**4. Accreditation Types**

As it was mentioned earlier, there are 3 accreditation types for biomedical calibration meas‐ urements. They are:

**•** Calibration laboratories


### **4.1. Calibration Laboratories**

A calibration laboratory is a laboratory that performs test, calibration and repair of measur‐ ing instruments. The calibration of equipment is achieved by means of a direct comparison against measurement standards or certified reference materials. These standards are also regularly calibrated themselves, in comparison with another standard of lower uncertainty.

Calibration laboratories give services to all industry, textile, paint, food or health care etc. The company's working area is not important. The parameter to be measured is essential. For example, the mass for the weighing of food, rotational speed of the paint mixing device, hardness of the material used in manufacturing, the temperature of refrigerators used for

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The biomedical measurements in calibration laboratories are also performed generally as pa‐ rameter measurements. The parameters can be classified as electrical parameters, pressurevacuum parameters, temperature-humidity parameters, mass-volume parameters. An

The accreditation of calibration measurements is carried out via parameter measurements. Unlike other types of accreditation studies, parameter measurement is accredited for calibra‐ tion laboratory. As of today, ISO IEC 17025 is taken as the basis for laboratory accreditation purposes. This standard is recognized worldwide. The requirements of this standard are provided for the general requirements on a laboratory's quality management system and technical competence. Laboratories accredited according to ISO IEC 17025 are re-evaluated periodically by the accreditation body and decision is made for the maintenance of accredi‐

Laboratories intending to maintain accreditation are required to participate inter-laboratory comparison and proficiency testing programs on their scope of accreditation and achieve

The biomedical measurements in testing laboratories are performed on the basis of the med‐ ical device. The test procedures are prepared to test all parameters in the medical device. Defibrillators, ventilators...etc. are tested completely to measure all parameters in it. If there are many parameters in a device such as ECG parameters (electrical), blood pressure param‐ eters (pressure), body temperature parameters (temperature), they are measured in accord‐ ing to the measurement procedures in the place of where medical device works and a

In Turkey, the standard of 17025 is applied to testing laboratories for the medical devices. The content of the accreditation studies of testing laboratories can be seen in Table 2 and Table 3.

**Device Under Test Testing Name Testing Method - Standard**

Patient auxiliary leakage

current

Earth resistance TS EN 60601-1 (item 8.7) Chassis leakage current TS EN 60601-1 (item 8.7) Patient leakage current TS EN 60601-1 (item 8.7)

TS EN 60601-1 (item 8.7)

drug store. The parameters are measured and a calibration certificate is prepared.

example study for accreditation of calibration laboratories can be seen in Table 1.

tation based on results obtained.

successful results.

**4.2. Testing Laboratories**

certificate is prepared.

Electrical Safety Tests for all Electrical Biomedical Devices


**Table 1.** The content of accreditation studies of calibration laboratories.

Calibration laboratories give services to all industry, textile, paint, food or health care etc. The company's working area is not important. The parameter to be measured is essential. For example, the mass for the weighing of food, rotational speed of the paint mixing device, hardness of the material used in manufacturing, the temperature of refrigerators used for drug store. The parameters are measured and a calibration certificate is prepared.

The biomedical measurements in calibration laboratories are also performed generally as pa‐ rameter measurements. The parameters can be classified as electrical parameters, pressurevacuum parameters, temperature-humidity parameters, mass-volume parameters. An example study for accreditation of calibration laboratories can be seen in Table 1.

The accreditation of calibration measurements is carried out via parameter measurements. Unlike other types of accreditation studies, parameter measurement is accredited for calibra‐ tion laboratory. As of today, ISO IEC 17025 is taken as the basis for laboratory accreditation purposes. This standard is recognized worldwide. The requirements of this standard are provided for the general requirements on a laboratory's quality management system and technical competence. Laboratories accredited according to ISO IEC 17025 are re-evaluated periodically by the accreditation body and decision is made for the maintenance of accredi‐ tation based on results obtained.

Laboratories intending to maintain accreditation are required to participate inter-laboratory comparison and proficiency testing programs on their scope of accreditation and achieve successful results.

