YY 9706.270-2021Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment (English PDF)

YY 9706.270-2021 is the English-translated version of 医用电气设备 第2-70部分：睡眠呼吸暂停治疗设备的基本安全和基本性能专用要求.

YY 9706.270 is the mandatory Chinese standard for sleep apnoea therapy equipment, the CPAP and bilevel devices used at home every night by a very large and growing number of Chinese patients. It sets the particular requirements for basic safety and essential performance on top of the general medical electrical safety standard, covering the pressure delivered and its stability, the response to leak, the rebreathing safeguards, the noise that determines whether the patient tolerates the device at all, and the behaviour on power interruption. Unlike a life-support ventilator the failure mode is not immediate death, which is exactly why compliance has to be enforced rather than assumed: the harm from an ineffective device is silent and cumulative. Being a YY standard without the /T suffix, compliance is compulsory. It takes effect in May 2024.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 30 pages — is available in the English PDF.

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