—   —  —  60601-1-3-2013 . 1-3. . .


60601-1-3-2013 . 1-3. . .

60601-1-3-2013 . 1-3. . .

60601-1-3-2013
" . 1-3. . . "
(. 8 2013 . N 1531-)

Medical electrical equipment. Part 1-3. General requirements for basic safety and essential performance. Collateral Standard. Radiation protection in diagnostic X-ray equipment

- 1 2015 .

, . - , - . . 60601-1 , , . . , . , , . .

, 60 (ICRP) [17]*, 4. . , . .

, . .

, . :

- ;

- , ;

- , , ;

- ;

- , ;

- , .

ICRP 33 [15], 34 [16], 60 [17], 73 [18], 85 [21], 87 [22] 93 [23].

60601-1 ( 5) , . , , , , .

1 ,

1.1

, ME ME .

, , .

1.2

, , .

, , , , . / , . .

, .

, , 60601-1, .

1.3

1.3.1 60601-1

60601-1 ME ME .

60601-1 , , :

- " " 60601-1;

- " " 60601-1-3;

- " " .

1.3.2

.

2

, . . ( ).

60336 . (IEC 60336, Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal sports)

60522:1999 . (IEC 60522:1999, Determination of the permanent filtration of X-ray tube assemblies)

60601-1:2005 . 1. (IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)

/ 60788:2004 . (IEC/TR 60788:2004, Medical electrical equipment - Glossary of defined terms)

497 , (ISO 497, Guide to choice of series of preferred numbers and of series containing more rounded values of preferred numbers)

3

, 60601-1, / 60788 .

- . 31 .

3.1 (ACCESSIBLE SURFACE): , , .

3.2 (ADDED FILTER): , .

3.3 (ADDITIONAL FILTRATION): , , .

3.4 , (AIR KERMA, ): dEtr dm:

mfimage001.gif,

dEtr , dm.

(-1) . () (ICRU 60) [20].

[ 60580, 3.2] [8]

3.5 (AIR KERMA RATE): dK dt:

mfimage002.gif,

dK - dt.

-1-1. , (-1) (ICRU 60) [20].

[ 60580, 3.3] [8]

3.6 ( ), H*(d) (Ambient dose equivalent): , , IRCU - d , .

-1.

() (ICRU 51) [19].

3.7 (ATTENUATION): , .

- , , . .

3.8 , δ (ATTENUATION EQUIVALENT): , . , .

3.9 (AUTOMATIC CONTROL SYSTEM): - , , , .

3.10 (AUTOMATIC EXPOSURE CONTROL): - , .

3.11 (BEAM LIMITING DEVICE): .

3.12 (BEAM LIMITING SYSTEM): , .

3.13 (CONTINUOUS ANODE INPUT POWER): , .

().

3.14 (CONTROL PANEL): , . .

3.15 (CONTROLLED AREA): , , , .

3.16 - (CURRENT TIME PRODUCT): - , , -; .

3.17 (DIAPHRAGM): .

3.18 , H (DOSE EQUIVALENT, ): D Q :

H=QD,

D - ;

Q - .

(-1). () (ICRU 51) [19].

3.19 (EDGE FILTER): , .

3.20 (EFFECTIVE IMAGE RECEPTION AREA): , , .

1 , , , .

2 , , , , .

3.21 (ENTRANCE SURFACE): - , .

3.22 (EXTRA-FOCAL RADIATION): - , , .

3.23 (FILTER): - , .

3.24 (FILTRATION): .

- : ; .

3.25 (FOCAL SPOT IMAGE RECEPTOR DISTANCE): .

3.26 - (FOCAL SPOT SKIN DISTANCE): - , , .

3.27 (HALF-VALUE LAYER HVL): , , , , . .

3.28 (IMAGE RECEPTION AREA): - , .

3.29 (IONIZING RADIATION): , . .

3.30 (IRRADIATION): . - , , .

3.31 (IRRADIATION SWITCH): - , / .

3.32 (IRRADIATION TIME): , ; , .

3.33 (LEAKAGE RADIATION): , , , (, , ).

3.34 (LOADING): - .

3.35 (LOADING FACTOR): , , , , , , .

3.36 (LOADING STATE): - , , .

3.37 (LOADING TIME): , .

3.38 (MEASURED VALUE): , .

