iTeh Standards logo
EURUSD
Your shopping cart is empty.
CLC

EN 60601-1-3:2008/A1:2013

(Amendment)

Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

2013-10-02 - BT146_DG9211 extended DOW to 2018-12-31 2013-05-02 - Publication editing allocated to aclausse@cencenelec.eu

Medizinische elektrische Geräte - Teil 1-3: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Strahlenschutz von diagnostischen Röntgengeräten

Appareils électromédicaux - Partie 1-3: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Radioprotection dans les appareils à rayonnement X de diagnostic

Medicinska električna oprema - 1-3. del: Splošne zahteve za osnovno varnost in bistvene lastnosti - Spremljevalni standard: Zaščita pred sevanjem pri rentgenski diagnostični opremi - Dopolnilo A1 (IEC 60601-1-3:2008/A1:2013)

Ta mednarodni standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI MEDICINSKE ELEKTRIČNE OPREME in MEDICINSKE ELEKTRIČNE SISTEME (v nadaljevanju tudi: ELEKTROMEDICINSKA OPREMA in ELEKTROMEDICINSKI SISTEMI). Ta spremljevalni standard se uporablja za RENTGENSKO OPREMO in podsestave tovrstne opreme,
kadar se RADIOLOŠKE SLIKE človeških PACIENTOV uporabljajo za diagnosticiranje, načrtovanje ali usmerjanje medicinskih postopkov.

General Information

Status
Published
Publication Date
13-Jun-2013
Withdrawal Date
30-Dec-2018
ICS
11.040.50 - Radiographic equipment
13.280 - Radiation protection
Technical Committee
CLC/TC 62 - Electrical equipment in medical practice
Drafting Committee
IEC/SC 62B - IEC_SC_62B
Current Stage
6060 - Document made available - Publishing
Start Date
14-Jun-2013
Completion Date
14-Jun-2013
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
Ref Project
SIST EN 60601-1-3:2008/A1:2014 - Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

Relations

Amends
EN 60601-1-3:2008 - Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
Effective Date
29-Jan-2023
Corrected By
EN 60601-1-3:2008/A1:2013/AC:2014 - Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
Effective Date
29-Jan-2023

Overview

EN 60601-1-3:2008/A1:2013 (IEC 60601-1-3:2008/A1:2013) is a European collateral standard for medical electrical equipment that specifies general requirements for basic safety and essential performance with a focus on radiation protection in diagnostic X‑ray equipment. Amendment A1 (approved May 24, 2013) updates the original 2008 edition to reference IEC 60601-1:2005+A1:2012 and aligns related normative references and defined terms. This harmonized standard supports essential requirements of EU medical device directives and is intended for diagnostic imaging devices that generate or use X‑ray radiation.

Key topics and technical requirements

  • Radiation protection: Collateral requirements for minimizing patient and operator exposure from diagnostic X‑ray equipment.
  • Basic safety and essential performance: Ensures devices perform their intended diagnostic function without introducing unacceptable risk.
  • Normative references: Incorporates and updates references to IEC 60601‑1:2005+A1:2012 and related documents that are indispensable for correct application.
  • Definitions and terminology: Clarifies terms such as essential performance, intended use, manufacturer, normal use, patient, risk, risk management, risk management file, and single fault condition by linking them to the amended IEC 60601‑1.
  • Conformity and national adoption: Amendment A1 was adopted by CENELEC and is to be implemented as a national standard without alteration.

Note: This summary does not invent measurement limits or test procedures; the full standard contains the specific technical and test details.

Applications

  • Design and development of diagnostic X‑ray systems (radiography, fluoroscopy, CT-related subsystems) to meet radiation protection and safety requirements.
  • Preparing technical documentation for CE marking and regulatory submissions in Europe.
  • Establishing risk management files and safety validation covering radiation-related hazards and single-fault conditions.
  • Test laboratories and conformity assessment bodies verifying compliance with the EN/IEC 60601 series.
  • Hospital and clinic procurement teams requiring suppliers to demonstrate compliance with harmonized standards for safety and radiation protection.

