SIST EN IEC 60601-2-28:2020/oprA1:2025

• Status: Not Published
• Public Enquiry End Date: 31-Dec-2025
• ICS: 11.040.50 - Radiographic equipment
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 12-Nov-2025
• Due Date: 01-Apr-2026
• Completion Date: 22-Dec-2025
• Ref Project: EN IEC 60601-2-28:2019/A1:2026 - Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis

• Amends: SIST EN IEC 60601-2-28:2020 - Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (IEC 60601-2-28:2017)
• Effective Date: 23-Sep-2025

SIST EN IEC 60601-2-28:2020/oprA1:2025 is the Slovenian adoption of EN IEC 60601-2-28:2019/prA1:2025, published by SIST. It is Amendment 1 to the part of the IEC 60601 series that covers the basic safety and essential performance of X-ray tube assemblies for medical diagnosis. The amendment updates safety-related marking, documentation, temperature, radiation and reference-text requirements for manufacturers, test organizations and others working with X-ray tube assemblies.

What does SIST EN IEC 60601-2-28:2020/oprA1:2025 specify?

SIST EN IEC 60601-2-28:2020/oprA1:2025 specifies changes to the existing particular standard for X-ray tube assemblies used in medical diagnosis. It does not rewrite the whole part - it amends selected clauses, notes, Annex AA, the bibliography and the index of defined terms.

The amendment text is organized by the clauses it changes, including 201, 203 and Annex AA. It also updates the normative references used inside the standard and aligns the wording with newer editions of related IEC and ISO documents.

What are the key requirements of SIST EN IEC 60601-2-28:2020/oprA1:2025?

Marking and accompanying documents

Clause 201.7.2.101 requires X-RAY TUBES to be marked with the manufacturer name or trademark, a model or type reference, and individual identification. The marking must stay clearly legible during the expected service life, so the product can be traced back to its documents and to the exact unit in use.

Clause 201.7.9.3.101 expands the technical description for X-RAY TUBE ASSEMBLIES. It calls for information on the compatible electrical supply equipment, the HIGH-VOLTAGE GENERATOR, electron emitter supply, beam-control supply, anode rotation supply where applicable, cathode emission characteristics, removable HIGH VOLTAGE connectors, auxiliary equipment such as cooling, and any additional supply-interface requirements needed for safe operation. In practice, the manufacturer has to provide enough detail for correct integration and safe use.

Temperatures, access and normal use

Clause 201.11.1.1 sets a specific limit for painted metal surfaces of an X-RAY TUBE ASSEMBLY that can be touched unintentionally for up to 1 second during NORMAL USE - 85 °C. For longer contact times, the general-standard temperature limits apply. This matters because the installer and user need to judge whether a surface can be touched during routine operation.

Clause 201.13.1.2 adds a related condition for surfaces likely to be touched for up to 1 second in NORMAL USE - the painted metal surface must not exceed 105 °C when measured and adjusted as described in the general standard. Clause 201.11.1.1 also states that the general-standard temperature table does not apply to assemblies protected by GUARDS, or otherwise not accessible to the OPERATOR or PATIENT during NORMAL USE.

Radiation properties and filtration

Clause 203.6.7.3 requires NOMINAL FOCAL SPOT VALUES to be stated according to IEC 60336. Clause 203.7.3 requires X-RAY TUBE ASSEMBLIES to be marked either with their PERMANENT FILTRATION according to IEC 60522-1:2020, or with the thicknesses of the relevant materials together with their chemical symbols. That gives users and test labs a clear basis for checking beam quality and filtration.

Clause 203.8.3 limits the DIAPHRAGM: the radiation aperture must not be larger than needed for the largest X-RAY BEAM across the intended applications, and the aperture-defining material must be as close as practicable to the FOCAL SPOT. Compliance is checked by design-data verification, so the design file becomes part of the evidence.

Risk management and EMC

The note in 201.7.9.1 states that the USABILITY ENGINEERING PROCESS is not the carrier for this equipment type; instead, the RISK MANAGEMENT PROCESS based on ISO 14971:2019 and ISO/TR 24971:2020 carries the usability considerations. Clause 201.17 also says the manufacturer is not required to check conformity with IEC 60601-1-2 on the stand-alone X-RAY TUBE ASSEMBLY.

What terms does SIST EN IEC 60601-2-28:2020/oprA1:2025 define?

• ELECTRON - the charged particle used in the tube assembly, referenced from IEC TR 60788:2004.
• RADIATION APERTURE - the opening that shapes the emitted radiation field, referenced from IEC 60601-3:2008.
• RADIATION FIELD - the area covered by the X-ray radiation, referenced from IEC 60601-3:2008.
• X-RAY BEAM - the radiation beam produced by the X-ray tube assembly, referenced from IEC 60601-3:2008.
• QUALITY EQUIVALENT FILTRATION - the filtration quantity used to characterize beam quality, referenced from IEC 60522-1:2020.
• RISK MANAGEMENT FILE - the documented record of risk management activities for the assembly.
• USABILITY - the property used in the risk-management context for how the interface can be used safely and effectively.

Who uses SIST EN IEC 60601-2-28:2020/oprA1:2025?

Manufacturers of X-ray tube assemblies use this standard when designing the product, writing technical documentation, and preparing markings. Testing organizations use it when checking temperature behavior, filtration information, focal spot statements, and design-data compliance.

It is also used by medical imaging equipment engineers, quality managers, regulatory teams and buyers who need to confirm that a tube assembly fits the safety and documentation expectations for diagnostic use.

What changed in SIST EN IEC 60601-2-28:2020/oprA1:2025 from the previous edition?

SIST EN IEC 60601-2-28:2020/oprA1:2025 is Amendment 1 to IEC 60601-2-28:2017. The amendment updates references to newer editions of IEC 60601-1 and IEC 60601-1-3, replaces older filtration references with IEC 60522-1:2020, revises marking and technical-description text, adds the stand-alone EMC note, updates temperature wording for painted metal surfaces, and adjusts Annex AA wording and the bibliography.

Which standards are used with SIST EN IEC 60601-2-28:2020/oprA1:2025?

• IEC 60601-1-3:2008, AMD1:2013 and AMD2:2021 - provides the radiation-protection collateral standard used throughout the amendment.
• IEC 60336 - provides the method and terminology for focal spot dimensions and related characteristics.
• 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 60601-1-2 - appears in the text as a standard the manufacturer is not required to check for the stand-alone X-RAY TUBE ASSEMBLY.

What does the SIST EN IEC 60601-2-28:2020/oprA1:2025 document contain?

The document contains amendment text that replaces or adds specific subclauses in the main standard. It updates marking rules, supply-terminal marking, accompanying-document content, temperature limits, EMC wording, radiation-protection references, focal spot statements, filtration marking, and the limiting diaphragm requirement.

It also revises Annex AA general considerations, adds bibliography entries for related standards and guides, and updates the index of defined terms used in the particular standard. For readers, that means the document is mainly a set of targeted technical corrections and updates, not a standalone rewrite of the whole part.

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
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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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