#### **4.2. Testing Laboratories**

**•** Testing laboratories

88 Practical Concepts of Quality Control

**4.1. Calibration Laboratories**

**Example Measurement Range**


50 – 100 µl

0 – 250 oC

20% - 70% RH

**Table 1.** The content of accreditation studies of calibration laboratories.

Pressure 0 - 70 bar Air 0,2 %

60 – 150 oC Dry block

A calibration laboratory is a laboratory that performs test, calibration and repair of measur‐ ing instruments. The calibration of equipment is achieved by means of a direct comparison against measurement standards or certified reference materials. These standards are also regularly calibrated themselves, in comparison with another standard of lower uncertainty.

> **Measurement Condition**

In controlled volume (oven, incubator, freezer….)

70 - 700 bar Hydraulic 0,2 %

0 – 600 gr E2 class mass 2 10-6

0 – 10 kg F1 class mass 1 10-5 0 – 150 kg M1 class mass 1 10-4 0 – 1000 kg M1-M2 mass 2 10-4

oil bath

200 µl 0,158 µl 500 µl 0,315 µl 1 ml 0,452 µl 2 ml 1,209 µl 5 ml 2,851 µl 10 ml 5,991 µl

in laboratory

Ice bath and dry block oven

Humidity cabinet

250 – 600 oC 0,82 oC

70% - 90% RH 2,2% RH

**Example Measurement Uncertainty**

0 – 60 oC Water bath 0,72 oC Measurement in

0,74 oC

0,100 µl

**Method Standard**

0,68 oC Euramet CG-13 / v.01

Euramet CG-17 / v.01

Euramet CG-18 / v.03

laboratory by using comparison method

laboratory by using comparison method

laboratory by using comparison method

TS ISO 4787 TS EN ISO 8655-2 TS EN ISO 8655-6

0,56 oC Measurement in

1,4% RH Measurement in

**•** Inspection bodies

**Measurement Parameter**

Temperature distribution of controlled volume

Scales (non automatic)

Temperature of glass thermometer

Volume Piston pipettes

Temperature meters with display

Moisture

The biomedical measurements in testing laboratories are performed on the basis of the med‐ ical device. The test procedures are prepared to test all parameters in the medical device. Defibrillators, ventilators...etc. are tested completely to measure all parameters in it. If there are many parameters in a device such as ECG parameters (electrical), blood pressure param‐ eters (pressure), body temperature parameters (temperature), they are measured in accord‐ ing to the measurement procedures in the place of where medical device works and a certificate is prepared.

In Turkey, the standard of 17025 is applied to testing laboratories for the medical devices. The content of the accreditation studies of testing laboratories can be seen in Table 2 and Table 3.



**Device Under Test Testing Name Testing Method - Standard**

Congestion performance

test

Air control test TS EN 60601-1-24 (item 51-104) Flow accuracy test TS EN 60601-1-24 (item 50-103)

Alarm test TS EN 60601-1-24 (item 51-106)

ECG pulse test TS EN 60601-2-27 (item 50.102.15) ECG amplitude test TS EN 60601-2-27 (item 50.102.15) ECG frequency test TS EN 60601-2-27 (item 50.102.8) ECG arythmia test TS EN 60601-2-27 (item 56.8) ECG ST test TS EN 60601-2-27 (item 50.102.15) ECG printer test TS EN 60601-2-27 (item 50.102.16) Pacemaker test TS EN 60601-2-27 (item 50.102.12) ECG alarm test TS EN 60601-2-27 (item 51.102) Breath performance test TS EN 60601-2-27 (item 50.102.8) Breath alarm test TS EN 60601-2-27 (item 51.102) NIBP performans test TS EN 60601-2-30 (item 50.2) NIBP cuff pressure test TS EN 60601-2-30 (item 22.4.1) NIBP cuff leakage test TS EN 60601-2-30 (item 50.2) NIBP alarm test TS EN 60601-2-30 (item 51.103) IBP static pressure test TS EN 60601-2-34 (item 51.102) IBP dynamic pressure TS EN 60601-2-34 (item 51.102) IBP alarm test TS EN 60601-2-34 (item 51.203.1) sPO2 performans test TS EN ISO 9919 (item 50.101) sPO2 alarm test TS EN ISO 9919 (item 104)

Vacuum test TS EN ISO 10079-1 Accuracy test TS EN ISO 10079-1 Flow test TS EN ISO 10079-1

