ISO 23328-2-2002 PDF

Full title and description

Breathing system filters for anaesthetic and respiratory use — Part 2: Non‑filtration aspects. This ISO standard specifies requirements and test considerations for the non‑filtration characteristics of breathing system filters (BSF) used with clinical anaesthetic and respiratory systems, covering connectors, leakage, resistance to flow, packaging, marking and information supplied.

Abstract

ISO 23328‑2:2002 defines the non‑filtration requirements and associated test method elements for BSF intended for clinical breathing systems. It addresses mechanical and labelling aspects (connection ports, leakage, flow resistance), packaging and the information manufacturers must supply; it is explicitly not applicable to other types of gas or vacuum filters. A complementary method for assessing filtration performance is given in ISO 23328‑1.

General information

• Status: Published (international standard; confirmed by ISO review processes and active as of confirmation in 2024).
• Publication date: October 2002 (edition 1; published 2002‑10 — commonly referenced with publication date 22 October 2002 in distributor records).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.10 (Anaesthetic, respiratory and reanimation equipment).
• Edition / version: Edition 1 (2002).
• Number of pages: 5 pages.

Scope

Specifies requirements for non‑filtration aspects of breathing system filters (BSF) intended for anaesthetic and respiratory use with clinical breathing systems. Topics covered include connection port dimensions and fit, permitted leakage levels, respiratory flow resistance limits, packaging and labelling requirements, and the nature of information to be supplied with the product. The standard excludes filters intended for vacuum lines, compressed gas filtration, gas sampling lines or protection of respiratory test equipment.

Key topics and requirements

• Connection ports and mechanical compatibility with clinical breathing system fittings (dimensions and fit).
• Maximum allowable leakage under specified test conditions and leak‑testing methods.
• Resistance to gas flow (pressure drop) limits and related measurement conditions relevant to clinical use.
• Packaging and protective requirements to preserve BSF integrity during storage and transport.
• Marking and information supplied: required labelling, intended use statements, limitations, and essential manufacturer data.
• Test method context and applicability: methods intended for BSF used in clinical breathing systems (non‑applicable to other filter types).

Typical use and users

Used by medical device manufacturers, test and certification laboratories, hospital biomedical engineering and procurement teams, regulatory bodies reviewing device compliance, and standards committees. The standard is applied when designing, testing, labelling and specifying breathing system filters for anaesthetic machines, ventilators and respiratory circuits in clinical settings.

Related standards

ISO 23328 is a multi‑part series: Part 1 (ISO 23328‑1:2003) addresses filtration performance (salt aerosol test method) while Part 2 (this document) addresses non‑filtration aspects. Regional/adopted versions (for example EN ISO 23328‑2) have also been published for application in specific markets.

Keywords

breathing system filter, BSF, anaesthetic equipment, respiratory equipment, non‑filtration aspects, leakage, connector, resistance to flow, packaging, marking, ISO 23328

FAQ

Q: What is this standard?

A: ISO 23328‑2:2002 is the international standard that specifies non‑filtration requirements (mechanical, labelling and packaging) for breathing system filters used in anaesthetic and respiratory clinical systems.

Q: What does it cover?

A: It covers connection port compatibility, leakage limits and test conditions, resistance to flow (pressure drop) requirements, packaging and marking, and information that manufacturers must supply. It does not define filtration efficiency tests (those are in ISO 23328‑1).

Q: Who typically uses it?

A: Medical device manufacturers, conformity assessment and test laboratories, hospital procurement/biomedical engineering teams, and regulators involved with anaesthetic and respiratory equipment. These users consult the standard for design, testing, specification and compliance purposes.

Q: Is it current or superseded?

A: ISO 23328‑2:2002 remains a published international standard and was last reviewed/confirmed by ISO during routine review activity (confirmed in 2024), so this edition is current. Users should check for any national/adopted versions or later revisions before applying it.

Q: Is it part of a series?

A: Yes — ISO 23328 is a multipart standard. ISO 23328‑1 covers filtration performance (salt aerosol test method; ISO 23328‑1:2003) and ISO 23328‑2 covers non‑filtration aspects (this document). Regional adoptions (e.g., EN ISO 23328‑2) also exist.

Q: What are the key keywords?

A: breathing system filter, BSF, anaesthetic, respiratory, non‑filtration, leakage, connector, resistance to flow, packaging, marking, ISO 23328.