—   —  —  60601-2-45-2014 . 2-45.


60601-2-45-2014 . 2-45.

60601-2-45-2014 . 2-45.

60601-2-45-2014
" . 2-45. "
(. 12 2014 . N 2077-)

Medical electrical equipment. Part 2-45. Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices

- 1 2016 .

1 "" ( "") , 4

2 011 " , "

3 12 2014 . N 2077-

4 60601-2-45:2011 " . 2-45. " (IEC 60601-2-45:2011 "Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices")

,

5

, 60601-1:2005 ( ) . , , . .

, , .

2-45, .

(*), , , .

201.1 ,

1 * :

201.1.1*

:

, , , .

1 - , .

:

- ;

- ;

- ;

- , ;

- ;

- , ;

- ;

- ;

- , ( ).

, . , , .

2 - 60601-2-7 60601-2-32 .

201.1.2

:

, .

201.1.3

:

, 2 201.2 .

60601-1-2 60601-1-3 202 203 . 60601-1-8, 60601-1-9, 60601-1-10 60601-1-11 **.

201.1.4

:

60601 , , ME , .

.

60601-1 " ". .

"201" (, 201.1 1 ) "20", "" - () () (, 202.4 4 60601-1-2, 203.4 4 60601-1-3 ..). :

- "" , ;

- "" , ;

- "" , .

, , , , 201.101. , 3.1 3.139, 201.3.201. , .., - ), bb) ..

, , , , 20, "" - () () , , 202 60601-1-2, 203 60601-1-3 ..

" " , , .

, ; , .

201.2

- . 37.

2 , :

:

60601-1-2:2007 . 1-2. . . . (IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests)

60601-1-3:2008 . 1-3. . . (IEC 60601-1-3:2008, Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment)

:

60336:2005 . . (IEC 60336:2005, Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots)

60613:2010 (IEC 60613:2010, Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis)

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

61223-3-2:2007 () . 3-2. . (IEC 61223-3-2:2007, Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment)

62220-1-2:2007 . . 1-2. . , (IEC 62220-1-2:2007, Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography)

9236:1999 / . 3. , (ISO 9236-3:1999, Photography - Sensitometry of screen/film systems for medical radiography - Part 3: Determination of sensitometric curve shape, speed and average gradient for mammography)

201.3

, 60601-1, 60601-1-3 / 60788 :

- , . 38.

:

201.3.201 (APPARENT RESISTANCE OF SUPPLY MAINS): .

201.3.202 , (AVERAGE GLANDULAR DOSE, AGD): ( ) , .

[ 61223-3-2:2007, 3.7]

- " " " " .

201.3.203 (BREAST COMPRESSION DEVICE): .

201.3.204 (DEFECTIVE DETECTOR ELEMENT): , , .

201.3.205 (DIRECT FOCAL DISTANCE): .

201.3.206 (MAMMOGRAPHIC STEREOTACTIC DEVICE): , , , .

- .

201.3.207 (MAMMOGRAPHIC X-RAY EQUIPMENT): , .

201.3.208 , (ORIGINAL DATA, DN): , .

[ 62220-1-2:2007, 3.11]

- " " 62220-1-2.

201.3.209 (RAW DATA): - .

[ 62220-1-2:2007, 3.13]

201.4

4 :

201.4.3

:

201.4.3.101*

201.101.

201.101 - ,

203.6.4.3.103

203.6.5

203.6.7

203.8.5.4.101

203.8.5.4.103

203.6.3.1.2

203.6.3.2

201.4.10.2

:

, . , , .

.

, , , .

- , , .

, 2%.

, , .

, . . , , .

.

:

201.4.101

:

- ( : , , , );

- (/ , , );

- ;

- .

, , DICOM ( 12052).

.

.

201.5

5 .

201.6

6 :

201.6.2

:

I .

, , .

201.7 ,

7 :

201.7.2

201.7.2.6

:

, , , 7.2.6 , .

201.7.2.7

:

, , , 7.2.7 , .

