T/CAMDI 029-2019 Active Group standards

T/CAMDI 029-2019 Customizable medical device monitoring and evaluation criteria and acceptance conditions for the entire process of physician-engineer interaction with reference to industry standards

Publish Date: 2019-06-28 Implement Date: 2019-07-20 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/CAMDI 029-2019

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2019-06-28

Implement Date: 2019-07-20

Scope

Main technical content: This standard specifies the monitoring and assessment indicators and acceptance criteria for the entire process of medical device-user interaction in customized medical devices. From the perspectives of technical and work norms, this standard includes: confirmation of interaction capabilities, data acquisition, data format and transmission, data verification, data analysis and treatment plans, data customization requirements, design and development, data storage, data traceability, privacy protection, production conditions, production records, product sampling, product traceability, device delivery, data delivery, assessment and acceptance objects and related indicators, measures related to device unsuitability, use follow-up and feedback. This standard applies to customized medical devices such as bone, joint, and oral hard tissues. It clearly defines the process and methods of quality assurance for customized medical devices, standardizes the relevant behaviors of medical device-user interaction, and realizes the sharing and exchange of medical device information, monitoring, and data acquisition from clinical needs to production and clinical use, as well as the entire process of design and development, device production, delivery and acceptance, and use follow-up. This standard provides a reference for matching medical devices with patients.