M00022406
New product
MEDICAL DEVICES - SLEEP APNOEA BREATHING THERAPY - MASKS AND APPLICATION ACCESSORIES
International Organization for Standardization
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Availability date: 11/05/2021
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
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).
Published | |
Document Type | Standard |
Status | Current |
Publisher | International Organization for Standardization |
Pages | |
ISBN | |
Committee | TC 121 |
Supersedes |
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