Test medical devices, products, equipment and associated systems within healthcare

Overview & Purpose

What This Standard Covers

This standard outlines the procedures for the physical, engineering, and technical testing of medical devices and associated systems to ensure they are safe and effective for clinical use. It emphasizes the use of established protocols to verify compliance with safety and performance standards.

Performance Criteria

• Work within competence, responsibility, and accountability levels.
• Liaise with stakeholders for planning tests and prioritizing actions.
• Verify equipment is not in use and check decontamination status prior to testing.
• Conduct decontamination and cleaning as necessary.
• Identify and ensure safety of tools and equipment for testing.
• Test components and measure performance parameters per approved procedures.
• Compare test results against expected values; complete testing procedures as specified.
• Report any variances or non-conformances to relevant individuals.
• Document faults or unexpected events in testing; refer items for further action.
• Clarify issues impacting testing outcomes with stakeholders.
• Provide repair or replacement information when equipment fails to meet standards.
• Maintain accurate records in compliance with legislation and policies.

Knowledge & Understanding Requirements

• Understanding of personal competence, authority, and specialized knowledge.
• Principles of scientific and engineering practices relevant to testing.
• Awareness of stakeholder roles, responsibilities, and information needs.
• Scheduling tests with stakeholders and obtaining consent.
• Knowledge of health and safety measures and infection control practices.
• Ability to assess resource capabilities and limitations for testing.
• Familiarity with test equipment and performance tests applicable to responsibilities.
• Ability to interpret manufacturers' service manuals for test procedures.
• Understanding the correct use of tools and service aids.
• Knowledge of relevant testing protocols and how to access them.
• Awareness of operational principles and expected performance parameters of equipment.
• Methods for validating data and their importance in testing.
• Understanding of quality control tests in the testing process.
• Contingency planning for unforeseen testing events.
• Knowledge of codes of conduct for diverse work environments.
• Awareness of current legislation, guidelines, and local protocols affecting practice.
• Understanding of policies guiding scope of practice and professional relationships.

Relevent Roles

• Healthcare Technicians
• Medical Equipment Testers
• Clinical Engineers
• Biomedical Technologists
• Health Care Professionals in testing and maintenance of medical devices