GB/T 16886.1-2011
Biological evaluation of medical devices.Part 1: Evaluation and testing within a risk management process (English Version)

Standard No.

GB/T 16886.1-2011

Language

Chinese, Available in English version

Release Date

2011

Published By

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China

Status

Be replaced 2023-05

Replace By

GB/T 16886.1-2022

Latest

GB/T 16886.1-2022

Replace

GB/T 16886.1-2001

Scope

This part of GB/T 16886 describes: - the basic principles guiding the biological evaluation of medical devices within the framework of medical device risk management; - a general classification according to the nature and duration of contact between the device and the human body; - a summary of relevant data from all sources Evaluation; - identification of deficiencies in available data sets based on risk analysis; - identification of other data sets required for biological safety analysis of medical devices; - assessment of biological safety of medical devices. This section does not include experiments on materials and devices that are not in direct or indirect contact with the patient's body, nor does it include any biological hazards caused by mechanical failure. Specific tests included in other parts of GB/T 16886 are given in the preface.

GB/T 16886.1-2011 Referenced Document

• ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
• ISO 10993-2 Biological evaluation of medical devices — Part 2: Animal welfare requirements*， 2022-11-03 Update
• ISO 10993-3 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity*， 2014-10-01 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*， 2016-12-01 Update
• ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1
• ISO 10993-9 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products*， 2019-11-26 Update
• ISO 14971 Medical devices - Application of risk management to medical devices*， 2019-12-01 Update

GB/T 16886.1-2011 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 16886.1-2011 Biological evaluation of medical devices.Part 1: Evaluation and testing within a risk management process was changed to FZ/T 54038-2014 Profiled polyester drawn textured yarns.

GB/T 16886.1-2011 -All Parts