YY 9706.256-2023 in English
VALIDMedical electrical equipment--Part 2-56: Particular requirements for basicsafety and essential performance of clinical thermometers for body temperature measurement
- Issued on:2023-03-14
- Implemented on:2026-05-01
- File Format:PDF
- Delivery:Via email within 5 business days
$650.00
| Standard No: | YY 9706.256-2023 |
| Document status: | VALID |
| Title in English: | Medical electrical equipment--Part 2-56: Particular requirements for basicsafety and essential performance of clinical thermometers for body temperature measurement |
| Title in Chinese: | 医用电气设备 第2-56部分：用于体温测量的临床体温计的基本安全和基本性能专用要求 |
| Language: | English |
| File Format: | Electronic (PDF) |
| Delivery: | Via email within 5 business days |
| Issued on: | 2023-03-14 |
| Implemented on: | 2026-05-01 |
| Superseding: |
YY 0785-2010 Clinical thermometers—Performance of electrical thermometers for continuous measurement
|
| ICS Classification: | 11.040.55-Diagnostic equipment |
| Chinese Classification: | C39-Medical electronic equipment |
| Professional Classification: | YY-Pharmaceutics |
| Related Keywords: | clinical thermometers
accuracy key performance requirements clinical confirmation clinical deviation electronic clinical thermometers medical electrical equipment |
| Related Topics: | body temperature
clinical confirmation body temperature clinical temperature |
本文件规定了临床体温计及其附件的基本安全性和基本性能专用要求。
本文件适用于所有用于测量患者体温的电子临床体温计，包括测量和显示体温的医用电气设备。临床体温计可以通过配备接口来包含次级指示器、打印设备和其他辅助设备，从而形成医用电气系统。
本文件不适用于辅助设备，也不适用于在室内环境条件下，对人群进行无创发热温度筛查所用的屏幕热像仪。
Introduction
Background of Standard Revision and Scope of Application
YY 9706.256-2023 replaces YY 0785-2010. As an important part of the medical electrical equipment series standard, it is applicable to all electronic clinical thermometers and their accessories. The standard adds special requirements for home care environment and emergency medical service environment, and strengthens the basic performance clauses.
Core terminology definitions and technological evolution
| Terminology | Definition | Technical significance |
|---|---|---|
| Adjustment mode | Operation mode that corrects sensor signals through algorithms (such as infrared ear thermometers) | Accuracy requires clinical confirmation |
| Clinical deviation (Δu) | Average temperature difference between the measured thermometer and the reference thermometer | ≤0.3℃ (rated range) |
| Probe cover | Hygiene barrier between probe and patient | Influence on EMC and accuracy |
Key performance requirements comparison
Laboratory accuracy verification:Direct mode thermometers need to be tested in a liquid bath/blackbody environment, with an error of ≤±0.3℃ within the rated range and ≤±0.4℃ within the extended range. The test points need to cover the upper and lower limits of the ambient temperature (e.g. +15℃~+40℃).
Special requirements for clinical confirmation:Adjustment mode thermometers need to be tested on 105 subjects, with 30%~50% of the patients having fever, and the age groups refer to standard table 201.102.
Implementation recommendations and risk management
- Marking requirements: The probe cover packaging must indicate the compatible thermometer model (201.103.2)
- Document management: The accompanying documents must include the clinical accuracy confirmation results (201.102.1)
- EMC protection: Basic performance must be restored within 30 seconds after the immunity test (202.6 supplement)
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