RECOMENDACIÓN INTERNACIONAL
OIML R 16-1 Traducción no ofcia a idio!a "#$a%o To!ado T o!ado d" a Edición Edición 2002 (E)
E#f&!o!anó!"tro# !"c'nico# no ina#io# Non-ina#i" !"canica #$*&!o!ano!"t"r# +$*&!o!ano!,tr"# non ina#i# !.cani/u"#
OIML IML R 16-1 Editio ition n2002 (E)
DE
ORANI+ATIONINTERNATIONALE MTROLOIELALE
ONRANIACIÓN
INTERNACIONAL METROLOIA
DE Tabla de Contenido
Traducción T raducción no ofcia d" a a OIML R 16-13 2002 2002 (E)
Prefacio .......................................................... ..................................................................................................................... ................................................................................................................. ...................................................... 3 1 Alcance ........................................................................................................................................................................... 4 2 Te Terminología rminología ................................................... .............................................................................................................. ................................................................................................................. ...................................................... 4 3 Descripción de la categoría del instrumento .................................................................................................................... 5 4 Unidades de medida ......................................................................................................................................................... 5 5 Metrological requirements ......................................................................................................................................... ......................................................................................................................................... 5 6
Tecnical Te cnical requirements ..................................................... ............................................................................................................. ......................................................................................... ................................. 6
!
Metrological controls .................................................... ............................................................................................................. ............................................................................................. .................................... "
Anne# A$ Te Test st procedures %Mandator&' ....................................................................................................................... ....................................................................................................................... 1( Anne# )$ Test report *ormat %Mandator& *or application +itin te OIML Certificate System for Measuring Instruments' Instruments ' ................................................................................. 15 Anne# ,$ Ad-ice to e included in te instructions accompan&ing a sp&gmomanometer using a mercur& manometer %/n*ormati-e' ............................................................. ............................................................. 31
2
Traducción T raducción no ofcia d" a a OIML R 16-13 2002 2002 (E)
Prefacio .......................................................... ..................................................................................................................... ................................................................................................................. ...................................................... 3 1 Alcance ........................................................................................................................................................................... 4 2 Te Terminología rminología ................................................... .............................................................................................................. ................................................................................................................. ...................................................... 4 3 Descripción de la categoría del instrumento .................................................................................................................... 5 4 Unidades de medida ......................................................................................................................................................... 5 5 Metrological requirements ......................................................................................................................................... ......................................................................................................................................... 5 6
Tecnical Te cnical requirements ..................................................... ............................................................................................................. ......................................................................................... ................................. 6
!
Metrological controls .................................................... ............................................................................................................. ............................................................................................. .................................... "
Anne# A$ Te Test st procedures %Mandator&' ....................................................................................................................... ....................................................................................................................... 1( Anne# )$ Test report *ormat %Mandator& *or application +itin te OIML Certificate System for Measuring Instruments' Instruments ' ................................................................................. 15 Anne# ,$ Ad-ice to e included in te instructions accompan&ing a sp&gmomanometer using a mercur& manometer %/n*ormati-e' ............................................................. ............................................................. 31
2
Traducción T raducción no ofcia d" a a OIML R 16-13 2002 2002 (E)
Prefacio
l 0rganiación /nternacional de Metrología egal %0/M' es una org organi aniac ación ión mund mundial ial int interg erguer uernam nament ental al cu& cu&o o oeti o eti-o -o pri princi ncipal pal es arm armoni oniar ar los reg reglam lament entos os & los cont co ntro role less me metr trol ológ ógic icos os ap apli lica cados dos por lo loss se serr-ic icio ioss metrológico metro lógicoss nacio nacionales nales u orga organiac niaciones iones cone#as de sus stad stados os Miemros.
as dos categorías principales de p ulicaciones de 0/M son$ Recomend Recomendacio aciones nes Inte Internac rnaciona ionales les (OIM (OIML L R) R) la lass cu cual ales es so son n regulaciones modelo que estalecen las características metrológicas requeridas de ciertos instrumentos de medición & que especi*ican m7todos m7tod os & equip equipos os para -eri*icar -eri*icar su con*o con*ormida rmidad8 d8 os stados miemros miemr os de la 0/M aplicar9 aplicar9n n esta estass :eco :ecomendac mendaciones iones en la ma&or medida posile8 Documentos Internacionales (OIML D) D) los cuales son de car9cter in*orm in* ormati ati-o -o & des destin tinado adoss a me meora orarr el tra traa ao o de los ser ser-ic -icios ios metrológicos. os ;ro&ectos de :ecomendaciones & Documentos de la 0/M son elaor ela orado adoss por com comit7 it7ss t7c t7cnic nicos os o suc sucomi omit7s t7s *or *ormad mados os por los stados Miemros. ,iertas instituciones internacionales & regionales tami7n participan en *orma consulti-a.
as as :eco :e come mend ndac acio ione ness /n /nte terrna naci cion onal ales es & loss Do lo Docu cume ment ntos os /nternacionales se pulican en *ranc7s %=' e ingl7s %' & est9n suetos a re-isiones periódicas. sta pu sta pulic licac ación ión > re* re*ere erenci nciaa 0/M 0/M : 16> 16>1 1 di dició ción n 2(( 2((2 2 > *ue desa de sarr rrol olla lada da por el
!5((@ ;aris > =rance Telepone$ Te lepone$ 33 %('1 4" !" 12 "2 and 42 "5 2! 11 =a#$ 33 %('1 42 "2 1! 2! >mail$ imloiml.org /nternet$ +++.oiml.org
3
Traducción no ofcia d" a OIML R 16-13 2002 (E)
sfigmoman$metro mec/nico no in%asi%o
2!* Presi$n
1
Alcance
a presente :ecomendación especi*ica los requisitos generales de *uncionamiento de e*iciencia & de seguridad mec9nica & el7ctrica incluidos los m7todos de ensa&o para la omologación tipo para los es*igmomanómetros mec9nicos no in-asi-os & sus accesorios que mediante un raalete in*lale se utilian para la medición no in-asi-a de la presión arterial de la sangre. a aplicación del raalete no est9 limitada a una e#tremidad particular del cuerpo umano %por eemplo el rao superior'. /ncluidos en el 9mito de esta :ecomendación est9n los es*igmomanómetros con un elemento mec9nico de detección de presión & una pantalla usados en cominación con un estetoscopio u otros m7todos manuales para detectar sonidos de BorotCo** & para el in*lado del raalete. Nota: No se utilizarán cerraduras de tipo Luer con estos dispositios !er ".#'.
arterial media (%alor)
alor de la integral de un ciclo de la cur-a de presión arterial di-idido por el tiempo de un período de latido cardíaco. Note: Deido a los e*ectos idrost9ticos este -alor dee medirse con el raalete a ni-el del coraón.
2!+
Medición indirecta de la presión arterial sin incisión arterial. 2!-
2!1
"e#iga
Presi$n en un %aso sanguneo
;resión en el sistema arterial del cuerpo. 2!&
'raalete
,omponente del es*igmomanómetro que comprende una -eiga & una manga que se en-uel-e alrededor de la e#tremidad del paciente. 2!
