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I.S. EN ISO 17510:2020

Current
Current

The latest, up-to-date edition.

Medical devices - Sleep apnoea breathing therapy - Masks and application accessories
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

03-08-2020

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Information to be supplied by the manufacturer
5 Construction requirements
6 Vibration and noise
Annex A (informative) Particular guidance and rationale
Annex B (normative) Exhaust flow test procedure
Annex C (normative) Resistance to flow (pressure drop)
Annex C (normative) Resistance to flow (pressure drop)
Annex D (normative) Anti-asphyxia valve pressure testing
Annex E (normative) Determination of the inspiratory and expiratory resistance under single fault condition
Annex F (normative) Carbon Dioxide rebreathing
Annex G (normative) Vibration and noise
Annex H (informative) Guide to information to be supplied by the manufacturer
Annex I (informative) Reference to the essential principles
Annex J (informative) Terminology — alphabetized index of defined terms
Bibliography

This International Standard applies to masks and their accessories used to connect sleep apnoea breathing therapy equipment to the patient.

Committee
TC 121
DocumentType
Standard
Pages
48
ProductNote
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

Standards Relationship
ISO 17510:2015 Identical
EN ISO 17510:2020 Identical

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