 3(.,.4.-! L.(! K)-&8),&.1! .L!
'-..8! E(7FF0(7! >7)F0(&1/! 87K&47F! &1! )80-,FC! Blood! Pressure! MonitoringN!
HaaHN!Z]JhDZd!$jW(&71!PC!I=7!W(&,&F=!#*E7(,71F&.1!<.4&7,*!E(.,.4.-!L.(!,=7!
7K)-0),&.1! .L! '-..8! E(7FF0(7! >7)F0(&1/! 87K&47FC! Journal! of! HypertensionN!
DYYJN!DD\<0EE-C!H_]<MJh<RHC!
MMC! ")1!UN!#717/=)1!+N!<,7K71F!fN!;4;)10F!f9N!")(8!:N!37(7()!fN!I=.>EF.1!
;C! 57,7(>&1&1/! `=&4=! )0,.>),&4! 8&/&,)-! '-..8! E(7FF0(7! 87K&47! E7(L.(>F!
)87g0),7-*]! )! F*F,7>),&4! (7K&7`C! Journal! of! Human! HypertensionN! HaDaN!
HM]MJDhMJ[C!
MOC! b)--&/)1! +! 7,! )-C! An! investigation! of! alternative! to! mercury! containing!
productsN! %.`7--! +71,7(! L.(! <0F,)&1)'-7! 3(.804,&.1N! l1&K7(F&,*! .L!
;)FF)4=0F7,,F!),!%.`7--N!HaaJ]HDC!
References 49
MRC! Non"invasive!sphygmomanometers—Part!1:!Requirements!and!test!methods!
for!non"automated!measurement!typeC!:X<S6::;S6S<$![DaRa2D]HaaZC!
MZC! Non"invasive!sphygmomanometers—Part!2:!Clinical!validation!of!automated!
measurement! typeC! :X<S6::;S6S<$! [DaRa2H]HaaY! \(7K&F&.1! .L! <3Da]HaaH!
)18!:>718>71,!D]HaaJ!)18!:>718>71,!H]HaaR_N!HaaYC!
M[C! Medical! electrical! equipment—Part! 2"30:! Particular! requirements! for! the!
basic!safety!and!essential!performance!of!automated!non"invasive!sphygmo"!
manometersC!X<S6::;S6P+![aRaD2H2Ja]HaaYC!
MYC! Clinical!investigation!of!medical!devices!for!human!subjects—Part!1:!General!
requirementsC!S<$!DMDOO2D]HaaJC!
!

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Replacement of mercury thermometers and sphygmomanometers in health care

Edited by: Jo Anna M Shimek,

iv Replacement of mercury themometers and sphygmomanometers in health care

$147! (7-7)F78N! >7(40(*! >)*! ,()K7-! /(7),! 8&F,)147F! '7L.(7! 87E.F&,&1/!

I=7! E.,71,&)-! 71K&(.1>71,)-! 8)>)/7N! =0>)1! ,.Q&4&,*! )18! 8&FE.F)-!

I=7! =7)-,=24)(7! F74,.(jF! 4.1,(&'0,&.1! ,.! ,=7! /-.')-! 71K&(.1>71,)-!

S1! =7)-,=24)(7! F7,,&1/FN! ,=7! 4.>>.1! '(7)?)/7! .L! >7(40(*24.1,)&1&1/!

6 Replacement of mercury themometers and sphygmomanometers in health care

5)1&7-! b)'(&7-! k)=(71=7&,! E(.80478! )! ,=7(>.>7,7(! 0F&1/! >7(40(*! &1!

b. Operation of mercury thermometers

3=)F724=)1/7! ,=7(>.>7,7(F! 0F7! )! /(&8! .L! 8.,F! ),,)4=78! ,.! )! ,=&1!

I*>E)1&4! &1L()(78! ,=7(>.>7,7(FN! .(! 7)(! ,=7(>.>7,7(FN! )(7! ,*E&4)--*!

10 Replacement of mercury themometers and sphygmomanometers in health care

e. Accuracy of mercury-free thermometers

k0(,=7(N! )! .172L.(2.17! (7E-)47>71,! &F! 1.,! 1747FF)(*! /&K71! ,=7!

g. Mercury thermometer replacement

12 Replacement of mercury themometers and sphygmomanometers in health care

Step!3! S>E-7>71,! E(.E7(! 4-7)120E! )18! F,.()/7! E(.4780(7F! L.(!

