This training is designed to covers the safety, essential performance and electromagnetic compatibility of Medical Electrical Equipment and Systems.
IEC 60601 is a family of standards whose scope covers the safety, essential performance and electromagnetic compatibility of Medical Electrical Equipment and Systems. The “Part 1” standard, IEC 60601-1 covers basic safety and essential performance for all Medical Electrical (ME) Equipment and ME Systems.
By the end of the training, participants would be able to:
- Describe the IEC 60601 and the family of standard, intend and purpose of IEC 60601-1 standard.
- Describe an effectively approach to review and understand this IEC standard
- Describe the application of this standard requirement
- Describe the application of IEC 60601-1
- Describe the use of ISO 14971 at IEC 60601-1 context
2 days (9.00am to 5.00pm) or duration proposed at quotation.
Training session includes classroom lecture, exercises, group work and discussion.
Business owner, Director, Regulatory Affair, Compliance, Product Manager.
- Definition of Medical Electrical (ME) Equipment and ME System
- Evolution of IEC 60601 and IEC 60601 part 1
- Introduce IEC 60601 and the family series
- Overview of normative references
- General requirements
- Testing requirements
- Classification ME Equipment and ME System
- Identification, marking and documents
- Protection specifications
- Accuracy of controls and instruments and protection against hazardous outputs
- Hazardous Situations and fault conditions
- Programmable Electrical Medical Systems (PEMS)
- Construction of ME equipment
- ME systems specifications
- Sequence of testing
- Marking and labelling requirements guide
- Marking Symbols
- Connection of the measuring device (MD) for measurement of the PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT
- Measure supply circuits
- PEMS structure, PEMS Development Life-Cycle and documentation
- Survey of insulation paths
- Simplified PATIENT LEAKAGE CURRENT diagrams
- Insulated winding wires for use without interleaved insulation
Certificate of Attendance will be issued to participants who fully participated the training and satisfied the attendance requirements.
Why Engage aNTS / Peplow-Warren?
Peplow-Warren Consultant Team is formed by a group of experienced sector expert, certification auditors, consultants and industry practitioners. They actively involve in international standard and specifications development by acting as active ISO and MOSTI Technical Committee Member. They carry a common mission: they are willing to share their good knowledge with current industry practitioners. Call us today for more detail. We are obliged to work together and grow your business.