COMITET TEHNIC ASRO/CT 377 Medicale

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1 Direcţia Standardizare Raport de activitate 2017 CMITET TEHNIC ASR/CT 377 Medicale 1 Domeniu de activitate: Standardizarea în domeniile terminologiei, specificaţii, alergeni, metode de încercare, securitate, mijloace ajutătoare pentru persoane cu deficienţe, echipamente de anestezie şi reanimare respiratorie, stomatologie, dispozitive medicale neactive, managementul calităţii şi aspecte corespunzătoare privind dispozitivele medicale. 2 Comitete tehnice europene/internaţionale corespondente: TC (nr.) CEN/CLC/ETSI Denumire TC (limba engleză) TC SC (nr.) CEN/CLC/TC 3 Quality management and corresponding general aspects for CEN/SS S02 Transfusion equipment IS/TC 106/SC 1 CEN/SS S03 Syringes IS/TC CEN/SS S99 CEN/TC 102 CEN/TC 140 CEN/TC 204 CEN/TC 205 CEN/TC 206 CEN/TC 215 Health, environment and medical equipment - Undetermined Sterilizers and associated equipment for processing of In vitro diagnostic Sterilization of medical devices Non-active medical devices Biological and clinical evaluation of medical devices Respiratory and anaesthetic equipment IS/CEI Denumire TC (limba engleză) IS/TC 106 Dentistry 106/SC 2 IS/TC 106/SC 3 IS/TC 106/SC 4 IS/TC 106/SC 6 IS/TC 106/SC 7 IS/TC 106/SC 8 IS/TC 106/SC 9 IS/TC 121 CEN/TC 239 Rescue systems IS/TC 121/SC 1 CEN/TC 285 Non-active surgical IS/TC implants 121/SC 2 CEN/TC 293 Assistive products for IS/TC persons with disability 121/SC 3 CEN/TC 316 Medical products IS/TC utilizing cells, tissues 121/SC 4 and/or their derivatives Filling and restorative materials Prosthodontic materials Terminology Dental instruments Dental equipment ral care products Dental implants Dental CAD/CAM systems Anaesthetic and respiratory equipment Breathing attachments and anaesthetic machines Airways and related equipment Lung ventilators and related equipment Terminology and semantics CEN/TC 347 Methods for analysis of IS/TC Medical gas systems allergens 121/SC 6 CEN/TC 367 Breath-alcohol testers IS/TC Suction devices for hospital and 121/SC 8 emergency care use CEN/TC 55 Dentistry IS/TC 150 Implants for surgery P Statut ASR ( sau P) P P

2 IS/TC Materials 150/SC 1 IS/TC Cardiovascular implants and 150/SC 2 extracorporeal systems IS/TC Neurosurgical implants 150/SC 3 IS/TC Bone and joint replacements 150/SC 4 IS/TC steosynthesis and spinal devices 150/SC 5 IS/TC Active implants 150/SC 6 IS/TC Tissue-engineered medical products 150/SC 7 IS/TC 157 Non-systemic contraceptives and STI barrier prophylactics IS/TC 168 Prosthetics and orthotics P IS/TC 170 Surgical instruments IS/TC 173 Assistive products for persons with P disability IS/TC Wheelchairs 173/SC 1 IS/TC Classification and terminology P 173/SC 2 IS/TC Aids for ostomy and incontinence P 173/SC 3 IS/TC Assistive products for persons with 173/SC 7 impaired sensory functions IS/TC 194 Biological and clinical evaluation of IS/TC Tissue product safety 194/SC 1 IS/TC 198 Sterilization of health care products IS/TC 201 Surface chemical analysis IS/TC Terminology 201/SC 1 IS/TC X-ray Reflectometry (XRR) and X- 201/SC 10 ray Fluorescence (XRF) Analysis IS/TC General procedures 201/SC 2 IS/TC Data management and treatment 201/SC 3 IS/TC Depth profiling 201/SC 4 IS/TC Secondary ion mass spectrometry 201/SC 6 IS/TC Electron spectroscopies 201/SC 7 IS/TC Glow discharge spectroscopy 201/SC 8 IS/TC Scanning probe microscopy 201/SC 9 IS/TC 202 Microbeam analysis IS/TC Terminology 202/SC 1 IS/TC 202/SC 2 Electron probe microanalysis (FP /01-rev0/ ). 2

3 IS/TC Analytical electron microscopy 202/SC 3 IS/TC Scanning electron microscopy 202/SC 4 (SEM) IS/TC 210 Quality management and corresponding general aspects for IS/TC 212 Clinical laboratory testing and in vitro diagnostic test systems IS/TC 249 Traditional chinese medicine IS/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use IS/TC 84 Devices for administration of medicinal products and catheters P 3 Componenţă: Preşedinte: KSTRAKIEVICI Sorin DALIS MED CNSULTING (Microîntreprindere/PFA) Secretar: BUCUR Doina DALIS MED CNSULTING (Microîntreprindere/PFA) Membri: reprezentant (nume, prenume ) Membru CT Instituţie ANDRNESCU Ecaterina UPB - CASM ARSENESCU ana AVRAMESCU Elena Taina ANMDM - Agenţia Naţională a Medicamentului şi a Dispozitivelor Medicale a Craiova Tip de organizaţie (societate comercială, microîntreprindere, asociaţie profesională, asociaţie, instituţie publică, institut de cercetare, instituţie de învăţământ, persoană fizică etc.) BANU Geanina Silviana Process Innovation Nucleus IMM BUZATU Mihaela Persoană fizică Persoana fizică CĂCIULAN Elena Federaţia Română a Asociaţiilor de Fizioterapie CIBANU Doriana Ioana a radea CIBTĂ Dan ul National de Cercetare Dezvoltare pentru Mecatronica si Tehnica Masurarii CIUCUREL Constantin a Piteşti CRDUN Mariana a Naţională de Educaţie Fizică şi Sport CSTACHE Nicolae Process Innovation Nucleus IMM DUMITRAŞCU Florica Fan Welding Microîntreprindere FICAI Anton UPB - CASM FLRICĂ Răzvan Airbus Helicopter Romania IMM (FP /01-rev0/ ). 3

