ISO 18562-1-2024 PDF

Full title and description

ISO 18562-1:2024 — Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process. This part defines the framework and principles for biological evaluation of materials and components that form breathing gas pathways in medical devices, including risk‑based identification of data gaps and selection of additional tests required to assess biological safety.

Abstract

Part 1 of ISO 18562 specifies the general principles for performing a biological evaluation of breathing gas pathways within a risk‑management process. It describes categorization of gas pathways by nature and duration of contact with the gas stream, how to evaluate existing data from all sources, how to identify gaps by risk analysis, which additional data sets or tests are needed, and how to assess overall biological safety of the gas pathway over the expected lifetime of the device. The document excludes biological evaluation of surfaces in direct contact with patients (covered by ISO 10993) and does not address contamination originating upstream from gas sources.

General information

• Status: Published.
• Publication date: 8 March 2024 (second edition, 2024-03).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.10 (Anaesthetic, respiratory and reanimation equipment).
• Edition / version: Edition 2 (2024).
• Number of pages: 34 pages.

Scope

Applies to medical devices, parts and accessories that contain breathing gas pathways intended to provide respiratory care or to deliver substances via the respiratory tract (examples include ventilators, anaesthesia workstations, breathing systems, oxygen concentrators, nebulizers, humidifiers, masks, respirators, incubator chambers and associated components). The standard addresses potential contamination of the gas stream arising from those internal gas pathways during normal use and over the expected service life, taking into account processing (cleaning, disinfection, sterilisation) and foreseeable use errors. It does not address biological hazards that originate from the gas supply upstream of the device or biological evaluation of surfaces that have direct patient contact (ISO 10993 applies to those surfaces).

Key topics and requirements

• Risk‑based framework for biological evaluation of breathing gas pathways, integrated into the device risk management process.
• Categorization of gas pathways by nature and duration of gas contact to guide testing needs.
• Systematic evaluation of existing data (materials, manufacturing, processing, literature, supplier information) and identification of data gaps.
• Selection and justification of additional tests (e.g., particulate, volatile substances, leachables in condensate — covered in other ISO 18562 parts) required to assess biological safety.
• Assessment of biological safety for the expected lifetime, considering degradation, processing and foreseeable use errors; explicit exclusion of direct‑contact surface biocompatibility (ISO 10993).

Typical use and users

Used by medical device manufacturers (design, materials and regulatory teams), risk managers, product development engineers, testing laboratories, notified bodies and competent authorities to plan, justify and demonstrate the biological safety evaluation of breathing gas pathways. Also referenced by clinical engineers and quality/regulatory affairs professionals preparing regulatory submissions and declarations of conformity. Test laboratories implement the specific test methods described in the companion parts of the ISO 18562 series.

Related standards

Closely linked to the other parts of the ISO 18562 series (ISO 18562-2:2024 — particulate emissions testing; ISO 18562-3:2024 — volatile organic/volatile organic substances testing; ISO 18562-4:2024 — tests for leachables in condensate). For surfaces with direct patient contact, the ISO 10993 biological evaluation series is the applicable reference. Manufacturers should consider applicable regional regulatory guidance (e.g., FDA recognition/extent of recognition for the 2024 revisions) when using ISO 18562 in submissions.

Keywords

breathing gas pathways; biocompatibility; risk management; volatile organic substances (VOS/VOC); particulate emissions; leachables; medical devices; ventilators; respiratory devices; ISO 18562; ISO 10993.

FAQ

Q: What is this standard?

A: ISO 18562-1:2024 is the first part of the ISO 18562 series providing the risk‑management framework and general principles for biological evaluation of breathing gas pathways in healthcare applications. It sets out how to evaluate existing data, identify testing needs and assess biological safety.

Q: What does it cover?

A: It covers principles for evaluating contaminants that can originate inside a device's gas pathway (particulates, volatile/organic substances, leachables) and specifies how to integrate testing and data review into the device risk assessment. Specific test methods and acceptance criteria are defined in other parts of the series (18562‑2, ‑3, ‑4). It does not cover direct‑contact surface biocompatibility (ISO 10993) or contamination already present in the supplied gas upstream of the device.

Q: Who typically uses it?

A: Medical device manufacturers, testing laboratories, regulatory and quality teams, notified bodies and competent authorities use this standard to plan and demonstrate biological evaluations of breathing gas pathways and to support regulatory submissions.

Q: Is it current or superseded?

A: ISO 18562-1:2024 is the current (second) edition, published in March 2024. It supersedes and replaces ISO 18562-1:2017 (the 2017 first edition has been withdrawn). Users updating conformity evidence should adopt the 2024 edition.

Q: Is it part of a series?

A: Yes — it is Part 1 of the ISO 18562 series. Companion parts define specific tests and acceptance criteria: ISO 18562-2 (particulates), ISO 18562-3 (volatile organic substances), and ISO 18562-4 (leachables in condensate). Together they form the evaluation package for breathing gas pathway biocompatibility.

Q: What are the key keywords?

A: Key keywords include breathing gas pathways, biocompatibility, risk management, particulates, VOS/VOC, leachables, respiratory devices, ISO 18562, ISO 10993, and medical device testing.