;arte esencialmente inel9stica del raalete que rodea la -eiga. 2!
sfigmoman$metro
/nstrumento utiliado para la medición no in-asi-a de la presión arterial. 2!13
Presi$n arterial sist$lica (%alor)
alor m9#imo de la presión arterial como resultado de la contracción del -entrículo sist7mico. Note: $e%ido a los efectos &idrostáticos' este alor de%e medirse con el manguito en el niel del coraz(n.
Presi$n arterial diast$lica (%alor)
alor mínimo de la presión arterial como resultado de la relaación del -entrículo sist7mico. Nota: $e%ido a los efectos &idrostáticos' este alor de%e medirse con el %razalete a niel del coraz(n.
4
Manga
Terminologa
,omponente in*lale del raalete. 2!2
.istema neum/tico
2
Medici$n no in%asi%a de la ,resi$n arterial
2!11
sfigmoman$metro mec/nico
s*igmomanómetro que utilia un manómetro de mercurio o un manómetro aneroide u otro dispositi-o mec9nico de medición para la medición no in-asi-a de la presión arterial de la sangre mediante un raalete incale. %7ase tami7n Eota ao 3.'.
Traducción no ofcia d" a OIML R 16-13 2002 (E)
2!12
M4todo Auscultatorio
T7cnica mediante la cual los sonidos %conocidos como sonidos de BorotCo**' se o&en sore una arteria ocluida a medida que la presión de oclusión se liera lentamente la aparición de sonidos coincidiendo con la presión sistólica & la desaparición de los sonidos con la presión diastólica en adultos. n niFos menores de 13 aFos el GC4G %es decir el sonido de BorotCo** de la 4H *ase' puede ser apropiado. 2!1&
"/l%ula de deflaci$n
9l-ula para el escape controlado del sistema neum9tico durante la medición. 2!1
"/l%ula de esca,e r/,ida
9l-ula para el escape r9pido del sistema neum9tico. 2!1*
Prueba de mani,ulaci$n
Medios para e-itar que el usuario pueda acceder *9cilmente al mecanismo de medición del dispositi-o.
&
Descri,ci$n de la categora de instrumento
os componentes 9sicos de un es*igmomanómetro son un raalete & una -eiga que se pueden en-ol-er alrededor de una e#tremidad del paciente un sistema manual para aplicar & lierar presión a la -eiga & un medio de medir & de -isualiar la presión instant9nea en la -eiga. os es*igmomanómetros mec9nicos utilian típicamente un mercurio o un manómetro aneroide u otro dispositi-o mec9nico de medición para la medición no in-asi-a de la presión arterial mediante un raalete in*lale. Nota: Los componentes de estos dispositios son man(metro' %razalete' álula para deflaci(n !a menudo en com%inaci(n con álula de escape rápida)' %om%a manual o %om%a electromecánica y mangueras de cone*i(n. +stos dispositios tam%i,n pueden contener componentes electromecánicos para el control de la presi(n.
5nidades de medida
a presión arterial se indicar9 en Cilopascales %C;a' o en milímetros de mercurio %mmIg'.
*
Re6uerimientos metrol$gicos
*!1
rrores m/7imos ,ermisibles de la indicaci$n de la ,resi$n del braalete
#.-.- a/o condiciones am%ientales ;ara cualquier conunto de condiciones dentro del rango de temperatura amiente de 15 J, a 25 J, & el rango de umedad relati-a del 2( K al "5 K tanto para aumentar como para disminuir la presión el error m9#imo permitido para la medición de la presión del raalete en cualquier punto del rango de escala ser9 L (4 C;a %L 3 mmIg' en caso de -eri*icar la primera -e & L (5 C;a %L 4 mmIg' para es*igmomanómetros en uso. as prueas se lle-ar9n a cao de acuerdo con A.1. #.-.0 a/o condiciones de almacenamiento l es*igmomanómetro mantendr9 los requisitos m9#imos de error admisiles especi*icados en la presente :ecomendación %5.1.1' despu7s de un almacenamiento de 24 a una temperatura de >2( J, & durante 24 a una temperatura de !( J, & una umedad relati-a del "5K %sin condensación'. as prueas se lle-ar9n a cao de con*ormidad con A.3. #.-.3 a/o condiciones de temperatura aria%les ;ara el rango de temperatura amiente de 1( J, a 4( J, & la umedad relati-a del "5K %sin condensación' la di*erencia de la indicación de presión del raalete del es*igmomanómetro no dee e#ceder L (.4 C;a %L 3 mmIg'. as prueas se e*ectuar9n de acuerdo con el punto A.2.
+
Re6uerimientos t4cnicos
+!1
Re6uisitos t4cnicos ,ara el braalete 8 la %e#iga
l raalete dee contener una -eiga. ;ara los raaletes reutiliales el *aricante indicar9 el m7todo de limpiea en los documentos de acompaFamiento %-7ase !.5'. Nota: +l tama1o (ptimo de la e/iga es uno con dimensiones tales 2ue su anc&o es 45 de la circunferencia de la e*tremidad en el punto medio de la aplicaci(n del %razalete y su longitud es al menos 645' preferi%lemente -445' de la circunferencia de la e*tremidad en el punto medio de aplicaci(n del %razalete. +l uso de un tama1o incorrecto puede afectar la precisi(n de la medici(n.
5
Traducción no ofcia d" a OIML R 16-13 2002 (E)
+!2
7.3.0.3 Interalo de escala
Re6uisitos t4cnicos ,ara el sistema neum/tico
l inter-alo de escala ser9$
7.0.- 8uga de aire a *uga de aire no dee e#ceder una caída de presión de (5 C;a?min %4 mmIg ? min'. as prueas se e*ectuar9n de acuerdo con el punto A.4. 7.0.0 9asa de reducci(n de presi(n as -9l-ulas de de*lación accionadas manualmente deer9n ser capaces de austarse a una -elocidad de de*lación de (3 C;a?sa (4 C;a?s %2 mmIg?sa3mmIg?s'. as -9l-ulas de desloqueo accionadas manualmente se austar9n *9cilmente a estos -alores. as -9l-ulas de de*lación deen ser ensa&adas de acuerdo con A.5. 7.0.3 +scape rápido Durante el escape r9pido del sistema neum9tico con la -9l-ula totalmente aierta el tiempo para la reducción de la presión de 35 C;a a 2 C;a %26( mmIg a 15 mmIg' no e#ceder9 de 1( s. as prueas se lle-ar9n a cao de con*ormidad con A.6. +!&
Re6uisitos t4cnicos ,ara los dis,ositi%os indicadores de ,resi$n
7.3.- ango nominal y rango de medici(n l rango nominal ser9 igual al rango de medición. l rango nominal para la presión de la galga del raalete dee e#tenderse de ( C;a a por lo menos 35 C;a %( mmIg a por lo menos 26( mmIg'. 7.3.0 Indicaci(n análoga 7.3.0.- ;lcance a escala deer9 estar diseFada & dispuesta de *orma que los -alores de medición puedan leerse con claridad & sean *9cilmente reconociles. as prueas se realiar9n mediante inspección -isual. 7.3.0.0 Marca de la primera escala a graduación comenar9 con la marca de la primera escala a ( C;a %( mmIg'. as prueas se realiar9n mediante inspección -isual.
