GB/T 16886.11-1997
Replaced
T/ZMDS 10015-2022
Active
Group standards
T/ZMDS 10015-2022 Joint surgery navigation system - Part 2: Usability
T/ZMDS 10015-2022 Joint surgery navigation system - Part 2: Usability
Price:
$ 20.00
Basic Information
Standard Code:
T/ZMDS 10015-2022
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:
16 pages
Scope
Scope: This standard 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: Chapter 4 Overview. The human-centered design principles introduced in this chapter aim to help design teams optimize the user interface design. Chapter 5 Risk management of use errors. The methods introduced in this chapter aim to help manufacturers identify, evaluate, and control use errors and their risks, ensuring the safe and effective use of medical devices. Chapter 6 Usability specifications for user interfaces. This chapter stipulates the basic requirements for the safe use of user interfaces in 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