GB 9706.271-2022

Active

Medical electrical equipment—Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment

医用电气设备 第2-71部分:功能性近红外光谱(NIRS)设备的基本安全和基本性能专用要求

Standard Type
GB
ICS
11.040.55
CCS
C40
Status
Active
Issue Date
2022-12-29
Implementation
2026-01-01
Centralized Committee
国家药监局
Issuing Authority
国家市场监督管理总局、国家标准化管理委员会

Application Summary AI generated

This standard specifies the basic safety and essential performance requirements for functional near-infrared spectroscopy (NIRS) equipment used in medical electrical systems. It applies specifically to devices that non-invasively monitor cerebral or tissue oxygenation by measuring light absorption changes, commonly used in operating rooms, intensive care units, and neonatal care settings. The standard ensures these devices meet rigorous safety and performance criteria for clinical diagnosis and patient monitoring.

Related Standards

Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.