Week 3 - Medical device standards part 1

Question 1

What is the definition of essential principles

Answer 1

Defines the basic principles for quality, safety, and performance of the device

Question 2

What do the essential principles of safety and performance comprise of?

Answer 2

• General requirement of safety and performance that apply to all medical device
• Design and manufacturing requirements of safety and performance, some of which are relevant to each medical device

Question 3

Some side notes ;

Answer 3

• The product owner determines the applicable essential principles and demonstrates conformity to each applicable essential principle
• The conformity to essential principles is documented in checklist format

Question 4

What are the general requirements of essential principles in terms of how it should be designed?

Answer 4

Medical devices should be designed and manufactured in a way that they will not compromise the clinical condition or the safety of the patients, and the health of users and other persons.

Question 5

What are the general requirements of essential principles in terms of solution for the design?

Answer 5

The solution for design and manufacture of the devices should conform to safety principles
•Identify known or foreseeable hazards
•Eliminate risks through inherently safe design and manufacture
•Reduce remaining risks
Inform the user of any residual risk

Question 6

What are the general requiements of essential principles in terms of performance for the design?

Answer 6

Devices should achieve the performance and be designed, manufactured and packaged so that they are suitable for the function of the device

Question 7

What is the general requirement of essential principles in terms of the characteristics

Answer 7

The characteristics and performance should not adversely affect the health or safety of the patient or anyone during the lifetime of the device when the device is subjected to the stresses and has been properly maintained

Question 8

What is the general requirement of essential principles in terms of performance and characteristics when under transportation?

Answer 8

Their characteristics and performance will not adversely affected under transport and storage conditions

Question 9

What is the general requirement of essential principles in terms of its benefits?

Answer 9

The benefits of use must outweigh any undesirable side effects

Question 10

What is the general requirement of essential principles in terms of its complication

Answer 10

Every medical devices requires clincical evidence, aproproate for the use and classification of the devices and complies with the applicable provisions of the essential principles

Question 11

What types of standards are there is medical device

Answer 11

Basic standards, Group standards, Product standards

Question 12

What are “Basic standards” in medical devices

Answer 12

• Standards indicating fundamental concepts, principles and requirements with regards to general safety aspects applicable to all kinds or a wide range of products and or/processes
• Sometimes referred to as horizontal standards and usually apply to more than one field.

Question 13

What are “Group standards” in medical devices

Answer 13

• Standards indicating aspects applicable to families of similar products and/ or processes making reference as far as possible to basic standards
• Sometimes referred to as semi-horizontal standards and usually apply to one field

Question 14

What are “Product Safety” in medical devices

Answer 14

•Standards that specifies necessary safety and performance requirements for a specific or family product s processes or services making reference, as far as possible, to basic standards and group standards

Question 15

What does IEC stands for?

Answer 15

Internation electrionical comission

Question 16

What does ITU stands for?

Answer 16

International telecomminicaiton union

Question 17

What does ISO stands for?

Answer 17

International organisation for standardization ( for all technical field)

Question 18

What does CEN stands for?

Answer 18

Europen comittee for standardization

Question 19

What does CENELEC stands for?

Answer 19

European committee for electrotechnical standardization

Question 20

What does COPANT stands for?

Answer 20

Pan american standards comission

Question 21

What does SPRING singapore stands for?

Answer 21

Standards, productivity and innovation board

Question 22

What does ANSI stands fo?

Answer 22

American national standards institue

Question 23

What does BSI stands for?

Answer 23

British standards institution

Question 24

What does JISC stnads for?

Answer 24

Japenses industrial standards commitee

Question 25

What are the alternative to recognised standards

Answer 25

•The use of standards is voluntary unless mandated
•Alternative may include:
-National and international standards that have not been given the status of a “recognized standard” by the regulatory authority
-Industry agreed methods ;

Question 26

what would be on the lifecycle of “pre-market “

Answer 26

• Conception and development
• Manufacture
• Packaging and labelling

Question 27

What would be on the lifecycle of “placing on the market”

Answer 27

• Distribution
• Storage
• Advertising
• Sale

Question 28

What would be on the lifecycle of “Post-market”

Answer 28

• Compliance
• Surveillance
• Vigillance

Question 29

Describe the elements of confortmity assement

Answer 29

Regulatory demands increase with the hazards presented. It also enable the manufacturer to demonstrate compliance to a regulatory authority or conformity assessment body

Question 30

What is the conformity assessment procedure

Answer 30

Process of demonstrating compliance to conformity assessment and also the procedure that the manufacturer must use to demonstrate that essential principles have been conformed to or met