Medical Device Preclinical Testing (Ch. 11)

Question 1

What is the purpose of preclinical testing?

Answer 1

The purpose of preclinical testing is to ensure the device meets all its requirements, including:

• user requirements
• regulatory requirements
• requirements from standards
• risk management requirements

Question 2

TRUE/FALSE: Preclinical testing covers only in vitro tests.

Answer 2

FALSE!

Preclinical testing covers both the in vitro and in vivo tests to ensure a device’s safety and efficacy.

Question 3

What factors should be considered in a device material selection?

Answer 3

Mechanical, chemical, biological, and toxicological properties, sterilization method

Question 4

What is a design traceability matrix?

Answer 4

Connects the requirements/specifications to the test results - connects design inputs (measurable specifications) to design outputs (test results)

Question 5

What are user requirements?

Answer 5

User requirements:

For the patient, user, or customer - defines the requirements that should meet the needs of the user

Question 6

What is a nonclinical laboratory study?

Answer 6

Nonclinical laboratory study:
An in vivo or in vitro test in which samples of the medical device are studied prospectively in test systems to determine whether the device meets all requirements as determined in the planning phase

Question 7

What are the main types of preclinical tests?

Answer 7

• Biocompatibility: ISO 10993-X
• Performance testing
• Packaging validation and transport studies
• Sterilization validation
• Electrical safety and electrical magnetic disturbance testing (IEC 60601-X, -X-X)
• Shelf life (aging) studies
• Software verification
• Usability (human factors) studies

Question 8

What is the standard for biocompatibility?

Answer 8

EN ISO 10993-1

Question 9

What are the requirements of the biocompatibility evaluation described in EN ISO 10993-1?

Answer 9

• Requires an analysis of the device type, the contact and the duration of the contact, and a risk assessment to determine the possible risks to the patient/user
• Data from toxicological databases/literature
• Preclinical biocompatibility testing may be required
• Consideration of manufacturing and sterilization methods

Question 10

What is the purpose of performance testing?

Answer 10

To demonstrate the device meets its intended performance

- There are some specific product standards