EN IEC 60601-2-28:2019/A1:2026
(Amendment)Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
- Status
- Not Published
- Publication Date
- 22-Oct-2026
- Technical Committee
- CLC/TC 62 - Electrical equipment in medical practice
- Current Stage
- 4060 - Enquiry results established and sent to TC, SR, BTTF - Enquiry
- Start Date
- 30-Jan-2026
- Completion Date
- 30-Jan-2026
EN IEC 60601-2-28:2019/A1:2026 is CLC’s amendment to the IEC 60601-2-28 standard for X-ray tube assemblies used in medical diagnosis. It updates the particular requirements for basic safety and essential performance, mainly for manufacturers, test organizations, and others who specify, mark, document, or verify this equipment. The amendment aligns the text with newer IEC references and clarifies several safety, radiation-protection, and documentation points.
What does EN IEC 60601-2-28:2019/A1:2026 specify?
EN IEC 60601-2-28:2019/A1:2026 specifies changes to the European adoption of Part 2-28 for X-ray tube assemblies for medical diagnosis. It is an amendment, so it revises selected subclauses of the existing part rather than replacing the whole document.
The amendment updates the links to the general IEC 60601 series, the collateral radiation-protection standard, the focal-spot and filtration references, and several product-information requirements. It also revises Annex AA, the bibliography, and the index of defined terms.
What are the key requirements of EN IEC 60601-2-28:2019/A1:2026?
Marking and identification
Clause 201.7.2.101 requires X-RAY TUBES to show the MANUFACTURER name or trademark, a MODEL OR TYPE REFERENCE, and individual identification. The markings must stay clearly legible over the expected service life, which matters because the tube has to be traceable back to its documents during service, repair, and acceptance checking.
Clause 201.7.3.7 says supply terminals must be marked adjacent to the terminals unless the design prevents interchange or interchange would not create an unacceptable RISK. In practice, this tells designers when terminal marking is needed and when the design itself provides the protection.
Clause 201.7.9.3.101 expands the technical description. It requires information on compatible supply equipment and HIGH-VOLTAGE GENERATOR(S), the required high voltage, ELECTRON emitter supply, beam-control supply functions, ANODE rotation supply where relevant, CATHODE emission characteristics, removable HIGH VOLTAGE connectors, auxiliary equipment, and any additional supply interfaces needed for safe operation and captured in the RISK MANAGEMENT FILE.
Safety, temperature, and usability-related approach
Clause 201.7.9.1 replaces the usability note with a risk-based approach. The amendment states that the USABILITY ENGINEERING PROCESS is not applicable for an X-RAY TUBE ASSEMBLY and points instead to the RISK MANAGEMENT PROCESS based on ISO 14971:2019 and ISO/TR 24971:2020. For users, that means usability concerns are handled through risk analysis and intended-use thinking rather than the separate usability process used elsewhere in IEC 60601.
Clause 201.11.1.1 sets a temperature limit for painted metal surfaces that may be touched unintentionally for up to 1 second during NORMAL USE. Clause 201.13.1.2 also uses a 1-second touch assumption when judging enclosure or temperature-related emission requirements. In practice, manufacturers need to classify touchable surfaces and document how they measured them.
Radiation protection and filtration
Clause 203.6.7.3 says the NOMINAL FOCAL SPOT VALUES of the X-RAY TUBE(S) FOCAL SPOT(S) in the equipment shall be stated according to IEC 60336. Clause 203.7.3 requires the X-RAY TUBE ASSEMBLY to be marked with PERMANENT FILTRATION according to IEC 60522-1:2020, or with the relevant material thicknesses and chemical symbols. That means the tube’s radiation output and filtration data must be stated in a way that supports compliance and comparison.
Clause 203.8.3 limits the DIAPHRAGM so the radiation aperture is no larger than needed for the largest X-RAY BEAM across the intended applications, and the material defining the aperture should be placed as close as practicable to the FOCAL SPOT. Compliance is checked by verifying the design data, so the design file matters as much as the physical build.
Clause 201.17 says the MANUFACTURER is not required to check conformity with IEC 60601-1-2 on the stand-alone X-RAY TUBE ASSEMBLY. This narrows the responsibility at the tube-assembly level and helps separate tube assessment from system-level EMC work.
What terms does EN IEC 60601-2-28:2019/A1:2026 define?
- X-RAY TUBE ASSEMBLY - the product covered by the part; the standard sets tube-specific safety and documentation requirements for medical diagnosis.
