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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 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 mechanical ventilation.

This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on mechanical 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 See also 4.2 of the General Standard.

This document is not applicable to high-frequency jet ventilators (HFJVs) or high-frequency oscillatory ventilators (HFOVs) [1], which are given in ISO 80601-2-87 [3].

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. [4]

This document does not specify the requirements for ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13. [5]

This document does not specify the requirements for ventilators or accessories intended for home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72. [6]

This document does not specify the requirements for ventilators or accessories intended for emergency and transport, which are given in ISO 10651-32). [7]

This document does not specify the requirements for ventilators or accessories intended for homecare ventilatory support, which are given in ISO 80601-2-79 [8] and ISO 80601-2-80.

This document is a particular standard in the IEC 60601-1 and ISO/IEC 80601 series of standards.

This part of ISO 80369 specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories.

EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female Luer slip connectors and Luer lock connectors.

NOTE 1 The Luer connector was originally designed for use at pressures up to 300 kPa.

This part of ISO 80369 does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular documents for specific medical devices or accessories.

This part of ISO 80369 does not specify requirements for the following small-bore connectors, which are specified in other documents:

— haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 and applicable portion of ISO 8638 referencing blood compartment ports);

— haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637);

— infusion system closure piercing connectors (ISO 8536-4).

NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in this part of ISO 80369 into medical devices or accessories, even if currently not required by the relevant particular medical device documents. It is expected that when the relevant particular medical device documents are revised, requirements for small-bore connectors, as specified in ISO 80369, will be included.

NOTE 3 ISO 80369-1:2018, Clause 7, specifies alternative methods of conformance with ISO 80369-1:2018, for small-bore connectors intended for use with intravascular applications or hypodermic application medical devices or accessories, which do not conform with this part of ISO 80369.

ISO 18190:2016 Clause 1 is replaced by the following

This document specifies essential performance and safety requirements for cuff pressure indicator devices used to indicate the intracuff pressure of airway devices. Such devices are primarily designed to indicate the intracuff pressure of airway devices, such as supralaryngeal airways, tracheal tubes or tracheostomy tubes. This standard is also applicable to devices that combine intracuff pressure indication with a method of cuff inflation (such as a syringe or pump). The device may also provide a method of automatically maintaining cuff inflation at a specific pressure or within a pressure range.

This International Standard establishes a vocabulary of terms used for anaesthetic and respiratory equipment and supplies, related devices and supply systems.

Note 1 to entry This International Standard is based on standards and drafts which have been produced by ISO/TC 121 and CEN/TC 215.

Note 2 to entry Contrary to the policy in ISO 4135 3rd edition of allowing multiple definitions of the same term in different categories, this document attempts to ensure consistency by the inclusion of a ‘general’ category, and by use of domain specifiers and unique pre-coordinated domain-specific term names.

Note 3 to entry In addition to terms and definitions used in two of the three official ISO languages (English and French), this International Standard gives the equivalent terms in the German language; these are published under the responsibility of the member body for Germany. However, only the terms and definitions given in the official languages can be considered as ISO terms and definitions.