T/ZSA 188-2023 Abolished Group standards

T/ZSA 188-2023 Joint surgery navigation system function safety

Publish Date: 2023-11-30 Implement Date: 2023-12-01 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/ZSA 188-2023

Standard Type: Group standards

Standard Status: Abolished

is_force_gb: no

CCS Name: Medical radiation equipment

ICS Name: Integrated medical equipment

Publish Date: 2023-11-30

Implement Date: 2023-12-01

Pages: 19 pages

Scope

Scope: This document specifies the functional safety requirements for joint surgery navigation and positioning systems using robotic technology, and describes the corresponding test methods. This document is applicable to the design of 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 adopts risk management and failure mode analysis methods, combined with the structural characteristics and clinical applications of joint surgery navigation and positioning systems, to develop functional safety standards applicable to the sub-fields of joint surgery navigation and positioning systems. It defines quantitative indicators and test methods for the performance of joint surgery navigation and positioning systems. The functional safety standards specified in this document can serve as a basis for manufacturers and testing institutions to conduct functional safety design and testing of joint surgery navigation and positioning systems.

Development Information

Pages: 19 pages

Related Standards

GB/T 16886.11-1997 Replaced

GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity

Publish Date: 1997-06-26

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

Publish Date: 1997-06-26

GB/T 16886.6-1997 Replaced

GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation

Publish Date: 1997-06-26

GB/T 16886.1-2001 Replaced

GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing

Publish Date: 2001-09-24

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

Publish Date: 2001-09-24

GB/T 16886.7-2001 Replaced

GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals

Publish Date: 2001-09-24