International Organization for Standardization (ISO)
Latest
ISO 21291:2019
Scope
This document specifies the requirements and test methods for therapeutic fumigation devices, hereafter referred to as the device.
This document does not apply to decoction pieces.
ISO 21291:2019 Referenced Document
IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests*, 2024-04-21 Update
IEC 60601-1-8 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems CO...*, 2020-07-01 Update
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 21291:2019 history
2019ISO 21291:2019 Traditional Chinese medicine —Therapeutic fumigation devices