BS EN 13868-2002 PDF

Full title and description

STB BS EN 13868:2002 — Catheters — Test methods for kinking of single-lumen catheters and medical tubing. This European/CEN standard (adopted as a national version by bodies such as BSI) specifies laboratory test methods to determine kink resistance of single-lumen catheters and similar medical tubing when presented for clinical use.

Abstract

EN 13868:2002 defines two normative test procedures (a short-term test for use ≤1 h and a long-term test for use >1 h) and associated definitions, instrumentation and reporting rules so that kink resistance is evaluated uniformly. The tests use water as the reference test medium, define a kink as flow reduced to 50% or less of straight-tube flow, and require samples to reflect the final product condition (e.g., sterilized and tested at intended-use temperature where applicable).

General information

• Status: Published / listed as confirmed/active in national catalogues (subject to periodic review by CEN/TC 205).
• Publication date: EN publication: 27 August 2002; BSI adoption/publication (BS EN): 13 September 2002.
• Publisher: CEN (European Committee for Standardization) — published/adopted by national bodies (e.g., BSI for the BS version).
• ICS / categories: 11.040.20 (Transfusion, infusion and injection equipment); 11.040.25 (Syringes, needles and catheters).
• Edition / version: 2002 (original EN edition, adopted as BS EN 13868:2002).
• Number of pages: 18 pages (typical published document length reported in standards catalogues).

Scope

This standard applies to single‑lumen catheters and medical tubing presented for clinical use and gives methods to determine their kink properties when bent on a single plane. It can be applied to multi‑lumen tubing when the worst‑case bending direction is selected. The purpose is to provide reproducible, comparable test results for design validation, quality control and regulatory documentation.

Key topics and requirements

• Definitions and terminology relevant to kinking (kink point, kink distance/length, plate distance).
• Short‑term test method (Annex A): arching a tube between grooved parallel plates, controlled plate motion, and measurement of plate distance when flow falls to 50% of straight‑tube flow.
• Long‑term test method (Annex B): forming loops in a long‑term kink tool, conditioning at intended temperature/time, and determining kink length where flow reduction criteria are met.
• Test medium and conditions: water as the reference medium; test pieces should represent final product condition (sterilized, conditioned at intended‑use temperature such as 37 °C, where applicable).
• Instrumentation and reporting: use of calibrated flow measurement, tensile/test apparatus for plate movement, recording of corrected kink distance/length and required sample numbers for statistical reporting.

Typical use and users

Manufacturers of catheters and medical tubing, R&D and materials teams, test laboratories performing performance verification, conformity assessment bodies and regulatory/quality engineers use EN 13868 to validate design choices, set production acceptance criteria and produce test evidence supporting device safety and performance claims.

Related standards

Standards related to catheter/tubing performance and testing include various ISO series for specific catheter types (for example ISO/EN series for intravascular, drainage and enteral catheters) and other CEN/ISO test methods covering dimensional, biocompatibility and mechanical properties. EN 13868 is typically referenced alongside device‑specific standards and biocompatibility/testing standards used in regulatory dossiers.

Keywords

kinking; catheter; single‑lumen; medical tubing; kink resistance; short‑term test; long‑term test; flow reduction; test method; EN 13868; BS EN 13868:2002.

FAQ

Q: What is this standard?

A: EN 13868:2002 (published as BS EN 13868:2002 when adopted by BSI) is a CEN test‑method standard that specifies laboratory procedures to measure the kinking behaviour of single‑lumen catheters and medical tubing.

Q: What does it cover?

A: It covers definitions, a short‑term test (≤1 h) and a long‑term test (>1 h), instrumentation, sample conditioning and reporting rules. A tube is considered kinked when flow drops to 50% or less of its straight‑tube flow; water is the reference test medium.

Q: Who typically uses it?

A: Medical device manufacturers (design, QC and validation), independent test laboratories, conformity assessment bodies and regulatory/quality teams preparing technical documentation.

Q: Is it current or superseded?

A: The document is the 2002 EN edition adopted as BS EN 13868:2002. Catalogue and review records indicate the standard remains published and was subject to periodic review by CEN/TC 205; national catalogues list it as active/confirmed. Users should check their national standards body for the absolute current status before relying on it for conformity decisions.

Q: Is it part of a series?

A: Not a multi‑part standard itself, but EN 13868 is commonly used together with device‑specific ISO/CEN standards for particular catheter types and with biocompatibility and mechanical testing standards.

Q: What are the key keywords?

A: Kinking, kink resistance, catheter, single‑lumen, medical tubing, short‑term test, long‑term test, EN 13868, BS EN 13868:2002.