- HIGH-VOLTAGE GENERATOR - the source that provides the high voltage needed to operate the tube assembly and must be identified in the technical description.
- RISK MANAGEMENT FILE - the file that records the safety justification for additional interfaces or design choices needed for safe operation.
- QUALITY EQUIVALENT FILTRATION - the filtration concept linked to diagnostic X-ray quality, with methods referenced to IEC 60522-1:2020.
- RADIATION APERTURE - the opening that shapes the beam; its size and placement are controlled by Clause 203.8.3.
- X-RAY BEAM - the emitted beam whose size and application range determine the diaphragm limit.
- USABILITY - a defined term carried over from the general IEC 60601 framework, but the amendment routes usability considerations through risk management for this product.
Who uses EN IEC 60601-2-28:2019/A1:2026?
Manufacturers of X-RAY TUBE ASSEMBLIES use this standard to define markings, technical data, filtration information, and safety-related design choices. Test organizations use it when checking temperature, identification, radiation-protection, and documentation-related points.
Regulatory and quality staff use it to review conformity files, risk management records, and product descriptions. System integrators and medical imaging equipment designers use it when selecting compatible supply equipment, HIGH-VOLTAGE GENERATOR(S), and auxiliary equipment. Buyers and technical evaluators use it to compare tube assemblies by documented performance and safety information.
What changed in EN IEC 60601-2-28:2019/A1:2026 from the previous edition?
This amendment to IEC 60601-2-28:2017 updates references to IEC 60601-1-3, IEC 60336, and IEC 60522-1:2020, and aligns the text with IEC 60601-1:2005/AMD2:2020. It revises marking, technical-description, temperature, EMC, and radiation-protection wording, and it updates Annex AA terminology from filament-based wording to ELECTRON emitter wording. The foreword says it was prepared to provide a complete set of safety requirements for X-RAY TUBE ASSEMBLIES and to correct references to actual standards.
Which standards are used with EN IEC 60601-2-28:2019/A1:2026?
- IEC 60601-1-3:2008 / AMD1:2013 / AMD2:2021 - provides the collateral radiation-protection requirements used throughout the amendment.
- IEC 60336 - gives the basis for focal spot dimensions and related characteristics, including nominal focal spot values.
- IEC 60522-1:2020 - provides methods for quality equivalent filtration and permanent filtration.
- ISO 14971:2019 and ISO/TR 24971:2020 - support the risk-management approach used for usability-related considerations.
- IEC 60806:2022 - is the reference for stating the maximum symmetrical radiation field when that value is given.
- IEC 60601-1-2 and IEC 60601-1-6 - are named in the text to clarify stand-alone EMC and usability handling for X-RAY TUBE ASSEMBLIES.
What does the EN IEC 60601-2-28:2019/A1:2026 document contain?
The amendment contains replacement text for several clauses, not a complete standalone test method. Its content focuses on updated references, marking rules, technical-description items, temperature notes, and radiation-protection requirements.
It also revises Annex AA general considerations, especially terminology around ELECTRON emitter supply. The bibliography is updated with the standards and guidance documents used by the amended requirements.
The document also includes an updated index of defined terms for items such as ELECTRON, RADIATION APERTURE, RADIATION FIELD, X-RAY BEAM, and QUALITY EQUIVALENT FILTRATION.
Relations
- Effective Date
- 23-Sep-2025
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Frequently Asked Questions
EN IEC 60601-2-28:2019/A1:2026 is a draft published by CLC. Its full title is "Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis". This standard covers: Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
EN IEC 60601-2-28:2019/A1:2026 is classified under the following ICS (International Classification for Standards) categories: 11.040.55 - Diagnostic equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN IEC 60601-2-28:2019/A1:2026 has the following relationships with other standards: It is inter standard links to EN IEC 60601-2-28:2019. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN IEC 60601-2-28:2019/A1:2026 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2025
Medicinska električna oprema - 2-28. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti rentgenskih sestavov za medicinsko diagnostiko - Dopolnilo A1
Amendment 1 - Medical electrical equipment - Part 2-28: Particular requirements for the
basic safety and essential performance of X-ray tube assemblies for medical diagnosis
Appareils électromédicaux - Partie 2-28: Exigences particulières pour la sécurité de base
et les performances essentielles des gaines équipées pour diagnostic médical
Ta slovenski standard je istoveten z: EN IEC 60601-2-28:2019/prA1:2025
ICS:
11.040.50 Radiografska oprema Radiographic equipment
11.040.55 Diagnostična oprema Diagnostic equipment
SIST EN IEC 60601-2- en
28:2020/oprA1:2025
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
62B/1396/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-28/AMD1 ED3
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2025-11-07 2026-01-30
SUPERSEDES DOCUMENTS:
62B/1392/RR
IEC SC 62B : MEDICAL IMAGING EQUIPMENT, SOFTWARE, AND SYSTEMS
SECRETARIAT: SECRETARY:
Germany Ms Regina Geierhofer
OF INTEREST TO THE FOLLOWING COMMITTEES: HORIZONTAL FUNCTION(S):
SC 62C
ASPECTS CONCERNED:
Safety
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of
which they are aware and to provide supporting documentation.
