ISO TS 23128-2019 PDF

Full title and description

ISO/TS 23128:2019 — Medical devices — Transfusion set and blood bag compatibility test method. This Technical Specification defines a standardized laboratory method, suitable equipment, acceptance criteria and recommended limits for measuring mechanical compatibility (by measuring insertion force) between a transfusion set closure‑piercing device (spike) and a blood bag outlet port. It supports implementation of existing transfusion‑set and blood‑bag standards by providing a repeatable test to verify safe, reliable connections and to reduce risk of bag damage, leakage or bedside injury during set‑up.

Abstract

The document specifies test apparatus, sample preparation, stepwise test procedure, recording/reporting format and guidance for interpreting measured spike insertion forces. The method is intended for use by blood bag and transfusion set manufacturers, testing laboratories and QA/regulatory assessors to assess and document compatibility between spikes and bag port septa. Typical compatibility guidance and acceptance ranges for insertion force are provided to aid design verification and supplier qualification.

General information

• Status: Published (Technical Specification; international standard confirmed).
• Publication date: December 2019 (Edition 1, 2019‑12).
• Publisher: International Organization for Standardization (ISO), ISO/TC 76 responsible committee.
• ICS / categories: 11.040.20 — Transfusion, infusion and injection equipment.
• Edition / version: Edition 1 (2019).
• Number of pages: 9 (English edition; French available).

These bibliographic and life‑cycle details are those provided by ISO; the publication was reviewed and the document confirmed in the 5‑year review cycle.

Scope

This Technical Specification details suitable equipment, a reproducible test method, acceptance criteria and advisable limits to ensure mechanical compatibility (measured insertion force) between transfusion set spikes and blood bag outlet ports. It is intended to support, not replace, the dimensional and product requirements given in the relevant transfusion‑set and blood‑bag standards; the method can be used by bag manufacturers to test compatibility with market spikes or by spike manufacturers to test compatibility with available blood bags.

Key topics and requirements

• Specified test apparatus for insertion‑force measurement (shaft/chuck assembly with calibrated base mass and incremental masses) and a worksheet/report format (informative annex).
• Controlled environmental and conditioning requirements (example: test/storage at approximately 23 ± 2 °C before testing).
• Sample preparation and minimum sample combinations (examples of testing multiple spike/port combinations; recommended repeat measurements).
• Stepwise insertion procedure: apply base loading, increment masses (commonly 0.25 kg steps) until septum penetration is achieved; record minimum insertion force; optional single‑point check at a higher force when quantitative data not required.
• Acceptance guidance and interpretation: typical compatibility/insertion force guidance ranges cited (illustrative range ~20 N to 50 N) and reporting of minimum, mean and maximum forces with test conclusions.
• Annexes: normative measurements for insertion‑force equipment and an informative example report worksheet to standardize results capture.

Typical use and users

Primary users include blood bag manufacturers, transfusion‑set (spike) manufacturers, independent medical‑device test laboratories and in‑house QA teams performing design verification, incoming inspection and supplier qualification. Regulatory reviewers and clinical risk assessors also use the test results and documentation when evaluating device interoperability and labeling/risk management. The method helps reduce bedside risks related to excessive insertion force, leakage and handling difficulties.

Related standards

This Technical Specification is intended to be used alongside product standards that define blood bag and transfusion set dimensions and product requirements, notably the ISO standards for transfusion sets (ISO 1135 series) and for blood bags (ISO 3826 series). It was developed within ISO/TC 76 (transfusion, infusion and injection equipment) to support these product standards.

Keywords

transfusion set; blood bag; compatibility test; insertion force; spike; port septum; medical devices; ISO/TS 23128; ISO/TC 76; test apparatus; acceptance criteria.

FAQ

Q: What is this standard?

A: ISO/TS 23128:2019 is a Technical Specification from ISO titled "Medical devices — Transfusion set and blood bag compatibility test method" that defines a laboratory procedure and equipment for measuring mechanical compatibility between transfusion set spikes and blood bag outlet ports.

Q: What does it cover?

A: It covers required test equipment, sample preparation, a stepwise insertion‑force test method, reporting worksheets, acceptance guidance and recommended limits to assess whether a spike and bag port are mechanically compatible. It provides annexes with equipment measurements and an example report format.

Q: Who typically uses it?

A: Blood bag and transfusion set manufacturers, independent testing laboratories, QA/validation teams and regulators or risk assessors who need repeatable evidence of mechanical compatibility and documented test results.

Q: Is it current or superseded?

A: The document was published in December 2019 (Edition 1) and was reviewed and confirmed in ISO’s periodic review (the standard remains current/confirmed as of the ISO review). Users should check national adoptions or ISO's catalogue for the latest status at time of use.

Q: Is it part of a series?

A: It is a Technical Specification developed to support related product standards (the ISO 1135 series for transfusion sets and the ISO 3826 series for blood bags) and was prepared under ISO/TC 76. It should be used together with those product standards for complete conformity and design verification.

Q: What are the key keywords?

A: Compatibility test, insertion force, spike, blood bag port, transfusion set, test apparatus, acceptance criteria, ISO/TS 23128:2019.