ISO 9360-1-2000 PDF

Full title and description

ISO 9360-1:2000 — Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml. The part specifies requirements and laboratory test methods for HMEs (including devices incorporating breathing system filters) intended primarily for patients with tidal volumes ≥ 250 ml, and for HMEs that incorporate at least one machine port.

Abstract

This international standard defines performance, safety and marking requirements plus reference test methods (moisture loss, pressure drop, leakage, compliance and related test apparatus and conditions) for heat-and-moisture-exchanger devices used to humidify respired gases in humans where minimum tidal volumes are 250 ml or greater. It is intended to provide objective, repeatable laboratory evaluation methods that manufacturers, test laboratories and clinical users can rely on for device comparison and acceptance.

General information

• Status: Published.
• Publication date: 16 March 2000 (Edition 1, 2000-03).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.10 (Anaesthetic and respiratory equipment).
• Edition / version: Edition 1 (2000).
• Number of pages: 19 pages.

Scope

Specifies requirements and test methods for heat-and-moisture-exchanger devices intended to humidify respired gases in humans where the device is designed for use with minimum tidal volumes of 250 ml. The standard covers HMEs that may include breathing-system filters, requires at least one machine port on the device, and describes laboratory test apparatus, environmental conditions for testing and mandatory marking/documentation elements for safe and intended use.

Key topics and requirements

• Performance metrics and test methods for moisture output / moisture loss (defined test apparatus and bidirectional flow generator, specified tidal volumes and frequencies).
• Airflow resistance (pressure drop) limits and measurement procedures to assess breathing effort added by the HME.
• Internal (dead) volume and compliance considerations and measurement.
• Gas leakage and integrity tests for device sealing and ports.
• Connector and machine-port requirements (compatibility with standard breathing system connectors) and marking of intended use, maximum recommended time of use, sterility where applicable and packaging guidance.
• Reference environmental conditions for testing (e.g., 23 °C ±2 °C, relative humidity ~50 % ±20 %, specified atmospheric pressure range).

Typical use and users

Used by manufacturers of anaesthetic and respiratory devices (design, verification and compliance testing), independent test laboratories, biomedical/clinical engineers, procurement teams and clinicians involved in ventilator and respiratory circuit selection. Common applications include operating theatre anaesthesia circuits, intensive-care ventilation circuits and other clinical settings where passive humidification of respired gases is required for patients with tidal volumes ≥ 250 ml.

Related standards

ISO 9360 is a two‑part framework; Part 2 (ISO 9360-2:2001) addresses HMEs intended for tracheostomized patients (minimum tidal volumes of 250 ml) and provides complementary requirements and tests. The original ISO 9360:1992 was withdrawn and superseded by ISO 9360-1:2000 and ISO 9360-2:2001. Regional/adopted versions (for example EN ISO variants) exist that reference the same technical content.

Keywords

Heat and moisture exchanger; HME; humidification; respired gases; anaesthetic equipment; respiratory equipment; moisture loss; pressure drop; testing; ISO 9360-1:2000.

FAQ

Q: What is this standard?

A: ISO 9360-1:2000 is an international standard that specifies performance, safety, marking and test-method requirements for heat-and-moisture-exchanger (HME) devices used to humidify respired gases in humans for minimum tidal volumes of 250 ml.

Q: What does it cover?

A: It covers device purpose, laboratory reference test methods (moisture measurement, pressure drop, leakage, compliance), connector/port requirements, test-environment conditions and marking/packaging information necessary to evaluate and label HMEs intended for adults or patients with tidal volumes ≥ 250 ml.

Q: Who typically uses it?

A: Manufacturers, product development and quality teams, independent test laboratories, biomedical engineers, clinical engineering departments and procurement or regulatory reviewers for hospitals and device distributors.

Q: Is it current or superseded?

A: ISO 9360-1:2000 is the published Part 1 edition from March 2000 and (per ISO records) has been subject to periodic review and confirmation; it remains the current Part 1 edition at ISO’s last confirmation. Users should check with their national standards body or ISO for any updates or revisions before relying on the standard for compliance actions.

Q: Is it part of a series?

A: Yes — ISO 9360 is a multipart standard. Part 1 (this document) covers HMEs for minimum tidal volumes of 250 ml; Part 2 (ISO 9360-2:2001) covers HMEs for tracheostomized patients (also with minimum tidal volumes of 250 ml) and the two parts together replaced the withdrawn ISO 9360:1992.

Q: What are the key keywords?

A: Heat and moisture exchanger (HME), humidification, moisture loss, pressure drop, respiratory equipment, anaesthesia, test methods, ISO 9360.