Recipients of this document are invited to submit, with their comments, notification of any relevant “In Some
Countries” clauses to be included should this proposal proceed. Recipients are reminded that the CDV stage is
the final stage for submitting ISC clauses. (SEE AC/22/2007 OR NEW GUIDANCE DOC).
TITLE:
Amendment 1 - Medical electrical equipment - Part 2-28: Particular requirements for the basic
safety and essential performance of X-ray tube assemblies for medical diagnosis
PROPOSED STABILITY DATE: 2028
NOTE FROM TC/SC OFFICERS:
electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions.
You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without
permission in writing from IEC.
IEC CDV 60601-2-28/AMD1 © IEC 2025
1 INTERNATIONAL ELECTROTECHNICAL COMMISSION
2 ____________
4 MEDICAL ELECTRICAL EQUIPMENT
6 Part 2-28: Particular requirements for the basic safety
7 and essential performance of X-ray tube assemblies for medical diagnosis
9 AMENDMENT 1
11 FOREWORD
12 Amendment 1 to IEC 60601-2-28:2017 has been prepared by subcommittee 62B: Medical
13 imaging equipment, software, and systems, of IEC technical committee 62: Medical equipment,
14 software, and systems.
15 The text of this Amendment is based on the following documents:
Draft / FDIS Report on voting
62B/XXXX/FDIS 62B/XXXX/RVD
17 Full information on the voting for its approval can be found in the report on voting indicated in
18 the above table.
19 The language used for the development of this amendment is English.
20 This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
21 accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
22 at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
23 described in greater detail at www.iec.ch/publications.
24 The committee has decided that the contents of this document will remain unchanged until the
25 stability date indicated on the IEC website under webstore.iec.ch in the data related to the
26 specific document. At this date, the document will be
27 • reconfirmed,
28 • withdrawn,
29 • replaced by a revised edition, or
30 • amended.
31 NOTE The attention of National Committees is drawn to the fact that equipment MANUFACTURERS and testing
32 organizations may need a transitional period following publication of a new, amended or revised IEC publication in
33 which to make products in accordance with the new requirements and to equip themselves for conducting new or
34 revised tests. It is the recommendation of the committee that the content of this publication be adopted for
35 implementation nationally not earlier than 3 years from the date of publication.
37 ____________
IEC CDV 60601-2-28/AMD1 © IEC 2025
39 INTRODUCTION to Amendment 1
40 This first amendment to the third edition of IEC 60601-2-28 has been prepared to provide a
41 complete set of safety requirements for X-RAY TUBE ASSEMBLIES, based on the second
42 amendment (2020) to IEC 60601-1:2005 and associated collateral standards. It corrects
43 references to actual standards (e.g. IEC 60336, IEC 60522-1, and the IEC 60601 series) and
44 clarifies single requirements within the standard.
45 Users of this document should note that when constructing the dated references to specific
46 elements in a standard, such as definitions, amendments are only referenced if they modified
47 the text being cited. For example, if a reference is made to a definition that has not been
48 modified by an amendment, then the reference to the amendment is not included in the dated
49 reference.
IEC CDV 60601-2-28/AMD1 © IEC 2025
51 201.1.1 Scope, object and related standards
52 Replace, in the existing footnote 1), “IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012”,
53 with “IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020”.
55 201.1.3 Collateral standards
56 Replace, in the existing second paragraph of the addition, “IEC 60601-1-3:2008 and IEC 60601-
57 1-3:2008/AMD1:2013”, with “IEC 60601-1-3:2008 and IEC 60601-1-3:2008/AMD1:2013 and
58 IEC 60601-1-3:2008/AMD2:2021”.
60 201.1.4 Particular standards
61 Replace, in the existing third paragraph of the replacement, “IEC 60601-1:2005 and IEC 60601-
62 1:2005/AMD1:2012”, with “IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
63 1:2005/AMD2:2020”.