5&/&,)-! 4-&1&4)-! ,=7(>.>7,7(F! F=.0-8! >77,! ,=7! (7g0&(7>71,F! .L! 7&,=7(!

Step!5! S871,&L*! K718.(F! ,=),! 4)1! E(.K&87! ,=7! 4=.F71! ,=7(>.>7,7(!

Mercury-free product listings1

Step!6! 57,7(>&17! ,=7! E=)F72&1! F4=780-7! L.(! ,=7! 17`! 01&,FC!

14 Replacement of mercury themometers and sphygmomanometers in health care

Step!8! 57K7-.E! )! '&8! FE74&L&4),&.1! L.(! ,=7! E0(4=)F7! .L! ,=7!

Step!9! f7K&7`! ,=7! F7-74,78! K718.(jF! (7g0&(7>71,F! L.(! 4)-&'(),&.1!

Step!10! 3(7E)(7! ,=7! &1,7(&>! F,.()/7! F&,7! L.(! E=)F782.0,! >7(40(*!

16 Replacement of mercury themometers and sphygmomanometers in health care

b. Operation of a manual sphygmomanometer

3(.E7(! >)&1,71)147! &14-087F! )! K&F0)-! &1FE74,&.1! .L! ,=7! 01&,! )18!

18 Replacement of mercury themometers and sphygmomanometers in health care

e. Accuracy of mercury-free sphygmomanometers

I=7! :>7(&4)1! #7)(,! :FF.4&),&.1N! &1! &,F! (74.>>718),&.1F! \40_N! 1.,7F!

Table 5.1 British Hypertension Society grading criteria

20 Replacement of mercury themometers and sphygmomanometers in health care

Step!2! W)F78! .1! ,=7! &1L.(>),&.1! E(.K&878! )'.K7N! 87,7(>&17! `=&4=!

Mercury-free product listings

Step!4! 57,7(>&17! ,=7! E=)F72&1! F4=780-7! L.(! ,=7! 17`! 01&,FC!

Step!6! 57K7-.E! )! '&8! FE74&L&4),&.1! L.(! ,=7! E0(4=)F7! .L! ,=7!

22 Replacement of mercury themometers and sphygmomanometers in health care

Step!7! f7K&7`! ,=7! F7-74,78! K718.(jF! (7g0&(7>71,F! L.(! 4)-&'(),&.1!

Step!8! 3(7E)(7! ,=7! &1,7(&>! F,.()/7! F&,7! L.(! E=)F782.0,! >7(40(*!

Step!13! ;.1&,.(! )18! 71F0(7! ,=),! ,=7! 1.12>7(40(*!

:-,7(1),&K7F! ,.! >7(40(*24.1,)&1&1/! ,=7(>.>7,7(F! )18! FE=*/>.2!

Table A1.1 Requirements for digital thermometers

Parameter Summary of the specification Test procedure

Parameter Summary of the specification Test procedure

28 Replacement of mercury themometers and sphygmomanometers in health care

30 Replacement of mercury themometers and sphygmomanometers in health care

Summary of the specification in Summary of the specification

32 Replacement of mercury themometers and sphygmomanometers in health care

Available features of digital thermometers

34 Replacement of mercury themometers and sphygmomanometers in health care

Parameter Summary of the specification Section

Parameter Summary of the specification Test procedure

36 Replacement of mercury themometers and sphygmomanometers in health care

Parameter Summary of the specification Section

Parameter Summary of the specification Section

38 Replacement of mercury themometers and sphygmomanometers in health care

Table A2.1 Requirements for aneroid sphygmomanometers

Parameter Summary of the specification Section

40 Replacement of mercury themometers and sphygmomanometers in health care

Parameter Summary of the specification Section

42 Replacement of mercury themometers and sphygmomanometers in health care

$147! (7-7)F78N! >7(40(! >)! ,()K7-! /(7),! 8&F,)147F! '7L.(7! 87E.F&,&1/!

I>E)1&4! &1L()(78! ,=7(>.>7,7(FN! .(! 7)(! ,=7(>.>7,7(FN! )(7! ,E&4)--*!

:-,7(1),&K7F! ,.! >7(40(24.1,)&1&1/! ,=7(>.>7,7(F! )18! FE=/>.2!