BS ISO 18562-1:2017

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles applying to
  BIOCOMPATIBILITY evaluation of MEDICAL DEVICES
5 Contamination of breathing gas from GAS
  PATHWAYS
6 Adjustment for different PATIENT groups
7 Deriving allowable limits
8 RISK benefit analysis
9 Assess the BIOCOMPATIBILITY of the MEDICAL DEVICE
Annex A (informative) - Rationale and guidance
Annex B (informative) - Reference to the essential principle
Annex C (informative) - Terminology - Alphabetized
        index of defined terms
Bibliography

Describes: - the general principles governing the biological evaluation within a RISK MANAGEMENT PROCESS of the GAS PATHWAYS of a MEDICAL DEVICE, its parts or ACCESSORIES, which are intended to provide respiratory care or supply substances via the respiratory tract to a PATIENT in all environments; - the general categorization of GAS PATHWAYS based on the nature and duration of their contact with the gas stream; - the evaluation of existing relevant data from all sources; - the identification of gaps in the available data set on the basis of a RISK ANALYSIS; - the identification of additional data sets necessary to analyse the biological safety of the GAS PATHWAY; - the assessment of the biological safety of the GAS PATHWAY.