Medical Device Safety Standards Flashcard

Front

What is the purpose of IEC 60601?

Back

To control all aspects of safety related to medical devices

Front

Which of the following is a characteristic of IEC 60601?

Back

It governs the safety of medical device design and manufacture

Front

What type of testing does IEC 62353 describe?

Back

Testing after repair and in-service testing

Front

What is the minimum test current for ground bound testing in IEC 60601?

Back

200 mA

Front

Which class of medical equipment relies on basic insulation and protective earthing?

Back

Class I

Front

What does Class II medical equipment utilize for protection against electric shock?

Back

Double insulation or reinforced insulation

Front

What is the main focus of Type B applied parts?

Back

To provide protection against electric shock without connection to earth

Front

What is the limit for earth leakage current in normal condition for Class I equipment?

Back

0.5 mA

Front

Single Fault Condition

Back

One means of protection is defective

Front

Which parameter is NOT measured during leakage current testing? Options: Earth resistance, Mains voltage, Enclosure leakage current, Patient leakage current.

Back

Mains voltage