65 Replace, in the existing eighth paragraph of the replacement, “3.147” with “3.154”.
67 201.2 Normative references
68 Replace the existing reference to “IEC 60601-1-3:2008” with:
69 IEC 60601-1-3:2008, Medical electrical equipment – Part 1-3: General requirements for basic
70 safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-
71 ray equipment
72 IEC 60601-1-3:2008/AMD1:2013
73 IEC 60601-1-3:2008/AMD2:2021
75 Replace the existing reference to “IEC 60336” with:
76 IEC 60336, Medical electrical equipment – X-ray tube assemblies for medical diagnosis – Focal
77 spot dimensions and related characteristics
79 Replace the existing reference to “IEC 60522” with:
80 IEC 60522-1:2020, Medical electrical equipment – Diagnostic X-rays – Part 1: Determination of
81 quality equivalent filtration and permanent filtration
IEC CDV 60601-2-28/AMD1 © IEC 2025
84 201.3 Terms and definitions
85 Replace the existing reference to “IEC 60522” with “IEC 60522-1:2020”.
87 201.7.2.11 Mode of operation
88 Delete the existing NOTE.
90 201.7.2.101 Marking of X-RAY TUBES
91 Replace the existing subclause by:
92 X-RAY TUBES shall be provided with the following markings:
93 • name or trademark of the MANUFACTURER;
94 • MODEL OR TYPE REFERENCE;
95 • individual identification.
96 The markings shall enable individual products, series or types to be correlated with their
97 ACCOMPANYING DOCUMENTS.
98 The markings on the X-RAY TUBE shall remain CLEARLY LEGIBLE during the EXPECTED SERVICE
99 LIFE.
100 The above markings may be given in the form of a combined designation explained in the
101 ACCOMPANYING DOCUMENTS.
103 Add, after the existing subclause 201.7.3.2, the following new subclause:
104 201.7.3.7 Supply terminals
105 Replacement of the first paragraph by:
106 If terminals for supply conductors are non-interchangeable by design, or, if otherwise, there is
107 no unacceptable RISK if the terminals are interchanged, then marking of the supply terminals or
108 marking adjacent to the supply terminals is not required. Otherwise, supply terminals shall be
109 marked adjacent to the terminals.
110 NOTE For this modification of the general standard the term supply terminal according to IEV 845-28-064 has been
111 considered.
113 201.7.9 ACCOMPANYING DOCUMENTS
114 201.7.9.1 General
115 Replace the existing NOTE 104 with:
116 NOTE 104 Instead of the USABILITY ENGINEERING PROCESS (IEC 60601-1-6 is not applicable for an X-RAY TUBE
117 ASSEMBLY), the RISK MANAGEMENT PROCESS (based on ISO 14971:2019 and its accompanying TR – ISO/TR
118 24971:2020) is the carrier of the considerations. ISO 14971:2019, 5.2 (INTENDED USE and reasonable foreseeable
119 misuse) and ISO/TR 24971:2020 A.2.31 (USABILITY of the user interface) cover the USABILITY aspects of X-RAY TUBE
120 ASSEMBLIES sufficiently.
IEC CDV 60601-2-28/AMD1 © IEC 2025
121 201.7.9.3.101 Technical description of X-RAY TUBE ASSEMBLIES
122 Replace, in the existing list item e), the reference to “IEC 60522” with “IEC 60522-1:2020”.
124 Replace the existing list items h) to k) with:
125 h) type-designation of compatible electrical supply equipment required to power the X-RAY
126 TUBE ASSEMBLY, including HIGH-VOLTAGE GENERATOR(S), or specifications concerning:
127 1) the HIGH VOLTAGE required from the HIGH-VOLTAGE GENERATOR,
128 2) electrical supply of the ELECTRON emitter(s),
129 3) electrical supply for electron beam control, e.g., focusing, pulsing, deflecting, etc. (as
130 applicable)
131 4) electrical supply for rotating the ANODE (as applicable),
132 5) CATHODE EMISSION CHARACTERISTICS.
133 i) type-designation or specification of HIGH VOLTAGE connectors, if removable in NORMAL USE;
134 j) type-designation of compatible auxiliary equipment (such as for cooling purposes), or
135 requirements for such auxiliary functions;
136 k) any supply interface requirement(s) in addition to items h) through j) above which are
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