Teaching you product compliance for evolving technology & expanding markets in the medical industry
The medical industry is rapidly adopting new technology that enables better communication and performance of products & systems to improve the safety of care. Manufacturers today, face a number of compliance challenges, as devices that do not meet the highest quality and safety standards present, a risk of injury, recalls, bans and liability.
The transition to IEC 60601-1 3rd introduced the concept and application of risk management, while 60601-1-2, 4th Edition introduced significant changes to specifications of immunity test levels according to the environments of intended use as well as a revamped classification system. It is imperative for everyone involved with product design to fully understand how the process of risk management and risk analysis incorporates with new requirements to achieve compliance.
At this Medical Testing, Certification, and Compliance Seminar you’ll gain critical insights into technical requirements, the standardization process, the development of IEC 60601-1- family, steps the manufacturer must perform fulfill risk management requirements, new methods of risk analysis, and new immunity requirements to mitigate interference and device malfunction.
What You’ll Learn
Product Safety Testing of Electrical Medical Products
This presentation with give you an overview of IEC 60601-1 3rd Edition with critical insights into significant differences when compared to previous editions, risk management and the manufacturer’s responsibility, mandated use of collaterals, Part 2 standards, as well as standards and regulatory activity with respect to the United States, FDA and OSHA, Canada and Health Canada, Europe, CB Scheme, participating and countries.
60601-1-11 Requirements for Home Healthcare equipment
Devices used in the home or other non-clinical environments are associated with unique risks created by the interactions among the user, the use environment, and the device. This presentation will go over the basic safety requirements for equipment used in the home healthcare environment including assisted living and nursing homes.
Electromagnetic Compatibility of Electrical Medical Products
IEC 60601-1-2 4th Edition introduced significant technical revisions such as risk analysis and immunity requirements. Significant changes include specification of immunity test levels according to the environments of intended use, which are categorized according to locations that are harmonized with IEC 60601-1-11: the professional healthcare facility environment, the home healthcare environment and special environments. This presentation with give you an overview of IEC 60601-1-2 4th Edition with critical insights into emissions and immunity aspects of medical product design, the revamped classification system based on the environments of intended use, and risk management.
This seminar will:
- Explain how existing and upcoming standards, certifications and their implementation are developing to incorporate risk management and risk analysis.
- Evaluate methodologies and best practices that the industry can adopt to ensure quality assurance for successful compliance.
- Evaluate both emissions and immunity aspects of medical product design for electromagnetic compatibility compliance.
- Explain significant changes to specifications of immunity test levels according to the environments of intended use.
IEC/UL/CSA 60601-1: 3rd Edition
IEC/UL/CSA 60601-1-2: 4th Edition Medical equipment in the presence of electromagnetic disturbances.
Safety requirements for equipment used in home healthcare environment according to 60601-1-11