Overview:

Medical devices are an important tool to improve patient care and treatment outcomes. Today’s advanced medical devices usually consist of unique combinations of mechanical, electrical and electronic components and technologies that are frequently controlled by software or programmable controllers. As a result, international regulations and standards applicable to medical devices are being continuously revised and updated to reflect potential safety issues that can result from increasingly complex device designs.

IEC 60601-1 signifies the benchmark for medical electrical equipment and compliance to this standard is mandatory in many countries including Europe (EN 60601-1:2006). TÜV Rheinland India is conducting a 2-day Training Program on IEC 60601 for Medical Equipment with an aim to support customers to get a clear understanding of the safety standards in the medical device sector and enable them to successfully comply with regulatory approvals. This online training will cover key topics such as risk management, protection against thermal-mechanical hazards, electrical shock and verification of electrical insulation in medical electrical systems.

Key Topics of the Course:

• The online IEC 60601 edition 3.1 Compliance Program includes the following main topics:
• IEC 60601-1 Ed 3.1 - Background and Introduction
• IEC 60601-1 Ed 3.1 - Risk Management and General Requirements
• IEC 60601-1 Ed 3.1 - Protection Against Electrical Hazards
• IEC 60601-1 Ed 3.1 - Medical Electrical Systems and Protection Against Mechanical Hazards
• IEC 60601-1 Ed 3.1 - Protection Against Thermal, Radiation and Other Hazards
• IEC 60601-1 Ed 3.1 - Accuracy of controls and protection against Hazardous outputs
• IEC 60601-1 Ed 3.1 – Requirements for Identification, Marking and Documentation
• Programmable Electrical Medical Systems (PEMS)
• IEC 60601-1 Ed 3.1 – Construction requirements for ME equipment’s

Learning Objectives:

• Upon successful completion of this program, learners will be able to successfully:
• Apply the standards within different geographic regions
• Obtain essential information from within the different sections of the standards
• Apply new points of the third edition which are not covered in the second edition for existing and new devices
• Implement risk management principles for electrical medical equipment and systems as well as integrate these principles while performing risk analysis under ISO 14971 requirements
• Employ classification and terminology to further study the requirements of the IEC 60601-1 edition 3.1 standard and related collaterals
• Establish correct and required markings for equipment, controls and instruments as well as recognize which safety signs are compulsory
• Identify the specific requirements and classification of medical electrical equipment
• Apply the requirements with regard to applicable mechanical testing
• Comprehend the changes with regard to mechanical testing since revision 2 of the standard and apply updates to existing devices wherever required
• Comprehend the design and related testing requirements to ensure protection against thermal and other hazards
• Apply the critical component requirements

Who will Benefit:

• Medical Device Industry Managers, Supervisors, Employees
• Electronic Industry Managers, Supervisors, Employees
• Quality Assurance Personnel
• Notified Body Auditors
• Technical Consultants

Why TÜV Rheinland?

Our team of experts from Active Medical Devices, Medical Electrical Equipment IEC 60601-1 specialty are here to help you gain confidence from our certification program. Build your ideal training program from a comprehensive list of courses through a single-source provider.

We are a globally operational Certification Body with a wide range of accreditations, testing facilities and certified staff serving an extensive portfolio of customers from every industry.