Now i will share ISO 18562-1:2017,the title is Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process.
ISO 18562-1:2017 represents the application of the best-known science, in order to improve PATIENT safety, by addressing the Risk of potentially hazardous substances being conveyed to the PATIENT by the gas stream.
ISO 18562-1:2017 is intended to cover the biological evaluation of GAS PATHWAYS of MEDICAL DEVICES withina RISK MANAGEMENT PROCESS, as part of the overall MEDICAL DEVICE evaluation and development. This approach combines the review and evaluation of existing data from all sources with, where necessary,the selection and application of additional tests.
In general, the ISO 10993 series is intended to cover the biological evaluation of MEDICAL DEVICES.However, the ISO 10993 series does not sufficiently address the biological evaluation of the GAS pathways of medical devices.
This document provides a guide to the development of a biological evaluation plan that minimizes the number and exposure of test animals by giving preference to chemical constituent testing and in vitro models.
Download ISO 18562-1:2017 pdf here now.