:

a) , (. 7.2.1 7.2.6 );

b) (. 7.2.1 7.2.6 );

c) , (. 7.2.1 7.2.6 );

d) , ;

e) .

- 60601-2-7:1998, 6.1 j).

201.7.2.15

:

, :

- , 100 ;

- , ;

- , , , .

:

201.7.2.101

:

- 7.2.2 ;

- / ;

- .

. , # .

- 60601-2-28. 6.1 60601-2-2.

201.7.8

:

201.7.8.101

7.8 . 203.6.4.2.

201.7.8.102

. : , , .

.

.

201.7.9

201.7.9.1

:

.

, . .

.

- .

, , :

- ;

- .

, , , , .

, , :

- , ;

- , .

.

201.7.9.2

201.7.9.2.1

:

:

- ;

- ;

- , :

● ;

● , 203.6.7.4.4.2 :

- ;

- , ;

- ;

● ;

● .

, ) i) 201.7.9.2.1.

:

a) , ;

b) , ;

c) , ;

d) , , 30 , 1 1 , , , 30 1 , 1 , 1 .

101 - , .

e) , .

102 - .

f) , -, - , -;

g) - , - , ;

h) , , / -;

i) , ;

j) , , , .

, .

201.7.9.3

:

201.7.9.3.101

" " :

a) , , ;

b) () ;

c) ;

d) (), 60336 .

- 6.8.3 60601-2-28.

e) ;

f) ;

g) .

:

201.7.9.101

:

201.4.10.2

201.7.2.6

201.7.2.7

201.7.2.15

203.5.2

203.6.2.1.101

203.6.5

203.6.7.4

203.7.3

203.11.101

201.8

8 :

201.8.4 ,

:

201.8.4.101

, , :

-

- ,

- .

.

- 15 ) 60601-2-7.

201.8.4.102

, , .

- 3.1 60601-2-7.

201.8.5

201.8.5.4

:

201.8.5.4.101

, , .

- 20.41 60601-2-7.

201.8.6 ,

:

201.8.6.101

, , , , 1 ×-1, . .

.

201.8.6.102

, , .

, .

.

201.8.7

201.8.7.3

:

, , .

. , , , .

101 - . , . , , , .

201.8.8

201.8.8.3

:

, 10 , 3 .

:

1,2 , .

, 1,2 , 1,1 .

, , .

100% 100 - 105% .

, , 110% .

:

) , , .

bb) , .

cc) , , 100% 100 - 105% .

- 20.4 60601-2-7.

201.9 , -

9 :

201.9.1

:

203.8.5.4.102 .

201.9.2 ,

201.9.2.1

:

, , , , (, , ), . .

, , , , , .

, , , , .

.

- 22.4.1 60601-2-32.

201.9.2.2

201.9.2.2.6 ()

:

50 , , .

201.9.2.3 ,

201.9.2.3.1

:

, . .

, 20 .

201.9.2.4

:

, , . .

.

- 22.4.1 60601-2-32.

:

201.9.2.101*

201.9.2.101.1

. . .

201.9.2.101.3.

201.9.2.101.2

() 0,5 0,5, 2 2 .

.

201.9.2.101.3.

201.9.2.101.3

, , z 1 .

.

a)

-, . - , , . , , .

, -. , . 5 , - 10 , , z, .

b)

, . 0,3 . - () , 5 , - 10 , , z, . , , 2 .

, .

- . . . , . , , z, . , , , 90 . , , , , , .

c)

, , z, .

201.10

10 :

201.10.1.2 ,

:

60601-1-3, 203 .

201.11

11 .

201.12

12 :

201.12.4

201.12.4.5

201.12.4.5.2

:

1 . , , .

2 12.4.5.2 , " " 60601-1-3 , 203.6.4.3.

201.13

13 .

201.14 ()

14 .

201.15

15 :

201.15.4

201.15.4.3

:

201.15.4.3.101

, .

- , , , ; .

201.16

16

201.17

17 .

202 .

60601-1-2 :

:

202.101

, 201.101 .

, , , .

.

.

.

.

203




( )

(0)