System leak test TS EN 1060 Manometer test TS EN 1060 Accuracy test TS EN 1060

TS EN 60601-1-24 (item 2-122)

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Performance-Safety Tests for Infusion Pumps

Performance-Safety Tests for Aspirators

Performance-Safety Tests for Shymphonometers

Performance-Safety Tests for Patient Monitor

**Table 3.** The content of accreditation studies of testing laboratories (continued).

**Table 2.** The content of accreditation studies of testing laboratories.


**Table 3.** The content of accreditation studies of testing laboratories (continued).

**Device Under Test Testing Name Testing Method - Standard**

RMS chassis voltage TS EN 60601-1 (item 8.9) DC chassis voltage TS EN 60601-1 (item 8.9) Mains voltage TS EN 60601-1 (item 8) Device current TS EN 60601-1 (item 8)

ECG pulse test TS EN 60601-2-27 (item 50.102.15) ECG amplitude test TS EN 60601-2-27 (item 50.102.15) ECG frequency test TS EN 60601-2-27 (item 50.102.8) ECG arythmia test TS EN 60601-2-27 (item 56.8) Energy test TS EN 60601-2-4 (item 50) Charge time test TS EN 60601-2-4 (item 101) Synchronized discharge testTS EN 60601-2-4 (item 104)

Power distribution test TS EN 60601-2-2 (item 50.1) HF leak test TS EN 60601-2-2 (item 19.3.101) REM alarm test TS EN 60601-2-2 (item 52)

sPO2 performans test TS EN ISO 9919 (item 50.101) ECG pulse test TS EN 60601-2-27 (item 50.102.15)

sPO2 alarm test TS EN ISO 9919 (item 104)

NIBP performans test TS EN 60601-2-30 (item 50.2) NIBP cuff pressure test TS EN 60601-2-30 (item 22.4.1) NIBP cuff leakage test TS EN 60601-2-30 (item 50.2) NIBP alarm test TS EN 60601-2-30 (item 51.103)

Vacuum test TS EN ISO 10079-1 Accuracy test TS EN ISO 10079-1 Flow test TS EN ISO 10079-1

ECG pulse test TS EN 60601-2-27 (item 50.102.15) ECG amplitude test TS EN 60601-2-27 (item 50.102.15) ECG frequency test TS EN 60601-2-27 (item 50.102.8) ECG arythmia test TS EN 60601-2-27 (item 56.8) ECG ST test TS EN 60601-2-27 (item 50.102.15) ECG printer test TS EN 60601-2-27 (item 50.102.16)

TS EN 60601-1 (item 8.7)

Applied part leakage

current

Performance-Safety Tests for Defibrillators

90 Practical Concepts of Quality Control

Performance-Safety Tests for Electrosurgical Units

Performance-Safety Tests for Pulse Oximeter (sPO2)

Performance-Safety Tests for Electrocardiography (ECG)

Performance-Safety Tests for Noninvasive Blood Pressure Monitor (NIBP)

Performance-Safety Tests for Aspirators

**Table 2.** The content of accreditation studies of testing laboratories.

#### **4.3. Inspection Bodies**

Inspection bodies which applied for accreditation must accomplish the requirements of stand‐ ard ISO IEC 17020:2004. Inspection means investigation of the product design, product, serv‐ ice, process or the factory and their professional judgment based on the determination of the conformity of the general rules. Inspection bodies are conformity assessment companies. After the inspection, they transmit report to the customer, no certification. In Turkey, 17020 standard is applied for the radiography systems and clean room classification. The content of the accred‐ itation studies of inspection bodies can be seen in Table 4.

**Medical Device Inspection Type Standard**

Filtration and half value layer

Focus film distance

kVp accuracy and repeatability

Tube output, tube output speed and repeatability

Filtration and half value

Mean glandular tissue

layer

dose

Exposure time European Commission Radiation Protection No 91 IPEM Report No 91

Tube output European Commission Radiation Protection No 91

Patient entrance dose IPEM Report N:91, European Commission Radiation Protection N 162