Who should use this standard

  • Medical device manufacturers and design engineers for diagnostic X‑ray equipment
  • Product safety and risk management professionals
  • Regulatory affairs specialists and notified bodies in Europe
  • Test laboratories and quality assurance teams
  • Healthcare engineering and procurement personnel assessing device safety

Related standards and references

  • IEC 60601-1:2005 + A1:2012 (general standard referenced by this collateral standard)
  • Other parts of the IEC 60601 series covering electrical safety, electromagnetic compatibility and particular diagnostic modalities.

Keywords: EN 60601-1-3, IEC 60601-1-3, radiation protection, diagnostic X‑ray equipment, medical electrical equipment, essential performance, basic safety, amendment A1, CENELEC, risk management, CE marking.

EN 60601-1-3:2008/A1:2014EN 60601-1-3:2008/A1:2014
PreviousNext
Amendment
EN 60601-1-3:2008/A1:2014
English language
6 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Frequently Asked Questions

EN 60601-1-3:2008/A1:2013 is a amendment published by CLC. Its full title is "Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment". This standard covers: 2013-10-02 - BT146_DG9211 extended DOW to 2018-12-31 2013-05-02 - Publication editing allocated to aclausse@cencenelec.eu

2013-10-02 - BT146_DG9211 extended DOW to 2018-12-31 2013-05-02 - Publication editing allocated to aclausse@cencenelec.eu

EN 60601-1-3:2008/A1:2013 is classified under the following ICS (International Classification for Standards) categories: 11.040.50 - Radiographic equipment; 13.280 - Radiation protection. The ICS classification helps identify the subject area and facilitates finding related standards.

EN 60601-1-3:2008/A1:2013 has the following relationships with other standards: It is inter standard links to EN 60601-1-3:2008, EN 60601-1-3:2008/A1:2013/AC:2014. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN 60601-1-3:2008/A1:2013 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/432. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.

You can purchase EN 60601-1-3:2008/A1:2013 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CLC standards.

Standards Content (Sample)


SLOVENSKI STANDARD
01-julij-2014
0HGLFLQVNDHOHNWULþQDRSUHPDGHO6SORãQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWL6SUHPOMHYDOQLVWDQGDUG=DãþLWDSUHGVHYDQMHPSULUHQWJHQVNL
GLDJQRVWLþQLRSUHPL'RSROQLOR$ ,(&$
Medical electrical equipment - Part 1-3: General requirements for basic safety and
essential performance - Collateral Standard: Radiation protection in diagnostic X-ray
equipment
Medizinische elektrische Geräte - Teil 1-3: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Strahlenschutz
von diagnostischen Röntgengeräten
Appareils électromédicaux - Partie 1-3: Exigences générales pour la sécurité de base et
les performances essentielles - Norme collatérale: Radioprotection dans les appareils à
rayonnement X de diagnostic
Ta slovenski standard je istoveten z: EN 60601-1-3:2008/A1:2013
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 60601-1-3/A1
NORME EUROPÉENNE
June 2013
EUROPÄISCHE NORM
ICS 11.040.50; 13.280
English version
Medical electrical equipment -
Part 1-3: General requirements for basic safety and essential performance -
Collateral Standard: Radiation protection in diagnostic X-ray equipment
(IEC 60601-1-3:2008/A1:2013)
Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 1-3: Exigences générales pour la Teil 1-3: Allgemeine Festlegungen für die
sécurité de base et les performances Sicherheit einschließlich der wesentlichen
essentielles - Leistungsmerkmale -
Norme collatérale: Radioprotection dans Ergänzungsnorm: Strahlenschutz von
les appareils à rayonnement X de diagnostischen Röntgengeräten
diagnostic (IEC 60601-1-3:2008/A1:2013)
(CEI 60601-1-3:2008/A1:2013)
This amendment A1 modifies the European Standard EN 60601-1-3:2008; it was approved by CENELEC on
2013-05-24. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which
stipulate the conditions for giving this amendment the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the CEN-CENELEC Management Centre or to any CENELEC member.

