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This document contains information regarding the registration process for a webinar about the New 60601-1 Amendment focusing on risk management and essential performance requirements for electronic
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What is form new 60601-1 amendment?
The new 60601-1 amendment refers to updates made to the IEC 60601-1 standard, which establishes safety and effectiveness criteria for medical electrical equipment. This amendment typically includes changes to safety and performance requirements that manufacturers must comply with.
Who is required to file form new 60601-1 amendment?
Manufacturers of medical electrical equipment that falls under the scope of the IEC 60601-1 standard are required to file the new 60601-1 amendment to ensure compliance with updated safety and performance criteria.
How to fill out form new 60601-1 amendment?
To fill out the form, manufacturers should provide accurate information regarding their medical devices, including details about compliance with the new amendments, testing results, and any relevant documentation that supports their claims of conformity.
What is the purpose of form new 60601-1 amendment?
The purpose of the form is to ensure that manufacturers formally record their compliance with the updated IEC 60601-1 standards, thereby promoting safety and efficacy of medical devices in the market.
What information must be reported on form new 60601-1 amendment?
The form must report information such as device identification, compliance testing results, risk management details, and any deviations from the previous version of the standard.
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