T/SSBME 1-2024 Active Group standards

T/SSBME 1-2024 Medical devices—Guidelines for compiling post market study and risk management plans

T/SSBME 1-2024 Medical devices—Guidelines for compiling post market study and risk management plans

Publish Date: 2024-09-06 Implement Date: 2024-09-07 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/SSBME 1-2024

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Medical equipment

Publish Date: 2024-09-06

Implement Date: 2024-09-07

Pages: 28 pages

Scope

This document specifies the scope, objectives, responsibilities, data collection, data analysis, and review requirements for the preparation of post-market research and risk control plans for medical devices.
This document is applicable to guiding registrants in preparing post-market research and risk control plans.

Development Information

Word Count: 34 Thousand words Pages: 28 pages

Referenced Standards

GB/T 42061-2022 Medical devices—Quality management systems—Requirements for regulatory purposes GB/T 42062-2022 Medical devices—Application of risk management to medical devices

Related Standards

GB 9706.8-1995 Replaced

GB 9706.8-1995 Medical electrical equipment—Part 2:Particular requirements for the safety of cardiac defibrillators and cardiac defibrillator-monitors

Publish Date: 1995-06-02

GB 11235-1997 Replaced

GB 11235-1997 VCu intra-uterine device

Publish Date: 1997-07-24

GB/T 17257.1-1998 Replaced

GB/T 17257.1-1998 Urine collection bags—Part 1:Vocabulary

Publish Date: 1998-03-18

GB/T 17257.2-1998 Replaced

GB/T 17257.2-1998 Urine collection bags—Part 2:Determination of dimensions

Publish Date: 1998-03-18

GB/T 17257.3-1998 Replaced

GB/T 17257.3-1998 Urine collection bags—Part 3:Verification of rated volume

Publish Date: 1998-03-18

GB/T 17257.4-1998 Replaced

GB/T 17257.4-1998 Urine collection bags—Part 4:Determination of freedom form leakage

Publish Date: 1998-03-18