Overview
EN ISO 23328-2:2009 (ISO 23328-2:2002) specifies the non‑filtration aspects of breathing system filters (BSF) used in anaesthetic and respiratory care. As Part 2 of the ISO 23328 series, this standard addresses mechanical, labelling, packaging and test‑method requirements that affect safe integration of BSF into clinical breathing systems. It is a CEN-adopted European Standard and supports conformity with EU medical device requirements (see Annex ZA and Directive 93/42/EEC).
Key topics and technical requirements
- Scope and exclusions
- Applies to BSF intended for anaesthetic and respiratory use with clinical breathing systems.
- Not applicable to filters for vacuum sources, gas sample lines, compressed gases, or devices used solely for physiological test equipment.
- Connectors
- BSF breathing system and patient connection ports must comply with ISO 5356‑1 (conical cones and sockets).
- Accessory ports must not accept 15 mm or 22 mm conical connectors per ISO 5356‑1/2 and must be provided with means of closure.
- Performance-related tests
- Pressure drop (resistance to flow): measured as the pressure difference across the BSF at defined flowrates (see test clause references).
- Gas leakage: standardized test methods for acceptable leakage limits.
- Ambient test conditions: specified test environment - temperature (23 ± 2) °C, relative humidity (60 ± 15) % RH, pressure (96 ± 10) kPa.
- Packaging and sterility
- Requirements for packaging of terminally sterilized BSF reference ISO 11607 principles.
- Marking and information
- Mandatory marking elements, symbol use and package labelling, including single‑use designation and manufacturer information.
- Documentation
- Information to be supplied by the manufacturer for safe selection and clinical use.
Practical applications and users
- Medical device manufacturers designing and producing breathing system filters (BSF) for anaesthesia, ventilation and respiratory care.
- Quality, regulatory and compliance teams seeking to demonstrate conformity with European medical device directives (EN ISO 23328-2 helps address Essential Requirements).
- Clinical engineers, procurement professionals and biomedical test laboratories that evaluate connector compatibility, pressure drop, leakage and packaging for hospital use.
- Test houses implementing standardized ambient conditions and test procedures for BSF performance verification.
Related standards
- ISO 23328‑1 - Salt test method to assess filtration performance (complements Part 2)
- ISO 5356‑1 / ISO 5356‑2 - Conical connectors for anaesthetic and respiratory equipment
- ISO 9360‑1 - Heat and moisture exchangers (HMEs)
- ISO 11607 - Packaging for terminally sterilized medical devices
- IEC 60601‑1 - Medical electrical equipment safety
EN ISO 23328-2:2009 is essential for ensuring connector compatibility, acceptable resistance to flow, leakage control, correct labelling and packaging - all critical for safe integration of breathing system filters in clinical anaesthesia and respiratory care.