6
(2 C;a para una escala graduada en C;a8 o 2 mmIg para una escala graduada en mmIg.
,ada quinta marca de escala se indicar9 con ma&or longitud & cada marca de d7cimo escala se numerar9. Un eemplo de una escala en mmIg se da en la =igura 1. as prueas se realiar9n mediante inspección -isual. 7.3.0. +spaciado de escala y grosor de las marcas de escala a distancia entre las marcas de escala ad&acentes no ser9 in*erior a 1( mm. l grosor de las marcas de la escala no dee e#ceder el 2(K del espaciamiento de la escala m9s pequeFa. Todas las marcas de escala deen tener el mismo grosor. as prueas se lle-ar9n a cao de con*ormidad con el punto A.!.
Traducción no ofcia d" a OIML R 16-13 2002 (E)
120 100
150 160
10 200
0
as prueas se e*ectuar9n de
220
60
250
50
260
20
20 700
0 !!4&
9igura 1 #em,lo de una escala de man$metro aneroide (di%isi$n en mm:g sin una ona de tolerancia en el ,unto cero)
+!
Re6uisitos t4cnicos adicionales ,ara los man$metros de mercurio
con*ormidad con los puntos A.@ & A.1(. 7.. Calidad del mercurio
7..- $iámetro interno del tu%o 2ue contiene el mercurio l di9metro interno nominal del tuo de mercurio ser9 de al menos 35 mm. a tolerancia de di9metro no dee e#ceder L (2 mm %-er tami7n !.4'.
6.4.4.1 l mercurio tendr9 una purea no in*erior al @@@@K de acuerdo con la declaración del pro-eedor del mercurio.
as prueas se e*ectuar9n de con*ormidad con A.".
6.4.4.2 l mercurio mostrar un menisco limpio & no contendr9 uruas.
7..0 $ispositios Porta%les
7..#
Un dispositi-o port9til deer9 estar pro-isto de un mecanismo de auste o loqueo para asegurarlo en la posición de uso especi*icada.
as graduaciones deen estar permanentemente marcadas en el tuo contenedor del mercurio.
as prueas se realiar9n mediante inspección -isual.
7..3 $ispositios para eitar el derramamiento de mercurio durante el uso y el transporte
as prueas se realiar9n mediante inspección -isual.
+!*
Re6uisitos t4cnicos adicionales ,ara los man$metros aneroides
7.#.- Marca de escala a cero
!
Traducción no ofcia d" a OIML R 16-13 2002 (E)
Eota$ as graduaciones dentro de la ona de tolerancia son opcionales. as prueas se realiar9n mediante inspección -isual. 7.#.0 Cero l mo-imiento del elemento sensor el9stico inclu&endo el puntero no dee ser ostruido dentro de (." C;a %6 mmIg' & deao del cero. l usuario no podr9 austar el dial ni el puntero.
Despu7s de las prueas el dispositi-o deer9 cumplir con los requisitos de 5.1.1 %de esta :ecomendación'. 7.7.0 Seguridad mecánica Dee ser posile aortar la medición de la presión arterial en cualquier momento acti-ando la -9l-ula manual de escape r9pido que ser9 *9cilmente accesile
7.7.3 Prue%a de manipulacion
as prueas se realiar9n mediante inspección -isual. 7.#.3 Puntero l puntero deer9 curir entre 1?3 & 2?3 de la longitud de la marca de escala m9s corta. n el lugar de indicación el puntero no deer9 ser m9s grueso que la marca de la escala. a distancia entre el puntero & el disco no dee superar los 2 mm. as prueas se realiar9n mediante inspección -isual.
a pruea de manipulación del manómetro se realiar9 e#igiendo el uso de una erramienta o rompiendo un sello. as prueas se realiar9n mediante inspección -isual. 7.7. Seguridad el,ctrica as regulaciones regionales o nacionales especi*icar requisitos de seguridad el7ctrica.
pueden
7.#. +rror de &ist,resis l error de ist7resis en todo el rango de presión dee estar dentro del rango de ( C;a a (5 C;a %( mmIg to 4 mmIg'. as prueas se realiar9n de acuerdo con A.11. 7.#.# Construcci(n y materiales a construcción del manómetro aneroide & el material para los elementos sensores el9sticos garantiar9n una estailidad adecuada de la medición. os elementos el9sticos de detección deen ser en-eecidos con respecto a la presión & la temperatura. Despu7s de 1( ((( ciclos de presión alterna el camio en la indicación de presión del manómetro aneroide no deer9 ser superior a (4 C;a %3 mmIg' en todo el rango de presión. as prueas se realiar9n de acuerdo con A.12. +!+
Re6uisitos de seguridad
7.7.- esistencia a i%raciones y golpes l es*igmomanómetro deer9 cumplir con los p9rra*os pertinentes del Documento /nternacional 0/M D 11 %por eemplo la sucl9usula A.2.2 de la edición de 1@@4 para los coques mec9nicos'.
"
-
Controles metrol$gicos
as regulaciones regionales o nacionales pueden prescriir la aproación de tipo la -eri*icación inicial & ? o periódica para los es*igmomanómetros no in-asi-os. stos controles deer9n cumplir las siguientes condiciones.
-!1Ti,o de ;omologaci$n
Al menos tres muestras de un nue-o es*igmomanómetro deer9n ser proadas.
tipo
de
os ensa&os para -eri*icar la con*ormidad con los requisitos metrológicos & t7cnicos se lle-ar9n a cao de con*ormidad con el ane#o A.
"erification
".0.- Initial erification At initial -eri*ication te requirements o* 5.1.1 6.2.1 and 6.4.4 sall e *ul*illed.
Traducción no ofcia d" a OIML R 16-13 2002 (E)
Testing sall e carried out according to A.1 A.4 and A.11. ".0.0 Su%se2uent erification ac instrument o* an appro-ed t&pe o* sp&gmomanometer sall e -eri*ied e-er& 2 &ears or a*ter repair. At least 5.1.1 sall e *ul*illed and tests must e carried out according to A.1.
-!&
.ealing
!.3.1 ,ontrol marCs +ill e put on lead seals *or +ic corresponding punced scre+s sall e attaced +ene-er necessar&. Tese seals sall pre-ent +itout destruction o* te control marCs$ in te case o* mercur& manometers$ te separation o* reser-oir and scale8 in te case o* all oter manometers$ te opening o* te casing. !.3.2 /* te construction o* te instrument guarantees securit& against an& inter*erence te metrological control marCs or te securit& marCs ma& e attaced in *orm o* laels. !.3.3 All seals sall e accessile +itout using a tool.
-!
Mar
Te de-ice sall e marCed +it te *ollo+ing in*ormation$ name and?or trademarC o* manu*acturer8 serial numer and &ear o* *arication8 measuring range and measuring unit8 t&pe appro-al numer %i* applicale'8 center o* te ladder indicating te correct position *or te cu** o-er te arter&8 and marCing on te cu** indicating te lim circum*erence *or +ic it is appropriate %see 6.1'. Te *ollo+ing additional marCings are required *or mercur& manometers$ s&mol *or see instructions *or useN8 indication o* te internal nominal diameter and te tolerance o* te tue containing mercur& %see 6.4.1'.