This amendment exists in three official versions (English, French, German). A version in any other language
made by translation under the responsibility of a CENELEC member into its own language and notified to the
CEN-CENELEC Management Centre has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus,
the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Management Centre: Avenue Marnix 17, B - 1000 Brussels

© 2013 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-1-3:2008/A1:2013 E

Foreword
The text of document 62B/895/CDV, future amendment 1 to edition 2 of IEC 60601-1-3, prepared by
SC 62B "Diagnostic imaging equipment" of IEC TC 62 "Electrical equipment in medical practice" was
submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
(dop) 2014-02-24
• latest date by which the document has
to be implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2016-05-24
• latest date by which the national
standards conflicting with the
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).

Endorsement notice
The text of the International Standard IEC 60601-1-3:2008/A1:2013 was approved by CENELEC as a
European Standard without any modification.

------
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

Loading comments...

This May Also Interest You

CLC
EN 60601-1-3:2008/A2:2021(Amendment)
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
SIST EN IEC 60601-1-3:2008/A2:2021
  • Amendment
    7 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN 60601-1-3:2008/A11:2016(Amendment)
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
SIST EN 60601-1-3:2008/A11:2017

D155/C032-C033: Publication of revised Annex ZA and Annex ZZ
2021: CLC legacy converted by DCLab NISOSTS

  • Amendment
    7 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN 60601-1-3:2008/A1:2013/AC:2014(Corrigendum)
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
SIST EN 60601-1-3:2008/A1:2014/AC:2014

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. This collateral standard applies to X-RAY EQUIPMENT and to subassemblies of such equipment,
where RADIOLOGICAL IMAGES of a human PATIENT are used for diagnosis, planning or guidance of medical procedures.

  • Corrigendum
    1 page
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN 61217:2012(Main)
Radiotherapy equipment - Coordinates, movements and scales
SIST EN 61217:2012

IEC 61217:2011 applies to equipment and data related to the process of teleradiotherapy, including patient image data used in relation with radiotherapy treatment planning systems, radiotherapy simulators, isocentric gamma beam therapy equipment, isocentric medical electron accelerators, and non-isocentric equipment when relevant. The object of this standard is to define a consistent set of coordinate systems for use throughout the process of teleradiotherapy, to define the marking of scales (where provided), to define the movements of equipment used in this process, and to facilitate computer control when used. This second edition cancels and replaces the first edition, published in 1996, amendment 1, published in 2000 and amendment 2, published in 2007. This edition constitutes a technical revision to include imager and focus coordinate systems in Subclause 3.12. Beyond this Subclause, changes were only introduced where needed to include the above coordinate systems.

  • Standard
    71 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN 60601-1-3:2008(Main)
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
SIST EN 60601-1-3:2008

This collateral standard applies to X-ray equipment and to subassemblies of such equipment, where radiological images of a human patient are used for diagnosis, planning or guidance of medical procedures. The object of this collateral standard is to establish general requirements for protection against X-radiation in X-ray equipment, in order that the irradiation of the human patient, the operator, staff and members of the public can be kept as low as reasonably achievable, without jeopardizing the benefit of the radiological procedure. Particular standards may specify their appropriate values and/or measures for general requirements specified in this collateral standard. The implementation of the general requirements or the reference to the particular standard instead, shall be justified in the risk management process. This collateral standard considers radiation protection aspects related to X-radiation only. Requirements for the control of the electrical energy used to generate X-radiation, which is also an important aspect of radiation protection, are included in IEC 60601-1 and in particular standards for the safety and essential performance of the equipment concerned. This document cancels and replaces the first edition of IEC 60601-1-3, published in 1994 (which replaced IEC 407 issued in 1973). It constitutes a technical revision. This edition has been restructured and aligned to IEC 60601-1(2005) and focussed on general requirements for RADIATION PROTECTION that apply to all diagnostic X-RAY EQUIPMENT. Requirements particular to specific equipment have been removed and will be covered in particular standards. For a description of the changes, see the mapping in Annex C.

