BS EN ISO 18562-1-2024 PDF

Full title and description

BS EN ISO 18562-1:2024 — Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process. This publication is the British/European adoption of ISO 18562-1:2024 and sets out the general principles for assessing biological safety of materials and components that make up breathing gas pathways in medical devices.

Abstract

This part of ISO 18562 specifies the risk‑based approach to biological evaluation of gas pathways in medical devices: categorisation of gas pathways by nature and duration of contact with the gas stream, evaluation of existing relevant data, identification of data gaps through risk analysis, identification of additional tests required, and the assessment of biological safety over the expected lifetime of the device. It excludes biological hazards arising solely from mechanical damage and does not replace the ISO 10993 direct‑contact requirements.

General information

• Status: Published / Active (BS EN adoption of ISO 18562-1:2024).
• Publication date: BS EN ISO publication: 28 October 2024 (original ISO edition published March 2024).
• Publisher: British Standards Institution (BSI) — adoption of the International Organization for Standardization (ISO) document.
• ICS / categories: 11.040.10 (Anaesthetic, respiratory and reanimation equipment).
• Edition / version: Edition 2 (2024), superseding ISO 18562-1:2017.
• Number of pages: BS/EN PDF typically published as ~52 pages (ISO master edition shorter; national publication pagination can differ).

Scope

Applies to medical devices, parts and accessories that contain gas pathways intended to provide respiratory care or to deliver substances via the respiratory tract (examples: ventilators, anaesthesia workstations, breathing systems, oxygen concentrators, nebulizers, humidifiers, heat‑and‑moisture exchangers, masks, resuscitators, breathing tubes, filters, incubator enclosures and oxygen hoods). The document addresses potential contamination added to the respirable gas stream by the device’s gas pathway during normal use and over the expected lifetime (including effects of cleaning, disinfection and sterilisation). It does not address contamination originating from gas sources (pipelines, cylinders or room air) nor direct patient‑contact biocompatibility (covered by ISO 10993).

Key topics and requirements

• Risk‑based framework for biological evaluation of breathing gas pathways (planning, data review, gap analysis, and determination of additional tests).
• Categorisation of gas pathways according to nature and duration of contact with the gas stream (to define testing requirements and exposure scenarios).
• Requirements to review existing information from materials, manufacturing, processing and prior testing before selecting additional laboratory tests.
• Identification and specification of additional test methods where necessary (see parts 2–4 of ISO 18562 for particulate, volatile organic substance and leachables testing).
• Guidance on interpreting results and integrating emissions/chemical data into a biological safety assessment for inhalation exposure.
• Reporting and documentation expectations to support regulatory submissions and device risk management.

Typical use and users

Used by medical device manufacturers, regulatory/quality teams, design engineers, materials scientists, and testing laboratories to plan and execute the biocompatibility evaluation of breathing gas pathways. It is referenced in regulatory dossiers and by test laboratories that perform ISO 18562‑2/3/4 particle, VOC and leachables testing for device clearance.

Related standards

Key related documents include the ISO 10993 series (biocompatibility of materials in direct patient contact), the other parts of the ISO 18562 series (Part 2: particulate emissions; Part 3: volatile organic substances; Part 4: leachables in condensate), and guidance on air/method sampling such as relevant ISO 16000 family methods used for VOC sampling and analysis. The series is commonly referenced alongside applicable medical device regulations (for example EU MDR 2017/745 and comparable regulatory frameworks).

Keywords

biocompatibility, breathing gas pathways, inhalation, respiratory devices, risk management, VOC, volatile organic compounds, particulate emissions, leachables, ISO 18562, ISO 10993, ventilator, anaesthesia workstation, oxygen concentrator

FAQ

Q: What is this standard?

A: It is the British/European adoption of ISO 18562-1:2024 (BS EN ISO 18562-1:2024), which defines a risk‑based approach for biological evaluation of breathing gas pathways in healthcare applications.

Q: What does it cover?

A: It covers the planning, data review, gap analysis and testing decisions for identifying inhalation hazards from materials and components that form the gas pathway of respiratory medical devices; it does not replace direct‑contact biocompatibility requirements in ISO 10993 and does not cover contamination from gas supply sources.

Q: Who typically uses it?

A: Medical device manufacturers (design, RA/QA), test laboratories, regulatory consultants and toxicologists involved in assessing inhalation exposure from respiratory device gas pathways. Test labs use it together with ISO 18562-2/3/4 to generate the required emissions and leachables data.

Q: Is it current or superseded?

A: Current — ISO 18562-1:2024 is the second edition (published March 2024) and replaces ISO 18562-1:2017; national/European/British adoptions (EN/BS) were published in late 2024.

Q: Is it part of a series?

A: Yes — it is Part 1 of the ISO 18562 series. Parts 2, 3 and 4 provide the specific test methods for particulate emissions, volatile organic substances (VOS/VOC) emissions and leachables in condensate, respectively. The parts are intended to be used together within the risk‑management framework described in Part 1.

Q: What are the key keywords?

A: Biocompatibility, breathing gas pathways, risk management, inhalation, VOC, particulate emissions, leachables, respiratory devices, ISO 18562.