DIN 13273-7 2020-12 PDF

Full title and description

STB DIN 13273-7 2020-12 — Catheters for medical use — Part 7: Determination of the X‑ray attenuation of catheters; requirements and testing. This part specifies a test setup, measurement procedure and acceptance criteria intended to ensure catheters are sufficiently radiopaque to be detected in radiographic imaging with the lowest reasonable patient radiation exposure.

Abstract

This standard defines methods to determine the X‑ray attenuation (radiopacity) of medical catheters, including specimen preparation, imaging conditions, measurement procedure and reporting. The objective is to provide reproducible, comparable results that manufacturers and conformity assessors can use to demonstrate that a catheter is visible under radiographic examination while minimising patient dose.

General information

• Status: Current / valid (DIN standard currently published as DIN 13273-7:2020-12).
• Publication date: 2020-12 (approved/issued December 2020).
• Publisher: Deutsches Institut für Normung (DIN).
• ICS / categories: 11.040.25 (Syringes, needles and catheters / medical device technology).
• Edition / version: 2020-12 (current edition replacing earlier editions).
• Number of pages: 12 pages.

Scope

This part of DIN 13273 specifies a laboratory test arrangement and a measurement procedure to determine the X‑ray attenuation (radiopacity) of catheters intended for medical use. The standard covers imaging conditions, reference markers/phantoms, image analysis and how to report results so that manufacturers, test laboratories and conformity assessors can decide whether a catheter is adequately visible in radiographic examinations while minimising radiation dose to the patient. It is limited to radiographic/radiological visibility testing and does not replace biocompatibility, mechanical or sterilisation requirements covered elsewhere.

Key topics and requirements

• Definition of test specimen preparation and positioning for radiographic imaging.
• Specified X‑ray imaging conditions (phantom, exposure geometry) to produce reproducible measurements.
• Measurement procedure for X‑ray attenuation (radiopacity) and image analysis methods.
• Criteria for reporting results and information to include in test reports.
• Notes on the purpose of radiopacity testing: ensure detectability in clinical imaging with minimal patient dose.

Typical use and users

Manufacturers of intravascular and other procedural catheters, independent test laboratories, notified bodies/conformity assessment organisations, regulatory and quality engineers in medical device companies, and clinical engineering teams concerned with device visibility in fluoroscopic or radiographic procedures. The standard is used to generate test evidence for design validation, product dossiers and regulatory submissions where radiopacity is relevant.

Related standards

DIN 13273 is a multi‑part series covering various catheter types and requirements; other parts of the series (for example Part 8 on epidural catheters) and related international standards for intravascular catheters and medical device testing (such as ISO/EN catheter standards) are commonly referenced alongside Part 7 during product development and conformity assessment. Users should consult the other parts of DIN 13273 and relevant ISO/EN standards for complementary requirements.

Keywords

Catheter, radiopacity, X‑ray attenuation, radiographic visibility, radiopacity test, medical device, DIN 13273, catheter testing, fluoroscopy, imaging phantom.

FAQ

Q: What is this standard?

A: DIN 13273-7:2020-12 is the part of the DIN 13273 series that specifies how to measure and report the X‑ray attenuation (radiopacity) of medical catheters to ensure adequate visibility in radiographic imaging.

Q: What does it cover?

A: It covers test specimen preparation, imaging/phantom setup, measurement procedures, image analysis and reporting requirements specifically for determining catheter radiopacity. It does not replace other safety, biocompatibility or mechanical tests.

Q: Who typically uses it?

A: Manufacturers, test laboratories, conformity assessment bodies, regulatory affairs and quality teams in the medical device sector, and clinical engineers who need to demonstrate or verify that catheters are sufficiently visible during X‑ray imaging.

Q: Is it current or superseded?

A: The 2020-12 edition is the current edition (published December 2020) and replaced earlier editions (for example the 2003 edition was superseded). Users should confirm there has been no later amendment or replacement since 2020-12 before relying on the text for certification activities.

Q: Is it part of a series?

A: Yes — DIN 13273 is a multi‑part series addressing catheters for medical use; Part 7 deals with radiopacity testing and other parts address specific catheter types and additional requirements. Consult the series index for other applicable parts.

Q: What are the key keywords?

A: Radiopacity, X‑ray attenuation, catheter, imaging phantom, radiographic visibility, DIN 13273, test method, medical catheter.