Slovenian legal metrology in the field of health

Transcription

1 Slovenian legal metrology in the field of health Mojca Požar, M. Sc., Metrology Institute of the Republic of Slovenia (MIRS) Metrology Supervision Division (SMN) Zvolen, Slovakia, 27 May 2015

2 Milestones of legal metrology in Slovenia Republic of Slovenia became independent (June 1991) Standard and Metrology Institute (USM) established (June 1991, from April 2001 Metrology Institute of the Republic of Slovenia (MIRS)) Slovene Law on Metrology (1995, updated in 2000, 2004) Significant number of measuring instruments deregulated (1998, ), validity of Yugoslav s Rules First designation for performing verification given (2001) SMN established (2002) EU Membership (2004) NAWID (2004)

3 Criteria for metrology legislation

4 National Metrology System in R Slovenia Ministry of economic development and technology Metrology Act (Official Gazette of RS no. 26/05) Metrology Board DESIGNATION / STEERING / COOPERATION Designated Institutes - DI Rules on national measurement standards (Official Gazette of RS no. 51/07) REPORTING / COOPERATION Metrology Institute of the Republic of Slovenia - MIRS NMI in Slovenia 2015: 40 employees Coordination of national metrology system Traceability Legal metrology Supervision (Inspection) MIRS/SIQ/Metrology [ A, s ] MIRS/UL-FE/LMK [ K ] MIRS/UM-FS/LTM [ m ] MIRS/SFM [ kg, l ] MIRS/KI/L-05 [ mol ] MIRS/IMT/LMT [ Pa ] MIRS/NIB/FITO [ mol ] MIRS/SKM [ mol ] MIRS/IJS/F-2,O-2 [ Sv, Gy, Bq, mol ] MIRS/ZAG/SM 480 [ mol ] MIRS/UP-ZRS/LPOO [ mol ] ISO/IEC CIPM MRA Calibration laboratories ISO/IEC 17025

5 NAWI MID Old approach National REPUBLIC OF SLOVENIA Legal Metrology in Slovenia Law on Metrology Units of measurement Authorization of legal entities for CA activities Preparation of national legislation in collaboration with other ministries Conformity assessment (CA) of measuring instruments Verification of measuring instruments in use Regional harmonization (EU directives, WELMEC) Pre-packed products Global harmonisation (OIML) Metrological supervision

6 Metrological control in Slovenia CONFORMITY ASSESMENT (CA) - for new measuring instruments (MI): MIRS authorised for national and old approach CA procedures; 2 notified bodies in Slovenia (MIRS and SIQ) VERIFICATION for MI in use : MIRS designated bodies (38) app verification per year SUPERVISION (INSPECTION) - for MI on the market and in use: MIRS, SMN

7 Designated bodies (DB) - verification MIRS is responsible for designation Initial, periodic and verifications after repair Requirements: ISO/IEC type C accreditation staff (technically competent, professional integrity, confidentiality), equipment, competency metrology requirements for MI and verification procedure MIRS s Surveilance upon designation - MIRS-Info database: planning and reporting of all verifications - Periodic audit to designated company - On-field unexpected visit

8 Metrological supervision (inspection) Performers an authorised official person of MIRS: INSPECTOR (at least high technical school, state exam for inspector) conduct more complex procedurs; 4 employees METROLOGICAL SUPERVISOR (at least secondary technical school, exam within MIRS) conduct simple procedurs, control testing: 8 1 employees Supervisional fields: 1. Measuring instruments (~ customers) 2. Pre-packed products(~700 customers) 3. Precious metal articles (~400 customers) 4. Unites of measurements

9 MIRS-Info

10 Legal metrology measuring instruments in health care system Metrology Act: health protection Non-automatic weighing instruments (NAWI) Blood pressure meters (BPM) Why these two only?

11 Non-automatic weighing instruments (NAWI) EU legislation 2009/23/EC (ex 90/384/EEC) Slovenian legislation Rules on metrological requirements for NAWI (RS Off. G. No. 97/03) Responsible body: MIRS Field of use: - in the practice of medicine for weighing patients for the purposes of monitoring, diagnosis and medical treatment - in medical and pharmaceutical laboratories? Mandatory marking:

12 manufacturer putting in use REPUBLIC OF SLOVENIA EU : notified bodies NAWI SLO: MIRS & Designated Bodies (12) conformity assessment national part 2009/23/EC Periodic/after repair verifications Metrological supervision Verification period: 2 years

13 Blood pressure meters (BPM) GLOBAL MARKET REGULATION: 93/42/EEC-Medical devices OIML R 16-1 Non-invasive mechanical sphygmomanometers OIML R 16-2 Non-invasive automated sphygmomanometers SLOVENIAN NEEDED: App BPM in use Very important measuring in helth services SLOVENIAN CAPABILITIES: Long tradition for performing verification - knowlage on MIRS and in private sector; performed 4 SI type approval certificates

14 Blood pressure meters (BPM) EU legislation 93/42/EEC MEDICAL DEVICES) Slovenian legislation Act and Rules for medical devices (RS Off. G. No...) Responsible body: Ministry of health, Public agency for medicament and medical devices (JAZMP) For instruments in use: Rules about procedures for regular verification of BMP(RS Off. G. No. 24/04, 37/06) Responsible body: MIRS Field of use: health care services

15 manufacturer putting in use REPUBLIC OF SLOVENIA conformity assessment EU : Notified bodies 93/42/EEC BPM SLO: Designated Bodies (6) national part XXXX Periodic/after repair verifications SLO: MIRS accordance with Yugoslavian BPM legislation Metrological supervision Verification period: 2 years

16 Periodical verification of BPM Metrological requirements and procedures: in accordance with OIML R 16-2 OIML R16-1 Different type of BPM: Mehanical Electronic-AUTOMATED ANEROID MARCURY Verification period: 2 years from beggining of use

17 Marking on BPM A producer (name or sign): Riester, OMRON, WelchAllyn, Speidel&Keller Serial number: year of production / CA procedure: 2013 CE mark and number of notify body: CE0123 or no. of type approval: SI e.notifiedbody&dir_id=13

18 Customers of supervision Health centres Hospitals Homes for the elderly Health resort (spa) Performed supervision in more than 600 customers, 1-3 visits beetwen Degree of quality in the field: about 0,77 (1,0 = suitable, 0,0 = non-suitabe) Non-suitabilities: non-valid verification mark, NAWI without CA procedures

19 Other medical devices in use Request: calibration according to manufacturer s instructions Controls: JAZMP like inspection body Control bodies certification accordance to ISO health centres Accreditation accordance to NIAHO or DIAS standard for hospitals