DIN 6859-1 2022-01 PDF

Full title and description

DIN 6859-1:2022-01 — Image quality assurance in diagnostic laboratories - Part 1: Constancy testing of ultrasound equipment for medical diagnosis and monitoring. (German title: Sicherung der Bildqualität in diagnostischen Betrieben - Teil 1: Konstanzprüfung an Ultraschallgeräten für die medizinischen Diagnostik und Überwachung). This document defines minimum procedures for routine (constancy) quality checks that ensure ultrasound systems and their transducers maintain stable image performance for diagnostic use.

Abstract

This standard specifies the initial and regular objective quality-control tests for imaging ultrasound equipment and associated probes used in medical diagnostics. It sets out test methods and key characteristics to be checked during constancy testing so that device parameters remain within defined tolerances over time, enabling quick, efficient routine checks that support reliable patient diagnostics.

General information

• Status: Current / active standard.
• Publication date: 2022-01 (published January 2022).
• Publisher: Deutsches Institut für Normung (DIN).
• ICS / categories: 11.040.50 (Radiographic and imaging equipment / Radiology).
• Edition / version: Edition 2022 (designation DIN 6859-1:2022-01).
• Number of pages: 38 pages.

Scope

Applies to the initial acceptance and the routine (periodic) objective constancy testing of diagnostic ultrasound devices and all associated transducers. The standard specifies the minimum required procedures and measurable characteristics for determining and monitoring device parameters (for example sensitivity, spatial resolution, uniformity, depth calibration and other image-quality metrics) that should remain constant within stated tolerances. It is designed for fast and efficient checks with a minimum of procedures to support clinical diagnostic reliability.

Key topics and requirements

• Definitions and general principles for image-quality assurance in diagnostic settings.
• Specification of constancy test procedures to be performed regularly (recommended test intervals and quick-check workflows).
• Test objects/phantoms and recommended measurement techniques for key image parameters (resolution, penetration/sensitivity, uniformity, artefact checks, depth/gain calibration).
• Checks and acceptance criteria for transducers/probes (including visual inspection, electrical/connectivity checks and image-based performance tests).
• Documentation, record keeping and reporting of test results and tolerances for trend monitoring.
• Roles and responsibilities: recommended competence levels for personnel performing constancy tests and for escalation if parameters drift outside tolerances.
• Guidance on test frequency, corrective actions, and basic safety considerations during QA operations.

Typical use and users

Intended for clinical engineering teams, medical physicists, radiology departments, ultrasound service engineers, biomedical/clinical technologists, QA coordinators and manufacturers who need standardized procedures for routine performance checks of ultrasound systems and probes. Also used by facility managers and regulators for establishing or auditing local QA programs.

Related standards

Part of the broader set of image-quality assurance standards for medical imaging maintained by DIN and related bodies. Related documents include earlier editions of DIN 6859-1 (superseded) and other DIN/EN standards on radiology image-quality assurance (for example standards in the DIN 6868 series) and international safety/performance standards for medical electrical equipment (e.g., IEC/EN 60601-2-37 for ultrasound device essential performance). Users should consult the relevant national/adopted versions and complementary parts of the DIN 6859 series where available.

Keywords

ultrasound, ultrasonic devices, image quality assurance, constancy testing, quality control, diagnostic ultrasound, transducer testing, medical imaging QA, radiology, routine checks

FAQ

Q: What is this standard?

A: DIN 6859-1:2022-01 is a DIN standard that provides minimum procedures and test criteria for routine (constancy) quality checks of ultrasound equipment used in medical diagnosis and monitoring.

Q: What does it cover?

A: It covers initial and periodic objective quality-control tests for imaging ultrasound systems and their probes, including recommended test methods, performance parameters to monitor (e.g., resolution, sensitivity, uniformity, depth calibration), documentation and recommended actions if results fall outside tolerances.

Q: Who typically uses it?

A: Clinical engineers, medical physicists, radiology/sonography departments, biomedical service personnel, equipment manufacturers and QA managers use this standard to implement and verify routine ultrasound performance checks.

Q: Is it current or superseded?

A: This is the current (2022) edition. It replaces the earlier 2020 edition (DIN 6859-1:2020-10) and is the active version for routine constancy testing guidance as published in January 2022. Users should verify national adoption and any subsequent amendments before relying on it for regulatory compliance.

Q: Is it part of a series?

A: Yes — DIN 6859-1 is presented as Part 1 in a set of image-quality assurance documents for diagnostic departments. It sits alongside other DIN documents addressing image-quality assurance in radiology (for example standards in the DIN 6868 family) and should be used in conjunction with applicable device safety and performance standards (such as IEC/EN 60601-2-37 for ultrasound performance requirements).

Q: What are the key keywords?

A: Ultrasound, constancy testing, image quality assurance, transducer testing, diagnostic ultrasound, radiology, quality control, inspection, maintenance.