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Medical Device Safety Standards Flashcard

Medical Device Safety Standards Flashcard

Assessment

Flashcard

Science

University

Practice Problem

Hard

Created by

Toh Puan

Used 1+ times

FREE Resource

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15 questions

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1.

FLASHCARD QUESTION

Front

What is the purpose of IEC 60601?

Back

To control all aspects of safety related to medical devices

2.

FLASHCARD QUESTION

Front

Which of the following is a characteristic of IEC 60601?

Back

It governs the safety of medical device design and manufacture

3.

FLASHCARD QUESTION

Front

What type of testing does IEC 62353 describe?

Back

Testing after repair and in-service testing

4.

FLASHCARD QUESTION

Front

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

Back

200 mA

5.

FLASHCARD QUESTION

Front

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

Back

Class I

6.

FLASHCARD QUESTION

Front

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

Back

Double insulation or reinforced insulation

7.

FLASHCARD QUESTION

Front

What is the main focus of Type B applied parts?

Back

To provide protection against electric shock without connection to earth

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