ISO 17510:2015

Name: ISO 17510:2015 — Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
SKU: ISO 17510:2015
Price: 25 EUR
Availability: InStock

Medical devices — Sleep apnoea breathing therapy — Masks and application accessories

Название (английский):

ISO 17510:2015

Medical devices — Sleep apnoea breathing therapy — Masks and application accessories

Статус документа:: Отменён
Формат:: Электронный (PDF)
Количество страниц:: 30
Дата публикации:: 23 июля 2015 г.
Издание:: ISO IS 17510 edition 1 version 1
ICS:: 11.040.10

Тип поставки:

Full version25 €Ask AI2 €Read online 24h10 €Read online 72h15 €

Язык документа:

ruen

Срок поставки:1 рабочий день

Цена:25 €

Описание (английский):

ISO 17510:2015 applies to masks and their accessories used to connect a 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).

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 17510:2015 - Medical devices - Sleep apnoea breathing therapy - Masks and application accessories - defines safety and performance requirements for masks and their application accessories used to connect sleep apnoea breathing therapy equipment to a patient. The standard covers nasal, oral and nasal‑oral mask types, headgear, exhaust ports, anti‑asphyxia devices and connecting elements required to form a complete sleep apnoea breathing system.

Key topics and technical requirements

Scope and definitions: Clarifies terms such as mask, headgear, anti‑asphyxia valve, exhaust flow, single‑fault condition and expected useful life.

Manufacturer information and labelling: Requires accompanying documents and protective‑packaging marks (manufacturer ID, device identity, intended purpose, storage/handling, warnings, shelf‑life symbols, batch/serial references).

Construction and connectors: Specifies connector compatibility, connector types and mechanical construction requirements to ensure safe connection to sleep apnoea therapy equipment.

Biocompatibility and materials: References biological evaluation (ISO 10993‑1) and expectations for safe materials in patient contact.

Protection against rebreathing: Addresses exhaust flow, CO2 rebreathing assessment and measures to limit rebreathing in normal and single‑fault conditions.

Single‑fault considerations: Identifies requirements for safety if a single risk‑reducing element fails (e.g., anti‑asphyxia valve behavior).

Cleaning, disinfection, sterilization and reuse: Requires manufacturer guidance for processing, and distinction between single‑patient and multi‑patient reuse.

Breathing resistance and filters: Includes test procedures for resistance to flow and breathing system filters.

Vibration and noise: Specifies noise measurement guidance and limits to reduce patient disturbance.

Normative test annexes: Contains detailed test procedures (Annexes B–G) for exhaust flow, pressure drop, anti‑asphyxia valve testing, single‑fault inspiratory/expiratory resistance, CO2 rebreathing, and acoustics.

Applications and users

ISO 17510:2015 is used by:

Medical device manufacturers designing masks, headgear and accessories for CPAP and other sleep apnoea therapy systems.

Regulatory and quality teams preparing technical documentation and conformity evidence.

Testing laboratories performing performance and safety testing (exhaust flow, resistance, CO2 rebreathing, noise).

Procurement and clinical engineers who specify compatible masks and accessories for sleep clinics and hospitals.

Healthcare providers seeking safe, labeled products with clear reuse and cleaning instructions.

Related standards

ISO 80601‑2‑70 (sleep apnoea therapy equipment)

ISO 10993‑1 (biocompatibility)

ISO 15223‑1 (medical device symbols and labelling)

ISO 23328 series (breathing system filters)

IEC 60601‑1 (general electrical safety)

ISO 17510:2015 helps ensure safe, interoperable mask and accessory design for effective sleep apnoea breathing therapy while reducing rebreathing risk and improving patient comfort.

ISO 17510:2015

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and users

Related standards

Технические детали

ISO 10993-12:2012

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

ISO 80601-2-70:2020

Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performa…

ISO 15223-1:2016

Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — P…

ISO 23328-1:2003

Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration…

IEC 60601-1-12:2014

Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - C…