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Foreword 0 Introduction 0 1 Scope 0 2 Normative references 0 3 Terms and definitions 0 4 General principles applying to biocompatibility evaluation of medical devices 0 4.1 General 0 4.2 Type tests 0 4.3 Biocompatibility hazard identification 0 4.4 Extent of risk assessment 0 4.5 Biocompatibility evaluation plan 0 4.6 Selection of tests 0 4.7 Subsequent evaluation 0 5 Contamination of breathing gas from gas pathways 0 5.1 * Duration of use 0 5.2 Particulate matter (pm) emissions 0 5.3 Volatile organic compound (voc) emissions 0 5.4 Leachable substances in condensate 0 6 Adjustment for different patient groups 0 6.1 General considerations 0 6.2 Adjustment for body weight 0 6.3 * Deriving a permitted concentration from a tolerable exposure 0 7 * Deriving allowable limits 0 7.1 General process 0 7.2 For medical devices intended for limited exposure use (≤24 h) 0 7.3 For medical devices intended for prolonged exposure use (>24 h but <30 d) 0 7.4 For medical devices intended for permanent contact (≥30 d) 0 8 Risk benefit analysis 0 9 Assess the biocompatibility of the medical device 0 Annex A (informative) Rationale and guidance 0 Annex B (informative) Reference to the essentia

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ISO

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EN

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reference