IEC 60601-2-76:2018/AMD1:2023
Amendment 1 - Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment
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About This Item
IEC 60601-2-76:2018/AMD1:2023 is an amendment to the medical electrical equipment requirements for low energy ionized gas haemostasis equipment. It is relevant where organizations need to review updated safety and essential performance expectations for this type of medical device, especially during engineering documentation, risk management, and conformity assessment. As a supporting document to IEC 60601-2-76:2018, it helps teams track changes that may affect technical validation, product evaluation, and regulatory preparation for devices used in controlled clinical settings.
Purpose of IEC 60601-2-76:2018/AMD1:2023
The purpose of IEC 60601-2-76:2018/AMD1:2023 is to modify the parent requirements for low energy ionized gas haemostasis equipment so that safety and essential performance considerations remain aligned with current technical expectations. In practice, it is used alongside the base document during technical review, test planning, and documented evaluation. For manufacturers, laboratories, and compliance teams, the amendment can support a more accurate reading of applicable requirements when updating engineering specifications, verification activities, and quality workflows.
Compliance applications of IEC 60601-2-76:2018/AMD1:2023
IEC 60601-2-76:2018/AMD1:2023 is commonly consulted in medical device compliance workflows where low energy ionized gas haemostasis equipment is being assessed, tested, or maintained under controlled design changes. It may be used by regulatory, test, and procurement teams to confirm that the current technical file reflects the amended requirements connected to IEC 60601-2-76:2018. The document is particularly useful during conformity assessment preparation, internal technical audit, and product evaluation when teams need to verify that relevant safety and performance obligations are being addressed consistently.
Benefits of IEC 60601-2-76:2018/AMD1:2023
Using IEC 60601-2-76:2018/AMD1:2023 helps organizations reduce ambiguity when applying amended requirements to a specialized medical electrical device category. It supports safer design decisions, more consistent testing workflows, and clearer documentation for engineering validation. For procurement and compliance functions, the amendment can also improve technical clarity when comparing supplier documentation or preparing for regulatory review. By keeping the parent requirements current, it supports operational consistency, risk reduction, and more reliable conformity assessment planning.
- Amendment reference linked to IEC 60601-2-76:2018 for low energy ionized gas haemostasis equipment
- Useful for updating safety and essential performance review files
- Supports testing, verification, and documented evaluation activities
- Relevant to conformity assessment, regulatory preparation, and technical audit workflows
- Publication Date: 2023-08-31
- Standard Status: Amendment
- Publisher: IEC
- Edition: 1
- This Version: IEC 60601-2-76:2018 (2023-08-31)
- Previous Version: IEC 60601-2-76:2018 (2018-10-04)
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