Lecture 6: Technical Management Standard

Question 1

Sections of 3551?

Answer 1

1. General Information
2. Medical Equipment Management Program
3. Regulatory Compliance
4. Procurement
5. Acceptance
6. Performance Verification and Maintenance
7. Medical Electrical Systems
8. Medical Equipment Not Owned by the Organisation
9. Modification of Medical Equipment
10. Assessment Intervals

Question 2

Section 1?

Answer 2

This Standard applies whether the medical equipment is owned by the responsible organization, privately owned, on loan, on hire, on trial or donated, and includes medical equipment provided by a responsible organization as part of a pool of medical equipment for
hire. It does not apply to the electrical commissioning requirements of permanently installed medical electrical devices as specified in AS/NZS 3003

Question 3

Section 2?

Answer 3

(a) Establishment of risk criteria to guide the medical equipment program.
(b) Criteria for selecting and acquiring medical equipment.
(c) High level policies on maintenance strategies.
(d) Provision of sufficient resources for implementing the requirements of this Standard.
(e) Criteria for replacing/upgrading medical equipment.
(f) Safe disposal of obsolete medical equipment.
(g) Ongoing evaluation of the effectiveness of the program.

Question 4

Section 3?

Answer 4

3. 1 GENERAL EVIDENCE OF REGULATORY COMPLIANCE
4. 2 MARKETING AUTHORIZATION
5. 3 ELECTROMAGNETIC COMPATIBILITY
6. 4 MEDICAL EQUIPMENT FOR CLINICAL TRIAL

Question 5

Section 4 - Process of procurement?

Answer 5

Committee
Standards
Pre-purchase evaluation
Tenders and quotations

Question 6

Section 4 - Process of acceptance?

Answer 6

Inspection
Test selection
Future Test Programs
Documentation