FINAL 06 - Medical Devices

Question 1

Refers to any instrument used for diagnosis and prevention of disease

Answer 1

Medical device

Question 1

Defined as medical devices requiring calibration, maintenance, repair, user training, and decommissioning, activities usually managed by clinical engineers

Answer 1

Medical equipment

Question 2

Includes medical imaging machines which are used to aid in diagnosis (Types of medical equipment)

Answer 2

Diagnostic equipment

Question 3

Includes infusion pumps, medical lasers, and LASIK surgical machines (Types of medical equipment)

Answer 3

Treatment equipment

Question 4

Is used to maintain a patient’s bodily function; includes medical ventilators and incubators (Types of medical equipment)

Answer 4

Life support equipment

Question 5

Allow medical staff to measure a patient’s medical state; includes ECG and EEG (Types of medical equipment)

Answer 5

Medical monitors

Question 6

Automates or helps analyze blood, urine, genes, and dissolved gases in the blood (Types of medical equipment)

Answer 6

Medical laboratory equipment

Question 7

Includes physical therapy machines like continuous passive range of motion (CPM) machines (Types of medical equipment)

Answer 7

Therapeutic equipment

Question 8

May be used in the periphery of the operating room or at point sources including near the surgical site for the removal of surgical plume (Types of medical equipment)

Answer 8

Air purifying equipment

Question 9

FDA circular which includes the guidelines covering the issuance of an authorization for a medical device

Answer 9

FDA 001-2020

Question 10

Meaning of CDRRHR

Answer 10

Center for Device Regulation, Radiation Health, and Research

Question 11

Meaning of CMDR

Answer 11

Certificate of Medical Device Registration

Question 12

Meaning of CMDN

Answer 12

Certificate of Medical Device Notification

Question 13

Meaning of CMDL

Answer 13

Certificate of Medical Device Listing

Question 14

The ISO standards for medical devices are covered by ICS __________ and ICS __________

Answer 14

ICS 11.100.20, ICS 11.040.01

Question 15

The quality and risk management regarding the topic for regulatory purposes is convened by ISO __________ and ISO __________

Answer 15

ISO 13485, ISO 14971

Question 16

ISO __________ is applicable to all providers and manufacturers of medical devices, components, contract services, and distributors of medical devices

Answer 16

ISO 13485:2016

Question 17

ISO __________ sets precedence because it signifies that a company engages in the creation of new products

Answer 17

ISO 9001:2008

Question 18

Standard guide for design and evaluation of primary flexible packaging for medical products (Relevant standards for medical device packaging)

Answer 18

ASTM

Question 19

Standard guide for biocompatibility evaluation of medical device packaging materials (Relevant standards for medical device packaging)

Answer 19

ASTM F2475-11

Question 20

Packaging materials and systems for medical devices to be sterilized, general requirements, and test methods (Relevant standards for medical device packaging)

Answer 20

EN 868

Question 21

Is a part of quality management system, including verification and validation

Answer 21

Package testing

Question 22

EN ISO __________ defines symbols that can be used to convey important information on packaging and labeling

Answer 22

Package testing

Question 23

Medical device cleanliness has come under greater scrutiny since 2000, when __________ recalled several thousand metal hip implants that contained a manufacturing residue

Answer 23

Sulzer Orthopedics

Question 24

Standard test method for extracting residue from metallic medical components and quantifying via gravimetric analysis (Standards for permanent implants)

Answer 24

ASTM F2459

Question 25

Standard practice for reporting and assessment of residues on single use implants (Standards for permanent implants)

Answer 25

ASTM F2847

Question 26

Standard guide for validating cleaning processes used during the manufacture of medical devices (Standards for permanent implants)

Answer 26

ASTM F3172