3.39 (MEDICAL RADIOLOGY): , , .

3.40 (MODE OF OPERATION): - , , .

1 , .

2 , , .

3.41 (NARROW BEAM CONDITION): .

3.42 (NOMINAL X-RAY TUBE VOLTAGE): .

3.43 (PATIENT ENTRANCE REFERENCE POINT): , .

- .

3.44 (PERCENTAGE RIPPLE): - .

3.45 (PERMANENT FILTRATION): , , , .

3.46 (PHANTOM): , .

3.47 (PRIMARY PROTECTIVE SHIELDING): , .

3.48 (PROTECTED AREA): , , , .

3.49 (PROTECTIVE BARRIER): , .

3.50 (PROTECTIVE DEVICE): , .

- , , , , , .

3.51 (PROTECTIVE SHIELDING): , .

- , , , , .

3.52 (QUALITY EQUIVALENT FILTRATION): , ( ), , , .

, .

3.53 (RADIATION): .

- :

- ; , , (), , , -;

- ; -, -, , .

3.54 (RADIATION APERTURE): , .

3.55 (RADIATION BEAM): - , , , .

.

- .

3.56 (RADIATION CONDITION): , , .

- " " , .

3.57 (RADIATION DETECTOR): (, ), , .

3.58 (RADIATION FIELD): , , .

- .

3.59 (RADIATION PROTECTION): :

- ;

- .

3.60 (RADIATION QUALITY): , .

- :

a) ;

b) ;

c) ;

d) ;

e) .

3.61 (RADIATION SOURCE): , .

3.62 (RADIATION SOURCE ASSEMBLY): , :

- ;

- , , , ;

- .

- .

3.63 (RADIOGRAPHIC RATING): - , .

3.64 (RADIOGRAPHY): , , , , , , .

3.65 (RADIOLOGICAL): , , , .

3.66 (RADIOLOGICAL IMAGE): , , , .

3.67 (RADIOLOGICAL INSTALLATION): , .

- .

3.68 (RADIOLOGY): .

3.69 (RADIOSCOPY): .

3.70 (REFERENCE AIR KERMA): , , .

3.71 (REFERENCE AIR KERMA RATE): , , .

3.72 (RESIDUAL RADIATION): , .

3.73 (SCATTERED RADIATION): , , / .

3.74 (SIGNIFICANT ZONE OF OCCUPANCY): - , , .

3.75 (STRAY RADIATION): - , , , .

3.76 (STRUCTURAL SHIELDING): , , .

3.77 (TOTAL FILTRATION): , .

3.78 (X-RAY EQUIPMENT): , , .

3.79 (X-RAY GENERATOR): , , , .

3.80 (X-RAY IMAGING ARRANGEMENT): .

3.81 (X-RAY IMAGE RECEPTOR): , , .

- , , .

3.82 (X-RAY PATTERN): , .

3.83 (X-RAY TUBE): , , , .

- , .

3.84 (X-RAY TUBE ASSEMBLY): .

3.85 (X-RAY TUBE CURRENT): , . ().

3.86 (X-RAY TUBE HOUSING): , , ; .

3.87 (X-RAY TUBE LOAD): , .

3.88 (X-RAY TUBE VOLTAGE): , . ().

4

4.1

:

" 60601-1-3",

- (, ), .

4.2

, 99, 9% .

5 , ME

5.1 ME

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5.1.2

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5.1.1

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5.2

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2 - , ,

5.2.2

5.2.3

5.2.4.1

5.2.4.2

5.2.4.3

5.2.4.4

5.2.4.5

5.2.4.6

6.3.2

6.4.3

6.4.5

6.5

6.6

6.7.2

6.7.4

7.3

8.5.2

- -

9.2

-

10.2

12.3

-

13.1

13.2

13.3

13.4

5.2.2

, , , .

.

5.2.3

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5.2.4.3

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.

5.2.4.4

, , , , / , , .

.

5.2.4.5 * (ICRP60) [17]

, , , . , , , :

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b) , , ;

c) , , ( ) .

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6

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6.4.1

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.

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1, 8

110

3, 9

60

2, 2

120

4, 3

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2, 5

130

4, 7

80

2, 9

140

5, 0

90

3, 2

150

5, 4

100

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11

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:

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- 60601-1-3 , .

