2 Safety

Question 1

What is the IEC 60601-1

Answer 1

A series of technical standards for the safety and efficacy of:
Medical electrical equipment
Medical electrical systems
Components used in medical electrical equipment and systems

Question 2

How many versions of the IEC 60601-1 is there?

Answer 2

4

Question 3

Which companies use which versions of the IEC 60601-1?

Answer 3

Europe, Canade, USA = 4
Brazil, South Korea, Japan = 3
China, Taiwan = 2

Question 4

What is the definition of EMC?

Answer 4

A system’s ability to work properly without disturbing or being disturbed by other equipment.

Question 4

What does EMC stand for?

Answer 4

Electromagnetic Compatibility

Question 5

What two bodies govern EMC standards?

Answer 5

IEC, CISPR

Question 6

What are the two categories of EMC testing?

Answer 6

Emissions: Noise generated by the device
Immunity: Ability to resist noise

Question 7

Name the 4 IEC standards and what they’re associated with

Answer 7

60601-1-2 = EMC
60601-1-3 = Radiation protection
60601-1-6 = Usability
60601-1-8 - Alarms