X-ray beam size European Commission Radiation Protection No 91 IPEM Report No 91

Patient focus distance European Commission Radiation Protection No 91

Diagnosis

Manual

89

Tube output-mAs IPEM Report No 91, IPEM Report No 89

Compression force European Commission Radiation Protection No 91,

Image repeatability IPEM Report No 91

Tissue thickness sensor IPEM Report 89

No 91 FDA 21 CFR 1020.30

European Commission Radiation Protection

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European Commission European Guidelines for Quality in Breast Cancer Screening and

European Commission European Guidelines for Quality in Breast Cancer Screening and Diagnosis, European Commission Radiation Protection No 91, ACR Mammography QC

European Commission European Guidelines for Quality in Breast Cancer Screening and Diagnosis, European Commission Radiation Protection No 91 IPSM Report N59, ACR Mammography QC Manual, IPEM Report No

European Commission European Guidelines for Quality in Breast Cancer Screening and

European Commission European Guidelines for Quality in Breast Cancer Screening and Diagnosis, ACR Mammography QC Manual

Diagnosis, IPEM Report 89, ACR Mammography QC Manual

**PANORAMIC CONVENTIONAL DENTAL RADIOGRAPHY**

**CONVENTIONAL MAMMOGRAPHY**



**4.3. Inspection Bodies**

92 Practical Concepts of Quality Control

**CONVENTIONAL RADIOGRAPHY**

itation studies of inspection bodies can be seen in Table 4.

**Medical Device Inspection Type Standard**

Exposure repeatability

and linearity

Filtration and half value layer

Automatic exposure control

Grid adjustment

Leakage radiation

Inspection bodies which applied for accreditation must accomplish the requirements of stand‐ ard ISO IEC 17020:2004. Inspection means investigation of the product design, product, serv‐ ice, process or the factory and their professional judgment based on the determination of the conformity of the general rules. Inspection bodies are conformity assessment companies. After the inspection, they transmit report to the customer, no certification. In Turkey, 17020 standard is applied for the radiography systems and clean room classification. The content of the accred‐

> kVp IPEM Report No 32, European Commission Radiation Protection No 91

> Exposure time IPEM Report No 32, European Commission Radiation Protection No 91

> Tube output and stability IPEM Report No 32, European Commission Radiation Protection No 91

> Collimation IPEM Report No 32, European Commission Radiation Protection No 91

> X-ray beam alignment European Commission Radiation Protection No 91

> Focal spot size IPEM Report No 32, European Commission Radiation Protection No 91

> > AAPM Report No 74

FDA 21 CFR 1020.30

No 91 IPEM Report No 91

No 91

No 91

**INTRA-ORAL and** kVp European Commission Radiation Protection

Radiation Protection No 91

IPEM Report No 32, European

Commission Radiation Protection No 91

European Commission Radiation Protection

European Commission Radiation Protection

No 91

IPEM Report No 32, AAPM Report No 74, European Commission Radiation Protection

IPEM Report No 32, AAPM Report No 74, FDA 21 CFR 1020.30, European Commission


**Medical Device Inspection Type Standard**

**FLOROSCOPY RADIOGRAPY (STOMACH TABLE)**

**COMPUTED TOMOGRAPHY** High contrast and low contrast resolution

Exposure repeatability

High contrast and low contrast resolution

Position of external and internal scanning lights

Coronal and Sagittal

Table axial motion

Table helical motion

Computed tomography dose index (CTDI)

Tube output (CTDI Air)

and linearity

Alignment

accuracy

accuracy

and linearity

Contrast detail IPEM Report No 32

kVp IPEM Report No 91

Gray scale IPEM Report No 32

Contrast detail IPEM Report No 32

kVp IPEM Report No 32, Half value layer test IPEM Report No 32,

The slope of gantry AAPM Report No 39

IEC 61223-2-6

IEC 61223-2-6 Table distance sensor IPEM Report No 32, IPEM Report No 91

IPEM Report No 32

Slice thickness IPEM Report No 32, IEC 61223-2-6

Exposure time IPEM Report No 91 and 32, European

Tube output and stability IPEM Report No 91 and 32, European

Collimation IPEM Report No 91 and 32, European

No 32

AAPM Report No 74

European Commission Radiation Protection

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Commission Radiation Protection No 91

Commission Radiation Protection No 91

Commission Radiation Protection No 91

European Commission Radiation Protection No 91, Draft European Commission Radiation Protection No 162, IPEM Report

