ANSI/AAMI/ISO 5367:2015 pdf download.Anaesthetic and respiratory equipment — Breathing sets and connectors.
This International Standard specifies basic requirements for breathing sets and breathing tubes intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers. It applies to breathing sets and breathing tubes and patient end adaptors supplied already assembled and to those supplied as components and assembled in accordance with the manufacturer's instructions.
This International Standard is applicable to breathing sets which include special components (e.g. water traps) between the patient end and machine end which are supplied already assembled.
This International Standard is not applicable to breathing sets and breathing tubes for special purposes.
EXAMPLE 1 Ventilators having special compliance, pressure or breathing frequency requirements.
EXAMPLE 2 High Frequency Oscillatory Ventilation, (HFOV) or High Frequency Jet Ventilation (HFJV).
EXAMPLE 3 Breathing sets and breathing tubes with special connectors for neonatal ventilation.
Provision is made for coaxial and related bifurcated, double-lumen, or multiple-lumen breathing sets and breathing tubes suitable for use with patient end adaptors.
NOTE 1 Examples of various types of breathing sets with patient end adaptors are depicted in Annex A.
Requirements for exhalation valves, exhaust valves, adjustable pressure-limiting (APL) valves, heat and moisture exchangers (HMEs), breathing filters, and reservoir bags, if provided, are not covered by this International Standard.
NOTE 2 ISO 80601 -2-1 2, ISO 80601 -2-1 3, ISO 9360-1 , ISO 23328-2, and ISO 5362 cover these.
NOTE 3 Certain aspects of heated-wire breathing tubes are discussed in ISO 81 85.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
NOTE See Annex A for information on the use of dated and undated normative references.
ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 7000, Graphical symbols for use on equipment — Registered symbols
ISO 1 0993-1 , Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 1 1 607-1 , Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 1 4971 , Medical devices — Application of risk management to medical devices.ANSI/AAMI/ISO 5367 pdf download.