Final Exam Flashcards
Waterfall design process
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Regulatory Bodies
Statutory Comittees
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MDEC
TGC
NCCTG
Medical Device definition
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Not a medical device?
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IVD devices
Risk management
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Electric risk safety triangle
AS/NZS 2500 - safe procedures
AS/NZS 3003 - safe installation
AS/NZS 3551 - safe equipment
ARGMD developed to?
guidance for regulatory requirements
MD apps to TGA meet legislative requirements
clarity and transparency
ARGMD scope?
To describe the information to be supplied with applications to manufacture, supply and export for MD in Aus. Also post-market requirements
Key elements of the medical device regulatory scheme?
product requirements compliance with EP use of standards ongoing monitoring regulatory controls provision for imposing penalties corrective actions
Essential Principles definition?
The EPs set out the requirements relating to the safety and performance of medical devices.
General requirements?
HS SP IP LT TS BAE
Principles about design and construction considerations?
CPB IMC CE MF Rad ES I CE IVD
Chemical infections construct measuring radiation energy sources information and clinical IVD
Standards orders
MDSO
CASO
Legislative instruments
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MD classification
intended use
level of risk
degree of invasiveness
duration of use
MD classification levels? flow chart?
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Standard definition?
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
Electrical circuit classification
Equipment in which protection against electric shock…
List the electrical safety standards
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
AS/NZS 2500 Scope
“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
AS/NZS 3100 Scope
“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”
AS/NZS 3200 Scope
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
AS/NZS 3551 Scope
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
AS/NZS 3551 Sections
- Scope and General
- Medical Equipment Management Program
- Regulatory Compliance
evidence, marketing authorisation, EM compatibility, MD for clinical trials - Procurement
committee, standards, pre-purchase eval, tenders & quotations - Acceptance
inspection, test selection, future testing, documentation - Performance verification and maintenance
- Medical electrical systems
- ME not owned
- ME mods
- Assessment intervals
Australian Electrical Supply Circuit
4 wire, 3 phase, 230/400 volt, MEN system
Draw MP, CP, AP
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Describe the heart and how it beats
SA -> AV -> bundle of His -> Purkinje fibres
Einthoven’s triangle and more
RA, LA, LL - 3 frontal leads
Goldberger Augmented Limb Leads and Wilson Center Tap –> 12 lead ECG diagnostic
Types of earthing?
Functional earth
Protective earthing - automatic disconnection (previals)
Equipotential earthing - cardiac protected area
Type of applied parts?
Type B applied part Type BF applied part Type CF applied part Type BF (defib proof) applied part Type CF (defib proof) applied part
Electrical safety tests as per AS/NZS 3551
Visual inspection Protective earthing tests Insulation resistance tests Touch current tests Earth leakage tests Patient leakage current tests Mains contact current tests
