GB/T 16886.11-2021
ActiveBiological evaluation of medical devices—Part 11: Tests for systemic toxicity
医疗器械生物学评价 第11部分：全身毒性试验
Application Summary AI generated
This standard specifies the requirements and procedures for evaluating the systemic toxicity of medical devices, covering acute, subacute, subchronic, and chronic toxicity through routes such as injection or implantation. It is applied in the biological evaluation of medical devices that contact the body directly or indirectly, ensuring patient safety by assessing potential toxic effects on organs and systems. The standard is used by manufacturers, testing laboratories, and regulatory bodies in the healthcare industry for pre-market approval and quality control of devices like implants, catheters, and drug delivery systems.
Related Standards
GB/T 19634-2005
In vitro diagnostic test systems-General technical requirements for blood-glucose monitoring systems for self-testing
GB/T 47486-2026
General technical requirements for vasculature-on-a-chip
GB/Z 30154-2013
Medical laboratories―Guidance on laboratory implementation of GB/T 22576-2008
GB/Z 16886.22-2022
Biological evaluation of medical devices—Part 22:Guidance on nanomaterials
GB/Z 43280-2023
Medical laboratories—Practical guidance for the estimation of measurement uncertainty
GB/Z 43281-2023
Guidance for supervisors and operators of point-of-care testing(POCT) devices
GB/Z 44363-2024
Pyrogenicity—Principles and methods for pyrogen testing of medical devices
GB/Z 157-2026
In vitro diagnostic test systems—Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods
Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.