BS EN 13328-1-2001 PDF

Full title and description

BS EN 13328-1:2001 — Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance. This British adoption of EN 13328-1 defines a short-term airborne sodium chloride aerosol challenge (salt test) and associated procedures for measuring the particle-filtration performance of breathing system filters (BSFs) used in clinical anaesthetic and respiratory circuits.

Abstract

Specifies a laboratory salt aerosol test method (NaCl aerosol challenge) to quantify the particle-filtration efficiency of BSFs intended for use in human anaesthetic and respiratory breathing systems. The method covers test atmosphere generation, sample conditioning, test sequence, calculation and reporting of results and limits its applicability to filters used in clinical breathing systems (not to vacuum protection, compressed-gas filters or filter elements for equipment protection).

General information

• Status: Withdrawn / superseded — replaced by the harmonised ISO-based publication BS EN ISO 23328-1:2008 (EN ISO 23328-1).
• Publication date: Original EN designation 2001 (British adoption published 27 March 2002).
• Publisher: British Standards Institution (BSI) — published as a British Standard adoption of EN 13328-1.
• ICS / categories: 11.040.10 (Anaesthetic, respiratory and reanimation equipment).
• Edition / version: BS EN 13328-1:2001 (first EN edition; adopted as a British Standard in 2002). Superseded by BS EN ISO 23328-1:2008.
• Number of pages: 20 pages (typical published PDF length for the BS adoption).

Scope

Gives a short-term airborne sodium chloride particle-challenge laboratory test for assessing the filtration performance of breathing system filters intended to filter respired gases in clinical breathing systems used in anaesthesia and respiratory care. It excludes filters designed for protecting vacuum sources, compressed-gas lines, gas-sampling lines or test equipment for physiological measurements. The standard sets out test conditions, aerosol generation, sample conditioning, measurement and reporting requirements.

Key topics and requirements

• Definition of breathing system filters (BSFs) and intended clinical application.
• Salt (sodium chloride) aerosol generation and characterization as the test challenge aerosol.
• Detailed test procedure: conditioning, flow rates, sample mounting and measurement sequence.
• Calculation of filtration efficiency and expression of test results (reporting format and required data).
• Limitations and applicability: short-term particle-filtration performance only; does not address other functional or biocompatibility properties (covered in Part 2 or later ISO-based standards).

Typical use and users

Used by medical-device manufacturers (design and verification of breathing system filters), independent test laboratories, hospital biomedical engineers verifying performance, procurement specialists evaluating filter performance claims, and regulators/standards bodies assessing conformity to filtration-performance methods. Test houses apply the method to generate comparative filtration-efficiency data for product specifications and regulatory dossiers.

Related standards

Closely related to ISO 23328-1 (Part 1 salt test method) and the later consolidated EN ISO edition BS EN ISO 23328-1:2008 which supersedes national/adopted EN versions. Part 2 of the EN/ISO series (EN 13328-2 / EN ISO 23328-2) covers non-filtration aspects of breathing system filters. National and industry adoptions (e.g., YY/T 0753.1) may exist that adopt ISO 23328-1 test methods identically.

Keywords

Breathing system filter, BSF, salt test, sodium chloride aerosol, filtration performance, particle filtration efficiency, anaesthesia, respiratory equipment, BS EN 13328-1, EN ISO 23328-1.

FAQ

Q: What is this standard?

A: BS EN 13328-1:2001 is the British adoption of EN 13328-1 (2001), specifying a laboratory salt aerosol (NaCl) test method to assess particle-filtration performance of breathing system filters for anaesthetic and respiratory use.

Q: What does it cover?

A: It covers generation and characterization of a sodium chloride aerosol challenge, conditioning and mounting of filter samples, test flow conditions, measurement procedures, calculation of filtration efficiency and reporting of results — specifically for filters used in clinical breathing systems. It does not cover non-filtration properties or filters for other gas-line or vacuum protection uses.

Q: Who typically uses it?

A: Medical-device manufacturers, independent test laboratories, hospital biomedical engineering departments, regulatory bodies and procurement/specification teams evaluating or verifying BSF filtration performance.

Q: Is it current or superseded?

A: BS EN 13328-1:2001 has been superseded by the ISO-based EN publication BS EN ISO 23328-1:2008 (EN ISO 23328-1). Users are generally advised to reference the current EN ISO edition (2008) or the corresponding ISO publication for up-to-date normative requirements.

Q: Is it part of a series?

A: Yes — it is Part 1 of the EN/ISO series on breathing system filters. Part 1 addresses the salt test filtration method; Part 2 covers non-filtration aspects and complementary requirements. The series has been harmonised under ISO 23328 and adopted in EN ISO 23328.

Q: What are the key keywords?

A: Breathing system filter (BSF), salt test, NaCl aerosol, filtration efficiency, particle filtration, anaesthesia, respiratory equipment, BS EN 13328-1, EN ISO 23328-1.