CEN -EN 1060-1:1995 Non-invasive sphygmomanometers — Part 1: General requirements -— --

CEN -EN 1060-1:1995 Sfigmomanometri mhux invażivi – Parti 1: Rekwiżiti ġenerali -— --

CEN -EN 1060-2:1995 Non-invasive sphygmomanometers — Part 2: Supplementary requirements for mechanical sphygmomanometers -— --

CEN -EN 1060-2:1995 Sfigmomanometri mhux invażivi – Parti 2: Rekwiżiti supplementari għal sfigmomanometri mekkaniċi -— --

CEN -EN 1060-3:1997 Non-invasive sphygmomanometers — Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems -— --

CEN -EN 1060-3:1997 Sfigmomanometri mhux invażivi – Parti 3: Rekwiżiti supplementari għal sistemi elettromekkaniċi għall-kejl tal-pressjoni tad-demm -— --

CEN -EN 1060-4:2004 Non-invasive sphygmomanometers — Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers -— --

CEN -EN 1060-4:2004 Sfigmomanometri mhux invażivi – Parti 4: Proċeduri ta'ttestjar għad-determinazzjoni ta'l-eżattezza tas-sistema ġenerali ta'sfigmomanometri mhux invażivi awtomati -— --

Whereas mercury sphygmomanometers will be needed for the foreseeable future for testing and calibrating other blood pressure manometers, the position should be reviewed if and when evidence becomes available that non-mercury sphygmomanometers are suitable not only for the measurement of blood pressure trends, but also for the diagnosis and treatment of hypertension and for clinical trials.

Filwaqt li, fil-ġejjieni li jista'jitbassar, se jkunu meħtieġa l-isfigmomanometri tal-merkurju għat-testjar u l-kalibrar ta'manometri oħra għall-pressjoni tad-demm, il-pożizzjoni għandha tiġi riveduta jekk u meta ssir disponibbli l-evidenza li l-isfigmomanometri li ma jużawx il-merkurju huma xierqa mhux biss għall-kejl tal-bidliet fil-pressjoni ta-demm, iżda wkoll għad-dijanjożi u t-trattament ta'l-ipertensjoni u għall-provi kliniċi.

Member States were asked to provide feedback to the analysis presented. In particular, if Member States requested a widening of the scope of the restriction, they were asked to supply the technical, scientific and economic information necessary to justify the restriction and to demonstrate the proportionality. Subsequently 5 replies were received. Four Member States requested widening the scope to include sphygmomanometers used in the healthcare sector whereas one had the opposite opinion.

L-Istati Membri ntalbu jagħtu fidbek dwar l-analiżi ppreżentata. B’mod partikolari, jekk l-Istati Membri kienu staqsew għal twessigħ tar-restrizzjoni, intalbu jipprovdu t-tagħrif tekniku, xjentifiku u ekonomiku meħtieġ sabiex jiġġustifikaw ir-restrizzjoni u juru l-proporzjonalità. Sussegwentament waslu 5 tweġibiet. Erba'Stati Membri talbu li t-twessigħ ta'l-ambitu jinkludi l-isfigmomanometri użati fis-settur tal-kura tas-saħħa filwaqt li Stat minnhom kien ta'opinjoni kuntrarja.

The Commission referred the question of a potential restriction on sphygmomanometers used in healthcare sector to the Member State experts on medical devices. This consultation concluded that hospitals need a high level of accuracy to treat life-threatening conditions such as hypertension, arrhythmia and pre-eclampsia. Mercury sphygmomanometers provide the appropriate level of accuracy and reliability to maintain patient's safety. The same level of reliability is not yet achievable by alternative blood pressure monitors.

Il-Kummissjoni rreferiet il-mistoqsija dwar restrizzjoni potenzjali fuq l-isfigmomanometri użati fis-settur tal-kura tas-saħħa lill-esperti ta'l-Istati Membri dwar it-tagħmir mediku. Il-konsultazzjoni kkonkludiet li l-isptarijiet jeħtieġu livell ta'preċiżjoni għoli sabiex jitrattaw kundizzjonijiet li jistgħu jheddu l-ħajja bħall-ipertensjoni, l-aritmija u l-pre-eclampsia. L-isfigmomanometri tal-merkurju jipprovdu l-livell xieraq ta'preċiżjoni u affidabbiltà meħtieġ għas-sikurezza tal-pazjent. L-istess livell ta'affidabbiltà għadu ma jistax jintlaħaq bl-użu ta'strumenti alternattivi għall-kejl tal-pressjoni tad-demm.

Aneroid sphygmomanometer

Sfigmomanometru anerojdu