T/ZZB 3300-2023 Active Group standards

T/ZZB 3300-2023 Dialysis water treatment equipment

Publish Date: 2023-10-30 Implement Date: 2023-11-20 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/ZZB 3300-2023

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

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

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2023-10-30

Implement Date: 2023-11-20

Pages: 14 pages

Scope

Main technical content: This document specifies the basic requirements, technical requirements, test methods, inspection rules, marking, product information, packaging, transportation, storage, and quality commitments for water treatment equipment used in hemodialysis. This document applies to devices that process drinking water for use in hemodialysis and related treatments. The water usage includes: a) preparing concentrated solutions from powders or other highly concentrated media in dialysis facilities; b) preparing dialysis solutions, including those that can be used to prepare replacement solutions; c) reprocessing dialyzers that can be used multiple times after a single use; d) reprocessing dialyzers that are not explicitly marked for single-use. This document applies to water treatment equipment, pipelines, and accessories used in hemodialysis from the delivery point of drinking water into the water treatment system to the point of use of dialysis water.