-!*
Manufacturer=s information
/n*ormation supplied & te manu*acturer sall compl& +it te speci*ications and requirements gi-en in tis :ecommendation. Te manu*acturerOs instruction manual sall contain te *ollo+ing in*ormation$ re*erence to 0/M : 16>1 including te completetitle8 e#planation o* te operating procedures +ic are important *or correct application %suc as te selection o* te appropriate cu** sie positioning o* te cu** and adustment o* te pressure reduction rate'8 a +arning to users o* equipment intended *or use inen-ironments emplo&ing inter-ascular *luid s&stems not to connect te output o* te lood pressure measuring de-ice to suc s&stems as air migt inad-ertentl& e pumped into a lood -essel i* *or e#ample uer locCs +ere used8 metods *or cleaning reusale cu**s8 nature and *requenc& o* te maintenance required to ensure tat te de-ice operates correctl& and sa*el& at all times8 it is recommended tat te per*ormance sould e cecCed at least e-er& 2 &ears and a*ter maintenance and repair & re>-eri*&ing at least te requirements in 5.1.1 6.2.1 %testing at least at ! C;a %5( mmIg' and 2! C;a %2(( mmIg'' and 6.4.48 internal nominal diameter and tolerance o* te tue containing mercur&8 and detailed instructions *or te sa*e andling o* mercur& %see Anne# ,'.
A!1 Met;od of test for t;e ma7imum ,ermissible errors of t;e cuff ,ressure indication A!1!1 A,,aratus
rigid metal -essel +it a capacit& o* 5(( ml L 5 K8 calirated re*erence manometer +it an uncertaint& less tan (.1 C;a %(." mmIg'8 pressure generator e.g. all pump %and pump' +ita de*lation -al-e8 T>piece connectors and oses.
Anne7 A Test ,rocedu (Mandator @
Traducción no ofcia d" a OIML R 16-13 2002 (E)
a climatic camer.
A!1!2 Procedure
:eplace te cu** +it te -essel. ,onnect te calirated re*erence manometer & means o* a T>piece connector and oses to te pneumatic s&stem %see =igure 2'. A*ter disaling te electromecanical pump %i* *itted' connect te pressure generator into te pressure s&stem & means o* anoter T>piece connector. ,arr& out te test in pressure steps o* not more tan ! C;a %5( mmIg' et+een ( C;a %( mmIg' and te ma#imum pressure o* te scale range. P
A!2!2 Procedure
:eplace te cu** +it te -essel. ,onnect te calirated re*erence manometer & means o* a T>piece connector to te pneumatic s&stem %see =igure 3'. A*ter disaling te electro>mecanical pump %i* *itted' connect te additional pressure generator into te pneumatic s&stem & means o* anoter T>piece connector.
1275
1275
A!1!& 7,ression of results 1
2
#press te results as te di**erences et+een te indicated pressure o* te manometer o* te de-ice to e tested and te corresponding readings o* te re*erence manometer %see ).2'. 500 ml
3
A!2 Met;od of test for t;e influence of tem,erature on cuff ,ressure indication A!2!1 A,,aratus
apparatus as speci*ied in A.1.18 plus P
1 2 &
/n case o* dout aout te linearit& spot cecCs sould e carried out or te +idt o* te pressure steps sould e reduced i.e. *rom te normall& recommended ! C;a %5( mmIg' to 3 C;a %2( mmIg'. Tis also applies to Tale 1 in Anne# ). > Reference manometer > Manometer of t;e de%ice to be tested > Metal %essel > Pressure generator 9igure 2 Measurement s8stem for determining t;e limits of error of t;e cuff ,ressure indication
1(
4
Traducción no ofcia d" a OIML R 16-13 2002 (E)
1275
3
1275
2
1
500 ml
4 5
1 > Reference manometer 2 > Climatic c;amber & > Manometer of t;e de%ice to be tested > Metal %essel * > Pressure generator 9igure & Measurement s8stem for determining t;e influence of tem,erature
=or eac o* te *ollo+ing cominations o* temperature and umidit& condition te de-ice *or at least 3 in te climatic camer to allo+ te de-ice to reac stead& conditions$
1( J, amient temperature "5 K relati-e umidit& %non>condensing'8
2( J, amient temperature "5 K relati-e umidit& %non>condensing'8 4( J, amient temperature "5 K relati-e umidit& %non>condensing'. ,arr& out te test o* te cu** pressure indication as descried in A.1.2 *or eac o* te cominations o* temperature and umidit& mentioned ao-e.
A!2!& 7,ression of results
#press te results as te di**erences et+een te indicated pressure o* te manometer o* te de-ice to e tested and te corresponding readings o* te re*erence manometer %see ).4' at te rele-ant temperature -alue.
11
Traducción no ofcia d" a OIML R 16-13 2002 (E)
A!& Met;od of test for t;e ma7imum ,ermissible error after storage
A!!2 Procedure
Rrap te cu** around te c&linder. A!&!1 A,,aratus
apparatus as speci*ied in A.1.1.
A!&!2 Procedure
:eplace te cu** +it te -essel. ,onnect te calirated re*erence manometer & means o* a T>piece connector to te pneumatic s&stem %see =igure 3'. A*ter disaling te electro>mecanical pump %i* *itted' connect te additional pressure generator into te pneumatic s&stem & means o* anoter T>piece connector.
Note: lectro>mecanical pumps +ic are part o* te de-ice ma& e used *or te test. ,arr& out te test o-er te +ole measuring range at at least *i-e equall& spaced pressure steps %e.g. ! C;a %5( mmIg' 13 C;a %1(( mmIg' 2( C;a %15( mmIg' 2! C;a %2(( mmIg' and 34 C;a %25( mmIg''. Test te air leaCage o-er a period o* 5 min and determine te measured -alue *rom tis.
A!!& 7,ression of results
#press te air leaCage as te rate o* te pressure loss per minute.
A!* Met;od of test for ,ressure reduction rate for deflation %al%es
Note: Tis is one test and not t+o separate tests. ,arr& out te test in pressure steps o* not more tan ! C;a %5( mmIg' et+een ( C;a %( mmIg' and te ma#imum pressure o* te scale range.
A!&!& 7,ression of results
#press te results as te di**erences et+een te indicated pressure o* te manometer o* te de-ice to e tested and te corresponding readings o* te re*erence manometer %see ).3'.
A! Met;od of test for air lea
A!!1 A,,aratus
rigid metal c&linder o* an appropriate sie %see 6.1'8 pressure generator e.g. all pump %and pump' +ita de*lation -al-e8 time measuring de-ice.
12
A!*!1 A,,aratus
T>piece connector8 calirated re*erence manometer +it signal output and an uncertaint& less tan (.1 C;a %(." mmIg'8 arti*icial lims %see Notes under A.5.2'8 recording unit.
A!*!2 Procedure
Measure te pressure reduction rate eiter on uman lims or arti*icial lims. Note -: Te intention is to use arti*icial lims ut as tese are still under consideration measurements per*ormed +it uman -olunteers are acceptale. Note 0: /t is intended tat te properties o* te arti*icial lims re*lect some elastic properties o* uman lims. )ecause cu** de*lation rate ma& e in*luenced & te +a& tat a cu** is applied te cu** sould e applied and remo-ed *or eac o* at least ten repeated measurements on at least t+o di**erent lim sies. Tese t+o lim sies sould e equal to te upper and lo+er limits o* lim circum*erences *or +ic a particular sie o* cu** is recommended to e used. A resetting o* te de*lation -al-e is permitted during te test.
