ISO 17510 Sleep Apnea Respiratory Therapy

The “ISO 17510 Sleep apnea respiratory therapy” standard, developed by the International Organization for Standardization (ISO), consists of the following subsections published under the same title:

• The standard "ISO 17510-1 Part 1: Sleep apnea respiratory therapy equipment" describes the requirements for equipment for sleep apnea respiratory therapy for use in the home, on ships, aircraft, and other means of transportation, and in healthcare settings. This standard applies to equipment intended for use by adults and children, excluding equipment intended for use by neonates.

Jet and very high frequency ventilation and oscillation are outside the scope of this standard. This standard does not apply to equipment covered by the following standards, including:

• ISO 80601-2-72 Part 2-72: Particular requirements for the basic safety and essential performance of ventilators for the home healthcare environment for ventilator-dependent patients
• ISO 80601-2-84 Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
• ISO 10651-4 Part 4: Particular requirements for user-operated resuscitators
• ISO 10651-5 Part 5: Gas-operated emergency resuscitators
• ISO 80601-2-79 Part 2-79: Particular requirements for the basic safety and essential performance of ventilation support equipment for ventilatory failure
• ISO 80601-2-80 Part 2-80: Particular requirements for the basic safety and essential performance of ventilation support equipment for ventilatory failure

ISO 17510-1 does not apply to equipment covered by IEC 60601-2-12. ISO 17510 covers sleep apnea respiratory therapy equipment for patient use. ISO 17510-2 applies to masks and accessories used to connect sleep apnea respiratory therapy equipment to the patient.

The requirements described in the IEC 60601-1 standard also apply here.

The classification and naming described in the IEC 60601-1 standard also apply here.

• The standard, "ISO 17510-2 Part 2: Masks and application accessories," describes the requirements for masks, their fastenings, and the accessories used to connect sleep apnea respiratory therapy equipment to a patient. It specifies the requirements for masks and accessories, including any connectors needed to connect the patient connection port of sleep apnea respiratory therapy equipment to a patient and used for sleep apnea respiratory therapy application, such as nasal masks, exhaust ports, and headgear. Sleep apnea respiratory therapy equipment is covered by ISO 17510-1. ISO 17510-2 does not cover oral appliances.

For the purposes of this standard, the following terms and definitions apply:

• Anti-asphyxia valve refers to the valve used in a naso-oral mask that is open to the atmosphere when the sleep apnea respiratory therapy equipment does not provide sufficient pressure in the mask and is closed to the atmosphere when the sleep apnea respiratory therapy equipment provides sufficient pressure in the mask.
• Exhaust flow refers to the flow from the mask or its application accessories to the atmosphere, excluding leaks resulting from an improper face seal. Exhaust flow may pass through openings in the mask, the connector, the mask, or the anti-asphyxia valve. Exhaust flow discharges exhaled gases into the atmosphere to reduce rebreathing of carbon dioxide.
• Multi-patient reuse refers to being reused multiple times on more than one patient.
• An oral device is a device designed to protect the oral airway by mechanical means and performs its purpose independently of sleep apnea respiratory therapy equipment.

Tapered mask connectors must be 15 mm or 22 mm male connectors conforming to ISO 5356-1 or ISO 5356-2. Non-tapered mask connectors must not be connected to tapered connectors conforming to ISO 5356-1 or ISO 5356-2 unless they comply with the connection, disconnection, and leakage requirements of ISO 5356-1 or ISO 5356-2. Compliance must be verified by inspection and functional testing.

Parts or materials intended to come into contact with the patient or the patient gas pathway during normal use must comply with the ISO 10993 series of standards. For nosepieces intended to be worn in the nostrils or mask components intended to be worn over the mouth, the external materials of the nosepieces or mask components should be considered for mucosal membrane contact. Additionally, for parts or materials not intended to be worn in the nostrils or mouth, the gas pathway materials should be considered for external tissue communication. For mask components intended to come into contact with the patient's head, including headgear, the materials should be considered for skin contact.

All materials are considered permanent contact as categorized in the ISO 10993 standard. Permanent contact is required because cumulative use of sleep apnea respiratory therapy equipment and accessories exceeds 30 days. Latex should not be used in masks and accessories. Compliance should be verified by applying the ISO 10993 series.

Means shall be provided to minimize the risk of rebreathing during normal and single-fault conditions. Under normal conditions, the relative carbon dioxide increase shall not exceed 20 percent when tested at minimum nominal, 5 hPa, and 10 hPa pressures. Under single-fault conditions, the relative carbon dioxide increase shall not exceed 60 percent. Compliance with the tests described in Annex F shall be checked.

Means must be provided to limit inspiratory and expiratory resistance in the event of a single fault. Resistance to flow must not exceed 10 hPa per l/s at flow rates of 50 l/min. If an anti-asphyxia valve is provided, the pressure open to atmosphere must be less than the minimum nominal pressure of the mask. The pressures open to atmosphere and closed to atmosphere must be specified in the instructions for use. Compliance must be checked using the tests described in Annex D and Annex E.

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