IPEM Report No 32, IPEM Report No 91

IPEM Report No 32, IPEM Report No 91

IPEM Report No 32, IPEM Report No 91,

IPEM Report No 32, IPEM Report No 91,

IPEM Report No 32, EC EUR 16262

IPEM Report No 91 and 32, European Commission Radiation Protection No 91,

No 91, IPEM Report No 32


**Medical Device Inspection Type Standard**

94 Practical Concepts of Quality Control

grid errors

Image contrast and high contrast resolution

Collimation, Grid factor and determination of

Image homogeneity and assessment of artifacts

Leakage radiation

Filtration and half value

Maximum exposure

Patient entrance dose

Compliance of areas (exposured-displayed)

Image amplified entrance

kVp

layer

speed

dose

**DIGITAL (FLAT PANEL) and CONVENTIONAL IMAGE AMPLIFIED FLOROSCOPY (DSA ANJIO, CARDIAC, C ARM MOBIL)**

European Commission European Guidelines for Quality in Breast Cancer Screening and Diagnosis, European Commission Radiation

European Commission European Guidelines for Quality in Breast Cancer Screening and Diagnosis, IPEM Report 89, European Commission Radiation Protection 91, ACR

European Commission European Guidelines for Quality in Breast Cancer Screening and

European Commission European Guidelines for Quality in Breast Cancer Screening and

IPEM Report No 32, IPEM Report No 91, European Commission Radiation Protection

IPEM Report No 32, IPEM Report No 91, IPEM Report No 32, European Commission Radiation Protection No 91, AAPM Report

European Commission Radiation Protection No 91 and 162, IPEM Report No 32, AAPM

European Commission Radiation Protection No 91 and 162, AAPM Report No 70 and 74

European Commission Radiation Protection

Draft European Commission Radiation Protection No 162, AAPM Report No 70,

No 91, AAPM Report No 74

Diagnosis, IPEM Report 89, ACR Mammography QC Manual

Protection No 91 and 162, ACR Mammography QC Mn

Mammo QC Manual

Diagnosis

No 74 Tube Output IPEM Report No 32, AAPM Report N:70

Report No 70 - 74

AAPM Report No 74

No 91, IPEM Report No 32

Brightness control IPEM Report N:32, AAPM Report No 70

Gray scale IPEM Report No 32 Image artifacts IPEM Report No 32


**6. Conclusion**

**Acknowledgements**

**Author details**

1 Istanbul University, Turkey

Mana Sezdi1\*

**References**

Quality service can be only taken from the accredited laboratories. As a matter of fact, the national and international procedures of accreditation say, "There is not an obligation. The

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Even if accreditation is not obligated, the expectation in medical calibration measurements is that the personnel must be professional, the calibration procedures and the test devices, cali‐

I would like to thank the co-operation of the calibration laboratories, the testing laboratories

[1] Abdel-Fatah Hesham , T. M. (2010, January). ISO/IEC 17025 Accreditation: Between

[2] Alexander, B. J. R., Flynn, A. R., Gibbons, A. M., Clover, G. R. G., & Herrera, V. E. (2008). New Zealand perspective on ISO 17025 accreditation of a plant diagnostic lab‐

[3] Brantner, C., Pope, R., Hannah, R., & Burans, J. (2011, July). Preparing a biological electron microscopy laboratory for ISO 17025 accreditation. *Microscopy & Microanaly‐*

[4] Bode, P. (2008, August). Role and evaluation of interlaboratory comparison results in

[5] Boldyrev, I. V., & Karpov, Y. A. (2004, January). Implementation of ISO/IEC 17025 standard for the accreditation of analytical laboratories in Russia. *Accreditation and*

laboratory accreditation. *AIP Conference Proceedings*, 1036(1), 29-37.

the desired gains and the reality. *Journal of Quality Assurance*, 13(1), 21-27.

and the inspection bodies that present the content of their accreditation studies.

accreditation depends on the base of voluntary." (TURKAK website).

brators must be appropriate to the international standards.

Address all correspondence to: mana@istanbul.edu.tr

oratory. *Bulletin OEPP*, 38(2), 172-177.

*Quality Assurance*, 9(1-2), 99-105.

*sis*, 17(52), 1154-1155.

**Table 4.** The content of accreditation studies of inspection bodies.