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, , 60 60 200 .

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f) ;

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_________

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5.2.4.5 (ICRP60) [17]

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13.6

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()

R'10 R'20 497

, 6.3 , , R'10 R'20.

.1 - R'10 R'20 497

R'10

R'20

1, 0000

1, 00

1, 00

1, 1220

-

1, 10

1, 2589

1, 25

1, 25

1, 4125

-

1, 40

1, 5849

1, 60

1, 60

1, 7783

-

1, 80

1, 9953

2, 00

2, 00

2, 2387

-

2, 20

2, 5119

2, 50

2, 50

2, 8184

-

2, 80

3, 1623

3, 20

3, 20

3, 5481

-

3, 60

3, 9811

4, 00

4, 00

4, 4668

-

4, 50

5, 0119

5, 00

5, 00

5, 6234

-

5, 60

6, 3096

6, 30

6, 30

7, 0795

-

7, 10

7, 9433

8, 00

8, 00

8, 9125

-

9, 00


()

2 60601-1-3 1

2

1

2.204

1

1

,

1.1

1.201

1.2

1.202

1.3

1.203

2

3

2

3

2.205

4

4.1

4.201.1

4.2

2.203

5

6

, ME

5.1

6.1

ME

5.1.1

6.1.202

5.1.2

6.1.201

5.2

6.8

5.2.1

6.8.201

5.2.2

5.2.3

6.8.202

5.2.4

6

6.1

6.2

6.3

6.4

6.5

6.6

6.7

7

29.201

7.1

29.201.2

29.201.5

7.2

7.3

29.201.6

7.4

29.201.7

,

7.5

29.201.8

7.6

29.201.9

8

29.202

8.1

8.2

29.202.1

8.3

29.202.2

8.4

29.202.3

8.5

29.203

8.5.1

8.5.2

29.203.2

8.5.3

29.203.4

8.5.4

9

29.205

-

9.1

9.2

29.205.3

10

29.206

,

10.1

10.2

29.206.2.

11

29.207

12

29.204

12.1

12.2

29.204.1

12.3

29.204.2

12.4

29.204.3

12.5

29.204.5

13

29.208

13.1

13.2

29.208.2

13.3

29.208.1

13.4

29.208.3

13.5

29.208.5

13.6

29.208.6

R'10 R'20 497

2 60601-1-3 1


()


.1

60336

IDT

60336-2010 " -. "

60522:1999

IDT

IEC 60522-2011 " . "

60601-1:2005

IDT

60601-1-2010 " . 1. "

/ 60788:2004

IDT

/ 60788-2009 " . "

497

-

*

* . . .

- :

- IDT - .

[1]

IEC 60601-2-7:1998, Medical electrical equipment - Part 2 - 7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators

[2]

IEC 60601-2-28:1993, Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis

[3]

IEC 60601-2-29:1999, Medical electrical equipment - Part 2 - 29: Particular requirements for the safety of radiotherapy simulators

[4]

IEC 60601-2-32:1994, Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment

[5]

IEC 60601-2-43:2000, Medical electrical equipment - Part 2 - 43: Particular requirements for the safety of X-ray equipment for interventional procedures

[6]

IEC 60601-2-44:2001, Medical electrical equipment - Part 2 - 44: Particular requirements for the safety of X-ray equipment for computed tomography* Amendment 1 (2002)

[7]

IEC 60601-2-45:2001, Medical electrical equipment - Part 2 - 45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices

[8]

IEC 60580:2000, Medical electrical equipment - Dose area product meters

[9]

IEC 60627:2001, Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids

[10]

IEC 60878, Graphical symbols for electrical equipment in medical practice

[11]

IEC 61262 (all parts), Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers

[12]

IEC 62220 (all parts), Medical electrical equipment - Characteristics of digital X-ray imaging devices

[13]

IEC 62220-1:2003, Medical electrical equipment - Characteristics of digital X-ray imaging devices - Determination of the detective quantum efficiency

[14]

ISO 7004:2002, Photography - Industrial radiographic films - Determination of ISO speed, ISO average gradient and ISO gradients G2 and G4 when exposed to X- and gamma-radiation

[15]

ICRP Publication 33: Protection against ionizing radiation from external sources used in medicine (Annals of the ICRP Vol. 9 No. 1, 1982). Published by Pergamon Press

