ISO 17510-1:2002/Cor 1:2004
(Corrigendum)Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing therapy devices — Technical Corrigendum 1
Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing therapy devices — Technical Corrigendum 1
Thérapie respiratoire de l'apnée du sommeil — Partie 1: Dispositifs de thérapie respiratoire de l'apnée du sommeil — Rectificatif technique 1
General Information
- Status
- Withdrawn
- Publication Date
- 11-Feb-2004
- Withdrawal Date
- 11-Feb-2004
- Current Stage
- 9599 - Withdrawal of International Standard
- Start Date
- 25-Sep-2007
- Completion Date
- 12-Feb-2026
Relations
- Effective Date
- 12-Feb-2026
- Effective Date
- 06-Jun-2022
- Consolidated By
ISO 8623:2015 - Tall-oil fatty acids for paints and varnishes — Test methods and characteristic values - Effective Date
- 06-Jun-2022
- Corrects
ISO 17510-1:2002 - Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing therapy devices - Effective Date
- 06-Jun-2022
- Revised
ISO 17510-1:2007 - Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing therapy equipment - Effective Date
- 15-Apr-2008
- Child
ISO 17510-1:2002 - Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing therapy devices - Effective Date
- 15-Apr-2008
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Frequently Asked Questions
ISO 17510-1:2002/Cor 1:2004 is a standard published by the International Organization for Standardization (ISO). Its full title is "Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing therapy devices — Technical Corrigendum 1". This standard covers: Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing therapy devices — Technical Corrigendum 1
Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing therapy devices — Technical Corrigendum 1
ISO 17510-1:2002/Cor 1:2004 is classified under the following ICS (International Classification for Standards) categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 17510-1:2002/Cor 1:2004 has the following relationships with other standards: It is inter standard links to EN ISO 17510-1:2002/AC:2003, ISO/IEC 13874:1995, ISO 8623:2015, ISO 17510-1:2002, ISO 17510-1:2007; is excused to ISO 17510-1:2002. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO 17510-1:2002/Cor 1:2004 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
NORME INTERNATIONALE ISO 17510-1:2002
RECTIFICATIF TECHNIQUE 1
Publié 2004-02-15
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Thérapie respiratoire de l’apnée du sommeil —
Partie 1:
Dispositifs de thérapie respiratoire de l’apnée du sommeil
RECTIFICATIF TECHNIQUE 1
Sleep apnoea breathing therapy —
Part 1: Sleep apnoea breathing therapy devices
TECHNICAL CORRIGENDUM 1
Le Rectificatif technique 1 à l'ISO 17510-1:2002 a été élaboré par le Comité européen de normalisation (CEN)
en collaboration avec le comité technique ISO/TC
...
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This document 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). This document applies to masks and their accessories used to connect sleep apnoea breathing therapy equipment to the patient. The requirements in this document take priority over the requirements in ISO 18190. This document does not cover oral appliances. NOTE This document has been prepared to address the relevant essential principles[14] and labelling principles[15] of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex I.
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This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions. Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the therapy settings. This document excludes sleep apnoea breathing therapy equipment intended for use with neonates. This document is applicable to ME equipment or an ME system intended for those patients who are not dependent on artificial ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on artificial ventilation such as patients with central sleep apnoea. This document is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment. Masks and application accessories intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. NOTE 2 See also 4.2 of the general standard. This document does not specify the requirements for: – ventilators or accessories intended for critical care ventilators for ventilator-dependent patients, which are given in ISO 80601‑2‑12. – ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13. – ventilators or accessories intended for home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72. – ventilators or accessories intended for emergency and transport, which are given in ISO 80601-2-84. – ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601‑2-79 and ISO 80601‑2‑80. – high-frequency ventilators[23], which are given in ISO 80601-2-87. – respiratory high flow equipment, which are given in ISO 80601‑2‑90; NOTE 3 ISO 80601-2-80 ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients. – user-powered resuscitators, which are given in ISO 10651-4; – gas-powered emergency resuscitators, which are given in ISO 10651-5; – oxygen therapy constant flow ME equipment; and – cuirass or “iron-lung” ventilation equipment.
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NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2. This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.302, for ventilatory insufficiency, as defined in 201.3.302, hereafter also referred to as ME equipment, in combination with its accessories: — intended for use in the home healthcare environment; NOTE 2 In the home healthcare environment, the supply mains driving the ventilatory support equipment is often not reliable. NOTE 3 Such ventilatory support equipment can also be used in professional health care facilities. — intended for use by a lay operator; — intended for use with patients who have ventilatory insufficiency or failure, the most fragile of which would likely experience injury with the loss of this artificial ventilation; — intended for transit-operable use; and — not intended for patients who are dependent on artificial ventilation for their immediate life support. EXAMPLE 1 Patients with moderate to severe chronic obstructive pulmonary disease (COPD), moderate amyotrophic lateral sclerosis (ALS), severe bronchopulmonary dysplasia or muscular dystrophy. Ventilatory support equipment is not considered to use a physiologic closed-loop control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings. This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system of ventilatory support equipment for ventilatory insufficiency, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory insufficiency. EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. NOTE 4 Additional information can be found in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2. NOTE 5 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient. This document does not specify the requirements for: — ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12; — ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13; — ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84; — ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72; — ventilatory support equipment or accessories intended for ventilatory impairment, which are given in ISO 80601‑2‑79; — sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70; — high-frequency jet ventilators (HFJVs), which are given in ISO 80601‑2‑87; — high-frequency oscillatory ventilators (HFOVs); — respiratory high flow equipment, which are given in ISO 80601‑2‑90; NOTE 6 Ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients. — user-powered resuscitators, which are given in ISO 10651-4; — gas-powered emergency resuscitators, which are given in ISO 10651-5; — oxygen therapy constant flow ME equipment; and — cuirass or “iron-lung” ventilation equipment
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NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2. This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.302, for ventilatory impairment, as defined in 201.3.300, hereafter also referred to as ME equipment, in combination with its accessories: — intended for use in the home healthcare environment; NOTE 2 In the home healthcare environment, the supply mains driving the ventilatory support equipment is often not reliable. NOTE 3 Such ventilatory support equipment can also be used in professional health care facilities. — intended for use by a lay operator; — intended for use with patients who have ventilatory impairment, the most fragile of these patients, would not likely experience injury with the loss of this artificial ventilation; and — not intended for patients who are dependent on artificial ventilation for their immediate life support. EXAMPLE 1 Patients with mild to moderate chronic obstructive pulmonary disease (COPD). Ventilatory support equipment is not considered to use a physiologic closed-loop control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings. This document is also applicable to those accessories intended by their manufacturer to be connected to the breathing system of ventilatory support equipment for ventilatory impairment, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory impairment. EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. NOTE 4 Additional information can be found in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2. NOTE 5 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient. This document does not specify the requirements for: — ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12; — ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13; — ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84; — ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72; — ventilatory support equipment or accessories intended for ventilatory insufficiency, which are given in ISO 80601‑2‑80; — sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70; — high-frequency jet ventilators (HFJVs), which are given in ISO 80601‑2‑87; — high-frequency oscillatory ventilators (HFOVs); — respiratory high flow equipment, which are given in ISO 80601‑2‑90; NOTE 6 Ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients. — user-powered resuscitators, which are given in ISO 10651-4; — gas-powered emergency resuscitators, which are given in ISO 10651-5; — oxygen therapy constant flow ME equipment; and — cuirass or “iron-lung” ventilation equipment.
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