BS EN ISO 17510:2020
$167.15
Medical devices. Sleep apnoea breathing therapy. Masks and application accessories
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 42 |
This International Standard applies to masks and their accessories used to connect sleep apnoea breathing therapy equipment to the patient. It specifies 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).
Sleep apnoea breathing therapy equipment is covered by ISO 80601‑2‑70. Figure A.1 shows the typical elements of this International Standard together with the sleep apnoea breathing therapy equipment of ISO 80601‑2‑70 that form a sleep apnoea breathing system.
This International Standard does not cover oral appliances.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 4 | European foreword Endorsement notice |
| 8 | Foreword |
| 9 | Introduction |
| 11 | 1 Scope 2 Normative references |
| 12 | 3 Terms and definitions |
| 13 | 4 Information to be supplied by the manufacturer 4.1 General 4.2 Marking on the protective packaging |
| 14 | 4.3 Accompanying document |
| 15 | 5 Construction requirements 5.1 Mask connectors 5.2 Biocompatibility |
| 16 | 5.3 * Protection against rebreathing 5.3.1 Normal condition protection 5.3.2 Single fault condition protection 5.4 Cleaning, disinfection, and sterilization |
| 17 | 5.5 * Breathing during single fault condition 5.6 Breathing system filter 6 Vibration and noise |
| 18 | Annex A (informative) Particular guidance and rationale |
| 22 | Annex B (normative) Exhaust flow test procedure |
| 24 | Annex C (normative) Resistance to flow (pressure drop) |
| 26 | Annex D (normative) Anti-asphyxia valve pressure testing |
| 28 | Annex E (normative) Determination of the inspiratory and expiratory resistance under single fault condition |
| 30 | Annex F (normative) Carbon Dioxide rebreathing |
| 33 | Annex G (normative) Vibration and noise |
| 35 | Annex H (informative) Guide to information to be supplied by the manufacturer |
| 36 | Annex I (informative) Reference to the essential principles |
| 38 | Annex J (informative) Terminology — alphabetized index of defined terms |
| 40 | Bibliography |
