GB 9706.216-2021

Active

Medical electrical equipment—Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

医用电气设备 第2-16部分:血液透析、血液透析滤过和血液滤过设备的基本安全和基本性能专用要求

Standard Type
GB
ICS
11.040.20
CCS
C45
Status
Active
Issue Date
2021-08-10
Implementation
2023-05-01
Centralized Committee
国家药监局
Issuing Authority
国家市场监督管理总局、中国国家标准化管理委员会

Application Summary AI generated

This standard specifies the particular safety and performance requirements for haemodialysis, haemodiafiltration, and haemofiltration equipment used in medical settings. It applies to the design, manufacturing, and testing of these devices to ensure patient and operator safety during renal replacement therapy. The standard is used by medical device manufacturers, testing laboratories, and healthcare facilities in China to verify compliance with national safety regulations.

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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.