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eLibrary > BS EN ISO 18562-1:2024 - TC Tracked Changes. Biocompatibility evaluation of breathing gas pathways in healthcare applications - Evaluation and testing within a risk management process >

BS EN ISO 18562-1:2024 - TC Tracked Changes. Biocompatibility evaluation of breathing gas pathways in healthcare applications - Evaluation and testing within a risk management process, 2024

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BS EN ISO 18562-1:2024 - TC Tracked Changes. Biocompatibility evaluation of breathing gas pathways in healthcare applications - Evaluation and testing within a risk management process, 2024

A-30441398.pdf [Go to Page]
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Annex ZA(informative)Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered [Go to Page]
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles applying to biocompatibility evaluation of medical devices [Go to Page]
4.1 General
4.2 Type tests
4.3 Biocompatibility hazard identification
4.4 Extent of risk assessment
4.5 Biological evaluation plan
4.6 Selection of tests
4.7 Subsequent evaluation
5 Contamination of breathing gas from gas pathways [Go to Page]
5.1 Duration of use
5.2 Particulate matter (PM) emissions
5.3 Volatile organic substance emissions
5.4 Leachables in condensate
6 Adjustment of exposure dose and inhalation dose for different patient groups [Go to Page]
6.1 General considerations
6.2 Adjustment for different patient groups
7 Deriving tolerable exposure (TE) for VOS [Go to Page]
7.1 General process
7.2 For medical devices intended for limited exposure use (≤24 h) and prolonged exposure use (>24 h but <30 d)
7.3 For medical devices intended for long-term exposure (≥30 d)
8 Determining values for leachables in condensate [Go to Page]
8.1 General
8.2 Adjustments for different patient groups
8.3 Exposure dose estimate for condensate
9 Risk control
10 Benefit-risk analysis
11 Biological evaluation report
Annex A (informative) Rationale and guidance
Annex B (informative) Reference to the IMDRF essential principles and labelling guidances
Annex C (informative) Reference to the essential principles
Annex D (informative) Terminology — Alphabetized index of defined terms
Bibliography [Go to Page]

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BS EN ISO 18562-1:2024 - TC Tracked Changes. Biocompatibility evaluation of breathing gas pathways in healthcare applications - Evaluation and testing within a risk management process, 2024

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