Traducción no ofcia d" a OIML R 16-13 2002 (E)
,onnect te calirated re*erence manometer to te cu** & means o* a T>piece connector. ,onnect te output o* te calirated re*erence manometer to te recording unit. ;lot te pressure reduction in te *orm o* a pressure cur-e as a *unction o* time.
A!*!& 7,ression of results
Determine te rate o* pressure reduction & grapical e-aluation %& dra+ing tangents' at te pressure -alues o* ".( C;a %6( mmIg' 16.( C;a %12( mmIg' and 24.( C;a %1"( mmIg'. Te pressure reduction rate is te mean -alue calculated separatel& *or tese tree pressure -alues and *or te -arious lim circum*erences.
A!-!2 Procedure
Determine te ticCness o* te scale marCs and te scale spacing using te scaled magni*&ing lens.
A!0 Met;od of test for t;e internal diameter of t;e mercur8 tube A!0!1 A,,aratus
limit plug gauges or similar de-ices +it a tolerance less tan (.(5 mm. A!0!2 Procedure
A!+ Met;od of test for t;e ra,id e7;aust %al%e
Test te nominal internal diameter o* te tue at eac end & using te limit plug gauge.
A!+!1 A,,aratus
rigid metal -essel +it a capacit& o* 5(( ml L 5 K8 calirated re*erence manometer +it an uncertaint& less tan (.1 C;a %(." mmIg'8 T>piece connector8 time measuring de-ice.
A! Met;od of test for securit8 against mercur8 losses A!!1 A,,aratus
A!+!2 Procedure
,arr& out te test +it te -essel in place o* te cu**. ,onnect te calirated re*erence manometer & means o* a T>piece to te pneumatic s&stem. /n*late to te ma#imum pressure and open te rapid e#aust -al-e.
collecting -essel o* an adequate sie8 calirated re*erence manometer +it an uncertaint& less tan (.1 C;a %(." mmIg'8 T>piece connector8 pressure generator e.g. all pump %and pump' +ita de*lation -al-e.
A!+!& 7,ression of results
A!!2 Procedure
Measure te time et+een te pressure -alues speci*ied in 6.2.3.
;lace te sp&gmomanometer to e tested in te collecting -essel. ,onnect te pressure generator and a T>piece connector attaced to a calirated re*erence manometer directl& to te ose leading to te mercur& reser-oir. Use te pressure generator to raise te pressure in te manometer to 13.3 C;a %1(( mmIg' greater tan te ma#imum indicated scale reading on te test manometer. Maintain tis pressure *or 5 s and ten release te pressure in te s&stem.
A!- Met;od of test for t;e t;ic
,ecC tat no mercur& as spilled.
scaled magni*&ing lens or similar de-ice.
13
Traducción no ofcia d" a OIML R 16-13 2002 (E)
A!13 Met;od of test for t;e influence of t;e mercur8 sto,,ing de%ice A!13!1 A,,aratus
time measuring de-ice e.g. a stop+atc or an electronic timing de-ice8 pressure generator e.g. all pump %and pump' +ita de*lation -al-e.
A!13!2 Procedure
,onnect te pressure generator directl& to te ose leading to te mercur& reser-oir i.e. +itout connecting a cu**. Ren a gauge pressure o* more tan 2! C;a %2(( mmIg' as een reaced occlude te tue and remo-e te pressure generator. A*ter remo-ing te occlusion *rom te tue measure te time taCen *or te mercur& column to *all *rom te 2! C;a %2(( mmIg' marC to te 5 C;a %4( mmIg' marC.
pressure generator into te pneumatic s&stem & means o* anoter T>piece connector. Test te de-ice +it increasing pressure steps o* not more tan ! C;a %5( mmIg' to te scale ma#imum at +ic point old te pressure *or 5 min and ten decrease it & te same steps. Disconnect te calirated re*erence manometer during te 5 min at ma#imum pressure. A!11!& 7,ression of results
#press te results as te di**erence et+een te indicated -alues on te manometer at te same test pressure steps +en increasing te pressure and +en decreasing te pressure.
A!12 Met;od of test for t;e construction
A!12!1 A,,aratus
,ecC tat te e#aust time does not e#ceed 1.5 s.
A!11 Met;od of test for t;e ;8steresis error of t;e aneroid manometer
A!11!1 A,,aratus
alternating pressure generator +ic generates a sinusoidal pressure -ariation et+een 3 C;a and 3( C;a %2( mmIg and 22( mmIg' at a ma#imum rate o* 6( c&cles per minute.
A!12!2 Procedure
rigid metal -essel +it a capacit& o* 5(( ml L 5 K8
,arr& out te procedure speci*ied in A.1.
calirated re*erence manometer +it an uncertaint& less tan (.1 C;a %(." mmIg'8
,onnect te aneroid manometer directl& to te alternating pressure generator and per*orm 1( ((( alternating pressure c&cles.
pressure generator e.g. all pump %and pump' +ita de*lation -al-e8 T>piece connectors.
0ne our a*ter te stress test carr& out te procedure as speci*ied in A.1 at te same test pressure le-els as e*ore te stress test.
A!11!2 Procedure A!12!& 7,ression of results
:eplace te cu** +it te -essel. ,onnect te calirated re*erence manometer & means o* a T>piece connector to te pneumatic s&stem. A*ter disaling te electromecanical pump %i* *itted' connect te additional
14
#press te results as te di**erences et+een te indicated -alues on te manometer at te same test pressure steps e*ore and a*ter te stress test.
Traducción no ofcia d" a OIML R 16-13 2002 (E)
Anne7 ' Test Re,ort 9ormat (Mandator8 for a,,lication ?it;in t;e OIML Certificate System for Measuring Instruments) Explanatory notes on the test report format
i) General
Tis 9est report format +ic is in*ormati-e +it regard to te implementation o* 0/M :ecommendation : 16>1 in national regulations presents a standardied *ormat *or te results o* te -arious tests and e#aminations to +ic a t&pe o* sp&gmomanometer sall e sumitted +it a -ie+ to its appro-al as +ell as *or te results o* -eri*ication tests. Te tests are listed in Anne# A o* tis /nternational :ecommendation. /t is recommended tat all metrolog& ser-ices or laoratories e-aluating t&pes o* sp&gmomanometers according to 0/M : 16>1 or to national or regional regulations ased on 0/M : 16>1 use tis 9est report format directl& or a*ter translation into a language oter tan nglis or =renc. /t is also recommended tat tis 9est report format in nglis or in =renc %or in ot languages' e transmitted & te countr& per*orming tese tests to te rele-ant autorities o* anoter countr& under i> or multi>lateral cooperation agreements. /n te *rame+orC o* te OIML Certificate System for Measuring Instruments use o* te 9est report format is mandator&.
ii) Page numbering and the use of report page formats
/n addition to te sequential numering at te ottom o* eac page a space as een le*t at te top o* eac page %starting on page 1"' *or numering te pages o* reports estalised *ollo+ing tis model. /n particular eac test is reported indi-iduall& on a separate page *ollo+ing te rele-ant *ormat. =or a gi-en report it is ad-isale to complete te sequential numering o* eac page & indicating te total numer o* pages in te report. Rere required pressure -alues in te Tales can e replaced & -alues e#pressed in C;a. Rere required tese *orms can e copied and used se-eral times in cases +ere te test in question as to e repeated under -ar&ing conditions.
iii) efinitions and formula
=or te purposes o* tis test report *ormat te *ollo+ing de*initions and *ormula taCen *rom te International =oca%ulary of asic and
Con%entional true %alue (of a 6uantit8) S/M 1.2(
-alue attriuted to a particular quantit& and accepted sometimes & con-ention as a-ing an uncertaint& appropriate *or gi-en purpose. AM;< a'
at a gi-en location te -alue assigned to te quantit& realied & a re*erence standard ma& e taCen as a con-entional true -alue8
'
te ,0DATA %1@"6' recommended -alue *or te A-ogadro constant N A$ 6(22 136 !
