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eLibrary > 23/30441405 DC BS EN ISO 18562-3 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3. Tests for emissions of volatile organic substances >

23/30441405 DC BS EN ISO 18562-3 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3. Tests for emissions of volatile organic substances, 2023

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23/30441405 DC BS EN ISO 18562-3 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3. Tests for emissions of volatile organic substances, 2023

ISO_DIS 18562-4 ed.2 - id.82898 Enquiry PDF (en).pdf [Go to Page]
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles [Go to Page]
4.1 Type tests
4.2 General
5 Leachables in condensate [Go to Page]
5.1 Identifying applicable gas pathway surfaces
5.2 Determining if testing is required
5.3 Test methods [Go to Page]
5.3.1 General
5.3.2 Sample collection
5.3.3 Chemical characterization of leachables in condensate
5.3.4 Calculation of tolerable exposure
5.3.5 Calculation of exposure dose estimate
5.3.6 Risk assessment
5.3.7 Biological evaluation according to ISO 10993 standards
6 Reporting
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€ZA (informative) Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
Bibliography
Terminology — Alphabetized index of defined terms
ISO_DIS 18562-3 ed.2 - id.83411 Enquiry PDF (en).pdf [Go to Page]
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles [Go to Page]
4.1 Type tests
4.2 General
5 Volatile organic substance emissions [Go to Page]
5.1 General
5.2 Acceptance criteria
5.3 Test method
5.4 Assessment of exposure dose
6 Reporting
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€ZA (informative) Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
Bibliography
Terminology — Alphabetized index of defined terms [Go to Page]

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23/30441405 DC BS EN ISO 18562-3 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3. Tests for emissions of volatile organic substances, 2023

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