ISO 18562-2-2024 PDF

Full title and description

St ISO 18562-2-2024 — Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter. Specifies test methods and acceptance criteria to quantify particulate emissions from medical-device gas pathways (particles from 0.25 µm to 10 µm) over the expected lifetime of the device; excludes nanoparticles (<0.25 µm) and particles >10 µm and does not address contamination already present in supplied gas streams.

Abstract

This part of ISO 18562 describes procedures to measure and evaluate particulate matter emitted into the respirable gas stream by medical devices, parts or accessories that include gas pathways (for example ventilators, anaesthesia workstations, breathing systems, masks, nebulizers, oxygen concentrators, incubator chambers and similar). The document establishes verifiable acceptance criteria for particle counts in the 0.25 µm–10 µm range and is intended to support toxicological risk assessment and device biocompatibility evaluation.

General information

• Status: Published.
• Publication date: March 2024 (Edition 2, published 08 March 2024).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.10 (Anaesthetic, respiratory and reanimation equipment).
• Edition / version: Edition 2 (2024), replaces ISO 18562-2:2017.
• Number of pages: 16.

Source details and publication metadata per ISO record.

Scope

Applies to tests for particulate matter emitted from gas pathways of medical devices, their parts or accessories intended to provide respiratory care or deliver substances via the respiratory tract in all environments. The standard covers measurement of particles from 0.25 µm to 10 µm, sets acceptance criteria and applies across the expected device lifetime including effects of intended processing; it excludes nanoparticles (<0.25 µm), particles >10 µm and contaminants already present in the supplied gas source.

Key topics and requirements

• Defines test methods for quantifying particulate emissions into the respirable gas stream (particle size range 0.25 µm–10 µm).
• Establishes verifiable acceptance criteria for particulate counts from gas pathways.
• Specifies test conditions representative of normal use and expected device lifetime, including intended processing (e.g., cleaning, sterilization) where relevant.
• Excludes nanoparticles (<0.25 µm) and particles >10 µm from its acceptance criteria and does not address particles deliberately produced by drug-delivery nebulizers.
• Focuses on contamination originating from device gas pathways and not contamination supplied from external gas sources.

Typical use and users

Used by medical device manufacturers (design, materials and manufacturing engineering), independent testing laboratories, regulatory and quality teams preparing premarket submissions or declarations of conformity, clinical engineers, and contract test houses verifying particulate emissions from ventilators, anesthesia equipment, breathing circuits, masks, nebulizers, oxygen concentrators and related accessories.

Related standards

Part of the ISO 18562 series on biocompatibility evaluation of breathing gas pathways; see ISO 18562-1:2024 (risk management and evaluation framework), ISO 18562-3:2024 (tests for emissions of volatile organic substances) and ISO 18562-4:2024 (tests for leachables in condensate). The standard references ISO 10993 for biological evaluation of surfaces in direct contact with patients where applicable.

Keywords

breathing gas pathways, particulate matter, biocompatibility, medical devices, ventilators, anesthesia workstations, nebulizers, particle testing, ISO 18562, acceptance criteria, respirable particles

FAQ

Q: What is this standard?

A: ISO 18562-2:2024 is the second part of the ISO 18562 series specifying tests and acceptance criteria for particulate emissions from medical-device breathing gas pathways (particle sizes 0.25 µm–10 µm).

Q: What does it cover?

A: It covers test methods, measurement ranges and acceptance criteria for particles added to the respirable gas stream by device materials or components, applicable over the expected device lifetime; it excludes nanoparticles (<0.25 µm), particles >10 µm and contamination originating in supplied gas sources.

Q: Who typically uses it?

A: Medical device manufacturers, test laboratories, regulatory/quality teams preparing submissions or declarations of conformity, clinical engineers and contract testing organizations.

Q: Is it current or superseded?

A: Current — Edition 2 (2024) published in March 2024; it replaces ISO 18562-2:2017.

Q: Is it part of a series?

A: Yes — ISO 18562 is a multi-part series. Relevant parts include ISO 18562-1:2024 (risk management & evaluation), ISO 18562-3:2024 (volatile organic substances testing) and ISO 18562-4:2024 (leachables in condensate). Compliance is typically considered across the series.

Q: What are the key keywords?

A: Breathing gas pathways, particulate emissions, respirable particles, biocompatibility, medical device testing, ISO 18562.