8 1(23 mol Q1.
E0T<
15
Traducción no ofcia d" a OIML R 16-13 2002 (E)
1 ,on-entional true -alueN is sometimes called assigned %alue best estimate o* te -alue con%entional %alue or reference %alue . :e*erence -alueN in tis sense sould not e con*used +it re*erence -alueN in te sense used in te note to /M 5.!. 2 =requentl& a numer o* results o* measurements o* a quantit& is used to estalis a con-entional true -alue.
7,erimental standard de%iation S/M 3."
*or a series o* n measurements o* te same measurand te quantit& s caracteriing te dispersion o* te results and gi-en & te *ormula$
9
i
n1
% *i Q *> '2
V s V n Q 1
Q
*i eing te result o* te it measurement and * eing te aritmetic mean o* te n results considered.
E0T< Q
1 ,onsidering te series o* n -alues as a sample o* a distriution * is an uniased estimate o* te mean te -ariance
: and s2 is an uniased estimate o*
; o* tat distriution. 2
Q
2 Te e#pression s ? n is an estimate o* te standard de-iation o* te distriution o* * and is called t;e e7,erimental standard de%iation of t;e mean. 3 #perimental standard de-iation o* te mean is sometimes incorrectl& called standard error of t;e mean .
5ncertaint8 of measurement S/M 3.@
parameter associated +it te result o* a measurement tat caracteries te dispersion o* te -alues tat could reasonal& e attriuted to te measurand.
E0T< 1 Te parameter ma& e *or e#ample a standard de-iation %or a gi-en multiple o* it' or te al*>+idt o* an inter-al a-ing a stated le-el o* con*idence. 2 Uncertaint& o* measurement comprises in general man& components.
minus a true -alue o* te measurand.
E0T< 1
16
Traducción no ofcia d" a OIML R 16-13 2002 (E)
2 Ren it is necessar& to distinguis error *rom relati-e errorN te *ormer is sometimes called absolute error of measurement . Tis sould not e con*used +it absolute %alue of error +ic is te modulus o* te error.
De%iation
S/M 3.11 -alue
minus its re*erence -alue.
.8stematic error S/M 3.14
mean tat +ould result *rom an in*inite numer o* measurements o* te same measurand carried out under repeatailit& conditions minus a true -alue o* te measurand.
E0T< 1 <&stematic error is equal to error minus random error 2 iCe true -alue s&stematic error and its causes cannot e completel& Cno+n. 3 =or a measuring instrument see iasN %/M 5.25'.
Ma7imum ,ermissible errors (of a measuring instrument) S/M 5.21 e#treme -alues o* an error permitted
& speci*ications regulations etc. *or a gi-en measuring instrument.
1!
R"$ort $a&" <<<<=<<<<
OIML R 16-13 2002 (E)
@on>in%asi%e mec;anical s,;8gmomanometers OIML R 1+>1 dition 2332 ()
T.T RPORT TX; A;;:0A T
name
and
address$ ..................................................................................................................................... ............................................ .................................................................................................................................................... ................................................................................................................................................................................................ ,ustomerOs name and address$ ............................................................................................................................................ ..................................... ........................................................................................................................................................... ................................................................................................................................................................................................ Date o* receipt$ ..................................................................................................................................................................... Date?period o* measurement$ .............................................................................................................................................. Date o* report$ .................................................................. Eumer o* pages$ ................................................................... /ssuing /nstituteOs name and address$ ................................................................................................................................. ................................................ ................................................................................................................................................ ............................................... ................................................................................................................................................. ,aracteristic -alues %principle o* measurement measuring unit measuring range range o* displa&'$ ................................................................................................................................... ............................................. ................................................................................................................................................... Additional de-ices %printer inter*ace etc.'$ ........................................................................................................................ .............................................................. .................................................................................................................................. :e*erence manometer %serial numer uncertaint& caliration certi*icate'$ ................................................................... ................................................................................................................................................................................................
OIML R 16-13 2002 (E)
R"$ort $a&" <<<<=<<<<
'!1
Test re%ie?
'!1!1 .ummar8 of test results for t8,e a,,ro%al
,lause
).2
,u** pressure indication
).3
**ect o* storage on cu** pressure indication
).4
**ect o* temperature on cu** pressure indication
).5
Air leaCage rate o* te pneumatic s&stem
).6
;ressure reduction rate *or de*lation -al-es
).!
:apid e#aust -al-e
)."
:esistance to -iration and socC
).@
lectrical sa*et&
).1(
;ressure indicating de-ice
).1(.1
Eominal range and measuring range
).1(.2
Analogue indication >
).1(.3
Analogue indication > =irst scale marC
).1(.4
Analogue indication >
).1(.5
).11
Additional tecnical requirements *or mercur& manometers
).11.1
/nternal diameter o* te tue containing mercur&
).11.2
;ortale de-ices
).11.3
De-ice to pre-ent mercur& *rom eing spilled %use?transport'
).11.4
;er*ormance o* tis de-ice
).11.5
Yualit& o* te mercur&
).11.6
Wraduation o* te mercur& tue
).12
Additional requirements *or aneroid manometer
).12.1
Ma#imum de-iation
Ma#imum permissile error
;assed
=ailed
R"$ort $a&" <<<<=<<<<
OIML R 16-13 2002 (E)
).12.2
Zero
).12.3.1
;ointer lengt
).12.3.2
;ointer ticCness
).12.4
I&steresis error
).12.5
,onstruction and materials
).13
Tamper proo*ing
'!1!2 .ummar8 of test results for %erification
,lause
Ma#imum de-iation
).2
,u** pressure indication
).5
Air leaCage rate o* te pneumatic s&stem
).!
:apid e#aust -al-e
).@
lectrical sa*et&
).11.4
;er*ormance o* te de-ice to pre-ent mercur& *rom eing spilled %use?transport'
).11.5
Yualit& o* te mercur&
).12.4
I&steresis error
).13
Tamper proo*ing
Ma#imum permissile error
;assed
=ailed
Note -: Te sequence o* te di**erent tests is aritrar&8 it *ollo+s te sequence o* te di**erent clauses in te te#t. Te sequence o* testing is at te discretion o* te person conducting te tests. Note 0: To e considered as appro-ed or -eri*ied an instrument must a-e success*ull& passed all te applicale tests.
