GB 9706.216-2021
Medical electrical equipment—Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (English Version)

Standard No.

GB 9706.216-2021

Language

Chinese, Available in English version

Release Date

2021

Published By

国家市场监督管理总局、中国国家标准化管理委员会

Latest

GB 9706.216-2021

Replace

GB 9706.2-2003

Scope

The relevant parts of this document are applicable to ME EQUIPMENT other than hemodialysis, hemodiafiltration, hemofiltration intended for extracorporeal blood purification therapy, e.g. in patients with renal failure, if no other specific standard exists. . Examples of such blood purification treatments include plasmafiltration, hemoperfusion, apheresis, adsorption or hepatic dialysis. Relevant parts include, for example, blood processing systems and extracorporeal circulation safety in its entirety. The safety details of dialysate control systems for hemodialysis equipment using dialysate regeneration or a central dialysate supply system should be part of the manufacturer's risk management process. AAMI's Nephrology and Detoxification Committee is preparing a Technical Information Report on Sorbent-Based Regeneration of Hemodialysis Devices [] (AAMITIR16). Clause 201.3.8 Applied parts of the patient are in direct contact with the hemodialysis equipment and may be in contact with the ME system through fluid or electrical connections. In order to determine the patient leakage current, it is also important to consider whether the ME system or non-ME system components come into direct or indirect contact with the patient through the operator. Clause 201.3.202 Bleeding

GB 9706.216-2021 Referenced Document

• GB/T 3767 Acoustics—Determination of sound power levels and sound energy levels of noise sources using sound pressure—Engineering methods for an essentially free field over a reflecting plane
• GB/T 3785.1 Electroacoustics—Sound level meters—Part 1: Specifications*， 2023-05-23 Update
• YY 9706.102-2021 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standards: Electromagnetic compatibility requirements and tests
• YY 9706.108-2021 Medical electrical equipment Part 1-8: General requirements for basic safety and essential performance Collateral standards: General requirements, testing and guidance for alarm systems in medical electrical equipment and medical electrical systems
• YY 9706.111-2021 Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance Collateral standards: Requirements for medical electrical equipment and medical electrical systems used in home care environments
• YY/T 9706.110-2021 Medical electrical equipment Part 1-10: General requirements for basic safety and essential performance Collateral standards: Requirements for the development of physiological closed-loop controllers

GB 9706.216-2021 history

• 2021 GB 9706.216-2021 Medical electrical equipment—Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
• 2003 GB 9706.2-2003 Medical electrical equipment--Part 2-16: Particular requirements for the safety of haemodialysis,haemodiafiltration and haemofiltration equipment
• 1991 GB 9706.2-1991 Medical electrical equipment--Particular requirements for safety of haemodialysis equipment

GB 9706.216-2021 Medical electrical equipment—Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment has been changed from GB 9706.2-2003 Medical electrical equipment--Part 2-16: Particular requirements for the safety of haemodialysis,haemodiafiltration and haemofiltration equipment.

GB 9706.216-2021 -All Parts