4 GHERGHIU Doina ILIESCU Alina KISS Katharina LAURENŢIU Mircea George ul National de Cercetare Dezvoltare pentru Mecatronica si Tehnica Masurarii a de Medicină şi Farmacie, Fac. de Moaşe şi Asistenţi Medicali Fundaţia Motivation România Asociaţia steore Altele MARIAN Justin Liviu Persoana fizică Persoana fizică MIHALACHE Margareta Ministerul Sănătăţii. Direcţia Generală Economică NANU Lavinia Mihaela Persoana fizică Persoana fizică NEAGE Daniela Anca Tehnoplus Medical IMM NEAGU Nicolae NISTR Mircea Iulian PRIŢA Bogdan a de Medicină şi Farmacie Tg. Mureş a Politehnica Bucuresti - Facultatea de Inginerie Mecanica şi Mecatronica Spitalul Clinic de Urgenţă Bucureşti - UPU SMURD PĂTRAŞCU Vasile Persoana fizică Persoana fizică PPA Constanţa PPA Iulian Marius RAVEICA Gabriela SAVU Nelida STANCA Daniela rdinul Biochimiştilor, Biologilor şi Chimiştilor în Sistemul Sanitar din Romania a de Medicina si Farmacie "Victor Babes" a "Vasile Alecsandri" Bacău ANMDM - Agenţia Naţională a Medicamentului şi a Dispozitivelor Medicale Federaţia Română a Asociaţiilor de Fizioterapie ŞERBESCU Carmen a radea THIERY Simona URSU Cornelia SPITALUL CLINIC DE URGENŢĂ pentru Copii Grigore Alexandrescu CLEGIUL JUDEŢEAN AL MEDICILR - IAŞI VLĂDICĂ Maria RENAR rganism acreditare ZAMFIR Aurelian Agenţia Naţională a Medicamentului şi a Dispozitivelor Medicale (FP /01-rev0/ ). 4

5 4 Număr de standarde aprobate în anul pentru care se efectuează evaluarea Standarde române originale elaborare 0 revizuire 0 Standarde române originale examinate 0 Versiune română (TR, NCT, FCT) 12 Notă de confirmare (NC) 52 Filă de confirmare (FC) 0 Total standarde 64 5 Finanţări Exemple: Contract MDRT, Proiect sectorial, furnizare traducere primară (de exemplu EN IS 9001) care devine versiune română oficială etc. Contract FPA, nr. standarde: 3 (3 realizate intern). Contract ANMDM, nr. standarde: 9 (8 subcontractate extern). Contracte alte ministere, proiecte, ASR, etc: 0 6 Număr şedinţe desfăşurate în anul pentru care se efectuează evaluarea Exemple de tematici posibile ale şedinţelor ASR/CT: elaborare standarde române originale, examinare standarde române originale, versiune română, analiza documentelor de vot, stabilire punct de vedere al comitetului ASR/CT referitor la documentele europene şi/sau internaţionale, alegere preşedinte, stabilire program de lucru pentru anul în curs etc. Nr. de şedinţe: 7. 7 Documente analizate şi votate (propunere de temă nouă, proiecte de CT pentru comentarii (CD), anchetă publică (CDV, DIS, ENQ_ faza 4020), vot final (FDIS _ faza 5020)) - se va trece numărul total pe organizaţie. rganizaţie CEN 183 CENELEC --- ETSI --- Număr documente analizate şi votate bservaţii (transmitere de comentarii, participare membri ASR/CT la elaborare documente de standardizare europene sau internaţionale, participare delegaţie R la întruniri ale organizaţiilor de standardizare europene, internaţionale etc.) IS 126 Comentarii privind indicativul standardului roman în cazul standardelor IS adoptate. CEI --- (FP /01-rev0/ ). 5

6 8 Patrimoniu naţional de standarde (la data evaluării) Patrimoniul ASR/CT cuprinde 581 standarde din care: Tip de standard Număr Metodă de Număr standarde adoptare standarde standarde române originale 15 NC+ER 346 standarde române care adoptă standarde sau documente de standardizare europene standarde române care adoptă standarde sau documente de standardizare internaţionale 534 FC TR, NCT, FCT Program de lucru pentru anul în curs 9.1 Proiecte aflate în program: elaborare/revizuire standarde române originale anchetă şi vot proiecte Nr. 0 CEN 167 IS 401 CENELEC --- CEI --- ETSI Adoptare de standarde şi documente de standardizare europene/internaţionale ca standarde române: Metodă de adoptare NC 7 FC 0 Nr.* TR (NCT,FCT) 21 * Numărul poate creşte funcţie de resursele disponibile (ex. contracte finanţare, realizare traduceri primare fără finanţare), de finalizarea proiectelor în lucru la CEN şi de cerinţele pieţii. (FP /01-rev0/ ). 6

7 10 Comentarii Comisie de Evaluare 11 Concluzii şi propuneri: stare ASR/CT Activ Suspendare Comasare Divizare Desfiinţare CMISIE CE DATA: NUME PRENUME FUNCŢIE SEMNĂTURĂ DINCĂ Valentina Expert standardizare ASR/CT LULEA Daniela CHILEA Iuliana Şef Serviciu Standardizare Generală Director Direcţie Standardizare (FP /01-rev0/ ). 7

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