'!2
Ma7imum ,ermissible errors of t;e cuff ,ressure indication
=or te limits o* temperature and umidit& see 5.1.1$ te temperature sould e et+een 15 J, and 25 J, te relati-e umidit& sould e et+een 2( K and "5 K. To *ind out te error o* te cu** pressure indication proceed as *ollo+s %up and do+n runs' at tree di**erent temperatures$ e.g. 15 J, and 2( K relati-e umidit& 2( J, and 6( K relati-e umidit& and 25 J, and "5 K relati-e umidit&. Table 1 1
7am,le Tem,erature 23 BC and ! relati%e ;umidit8 2
3
4
1st reading
5
6
2nd reading
!
"
me an
@ de-iation
11 &steresis
reading
2nd reading
2
2
4
3
4
2
(
5
2
6
(
pressure mmIg
up
do+n
up
do+n
up
do+n
up
do+n
(
2
(
(
4
1
2
1
5(
52
54
54
54
53
54
1((
1(6
1((
1(4
1(4
1( 5
1(2
15(
1(
1st
OIML R 16-13 2002 (E)
R"$ort $a&" <<<<=<<<<
2(( 25(
ma#imum de-iation$ 5 mmIg
ma#imum &steresis$ 6 mmIg
,olumn 1 V -alues measured & te re*erence manometer ,olumn 2 3 4 and 5 V results o* te measurement o* te instrument under test ,olumn 6 V %column 2 [ column 4' ? 2 ,olumn ! V %column 3 [ column 5' ? 2 ,olumn " V column 6 Q column 1 ,olumn @ V column ! Q column 1 ,olumn 1( V as %column 2 Q column 3' ,olumn 11 V as %column 4 Q column 5'
Table 2 Tem,erature 23 BC and !!!!! relati%e ;umidit8 1
2
3
4
1st reading pressure mmIg
up
do+n
5
6
2nd reading up
do+n
!
"
mean up
@
1(
de-iation do+n
up
do+n
11 &steresis
1st reading
2nd reading
( 5( 1(( 15( 2(( 25( 3(( ma#
or
Ma#imum de-iation$ .............
Ma#imum &steresis$ .............
Note -: Te &steresis error is te di**erence et+een te indications o* te instrument +en te same pressure is reaced & increasing or decreasing te pressure. Note 0: Te time et+een up and do+n run sould not e less tan 5 minutes at te ma#imum pressure %see A.11.2'. A time di**erence *rom te *irst run to te second run o* one our is recommended. /s te ma#imum de-iation o* all o* te readings o* te instrument under test and o* te re*erence manometer less tan or equal to L (.4 C;a %L 3 mmIg' *or t&pe appro-al test and *irst -eri*ication and less tan or equal to L (.5 C;a %L 4 mmIg' *or susequent -eri*ication respecti-el& %see 5.1.1'\
&es passed
no *ailed
R"$ort $a&" <<<<=<<<<
'!&
OIML R 16-13 2002 (E)
ffect of storage on cuff ,ressure indication
:e*er to 5.1.2. Determine te error a*ter te storage *or 24 at a temperature o* Q 2( J, and *or 24 at a temperature o* !( J, and a relati-e umidit& o* "5 K %re*er to Note - elo+'. Note -: Te measurements are to e per*ormed e*ore and a*ter appl&ing te test conditions respecti-el&$
=irst measurement at 2( J, and 6( K relati-e umidit& e*ore te test %re*er to Tale 2'8
ac measurement requires t+o readings. ,alculate te de-iation o* te mean o* te t+o readings a*ter storage in Tale 3 *rom te mean calculated in Tale 2. Te result sould e +itin te error limits mentioned elo+. Note 0: Tese conditions appl& *or mecanical lood pressure measuring instruments onl&. Table & Measurement at 23 BC and +3 relati%e ;umidit8 after storage at E 23 BC and -3 BC pressure mmIg
1st reading a*ter storage up
do+n
2nd reading a*ter storage up
do+n
m ean up
do+n
de-iation et+een te mean a*ter storage and Tale 2 up do+n
( 5( 1(( 15( 2(( 25( 3(( or ma#
Ma#imum de-iation$ ............. /s te ma#imum de-iation o* te cu** pressure indication %mean -alue' a*ter storage at Q 2( J, and !( J, less tan or equal to L (.4 C;a %L 3 mmIg' compared to te mean -alues at 2( J, and 6( K relati-e umidit& e*ore storage\ &es passed
no *ailed
'!
ffect of tem,erature on cuff ,ressure indication
:e*er to 5.1.3. Note -: =or a t&pe appro-al test report testing as to e carried out also at 1( J, and 4( J, %see A.2.2'. Note 0: TaCe te *irst mean o* te readings o* te measuring instrument e*ore storage as re*erence -alue %Tale 2' and calculate te de-iation o* te mean o* te -alues measured a*ter storage %mean -alues ere in Tale 4' *rom te mean -alues o* Tale 2. Te result sould e +itin te error limits mentioned elo+. =or eac o* te *ollo+ing cominations o* temperature and umidit& condition te de-ice *or at least 3 in te climatic camer to allo+ te de-ice to reac stead& conditions. Table Tem,erature 13 BC and 0* relati%e ;umidit8
OIML R 16-13 2002 (E)
pressure mmIg
R"$ort $a&" <<<<=<<<<
1st reading up
2nd reading do+n
up
m ean do+n
up
de-iation *rom Tale 2 do+n
up
do+n
( 5( 1(( 15( 2(( 25( 3(( or ma#
Ma#imum de-iation$ ............. Table * Tem,erature 3 BC and 0* relati%e ;umidit8 pressure mmIg
1st reading up
2nd reading do+n
up
m ean do+n
up
de-iation *rom Tale 2 do+n
up
do+n
( 5( 1(( 15( 2(( 25( 3(( or ma#
Ma#imum de-iation$ ............. /s te ma#imum de-iation o* all o* te readings o* te instrument under test and te re*erence manometer less tan or equal to L (.4 C;a %L 3 mmIg'\ &es passed
no *ailed
'!*
Air lea
,arr& out te test o-er te +ole measuring range at *i-e equall& spaced pressure steps at least %e.g. ! C;a %5( mmIg' 13 C;a %1(( mmIg' 2( C;a %15( mmIg' 2! C;a %2(( mmIg' and 33 C;a %25( mmIg''. Test te air leaCage rate o-er a period o* 5 min %see A.4.2' and determine te measured -alue *rom tis.
