ISO/TS 23128:2019 PDF

Medical devices — Transfusion set and blood bag compatibility test method

Название (английский):

ISO/TS 23128:2019

Medical devices — Transfusion set and blood bag compatibility test method

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 9
Дата публикации:: 18 декабря 2019 г.
Издание:: ISO TS 23128 edition 1 version 1
ICS:: 11.040.20

Тип поставки:

Full version135 €Read online 24h10 €Read online 72h15 €

Язык документа:

ruen

Срок поставки:2 раб. дн. (перевод)

Цена:135 €

Описание (английский):

This document details suitable equipment, a test method, acceptance criteria and advisable limits to help to ensure that there is compatibility (by measuring the insertion force) between a transfusion set closure piercing device (referred to in this document by the abbreviation 'spike') and a blood bag outlet port. The test procedure in its entirety is complex and beyond the scope of each of the relevant transfusion set and blood bag standards. This document was therefore developed to support the implementation of the existing standards for blood bags and transfusion sets. The procedure described in this document can be used by manufacturers of blood bags to test the compatibility with transfusion set spikes available on the market or by manufacturers of the transfusion set spikes to test the compatibility with blood bags available on the market.

Технические детали

Технический комитет: ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
SKU: ISO/TS 23128:2019

Abstract

Overview

ISO/TS 23128:2019 - Medical devices - Transfusion set and blood bag compatibility test method - defines a standardized test method to evaluate mechanical compatibility between a transfusion set spike (closure-piercing device) and a blood bag outlet port. The Technical Specification describes suitable equipment, test setup, stepwise procedure, recording format and guidance on interpreting spike insertion force measurements to help ensure safe, reliable connections during blood transfusion.

Key Topics and Requirements

Objective: Measure the minimum insertion force required for a spike to fully penetrate a blood bag port septum and determine compatibility.
Test samples: Three separate spike/port combinations (from transfusion sets and blood bags conforming to ISO 1135-x and ISO 3826-x).
Environmental control: Test and storage at (23 ± 2) °C for at least 12 hours before testing.
Test equipment: A calibrated insertion force apparatus (shaft/chuck assembly and standard masses); base mass of shaft + chuck + nuts = 2 000 g → base force 20 N. Additional masses of 0,25 kg are added incrementally following the standard.
Procedure highlights:
- Isolate spikes and prepare fluid-filled blood bag ports (water or anticoagulant solution acceptable).
- Introduce spike into port under controlled loading and twist the spike 5 times through 180° to confirm penetration.
- Increase loading in 0,25 kg steps until septum penetration occurs; record minimum insertion force.
- Optional simplified check: single test at 50 N if quantitative data not required.
Reporting: Use worksheet/report format (Annex B) capturing sample IDs, environmental checks, measured insertion forces (minimum, mean, maximum) and test conclusion.
Interpretation: Typical compatibility range cited is 20 N to 50 N.

Applications and Who Uses It

Blood bag manufacturers - validate that bag ports accommodate market spikes safely.
Transfusion set (spike) manufacturers - verify spike designs are compatible with common blood bag ports.
Medical device test laboratories and QA teams - perform incoming inspection, design verification, bench testing and supplier qualification.
Regulatory and clinical risk assessors - incorporate test evidence into conformity assessment, risk management and labeling guidance.
Practical benefits include reduced risk of bag damage, leakage, needle-stick-type injuries during bedside setup, and improved interoperability in transfusion workflows.

Related Standards

ISO 1135-4, ISO 1135-5 - Transfusion set requirements
ISO 3826-1, ISO 3826-3, ISO 3826-4 - Plastics collapsible containers for blood and blood components

Keywords: ISO/TS 23128:2019, transfusion set spike, blood bag compatibility, insertion force test, medical devices standard, spike insertion force.

Overview

Key Topics and Requirements

Objective: Measure the minimum insertion force required for a spike to fully penetrate a blood bag port septum and determine compatibility.
Test samples: Three separate spike/port combinations (from transfusion sets and blood bags conforming to ISO 1135-x and ISO 3826-x).
Environmental control: Test and storage at (23 ± 2) °C for at least 12 hours before testing.
Test equipment: A calibrated insertion force apparatus (shaft/chuck assembly and standard masses); base mass of shaft + chuck + nuts = 2 000 g → base force 20 N. Additional masses of 0,25 kg are added incrementally following the standard.
Procedure highlights:
- Isolate spikes and prepare fluid-filled blood bag ports (water or anticoagulant solution acceptable).
- Introduce spike into port under controlled loading and twist the spike 5 times through 180° to confirm penetration.
- Increase loading in 0,25 kg steps until septum penetration occurs; record minimum insertion force.
- Optional simplified check: single test at 50 N if quantitative data not required.
Reporting: Use worksheet/report format (Annex B) capturing sample IDs, environmental checks, measured insertion forces (minimum, mean, maximum) and test conclusion.
Interpretation: Typical compatibility range cited is 20 N to 50 N.

Applications and Who Uses It

Blood bag manufacturers - validate that bag ports accommodate market spikes safely.
Transfusion set (spike) manufacturers - verify spike designs are compatible with common blood bag ports.
Medical device test laboratories and QA teams - perform incoming inspection, design verification, bench testing and supplier qualification.
Regulatory and clinical risk assessors - incorporate test evidence into conformity assessment, risk management and labeling guidance.
Practical benefits include reduced risk of bag damage, leakage, needle-stick-type injuries during bedside setup, and improved interoperability in transfusion workflows.

Related Standards

ISO 1135-4, ISO 1135-5 - Transfusion set requirements
ISO 3826-1, ISO 3826-3, ISO 3826-4 - Plastics collapsible containers for blood and blood components

Keywords: ISO/TS 23128:2019, transfusion set spike, blood bag compatibility, insertion force test, medical devices standard, spike insertion force.

ISO/TS 23128:2019 PDF

Технические детали

Abstract

Overview

Key Topics and Requirements

Applications and Who Uses It

Related Standards

Похожие стандарты

Abstract

Overview

Key Topics and Requirements

Applications and Who Uses It

Related Standards

Похожие стандарты

Plastics. Differential scanning calorimetry (DSC). Determination of specific heat capacity.

Plastics collapsible containers for human blood and blood components. Aphaeresis blood bag systems with integ…

Advanced automation technologies and their applications. Requirements for establishing manufacturing enterpri…

Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion appara…

Plastics collapsible containers for human blood and blood components — Part 1: Conventional containers — Amen…

Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integra…