GB/T 16886.11-1997
Replaced
T/CAMDI 175-2026
Active
Group standards
T/CAMDI 175-2026 Guidelines for the Evaluation Format of the Service Life of Active Medical Devices
T/CAMDI 175-2026 Guidelines for the Evaluation Format of the Service Life of Active Medical Devices
Price:
$ 20.00
Basic Information
Standard Code:
T/CAMDI 175-2026
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Orthopaedic surgery, orthopaedic instruments
ICS Name:
Integrated medical equipment
Publish Date:
2026-01-15
Implement Date:
2026-07-15
Scope
This document specifies the requirements for the preparation of evaluation documents for the expected lifespan of active medical devices, covering the objects of the evaluation of the expected lifespan, path planning, failure analysis, evaluation methods, and test records and reports, etc. This document applies to active non-implantable medical devices (excluding medical device software) and active implantable medical devices, providing a standardized technical framework and operational guidelines for the evaluation of their expected lifespan.
Development Information
Related Standards
GB/T 16886.3-1997
Replaced
GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.6-1997
Replaced
GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.1-2001
Replaced
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.13-2001
Replaced
GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices
GB/T 16886.7-2001
Replaced