Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

Clinical Trials and Regulations > Final Exam > Flashcards

Final Exam Flashcards

1
Q

Waterfall design process

A

-

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

Regulatory Bodies

Statutory Comittees

A

-
MDEC
TGC
NCCTG

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

Medical Device definition

A

-

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

Not a medical device?

A

-

IVD devices

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Risk management

A

-

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Electric risk safety triangle

A

AS/NZS 2500 - safe procedures
AS/NZS 3003 - safe installation
AS/NZS 3551 - safe equipment

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

ARGMD developed to?

A

guidance for regulatory requirements
MD apps to TGA meet legislative requirements
clarity and transparency

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

ARGMD scope?

A

To describe the information to be supplied with applications to manufacture, supply and export for MD in Aus. Also post-market requirements

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Key elements of the medical device regulatory scheme?

A 
product requirements
compliance with EP
use of standards
ongoing monitoring
regulatory controls
provision for imposing penalties
corrective actions
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Essential Principles definition?

A

The EPs set out the requirements relating to the safety and performance of medical devices.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

General requirements?

A 
HS
SP
IP
LT
TS
BAE
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Principles about design and construction considerations?

A 
CPB
IMC
CE
MF
Rad
ES
I
CE
IVD

Chemical infections construct measuring radiation energy sources information and clinical IVD

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

Standards orders

A

MDSO

CASO

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Legislative instruments

A

-

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

MD classification

A

intended use
level of risk
degree of invasiveness
duration of use

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

MD classification levels? flow chart?

A

-

17
Q

Standard definition?

A

A published document which sets out specifications and procedures to ensure that a material, product, method or service is fit for its purpose and consistently performs the way it was intended to

18
Q

Electrical circuit classification

A

Equipment in which protection against electric shock…

19
Q

List the electrical safety standards

A

AS/NZS 2500 - Guide for safe use of electricity in patient care
AS/NZS 3000 - Wiring rules
AS/NZS 3003 - Electrical installations - Patient areas
AS/NZS 3100 - General requirements for electrical equipment
AS/NZS 3200 - Medical electrical equipment - General requirements for safety:Approval and test specification - Medical electrical equipment
AS/NZS 3200.1 - General requirements for safety
AS/NZS 3200.2 - Particular requirements for safety
AS/NZS 3200.3 - Essential performance requirements

20
Q

AS/NZS 2500 Scope

A

“This Standard provides a guide to the safe use and application of electrically operated equipment used in health care.
- electric shock hazard to patients and staff,
- other hazards, e.g. thermal, radiant or mechanical
Measures required to provide and maintain patient and operator safety, including specification of the class of equipment and electrical installation to be employed for particular medical procedures, are also included

21
Q

AS/NZS 3100 Scope

A

“This Standard specifies the general safety requirements for, or with respect to, equipment (including fittings, accessories, appliances and apparatus) of classes and types that are used in, or intended for use in, or in connection with, electrical installations in buildings, structures, and premises”

22
Q

AS/NZS 3200 Scope

A

Although this Standard is primarily concerned with safety,
Figure 1: The Mains Part of a Class I Electrical Device
it contains some requirements regarding
reliable operation where this is connected with safety. SAFETY HAZARDS resulting from the intended physiological function of EQUIPMENT covered by this Standard are not considered

23
Q

AS/NZS 3551 Scope

A

This standard outlines procedures required to develop management programs fro medical equipment. These include protocols and procedures for procurement, acceptance, maintenance activities throughout the service life of the medical equipment, and finally disposal of medical equipment

24
Q

AS/NZS 3551 Sections

A
  1. Scope and General
  2. Medical Equipment Management Program
  3. Regulatory Compliance
    evidence, marketing authorisation, EM compatibility, MD for clinical trials
  4. Procurement
    committee, standards, pre-purchase eval, tenders & quotations
  5. Acceptance
    inspection, test selection, future testing, documentation
  6. Performance verification and maintenance
  7. Medical electrical systems
  8. ME not owned
  9. ME mods
  10. Assessment intervals
25
Q

Australian Electrical Supply Circuit

A

4 wire, 3 phase, 230/400 volt, MEN system

26
Q

Draw MP, CP, AP

A

-

27
Q

Describe the heart and how it beats

A

SA -> AV -> bundle of His -> Purkinje fibres

28
Q

Einthoven’s triangle and more

A

RA, LA, LL - 3 frontal leads

Goldberger Augmented Limb Leads and Wilson Center Tap –> 12 lead ECG diagnostic

29
Q

Types of earthing?

A

Functional earth
Protective earthing - automatic disconnection (previals)
Equipotential earthing - cardiac protected area

30
Q

Type of applied parts?

A 
Type B applied part
Type BF applied part
Type CF applied part
Type BF (defib proof) applied part
Type CF (defib proof) applied part
31
Q

Electrical safety tests as per AS/NZS 3551

A 
Visual inspection
Protective earthing tests
Insulation resistance tests
Touch current tests
Earth leakage tests
Patient leakage current tests
Mains contact current tests

Clinical Trials and Regulations (16 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions