YY/T 1778.1-2021 Active
YY/T 1778.1-2021 Biocompatibility evaluation of breathing gas pathways in healthcare applications—Part 1:Evaluation and testing within a risk management process
Abstract
This section stipulates the general principles to be followed in the evaluation of the biocompatibility of medical device materials that make up the gas pathway, including:
——The basic principles to be followed in the evaluation of the biological risks of medical devices, their components, or accessories used to supply gas or other substances to patients through the respiratory tract in various environments during the risk management process;
——A general classification of gas pathways according to the nature and duration of contact with airflow;
——The evaluation of existing data from all sources;
——The identification of defects in the available data sets based on risk analysis;
——The identification of other data sets required for the biological safety analysis of gas pathways;
——The evaluation of the biological safety of gas pathways.
General Product Information
| Document Type | Industry standards-Medicine |
|---|---|
| Standard Status | Active |
| Standard Code | YY/T 1778.1-2021 |
| CCS | Surgical room equipment |
| ICS | Anesthesia, respiration, and resuscitation equipment |
| Implement Date | 2022-09-01 |