GB/T 16886.11-1997
Replaced
T/ZMDS 10013-2022
Active
Group standards
T/ZMDS 10013-2022 Near-infrared brain function imaging device general technical requirements
T/ZMDS 10013-2022 Near-infrared brain function imaging device general technical requirements
Price:
$ 20.00
Basic Information
Standard Code:
T/ZMDS 10013-2022
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
-
ICS Name:
Integrated medical equipment
Publish Date:
2022-08-25
Implement Date:
2022-08-25
Pages:
10 pages
Scope
Scope: This document specifies the terms and definitions, components, requirements, test methods, packaging, transportation, and storage of near-infrared brain functional imaging equipment. This document applies to devices that use near-infrared spectroscopy technology to measure changes in hemoglobin concentration in the blood of the brain cortical surface area at multiple points and present images of the relative distribution of cerebral oxygenation in the brain cortex. Main technical content: This document proposes the basic requirements for the composition, appearance and structure, technical parameters, software, continuous working time, power supply voltage compatibility, electromagnetic compatibility, and environmental testing of near-infrared brain functional imaging equipment, as well as corresponding test methods.
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