[16]

ICRP Publication 34: Protection of the patient in diagnostic radiology (Annals of the ICRP Vol. 9 No. 213, 1982). Published by Pergamon Press

[17]

ICRP Publication 60:1990 Recommendations of the International Commission on Radiological Protection (Annals of the ICRP Vol. 21 No. 1 - 3, 1991). Published by Pergamon Press

[18]

ICRP Publication 73: Radiological protection and safety in medicine (Annals of the ICRP Vol. 26 No. 2, 1996). Published by Pergamon Press

[19]

ICRP Report 51: Quantities and Units in Radiation Protection Dosimetry (1993)

[20]

ICRP Report 60: Fundamental Quantities and Units for Ionizing Radiation (1998)

[21]

ICRP Publication 85: Avoidance of Radiation Injuries from Medical Interventional Procedures (Annals of the ICRP Vol. 30 No. 2, 2000). Published by Pergamon Press

[22]

ICRP Publication 87: Managing Patient Dose in Computed Tomography (Annals of the ICRP Vol. 30 No. 4, 2000). Published by Pergamon Press

[23]

Publication 93: Managing Dose in Digital Radiology (Annals of the ICRP Vol. 34 No. 1, 2004). Published by Elsevier

[24]

ICRP Report 74: Patient dosimetry for x-rays used in medical imaging (2005), Published by Oxford University Press, Oxford

_____________________

* 2.1, 60601-2-44:2001 1 (2002).

AUTOMATIC EXPOSURE CONTROL

3.10

ANODE

/ 60788, rm-22-06

X-RAY TUBE VOLTAGE

3.88

X-RAY TUBE CURRENT

3.85

EXTRA-FOCAL RADIATION

3.22

RADIATION SOURCE ASSEMBLY

3.62

X-RAY SOURCE ASSEMBLY

3.62

AIR KERMA

3.4

LOADING TIME

3.37

IRRADIATION TIME

3.32

ASSOCIATED EQUIPMENT

/ 60788, rm-30-01

ANODE INPUT POWER

/ 60788, rm-36-22

PATIENT ENTRANCE REFERENCE POINT

3.43

ENTRANCE SURFACE

3.21

IRRADIATION SWITCH

3.31

ACTUAL FOCAL SPOT

/ 60788, rm-20-12

RADIATION DETECTOR

3.57

DIAPHRAGM

3.17

ACCOMPANYING DOCUMENTS

60601-1, 3.4

ADDITIONAL FILTRATION

3.3

ADDED FILTER

3.2

ACCESSIBLE SURFACE

3.1

PROTECTIVE CLOTHING

3.50

PROTECTIVE BARRIER

3.49

PROTECTIVE SHIELDING

3.51

PROTECTIVE DEVICE

3.50

PROTECTED AREA

3.48

MANUFACTURER

60601-1, 3.55

EQUIPMENT

60601-1, 3.63

RADIATION

3.53

LEAKAGE RADIATION

3.33

MEASURED VALUE

3.38

IONIZATION RADIATION

3.29

TRUE VALUE

/ 60788, rm-73-07

RADIATION SOURCE

3.61

CATHODE

/ 60788, rm-22-05

RADIATION QUALITY

3.60

X-RAY TUBE HOUSING

3.86

CONTROLLED AREA

3.15

X-RAY IMAGING ARRANGEMENT

3.80

EDGE FILTER

3.19

MEDICAL DIAGNOSTIC RADIOLOGY

/ 60788, rm-40-04

(ME )

MEDICAL ELECTRICAL SYSTEM

(ME SYSTEM)

60601-1, 3.64

(ME )

MEDICAL ELECTRICAL EQUIPMENT (ME EQUIPMENT)

