T/CSBME 025-2021 Medical Device Reliability Management Standards
T/CSBME 025-2021 Medical Device Reliability Management Standards
Basic Information
Scope
Scope: This document specifies the construction method of a reliability management system for medical devices. This document is applicable to the construction of reliability management systems for organizations of various types, different sizes, and those providing different medical device products. If any requirements of this standard are not applicable due to the nature of the organization and its products, it may be considered to delete them. Main technical content: This document is applicable to the construction of reliability management systems for organizations of various types, different sizes, and those providing different medical device products. If any requirements of this standard are not applicable due to the nature of the organization and its products, it may be considered to delete them.