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ISO 17510 : 2015

M00022406

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ISO 17510 : 2015

MEDICAL DEVICES - SLEEP APNOEA BREATHING THERAPY - MASKS AND APPLICATION ACCESSORIES

International Organization for Standardization

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Table of Contents

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 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

Abstract

Defines requirements for masks and accessories, including any connecting element, that are required to connect the patient-connection port of sleep apnoea breathing therapy equipment to a patient for the application of sleep apnoea breathing therapy (e.g. nasal masks, exhaust ports and headgear).

General Product Information

Document Type Standard
Status Current
Publisher International Organization for Standardization
Committee TC 121
Supersedes
  • ISO/DIS 17510 : 60.00 (2015)