GB/T 16886.11-1997
Replaced
T/ZMDS 10014-2022
Active
Group standards
T/ZMDS 10014-2022 Joint surgery navigation system - Part 1: Functional safety
T/ZMDS 10014-2022 Joint surgery navigation system - Part 1: Functional safety
Price:
$ 20.00
Basic Information
Standard Code:
T/ZMDS 10014-2022
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical radiation equipment
ICS Name:
Integrated medical equipment
Publish Date:
2022-12-30
Implement Date:
2022-12-30
Pages:
22 pages
Scope
Scope: This document applies to joint surgery navigation positioning systems based on optical navigation technology, including total knee joint replacement surgery navigation positioning systems and total hip joint replacement surgery navigation positioning systems; Main technical content: Terms and definitions, requirements, and test methods related to the functional safety of joint surgery navigation positioning systems.
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