T/CAMDI 021-2019 Active Group standards

T/CAMDI 021-2019 Disposable hydrophilic coating guide wire

T/CAMDI 021-2019 Disposable hydrophilic coating guide wire

Publish Date: 2019-01-01 Implement Date: 2019-07-01 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 021-2019
Standard Type: Group standards
Standard Status: Active
is_force_gb: no
CCS Name: \nBasic standards
ICS Name: Integrated medical science and healthcare devices
Publish Date: 2019-01-01
Implement Date: 2019-07-01

Scope

Main technical content: Disposable hydrophilic coated guidewires are currently one of the commonly used medical devices in percutaneous coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This product has been widely used both domestically and internationally. However, there are no corresponding industry or national standards for hydrophilic coated guidewires. The closest standard is YY 0450.1-2003 "Disposable Sterile Endovascular Catheter Accessories - Part 1: Guide Instruments", but this standard only applies to non-hydrophilic coated guidewires and does not specify the special requirements for hydrophilic coated guidewires. Therefore, in order to standardize and guide the development of disposable hydrophilic coated guidewires in China and further ensure the safety of percutaneous coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) in clinical practice in China, we have developed this group standard on the basis of YY 0450.1-2003 standard.

Development Information

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