Table +
pressure 5( mmIg 1(( mmIg 15( mmIg 2(( mmIg
*irst reading
reading a*ter 5 min
di**erence et+een te readings
R"$ort $a&" <<<<=<<<<
OIML R 16-13 2002 (E)
25( mmIg Does te air leaCage rate o-er a period o* 5 minutes correspond to a pressure drop less tan or equal to (.5 C;a?min %4 mmIg?min'\ &es passed
no *ailed
'!+
Pressure reduction rate for deflation %al%es
Manuall& operated de*lation -al-es sall e capale o* adustment to a de*lation rate o* (.3 C;a?s to (.4 C;a?s %2 mmIg?s to 3 mmIg?s'. Manuall& operated de*lation -al-es sall e easil& adusted to tese -alues. De*lation -al-es sall e tested in accordance +it 6.2.2 and A.5. /s te de*lation rate adustale to a -alue et+een (.3 C;a?s and (.4 C;a?s %2 mmIg?s and 3 mmIg?s'\
&es passed
no *ailed
'!-
Ra,id e7;aust %al%e
Testing sall e carried out in accordance +it 6.2.3 and A.6. Time *or te pressure reduction *rom 35 C;a to 2 C;a %26( mmIg to 15 mmIg'$
t:e V .........s
/s t:e less tan 1( s\ &es passed
no *ailed
'!0
Resistance to %ibration and s;oc<
:e*er to 6.6.1. Te mecanical conditions can e *ound in 0/M D 11 %*or e#ample clause A.2.2 o* te 1@@4 edition'. Does te instrument compl& +it 5.1.1 o* tis :ecommendation a*ter te -iration and socC test\
&es passed
no *ailed
'!
lectrical safet8 (T;is test is o,tional ?it;in t;e OIML Certificate .8stem)
OIML R 16-13 2002 (E)
R"$ort $a&" <<<<=<<<<
/* te instrument is equipped +it electrical de-ices do tese de-ices compl& +it regional and national sa*et& regulations\ &es passed
no *ailed
'!13 Pressure indicating de%ices All te tests can e carried out & -isual inspection. =or re*erence see$
'!13!1 @ominal range and measuring range
Does te nominal range e#tend *rom ( C;a to at least 35 C;a %( mmIg to at least 26( mmIg'\ &es no
passe d *ailed
'!13!2 Analogue indication > .cale
/s te scale clearl& readale\ &es no '!13!& Analogue indication > 9irst scale mar< /s tere a scale marC at ( C;a %( m mIg'\
passe d *ailed
& e s n o ' 13! Analogue indication > .cale inter%al
pass ed *aile d
/s te scale inter-al (.2 C;a or 2 mmIg *or a scale graduated in C;a or mmIg respecti-el&\
&es passed
R"$ort $a&" <<<<=<<<<
OIML R 16-13 2002 (E)
no *ailed
'!13!* Analogue indication > .cale s,acing and t;ic
/s te distance et+een adacent scale marCs not less tan 1.( mm and does te ticCness o* te scale marCs not e#ceed 2( K o* te smallest scale spacing\ &es passe d no *ailed Are te scale marCs o* equal ticCness\ &es
passe d
no
*ailed
'!11 Additional tec;nical re6uirements for mercur8 manometers '!11!1 Internal diameter of t;e tube containing mercur8
/s te nominal internal diameter o* te mercur& tue at least 3.5 mm L (.2 mm\
&es passed
no *ailed =or re*erence see 6.4.1. '!11!2 Portable de%ices
Does te portale de-ice a-e an adusting or locCing mecanism to secure it in a speci*ied position o* use\ &es passed
no *ailed =or re*erence see 6.4.2.
'!11!& De%ice to ,re%ent mercur8 from being s,illed during use and trans,ort
Does te tue a-e a de-ice to pre-ent te mercur& *rom eing spilled during transport and use and is tis de-ice e**icient\ &es passed
no *ailed
OIML R 16-13 2002 (E)
R"$ort $a&" <<<<=<<<<
=or re*erence see 6.4.3.
'!11! Influence of t;e de%ice to ,re%ent mercur8 from being s,illed during use and trans,ort
Does te dela& in te setting o* te mercur& column due to tis de-ice e#ceed 1.5 s *or te *lo+ o* te mercur& *rom 2! C;a to 5 C;a %*rom 2(( mmIg to 4( mmIg ' +en te pressure in te s&stem drops rapidl& *rom 2! C;a to ( C;a %*rom 2(( mmIg to ( mmIg'\ &es *ailed
no passed
=or re*erence see 6.4.3.
'!11!* Fualit8 of t;e mercur8
=or t&pe appro-al onl&$ Does te supplier con*irm tat te purit& o* te mercur& is not less tan @@.@@ K\ &es passed
no *ailed
=or re*erence see 6.4.4.1 =or t&pe appro-al and *or -eri*ication$ Does a -isual inspection so+ a clean meniscus and no ules o* air\ &es passed
no *ailed =or re*erence see 6.4.4.2.
'!11!+ Graduation of t;e mercur8 tube
Are te graduations permanentl& marCed on te tue containing mercur&\ &es passed
no *ailed =or re*erence see 6.4.5.
R"$ort $a&" <<<<=<<<<
OIML R 16-13 2002 (E)
Note: Eumered at eac *i*t scale marC te numering sall e alternatel& on te rigt>and and le*t>and side o* and adacent to te tue. All te tests can e carried out & -isual inspection.
'!12 Additional re6uirements for aneroid manometers '!12!1 .cale mar< at ero
/* a tolerance one is so+n at ero is it smaller tan L (.4 C;a %L 3 mmIg'\ &es passed
no *ailed
=or re*erence see 6.5.1. Note: Wraduations +itin te tolerance one are optional.
'!12!2 Hero
/s te mo-ement o* te elastic sensing element including te pointer ostructed +itin (." C;a %6 mmIg' elo+ ero\ &es *ailed
no passed
=or re*erence see 6.5.2. Note: Eeiter te dial nor te pointer sall e adustale & te user. '!12!& Pointer
=or re*erence see 6.5.3. All te tests can e carried out & -isual inspection.
.-0.3.- Pointer lengt& Does te pointer co-er et+een 1?3 and 2?3 o* te lengt o* te sortest scale marC o* te scale\ &es passed
no *ailed
OIML R 16-13 2002 (E)
R"$ort $a&" <<<<=<<<<
.-0.3.0 Pointer t&ic?ness /s te pointer ticCer tan te scale marC at te place o* indication and does te distance et+een te pointer and te dial e#ceed 2 mm\ &es *ailed
no passed
'!12! :8steresis error
/s te ma#imum &steresis error trougout te pressure range less tan or equal to (.5 C;a %4 mmIg' according to Tale 2\ &es passed
no *ailed
Note: Te purpose o* tis test is to determine i* te elastic sensing element as een e#posed to a tension +itin te elastic range %i.e. te IooCeOsN range' or not trougout te +ole pressure range. =or re*erence see 6.5.4. Te test sould e carried out according to A.11. '!12!* Construction and materials
/s te di**erence in te pressure indication o* te aneroid manometer a*ter 1( ((( alternating pressure c&cles more tan (.4 C;a %3 mmIg' at an& point +itin te pressure range\ &es *ailed
no passed
=or re*erence see 6.5.5. Te test sould e carried out according to A.12. Te pressure test as to e per*ormed according to ).2. Note: Te construction o* te aneroid manometer and te material *or te elastic sensing elements sall ensure an adequate stailit& o* te measurement. Te elastic sensing elements sall e aged +it respect to pressure and temperature.
'!1& Tam,er ,roofing Tamper proo*ing o* te manometer sall e acie-ed & requiring te use o* a tool. /s te manometer tamper proo*\ &es passed
R"$ort $a&" <<<<=<<<<
OIML R 16-13 2002 (E)
no *ailed
=or re*erence see 6.6.3. Tests sould e done & an appropriate inspection.