ISO 18250-8-2018 PDF

Full title and description

Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 8: Citrate-based anticoagulant solution for apheresis applications (ISO 18250-8:2018). This part of the ISO 18250 series defines the connector interface and functional requirements for reservoirs containing citrate-based anticoagulant solution used in apheresis tubing sets and mating reservoirs.

Abstract

Specifies dimensions and requirements for the design and functional performance of apheresis anticoagulant (AC) reservoir connectors. It does not specify requirements for the medical devices or accessories that use these connectors (those are covered in particular device standards). Examples of intended use include apheresis tubing sets and mating reservoirs containing citrate-based anticoagulant solution; manufacturers are encouraged to adopt these connectors to reduce misconnections and harmonize connector interfaces across apheresis products.

General information

• Status: Published (International Standard, confirmed).
• Publication date: 21 August 2018.
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.25 (Syringes, needles and catheters).
• Edition / version: Edition 1 (2018).
• Number of pages: 24 (as published by ISO).

Scope

Defines the geometric interface, performance and functional requirements for connectors intended for reservoirs that contain citrate‑based anticoagulant solutions used in apheresis applications. The scope covers dimensional specifications and tests needed to ensure reliable connection, leakage control and non‑interconnectability with connectors from other application areas. It explicitly excludes requirements for the medical devices or accessories that use these connectors; those remain in the relevant product standards.

Key topics and requirements

• Interface dimensions and tolerances for apheresis AC reservoir connectors (ensures consistent mating and prevents unintended connections).
• Functional performance requirements: leak resistance, retention/engagement forces, and mechanical durability under expected use.
• Test methods and verification procedures (dimensional analysis, pressure/leakage tests and connection/disconnection force tests) — common test methods are defined in the series' general part (ISO 18250‑1).
• Design for non‑interconnectability with connectors from other medical applications to reduce misconnections.
• Guidance for manufacturers to adopt the connector geometry even where not yet mandated by device‑specific standards.

Typical use and users

Used by medical device manufacturers (apheresis tubing sets, reservoirs), accessory producers, quality and regulatory teams, test laboratories and procurement teams in transfusion and apheresis centers. Designers and R&D teams use the standard to specify connector interfaces; regulatory bodies and conformity assessment labs reference it when assessing connector compatibility and performance.

Related standards

Part of the ISO 18250 series (connectors for reservoir delivery systems) — see ISO 18250‑1 (general requirements and common test methods), and other application parts such as ISO 18250‑3 (enteral), ISO 18250‑6 (neural) and ISO 18250‑7 (intravascular). The ISO 80369 series (small‑bore connectors) and related connector standards (e.g., Luer/ISO 80369‑7) are relevant background documents addressing misconnections and small‑bore connector requirements in healthcare.

Keywords

apheresis, citrate anticoagulant, reservoir connector, medical device connector, ISO 18250, non‑interconnectable, connector dimensions, leakage testing, apheresis tubing set

FAQ

Q: What is this standard?

A: ISO 18250‑8:2018 is an international standard that specifies the connector interface and performance requirements for reservoirs containing citrate‑based anticoagulant solution used in apheresis applications.

Q: What does it cover?

A: It covers connector geometry, functional performance (e.g., leak resistance and retention forces) and verification tests for apheresis AC reservoir connectors; it does not set requirements for the medical devices that use these connectors.

Q: Who typically uses it?

A: Device and accessory manufacturers (apheresis tubing sets and reservoirs), test laboratories, regulatory and quality engineers, procurement teams and clinical engineering groups dealing with apheresis equipment and disposables.

Q: Is it current or superseded?

A: ISO 18250‑8:2018 is published and listed as an active international standard; parts of the ISO 18250 series are subject to periodic review (typically every five years). Users should check with the national standards body or ISO for the most recent confirmation or amendments before relying on the text for compliance work.

Q: Is it part of a series?

A: Yes — ISO 18250 is a multipart series covering connectors for reservoir delivery systems for healthcare applications. ISO 18250‑1 contains general requirements and common test methods; other parts address specific application areas (examples: ISO 18250‑3 enteral, ISO 18250‑6 neural, ISO 18250‑7 intravascular).

Q: What are the key keywords?

A: apheresis, citrate anticoagulant, reservoir connector, non‑interconnectable, connector dimensions, ISO 18250, leakage test, tubing set