GB/T 16886.11-1997
Replaced
T/ZMDS 10016-2022
Active
Group standards
T/ZMDS 10016-2022 Joint surgery navigation positioning system Part 3: Accelerated life test
T/ZMDS 10016-2022 Joint surgery navigation positioning system Part 3: Accelerated life test
Price:
$ 20.00
Basic Information
Standard Code:
T/ZMDS 10016-2022
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
-
ICS Name:
Integrated medical equipment
Publish Date:
2022-12-30
Implement Date:
2022-12-30
Pages:
33 pages
Scope
Scope: This document specifies the general requirements, accelerated life test models, and test methods for joint surgery navigation and positioning systems that adopt robotics technology. This document is applicable to joint surgery navigation and positioning systems based on optical navigation technology, including total knee replacement surgery navigation and positioning systems and total hip replacement surgery navigation and positioning systems. Main technical content: This document details several accelerated aging test methods based on single-stress models, multi-stress models, event-compression acceleration models, and time-compression models. It also provides general requirements and accelerated test models for key components of surgery navigation and positioning systems. It separately explains accelerated aging test methods and rapid verification methods for reliability indicators, providing a reference for conducting accelerated tests on surgery navigation and positioning systems, supporting the rapid verification of indicators and brand building for domestically produced surgery navigation and positioning systems, and providing a feasible standard guide for comprehensively improving the quality and reliability of surgery navigation and positioning systems in China. The main methods of this document have been applied to multiple surgery navigation and positioning system products and are highly practical.
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