T/CAMDI 034-2020 Active Group standards

T/CAMDI 034-2020 Biological evaluation of medical devices with hydrophilic polymer coating: Sample preparation

Publish Date: 2020-02-01 Implement Date: 2020-08-01 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/CAMDI 034-2020

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Integrated medical science and healthcare devices

Publish Date: 2020-02-01

Implement Date: 2020-08-01

Scope

Main technical content: This standard specifies the terminology, sample selection, sample preparation, and coating integrity identification methods for medical catheters with hydrophilic polymer coatings made from materials such as polyurethane, nylon, silicone, latex, polyvinyl chloride, fluoroplastic, and polyolefins. It is a dedicated requirement for the preparation of biological evaluation samples for this type of product.

Development Information

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