GB/T 16886.1-2022
Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process (English Version)

Standard No.

GB/T 16886.1-2022

Language

Chinese, Available in English version

Release Date

2022

Published By

国家市场监督管理总局、中国国家标准化管理委员会

Latest

GB/T 16886.1-2022

Replace

GB/T 16886.1-2011

Scope

This document stipulates: --- the basic principles guiding the biological evaluation of medical devices in the risk management process; --- the basic classification according to the nature and time of the contact between the device and the human body; --- the evaluation of the existing relevant data from all sources; — identification of deficiencies in the available data sets based on the risk analysis; — identification of other data sets required for the biological safety analysis of the medical device; — assessment of the biological safety of the medical device. This document applies to the evaluation of materials and medical devices that are expected to come into direct or indirect contact with: --- the patient's body during the intended use; --- the user's body, if the medical device is used for protective purposes (such as , surgical gloves, masks, etc.). This document is applicable to the biological evaluation of various types of medical devices, including active, passive, implantable and non-implantable medical devices. This document also gives guidance on the assessment of biological hazards (sources) arising from: --- as part of the overall biological safety assessment, risks caused by changes in medical devices over time; --- medical devices or Breakage of medical device components exposes human tissue to new or innovative materials. Other parts of GB/T 16886 contain the specific content of biological evaluation and related tests. Mechanical performance tests are given in medical device specific standards or product standards. This document does not apply to hazards (sources) associated with bacteria, fungi, yeasts, viruses, agents of transmissible spongiform encephalopathy (TSE) and other pathogens.

GB/T 16886.1-2022 Referenced Document

• GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity
• GB/T 16886.2-2011 Biological evaluation of medical devices.Part 2: Animal welfare requirements
• ISO 10993-2 Biological evaluation of medical devices — Part 2: Animal welfare requirements*， 2022-11-03 Update
• ISO 10993-4 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1
• ISO 10993-5 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
• ISO 10993-6 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
• ISO 10993-9 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
• ISO 14971 Medical devices - Application of risk management to medical devices
• YY/T 0316-2016 Medical devices.Application of risk management to medical devices

GB/T 16886.1-2022 history

• 2022 GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
• 2011 GB/T 16886.1-2011 Biological evaluation of medical devices.Part 1: Evaluation and testing within a risk management process
• 2001 GB/T 16886.1-2001 Biological evaluation of medical devices--Part 1: Evaluation and testing

GB/T 16886.1-2022 -All Parts