YY 0790-2024 Pending Industry standards-Medicine

YY 0790-2024 Hemoperfusion equipment

YY 0790-2024 Hemoperfusion equipment

Publish Date: 2024-09-29 Implement Date: 2027-10-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0790-2024

Standard Type: Industry standards

Standard Status: Pending

is_force_gb: no

CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2024-09-29

Implement Date: 2027-10-15

Pages: 10 pages

Scope

This document specifies the requirements for blood perfusion equipment and describes the corresponding test methods.
This document applies to the blood perfusion equipment defined in 3.1 (hereinafter referred to as the equipment).
This document does not apply to:
—— Peritoneal dialysis equipment;
—— Centrifugal blood component separation equipment;
—— Continuous blood purification equipment;
—— Plasma exchange equipment;
—— Plasma adsorption equipment;
—— Hemodialysis equipment.

Development Information

Word Count: 19 Thousand words Pages: 10 pages

Replace the following standards

YY 0790-2010 Hemoperfusion equipment

Referenced Standards

GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance 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 YY 9706.102-2021 Medical electrical equipment—Part 1-2:General requirements for basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests YY 9706.108-2021 Medical electrical equipment—Part 1-8:General requirements for basic safety and essential performance-Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

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