ISO 80601-2-55:2018/AMD1:2023
Amendment 1 - Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
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About This Item
ISO 80601-2-55:2018/AMD1:2023 is an amendment to the parent document for medical electrical equipment used as respiratory gas monitors, adding a targeted update to the requirements for basic safety and essential performance. For engineering teams, test laboratories, and compliance reviewers, it serves as a supporting technical reference that must be read alongside ISO 80601-2-55:2018. It is relevant where documented evaluation, risk management, and verification activities must align with the amended requirements for respiratory gas monitoring equipment.
ISO 80601-2-55:2018/AMD1:2023 standard overview
This amendment refines the technical basis for respiratory gas monitor conformity assessment rather than functioning as a standalone product specification. ISO 80601-2-55:2018/AMD1:2023 is used to understand how the parent standard’s safety and performance expectations are updated, which is important during technical review, product validation, and regulatory preparation. In practice, it helps organizations maintain accurate engineering documentation, confirm testing workflows, and apply the correct compliance reference when assessing medical electrical equipment in this category.
Applications of ISO 80601-2-55:2018/AMD1:2023
Organizations may use this amendment when reviewing respiratory gas monitors for design changes, procurement checks, laboratory evaluation, or conformity assessment planning. It is particularly relevant for teams preparing technical files, updating verification protocols, or confirming that testing aligns with the current parent document and amendment set. In quality workflows, it can support controlled document review, performance criteria checks, and consistency between engineering validation results and compliance records for medical electrical equipment.
Why ISO 80601-2-55:2018/AMD1:2023 matters
Keeping track of the amended requirements helps reduce compliance gaps and improves confidence in safety-focused design and testing decisions. For manufacturers and labs, ISO 80601-2-55:2018/AMD1:2023 supports more reliable technical assessment by clarifying what has changed in the parent framework for respiratory gas monitors. That can improve testing consistency, strengthen conformity assessment preparation, and reduce risk during procurement review or regulatory submission. It is most valuable when operational consistency and documented compliance must be maintained across product lifecycle activities.
- Supporting amendment linked to ISO 80601-2-55:2018 for respiratory gas monitor requirements
- Relevant to basic safety, essential performance, and structured risk management review
- Useful for testing workflows, technical validation, and compliance documentation updates
- Helps align engineering assessment with current conformity assessment expectations
- Publication Date: 2023-06-12
- Standard Status: Amendment
- Publisher: IEC
- Edition: 2
- This Version: ISO 80601-2-55:2018 (2023-06-12)
- Previous Version: ISO 80601-2-55:2018 (2018-12-02)
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