YY/T 1778.1-2021 Active Industry standards-Medicine

YY/T 1778.1-2021 Biocompatibility evaluation of breathing gas pathways in healthcare applications—Part 1:Evaluation and testing within a risk management process

Publish Date: 2021-09-06 Implement Date: 2022-09-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Price: $ 57

Download

Basic Information

Standard Code: YY/T 1778.1-2021

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Surgical room equipment

ICS Name: Anesthesia, respiration, and resuscitation equipment

Publish Date: 2021-09-06

Implement Date: 2022-09-01

Pages: 24 pages

Scope

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.