Foreword
European 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 Adjustment of TOLERABLE EXPOSURE for benefit
of the treatment
9 Assess the BIOCOMPATIBILITY of the MEDICAL DEVICE
Annex A (informative) - Rationale and guidance
Annex B (informative) - Reference to the Essential Principles
Annex C (informative) - Terminology - alphabetized index
of defined terms
Annex ZA (informative) - Relationship between this Document
and the Essential Requirements of EU Directive 93/42/EEC
Bibliography