IEC 61326-2-6-2025 PDF

Full title and description

St IEC 61326-2-6-2025 — Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 2-6: Particular requirements — In vitro diagnostic (IVD) medical electrical equipment. This part of IEC 61326 specifies electromagnetic compatibility (EMC) requirements (immunity and emissions) that apply to the BASIC SAFETY and ESSENTIAL PERFORMANCE of IVD medical electrical equipment in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by IVD equipment.

Abstract

This standard (Edition 4.0, 2025) defines particular EMC requirements and test/documentation expectations for in‑vitro diagnostic (IVD) medical electrical equipment (MEE). It clarifies which aspects of EMC affect BASIC SAFETY and ESSENTIAL PERFORMANCE for IVD devices, and it updates test levels and documentation requirements compared with previous editions. NOTE: performance aspects beyond ESSENTIAL PERFORMANCE are addressed in IEC 61326‑1:2020.

General information

• Status: Published (current international standard).
• Publication date: 18 June 2025.
• Publisher: International Electrotechnical Commission (IEC).
• ICS / categories: 17.220.20; 25.040.40; 33.100.20.
• Edition / version: Edition 4.0 (2025).
• Number of pages: 70 pages.

Key bibliographic and release metadata above are taken from the IEC publication record and national catalogue listings for the 2025 edition.

Scope

IEC 61326‑2‑6:2025 applies to IVD medical electrical equipment (IVD MEE) and covers EMC aspects required to ensure BASIC SAFETY and ESSENTIAL PERFORMANCE in the intended electromagnetic environment. The part addresses immunity and emission requirements, special considerations where IT equipment forms part of an IVD MEE, and the documentation and test-level updates necessary for conformity assessment. For EMC performance aspects that do not affect ESSENTIAL PERFORMANCE, reference is made to IEC 61326‑1:2020.

Key topics and requirements

• EMC immunity and emissions requirements targeted specifically at in‑vitro diagnostic medical electrical equipment (IVD MEE).
• Clarification of which EMC phenomena affect BASIC SAFETY versus ESSENTIAL PERFORMANCE.
• Updated test levels, test methods and measurement/documentation requirements (technical changes from previous edition).
• Requirements for IT equipment that is part of an IVD MEE when that IT is necessary for BASIC SAFETY or ESSENTIAL PERFORMANCE.
• Guidance for manufacturers and test laboratories on test setups, reporting and documentation needed for conformity assessment.

Typical use and users

Primary users include manufacturers and designers of in‑vitro diagnostic devices, EMC test laboratories, conformity assessment bodies, regulatory and notified bodies involved in medical device approval, and quality/verification engineers responsible for device safety and performance. The standard is used to design EMC test plans, prepare technical documentation, and demonstrate that EMC behaviour does not compromise BASIC SAFETY or ESSENTIAL PERFORMANCE of IVD equipment.

Related standards

Key related documents and series include IEC 61326‑1 (general EMC requirements for laboratory, measurement and control equipment — IEC 61326‑1:2020 is referenced by this part), earlier editions of IEC 61326‑2‑6 (2005/2012), and applicable parts of the IEC 61000 series (electromagnetic immunity and emissions test methods, e.g., IEC 61000‑4‑2, ‑4‑3, etc.). National and regional adoptions (EN/IEC national editions) may also apply for regulatory conformity in specific markets.

Keywords

EMC; electromagnetic compatibility; IVD; in‑vitro diagnostic; medical electrical equipment; immunity; emissions; basic safety; essential performance; test levels; documentation; IEC 61326.

FAQ

Q: What is this standard?

A: IEC 61326‑2‑6:2025 is the part of the IEC 61326 series that sets particular EMC requirements for in‑vitro diagnostic (IVD) medical electrical equipment—focusing on how electromagnetic disturbances affect BASIC SAFETY and ESSENTIAL PERFORMANCE.

Q: What does it cover?

A: It covers immunity and emissions requirements, test levels and methods, documentation expectations, and special considerations where IT equipment forms part of an IVD MEE; it distinguishes EMC effects that impact BASIC SAFETY and ESSENTIAL PERFORMANCE from other performance aspects.

Q: Who typically uses it?

A: IVD device manufacturers, EMC test laboratories, conformity assessment and regulatory bodies, design and verification engineers working on medical diagnostics. The standard supports product development, EMC testing and regulatory submissions.

Q: Is it current or superseded?

A: The 2025 edition is the current published edition (Edition 4.0, published 18 June 2025). Earlier editions and corrigenda have been superseded by this release.

Q: Is it part of a series?

A: Yes — it is Part 2‑6 of the IEC 61326 family (general requirements are in IEC 61326‑1; other specific parts address other equipment classes). It should be used together with IEC 61326‑1 and relevant IEC 61000 test‑method standards as applicable.

Q: What are the key keywords?

A: EMC, IVD, medical electrical equipment, immunity, emissions, basic safety, essential performance, test levels, documentation, IEC 61326.