DZ/T 0101.12-1994
Active
GB/T 16886.23-2023
Active
National standards
GB/T 16886.23-2023 Biological evaluation of medical devices—Part 23:Tests for irritation
GB/T 16886.23-2023 Biological evaluation of medical devices—Part 23:Tests for irritation
Price:
$ 129
Basic Information
Standard Code:
GB/T 16886.23-2023
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
-
Publish Date:
2023-11-27
Implement Date:
2024-12-01
Pages:
68 pages
Scope
This document specifies the evaluation steps for potential irritation of medical devices and their constituent materials, including the following: -- Considerations before irritation testing, including computer simulation tests and in vitro methods for skin contact; -- Detailed in vitro and in vivo irritation testing steps; -- Key factors for result interpretation. This document is applicable to predicting and classifying the potential irritation of medical devices, materials, or their extracts according to ISO 109931 and ISO 109932.
Development Information
Same series standard
Referenced Standards
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
ISO 10993-1
ISO 10993-2
ISO 10993-9
ISO 10993-12
ISO 10993-13
ISO 10993-14
ISO 10993-15
ISO 10993-18
ISO 14155
OECD 404
OECD 439
Adopt standards
ISO 10993-23:2021
Related Standards
JJG 204-1980
Active
JJG 204-1980 Meteorological Ventilation Psychrometer
SC 53-1980
Active
SC 53-1980 Transfer blade hydraulic steering gear repair quality standard
DZ 4-1981
Replaced
\nDZ 4-1981 Method for Compiling Product Models of Geological Instrumentation Equipment
SC 69-1982
Active
SC 69-1982 ZSS-12 Flash-type seawater desalination production device technical specifications
SC 72-1982
Active