60601-1, 3.63

RISK MANAGEMENT

60601-1, 3.107

TARGET

/ 60788, rm-20-08

AIR KERMA RATE

3.5

LOADING

3.34

X-RAY TUBE LOAD

3.87

LOADING STATE

3.36

STRAY RADIATION

3.75

CONTINUOUS ANODE INPUT POWER

3.13

NOMINAL X-RAY TUBE VOLTAGE

3.42

NORMAL USE

60601-1, 3.71

IRRADIATION

3.30

TOTAL FILTRATION

3.77

OPERATOR

60601-1, 3.73

REFERENCE AXIS

/ 60788, rm-37-03

REFERENCE PLANE

/ 60788, rm-37-04

REFERENCE AIR KERMA

3.70

REFERENCE AIR KERMA RATE

3.71

REFERENCE DIRECTION

/ 60788, rm-37-02

ATTENUATION

3.7

BASIC SAFETY

60601-1, 3.10

ESSENTIAL PERFORMANCE

60601-1, 3.27

SIGNIFICANT ZONE OF OCCUPATION

3.74

RESIDUAL RADIATION

3.72

X-RAY BEAM AXIS

/ 60788, rm-37-06

RESPONSIBLE ORGANIZATION

60601-1, 3.101

LOADING FACTOR

3.35

RADIOGRAPHIC RATING

3.63

PATIENT

60601-1, 3.76

PRIMARY PROTECTIVE SHIELDING

3.47

TRANSFER

/ 60788, rm-84-02

IMAGE RECEPTION AREA

3.28

ABSORPTION

/ 60788, rm-12-05

ABSORBED DOSE

/ 60788, rm-13-08

X-RAY FIELD

3.58

CORRECTION FACTOR

/ 60788, rm-73-14

PERMANENT FILTRATION

3.45

/

INTENDED USE

60601-1, 3.44

INDICATED VALUE

/ 60788, rm-73-10

X-RAY IMAGE RECEPTOR

3.81

ACCESSORY

60601-1, 3.3

-

DOSE AREA PRODUCT

/ 60788, rm-13-54

-

CURRENT TIME PRODUCT

3.16

PERCENTAGE RIPPLE

3.44

CONTROL PANEL

3.14

RADIATION BEAM

3.55

X-RAY BEAM

3.55

WORKLOAD

/ 60788, rm-61-03

RADIATION QUANTITY

/ 60788, rm-13-01

RADIATION PROTECTION

3.59

RADIATION APERTURE

3.54

RADIATION FIELD

3.58

RADIATION CONDITION

3.56

RADIOLOGICAL INSTALLATION

3.67

RADIOLOGICAL

3.65

RADIOLOGICAL IMAGE

3.66

RADIOLOGY

3.68

MEDICAL RADIOLOGY

3.39

SCATTERED RADIATION

3.73

FOCAL SPOT IMAGE RECEPTOR DISTANCE

3.25

-

FOCAL SPOT SKIN DISTANCE

3.26

MODE OF OPERATION

3.40

X-RAY TUBE

3.83

X-RAY EQUIPMENT

3.78

X-RAY GENERATOR

3.79

X-RAY TUBE ASSEMBLY

3.84

X-RADIATION

3.53

X-RAY PATTERN

3.82

HIGH-VOLTAGE GENERATOR

/ 60788, rm-21-01

()

RADIOGRAPHY

3.64

RADIOSCOPY

3.69

RISK

60601-1, 3.102

AUTOMATIC CONTROL SYSTEM

3.9

BEAM LIMITING SYSTEM

3.12

HALF-VALUE LAYER

3.27

READY STATE

/ 60788, rm-84-05

STRUCTURAL SHIELDING

3.76

TYPE TEST

60601-1, 3.135

POINT SOURCE

/ 60788, rm-34-36

NARROW BEAM

/ 60788, rm-37-22

SINGLE FAULT CONDITION

60601-1, 3.116

NARROW BEAM CONDITION

3.41

DIGITAL X-RAY IMAGING DEVICE

62220-1, 3.5

IMAGE DISPLAY DEVICE

/ 60788, rm-80-08

BEAM LIMITING DEVICE

3.11

RISK MANAGEMENT FILE

60601-1, 3.108

PHANTOM

3.46

FILTER

3.23

FILTRATION

3.24

FOCAL SPOT

/ 60788, rm-20-13S

QUALITY EQUIVALENT FILTRATION

3.52

ATTENUATION EQUIVALENT

3.8

DOSE EQUIVALENT

3.18

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AMBIENT DOSE EQUIVALENT

3.6

ELECTRON

/ 60788, rm-11-18

RADIATION ENERGY

/ 60788, rm-13-29

EFFECTIVE IMAGE RECEPTION AREA

3.20

EFFECTIVE FOCAL SPOT

/ 60788, rm-20-13




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