  • Standard
    53 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN 60976:2007(Main)
Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
SIST EN 60976:2008

Applies to medical electron accelerators when used, for therapy purposes, in human medical practice. This standard applies to medical electron accelerators which deliver a radiation beam of either X-radiation or electron radiation with nominal energies in the range 1 MeV to 50 MeV at maximum absorbed dose rates between 0,001 Gy s-1 and 1 Gy s-1 at 1 m from the radiation source and at normal treatment distances between 50 cm and 200 cm from the radiation source. The present standard describes measurements and test procedures to be performed by the manufacturer at the design and construction stage of a medical electron accelerator but does not specify acceptance tests to be performed after installation at the purchaser's site. The accompanying report, IEC 60977, however, does suggest that many of the test procedures are appropriate for acceptance tests. The measurement conditions described in the present standard differ from those previously in use. This applies particularly to the phantom position for measurements and the measurement of distances from the isocentre. These new conditions should be substituted for and not be added to previous methods. This standard specifies test procedures for the determination and disclosure of functional performance characteristics, knowledge of which is deemed necessary for proper application and use of a medical electron accelerator and which are to be declared in the accompanying documents together with the greatest deviation or variation to be expected under specific conditions in normal use. A format for presentation of functional performance values is given in Annex A. It is recognized that inaccuracies in the test methods must be allowed for when assessing performance. However, it was not felt to be advisable to combine the errors into an overall performance tolerance but to keep them separate in the expectation that more accurate test methods will be evolved. It is not intended that this standard should in any way inhibit the future development of new designs of equipment which may have operating modes and parameters different from those described herein, provided that such equipment achieves equivalent levels of performance for the treatment of patients. Except where otherwise stated this standard assumes that the medical electron accelerators have an isocentric gantry. Where the equipment is non-isocentric, the description of performance and test methods may need to be suitably adapted. This second edition cancels and replaces the first edition published in 1989. It constitutes a technical revision. This second edition includes the addition of performance standards and test methods relating to the following new technologies: - dynamic beam delivery techniques, such as moving beam radiotherapy, intensity-modulated radiation therapy (IMRT), image-guided radiotherapy (IGRT) and programmable wedge fields; - stereotactic radiotherapy (SRT) / stereotactic radiosurgery (SRS); - use of electronic imaging devices. This standard, together with IEC TR 60977, should be read in conjunction with IEC 60601-2-1.

  • Standard
    101 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN 60068-2-75:2014/A1:2025(Amendment)
Environmental testing - Part 2-75: Tests - Test Eh: Hammer tests
SIST EN IEC 60068-2-75:2014/A1:2026

The content of the corrigendum 1 of amendment 1 (2025-12) applies only to the French version.

  • Draft
    2 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN IEC 63129:2020/A1:2025(Amendment)
Determination of inrush current characteristics of lighting products
SIST EN IEC 63129:2020/kFprA1:2025
  • Draft
    8 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN 50152-3-1:2017/A1:2025(Amendment)
Railway applications - Fixed installations - Particular requirements for a.c. switchgear - Part 3-1: Measurement, control and protection devices for specific use in a.c. traction systems - Devices
SIST EN 50152-3-1:2017/FprA1:2025

This European Standard is applicable to new low voltage devices for measurement, control and protection which are: — for indoor or outdoor fixed installations in traction systems, and — operated in conjunction with high voltage equipment with an a.c. line voltage and frequency as specified in EN 50163. This European Standard also applies to measurement, control and protective devices other than low voltage devices and not covered by a specific railway product standard as far as reasonably possible. Requirements of this document prevail. Scope of amendment Implementation of 2 technical changes: — Modification of subclause 5.4, second item in list of protection functions. — Aligning the value for short-circuit current of 50 Hz traction systems given in Annex A subclause A.2.1 ‘Line testing – General’ with EN 50388-1:2022 Table 7

  • Draft
    4 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CLC
EN IEC 63296-3:2025(Main)
Portable multimedia equipment - Determination of battery duration - Part 3: Wearable powered loudspeaker equipment
oSIST prEN IEC 63296-3:2025

IEC 63296-3:2025 specifies the method for measuring the battery duration at a defined sound pressure level for continuous music playback of battery-operated wearable powered loudspeaker equipment. A primary battery or secondary battery can be used as a power source for such a shoulder-carried or body-worn loudspeaker and its composite device. In addition, only equipment that can be placed on or hung from a head and torso simulator (HATS) is covered. Bone conduction speakers are excluded. Portable loudspeaker equipment also supporting video playback as the main function is not covered by this document.

  • Draft
    14 pages
    English language
    sale 10% off
    e-Library read for
    1 day