T/CSBM 0036-2023 Active Group standards

T/CSBM 0036-2023 The casting billet of high-purity CoCr base alloy used for cardiovascular stents

Publish Date: 2023-04-24 Implement Date: 2023-10-01 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 0036-2023

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2023-04-24

Implement Date: 2023-10-01

Scope

Main Technical Content: 4 Technical Requirements 4.1 Melt Conditions for Alloys 4.1.1 Obtain high-purity CoCr-based alloy casting rods using vacuum horizontal continuous casting or vacuum centrifugal casting technology, and machine-process the rods into tubes according to the processing and usage specifications (φ40–φ60). 4.1.2 Use high-purity raw materials for smelting (purity >99.9%). 4.1.3 Do not use any recycled materials of cobalt and cobalt alloys as raw materials for master alloys. 4.2 Elemental Composition and Deviations 4.2.1 The chemical composition of CoCr-based alloys for cardiovascular stents shall comply with Table 1. Table 1 Chemical Composition of CoCr-Based Alloys for Cardiovascular Stents 4.2.2 The allowable deviations of chemical composition shall comply with GB/T 222 when the buyer conducts reinspection. 4.3 Impurity Content The size and quantity of all impurities shall not exceed the values specified in Table 2. Table 2 Minimum Definitions of Impurities 4.4 Mechanical Tensile Properties The room-temperature and 650°C tensile properties of the casting rods shall comply with Table 3. Table 3 Tensile Properties of Casting Rods 4.5 Dimensional Tolerances 4.5.1 The outer diameter, wall thickness, and length of the casting rods, as well as their allowable deviations, shall comply with Table 4. Table 4 Diameter, Wall Thickness, and Length of Casting Rods and Their Allowable Deviations 4.5.2 The linearity of the casting rods shall be less than 5 mm/500 mm. 4.5.3 The concentricity of the casting rods shall be less than 0.1 mm. 4.5.4 The edges of the casting rods shall be cut at right angles without cracks, burrs, or chamfers. The angle of the cut shall not exceed the allowable deviations of the rod’s diameter and wall thickness. 4.6 Grain Size The microstructure of the CoCr-based casting rods shall be columnar, with a columnar crystal fraction greater than 80%.