International standards

Question 1

What is the limit for Ispta?

Answer 1

720 mW/cm^2

Question 2

What is the limit for Isppa?

Answer 2

190 W/cm^2

Question 3

What are the limits for MI and TI?

Answer 3

MI 1.9
TI 6.0

Question 4

What is the ophthalmic limit for Ispta?

Answer 4

50 mW/cm^2

Question 5

What are the ophthalmic limits for MI and TI?

Answer 5

MI 0.23
TI 1.0

Question 6

What are the European optical display standards?

Answer 6

IEC 60601-2-37
Specifies when TI and MI must be displayed

IEC 62359
Specifies how to measure MI and TI

Question 7

What are the IEC 60601-2-37 limits for transducer surface temperature?

Answer 7

<43 degree C in tissue
<50 degree C in air

Question 8

When must a manufacturer display probe surface temperature for a TOE probe?

Answer 8

When T > 41 degree C

Question 9

What are two tracks in the US FDA Information for manufacturers?

Answer 9

Track 1 - scanners that do not conform to ODS:

must conform to old (lower) application limits for TI and MI

Track 2 - scanners that do conform to ODS (MI and TI displayed):

conform to new limits if
1) education programme provided
2) max MI and TI provided in manuals

Question 10

Four things that should an US FDA Track 3 education programme include?

Answer 10

risk of not using US
risk of using US
why to use ALARA ppl
how to use ALARA ppl