ISO 23328-1-2003 PDF
Name in English:
St ISO 23328-1-2003
Name in Russian:
Ст ISO 23328-1-2003
Original standard ISO 23328-1-2003 in PDF full version. Additional info + preview on request
Full title and description
Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance. This international standard specifies a short-term airborne sodium chloride (NaCl) particle challenge test for assessing the filtration performance of breathing system filters (BSF) used in clinical breathing systems.
Abstract
ISO 23328-1:2003 defines a NaCl aerosol challenge (salt test) method to evaluate BSF filtration efficiency for respired gases. It covers test generation, test apparatus principles, measurement and calculation of filtration performance for short-term exposures. Non-filtration aspects of BSF (mechanical, dimensional, compatibility) are addressed in ISO 23328-2.
General information
- Status: Published (International Standard; confirmed in systematic review processes and listed as current).
- Publication date: 2003-08 (first edition published August 2003; commonly shown as 20 August 2003).
- Publisher: International Organization for Standardization (ISO).
- ICS / categories: 11.040.10 (Anaesthetic, respiratory and reanimation equipment).
- Edition / version: Edition 1 (ISO 23328-1:2003).
- Number of pages: 12 (original published PDF/print length).
Scope
Applies to breathing system filters (BSF) intended for use with clinical breathing systems to filter respired gases. It is not intended for filters designed to protect vacuum sources, gas sample lines, compressed gas supplies, or to protect physiological measurement equipment. The part is limited to filtration performance assessed by a short-term sodium chloride aerosol challenge; other performance and non-filtration characteristics are outside its scope and are treated in ISO 23328-2.
Key topics and requirements
- Definition of a short-term airborne sodium chloride (NaCl) particle challenge (salt test) to evaluate filtration efficiency.
- Requirements for test aerosol generation, conditioning and challenge concentration for the NaCl test.
- Test apparatus and measurement principles for determining particle penetration and filtration efficiency under defined conditions.
- Procedures for sample mounting, test repetition, data reduction and reporting of filtration results.
- Clarification that non-filtration aspects (e.g., mechanical integrity, dimensions, compatibility) are handled in ISO 23328-2.
Typical use and users
Primary users include medical-device manufacturers of breathing system filters, independent test laboratories that perform filtration performance verification, hospital biomedical engineering and infection-control teams evaluating filter performance, regulatory bodies reviewing device claims, and procurement/specification teams. Several national bodies and standards organizations have adopted or referenced ISO 23328-1 for conformity and purchase specifications.
Related standards
Closely related documents include ISO 23328-2 (non-filtration aspects of breathing system filters) and national/adopted versions such as EN/ISO adoptions and regional equivalents (examples: STN EN ISO 23328-1, CSA adoption). Users often reference other medical-device and respiratory equipment standards for complementary requirements (biocompatibility, labeling, electrical/functional standards as applicable).
Keywords
ISO 23328-1, breathing system filter, BSF, salt test, sodium chloride aerosol, filtration efficiency, anaesthetic equipment, respiratory use, test method.
FAQ
Q: What is this standard?
A: ISO 23328-1:2003 is an international standard that specifies a salt (NaCl aerosol) test method to assess the filtration performance of breathing system filters used in anaesthetic and respiratory clinical breathing systems.
Q: What does it cover?
A: It covers a short-term airborne sodium chloride particle challenge test: aerosol generation, test apparatus principles, sampling and measurement, calculation of penetration/efficiency, and reporting. It does not cover non-filtration aspects of BSF, which are in ISO 23328-2.
Q: Who typically uses it?
A: Manufacturers of breathing system filters, test laboratories performing performance verification, hospital biomedical and infection-control staff, regulatory reviewers and procurement/specification teams. The standard is also adopted or referenced by some national standards organizations.
Q: Is it current or superseded?
A: The published version is ISO 23328-1:2003 (first edition). The ISO record shows the standard has been subject to periodic review and was confirmed in ISO’s review process (the ISO catalogue indicates confirmation activity in 2024), so the 2003 edition remains the current published text unless a new revision is issued. Users should check with their national standards body or ISO for any revision notices before relying on it for new procurement or regulatory submissions.
Q: Is it part of a series?
A: Yes — it is Part 1 of ISO 23328. Part 2 (ISO 23328-2) covers non-filtration aspects of breathing system filters; together the parts address both filtration performance and other product characteristics.
Q: What are the key keywords?
A: Breathing system filter, BSF, salt test, sodium chloride aerosol, filtration efficiency, anaesthetic, respiratory, ISO 23328-1.