ISO 9360-2-2001 PDF

Full title and description

Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml. This part of ISO 9360 specifies performance, testing, marking and information requirements for HMEs intended specifically for tracheostomized patients with minimum tidal volumes of 250 ml.

Abstract

ISO 9360-2:2001 defines the design and test requirements for heat-and-moisture-exchanger (HME) devices used to humidify respired gases for tracheostomized patients with relatively low tidal volumes (≥ 250 ml). The standard covers connector compatibility, moisture delivery and pressure-drop test methods, environmental and conditioning parameters for testing, and required labelling and accompanying performance data for safe clinical use.

General information

• Status: Published (confirmed as current in ISO systematic reviews; listed as stage to be revised in later lifecycle notes).
• Publication date: April 2001 (Edition 1, 2001-04).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: Anaesthetic, respiratory and reanimation equipment — ICS 11.040.10 (medical respiratory equipment).
• Edition / version: Edition 1 (2001).
• Number of pages: 7 pages.

Scope

Specifies requirements for HMEs intended for use with tracheostomized patients whose minimum tidal volume is 250 ml. It applies to clinical-type HMEs (single-patient or single-use devices) without machine connector ports and establishes test conditions and performance limits for moisture loss, pressure drop and related characteristics under defined environmental and conditioning parameters. The standard also requires manufacturers to supply specific performance data and marking information.

Key topics and requirements

• Device scope and intended patient tidal volume (≥ 250 ml) and exclusion of devices with machine connector ports.
• Connector compatibility: patient port to mate with a 15 mm male connector (in accordance with ISO connector standards) and provision for common breathing circuit interfaces.
• Performance testing methods: moisture-loss measurement under conditioned (37 °C) and specified ambient conditions, and pressure-drop measurement at defined flow/respiratory settings.
• Test environment and conditioning: specified ambient temperature, relative humidity and atmospheric pressure ranges, plus preconditioning procedures and calibration apparatus description.
• Marking, labelling and information: orientation marking (if required), sterile/single-use indications, recommended tidal volume range, moisture-loss and pressure-drop performance data, internal volume, recommended maximum time of use, and reuse/sterilization or disposal guidance.

Typical use and users

Primary users include HME manufacturers (for design and compliance), medical device test laboratories (for type testing and verification), regulatory reviewers and procurement/clinical engineering teams (for evaluation and specification), and clinicians who require objective performance data to select appropriate HMEs for tracheostomized patients. The standard supports safe device interoperability with breathing circuits and consistent humidification performance.

Related standards

ISO 9360-2 is part of the ISO 9360 series on HMEs and is closely related to ISO 9360-1 (general HME requirements and HMEs for use with minimum tidal volumes), connector standards such as ISO 5356‑1 (conical connectors for breathing systems), graphical symbol standards (ISO 7000) and packaging/sterility standards (ISO 11607) that influence labelling and sterile-packaging requirements.

Keywords

HME, heat-and-moisture exchanger, humidification, tracheostomy, tracheostomized patients, tidal volume 250 ml, respiratory equipment, moisture loss, pressure drop, connector compatibility, medical device testing.

FAQ

Q: What is this standard?

A: ISO 9360-2:2001 is an international standard that specifies requirements and test methods for heat-and-moisture-exchanger devices intended for tracheostomized patients with minimum tidal volumes of 250 ml.

Q: What does it cover?

A: It covers device scope, connector compatibility, laboratory test methods for moisture delivery and pressure drop (including conditioning and ambient test parameters), marking and labelling requirements, and the performance data manufacturers must supply.

Q: Who typically uses it?

A: Manufacturers, test laboratories, regulatory reviewers, procurement and clinical engineers, and clinicians involved in respiratory care for tracheostomized patients commonly use this standard.

Q: Is it current or superseded?

A: ISO 9360-2:2001 is published and was confirmed during ISO periodic reviews; later lifecycle notes indicate it has been subject to review and stage entries (including indications for revision in ISO lifecycle records). Users should check the issuing body for any amendments or newer editions before relying on it for regulatory compliance.

Q: Is it part of a series?

A: Yes — it is Part 2 of the ISO 9360 series on heat-and-moisture exchangers (see ISO 9360-1 and other related parts).

Q: What are the key keywords?

A: HME, humidification, tracheostomy, tidal volume 250 ml, moisture loss, pressure drop, respiratory equipment, connector compatibility.