Medical Device Safety Standards Quiz

What is the purpose of IEC 60601?

• To govern the design of software

• To control all aspects of safety related to medical devices

• To provide guidelines for medical staff

• To regulate pharmaceutical products

Which of the following is a characteristic of IEC 60601?

• It governs the safety of medical device design and manufacture

• It does not include stress tests

• It is only applicable to Class II devices

• It includes only routine testing

What type of testing does IEC 62353 describe?

• Only destructive testing

• Routine testing only

• Testing after repair and in-service testing

• Testing for software applications

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

• 200 mA

• 10 mA

• 50 mA

• 25 A

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

• Class III

• Internally Powered Equipment

• Class II

• Class I

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

• Double insulation or reinforced insulation

• Protective earthing only

• No insulation

• Basic insulation only

What is the main focus of Type B applied parts?

• To provide no protection against electric shock

• To provide high-level insulation

• To provide protection against electric shock with earth connection

• To provide protection against electric shock without connection to earth

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

• 0.5 mA

• 0.1 mA

• 1 mA

• 5 mA

What does the term 'Single Fault Condition' refer to in IEC 60601?

• One means of protection is defective

• Multiple faults occurring simultaneously

• All protection means are intact

• No faults present

Which of the following is NOT a parameter measured during leakage current testing?

• Earth resistance

• Mains voltage

• Enclosure leakage current

• Patient leakage current