ISO 80601-2-87:2021
Medical electrical equipment - Part 2-87: Particular requirements for the basic safety and essential performance of high frequency ventilators
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About This Item
ISO 80601-2-87:2021 defines particular requirements for the basic safety and essential performance of high frequency ventilators, making it a relevant technical document for teams that evaluate respiratory care equipment. It supports engineering review, documented evaluation, and compliance workflows by focusing attention on the safety-related and performance-related aspects that matter during design control, verification activities, and procurement assessment. For organizations working on medical electrical equipment, ISO 80601-2-87:2021 can help structure technical assessment and conformity assessment preparation.
Purpose of ISO 80601-2-87:2021
The purpose of ISO 80601-2-87:2021 is to establish particular requirements that supplement the general safety framework for medical electrical equipment, specifically for high frequency ventilators. Its scope is aimed at basic safety and essential performance, which are central to risk management, technical validation, and regulatory preparation. For manufacturers, laboratories, and compliance teams, the document provides a focused engineering specification that can support consistent interpretation of performance criteria during development, testing workflows, and quality assurance review.
Compliance applications of ISO 80601-2-87:2021
ISO 80601-2-87:2021 is typically used when preparing technical documentation for high frequency ventilators intended for clinical use and when organizing verification and validation evidence for product evaluation. It is also relevant in laboratory evaluation, procurement review, and conformity assessment activities where safety and essential performance must be demonstrated in a controlled and repeatable way. The standard can help align engineering documentation, test planning, and compliance workflows so that review teams assess the same technical compliance basis throughout the product lifecycle.
Benefits of ISO 80601-2-87:2021
Using ISO 80601-2-87:2021 as a compliance reference can improve consistency in safety review, reduce ambiguity during technical assessment, and support more efficient testing and documentation processes. It helps teams focus on the requirements most relevant to high frequency ventilators, which can strengthen engineering validation and reduce risk during product development or procurement decision-making. For organizations facing conformity assessment or internal quality workflows, the document provides a structured basis for comparing design outputs, test results, and regulatory expectations.
- Particular requirements for the basic safety and essential performance of high frequency ventilators
- Useful for design review, verification planning, and documented evaluation
- Supports conformity assessment, regulatory preparation, and compliance workflows
- Relevant to laboratory testing, product evaluation, and quality assurance review
- Publication Date: 2021-12-04
- Standard Status: Original
- Publisher: IEC
- Edition: 1
- This Version: ISO 80601-2-87:2021 (2021-12-04)
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