Slovenian legal metrology in the field of healthmetrolog.sk/wp-content/uploads/2015/06/Legal-metrology-health-Po... · measurement standards ... Blood pressure meters (BPM) Why these

REPUBLIC OF SLOVENIA MINISTRY OF ECONOMIC DEVELOPEMENT AND TECHNOLOGY METROLOGY INSTITUTE OF THE REPUBLIC OF SLOVENIA

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


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,

2000-2002), validity of Yugoslav‘s Rules…

• First designation for performing verification given (2001)

• SMN established (2002)

• EU Membership (2004)

• NAWID (2004)


Criteria for metrology legislation


Metrology Institute of the Republic of Slovenia - MIRS

NMI in Slovenia

Coordination of national metrology system

Traceability Legal metrology Supervision (Inspection)

ISO/IEC 17025 CIPM MRA

National Metrology System

in R Slovenia

Metrology Board

Ministry of economic development and technology

Calibration laboratories ISO/IEC 17025

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 ]

Rules on national

measurement standards (Official Gazette of RS no. 51/07)

DESIGNATION / STEERING / COOPERATION

REPORTING / COOPERATION

Metrology Act (Official Gazette of RS no. 26/05)

Designated Institutes - DI

2015: 40 employees


Legal Metrology in Slovenia

Law on Metrology

Units of measurement

Conformity assessment (CA)

of measuring instruments

NA

WI

MID

Old

ap

pro

ach

Na

tio

na

l

Authorization

of legal entities

for CA activities

Me

trolo

gic

al s

up

erv

isio

n

Pre-packed

products

Preparation of

national legislation in

collaboration with

other ministries

Global

harmonisation

(OIML)

Regional harmonization

(EU directives, WELMEC)

Verification of measuring

instruments in use


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. 300.000 verification per year

SUPERVISION (INSPECTION) - for MI on the market and in use:

• MIRS, SMN


Designated bodies (DB) - verification

• MIRS is responsible for designation

Initial, periodic and verifications after repair

Requirements:

ISO/IEC 17020 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


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 (~40.000 customers)

2. Pre-packed products(~700 customers)

3. Precious metal articles (~400 customers)

4. Unites of measurements


MIRS-Info


Legal metrology – measuring instruments

in health care system

Non-automatic weighing instruments (NAWI)

Blood pressure meters (BPM)

Why these two

only?

Metrology Act: health protection


Non-automatic weighing instruments (NAWI)

EU legislation Slovenian legislation

2009/23/EC (ex 90/384/EEC) 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:

?

REPUBLIC OF SLOVENIA MINISTRY OF ECONOMIC DEVELOPEMENT AND TECHNOLOGY METROLOGY INSTITUTE OF THE REPUBLIC OF SLOVENIA NAWI

conformity assessment national part

manufa

cture

r

putt

ing in u

se

Periodic/after repair verifications

Metrological supervision

EU : notified bodies SLO: MIRS &

Designated Bodies (12)

Verification period: 2 years

2009/23/EC



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. 10.000 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



EU legislation Slovenian legislation

93/42/EEC – MEDICAL DEVICES) 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


BPM conformity assessment

national part

manufa

cture

r

putt

ing in u

se

Periodic/after repair verifications

Metrological supervision

EU : Notified bodies

SLO: Designated Bodies (6)

Verification period: 2 years

SLO: MIRS accordance with

Yugoslavian BPM legislation

93/42/EEC

XXXX


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


A producer (name or sign): Riester, OMRON, WelchAllyn,

Speidel&Keller…

Serial number: 130715202044

year of production / CA procedure: 2013

CE mark and number of notify body: CE0123

or no. of type approval: SI 99-10-1

Marking on BPM

http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=directiv

e.notifiedbody&dir_id=13


Customers of supervision

• Health centres

• Hospitals

• Homes for the elderly

• Health resort (spa)

Performed supervision in more than 600 customers,

1-3 visits beetwen 2004-2015

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


Other medical devices in use

Controls:

• JAZMP like inspection body

Control bodies certification accordance to ISO 9001 - health

centres

Accreditation accordance to NIAHO or DIAS standard for

hospitals

Request: calibration according to manufacturer‘s instructions

Documents

Slovenian legal metrology in the field of healthmetrolog.sk/wp-content/uploads/2015/06/Legal-metrology-health-Po... · measurement standards ... Blood pressure meters (BPM) Why these