T/CSBM 0053-2024 Active Group standards

T/CSBM 0053-2024 Polyvinyl alcohol (PVA) embolization microspheres

Publish Date: 2024-11-25 Implement Date: 2025-04-01 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/CSBM 0053-2024

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2024-11-25

Implement Date: 2025-04-01

Scope

Scope: This document specifies the requirements, test methods, sterilization, packaging, and manufacturer-provided information for polyvinyl alcohol embolization microspheres (hereinafter referred to as microspheres). This document applies to spherical or spheroidal polyvinyl alcohol embolization microspheres used in the field of vascular intervention, while other material embolization microspheres can be used for reference. This document does not apply to liquid embolic agents or radioactive embolization microspheres. Main Technical Content: 3. Terms and Definitions The following terms and definitions apply to this document. 3.1 Wet Microsphere A microsphere that is fully swollen in the preservation solution. 3.2 Dry Microsphere A microsphere that has been dehydrated by vacuum drying or other specific drying methods. 3.3 Suspended State The state in which at least 2/3 of the volume of the mixed solution containing embolization microspheres and contrast agents remains in the microsphere when the mixture is placed vertically and allowed to stand. 3.4 Equilibrium Swelling The state in which a cross-linked polymer absorbs solvent and the chain segments between cross-linking points expand, with the expansion force and network elastic recovery force being equal. Note: In this state, the polymer volume no longer changes. 3.5 Swelling Time The time required for a dry microsphere to reach equilibrium swelling when immersed in the preservation solution. 3.6 Swelling Degree The measure of the weight change of a dry microsphere after reaching equilibrium swelling. 4. Requirements 4.1 Identification It shall comply with the infrared spectrum characteristic peaks specified by the manufacturer. 4.2 Appearance There shall be no impurities. If there is a preservation solution, it shall be clear, and the microspheres shall be spherical or spheroidal. 4.3 Physical and Mechanical Properties 4.3.1 The filling quantity shall be expressed i