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
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
Medicinska električna oprema - 1-3. del: Splošne zahteve za osnovno varnost in bistvene lastnosti - Spremljevalni standard: Varstvo pred sevanjem pri rentgenski diagnostični opremi - Dopolnilo A2 (IEC 60601-1-3:2008/A2:2021)
General Information
Relations
Overview
EN 60601-1-3:2008/A2:2021 is a European standard developed by CLC that addresses medical electrical equipment, specifically focusing on the general requirements for basic safety and essential performance with a collateral emphasis on radiation protection in diagnostic X-ray equipment. This standard serves as an amendment (A2:2021) to the original EN 60601-1-3:2008 and aligns with the international IEC 60601-1-3:2008/A2:2021 standard. It incorporates updated references, terms, and definitions consistent with the latest requirements in medical device safety and radiation protection protocols.
The document ensures that manufacturers and healthcare providers adhere to rigorous guidelines for radiation safety while maintaining clinical diagnostic functionality. Compliance is mandatory for national standardization across European countries and addresses critical aspects of patient and operator protection from ionizing radiation risks inherent in diagnostic radiography.
Key Topics
Basic Safety and Essential Performance
- Establishes the framework for medical electrical equipment safety, particularly in diagnostic imaging devices.
- Defines critical performance criteria to ensure functional reliability during medical procedures.
Radiation Protection Requirements
- Specifies safety measures to minimize exposure to harmful ionizing radiation during diagnostic X-ray examinations.
- Includes technical safeguards to limit unintended radiation doses to patients, operators, and the environment.
Normative References Update
- Integrates the latest amendments to IEC 60601-1:2005, including amendments A1:2012 and A2:2020.
- Ensures up-to-date terminologies and risk management practices according to current international standards.
Defined Terms and Concepts
- Clarifies the definitions for intended use, manufacturer responsibilities, and risk management practices within the context of diagnostic X-ray equipment.
- Facilitates consistent understanding and application of the standard across manufacturers and regulatory bodies.
Applications
EN 60601-1-3:2008/A2:2021 standard is pivotal for:
- Manufacturers of diagnostic X-ray machines ensuring compliance with updated safety and radiation protection regulations.
- Healthcare facilities implementing robust radiation safety protocols to protect patients and staff.
- Regulatory agencies enforcing safety standards for medical electrical devices in diagnostic radiography.
- Design and quality assurance teams focusing on risk assessment and mitigation in the development of X-ray imaging equipment.
- Training and certification programs for radiology professionals emphasizing safe operational practices based on recognized safety standards.
Related Standards
IEC 60601-1:2005 Series
- The foundational general standard for medical electrical equipment safety and performance, inclusive of amendments A1 (2012) and A2 (2020).
- EN 60601-1 serves as the core reference linked to this collateral radiation protection standard.
IEC 60601-1-2
- Covers electromagnetic compatibility requirements for medical electrical equipment.
IEC 60601-2-X Series
- Specific standards addressing particular types of medical electrical equipment, often complementing the general standard.
Radiation Protection Standards (General)
- Related regulatory documents and guidelines governing ionizing radiation exposure limits and safe usage practices in medical diagnostics.
The EN 60601-1-3:2008/A2:2021 standard is integral for enhancing the safety framework in diagnostic X-ray equipment manufacture and clinical use. It supports the delivery of high-quality medical imaging services while prioritizing radiation protection, offering clear guidelines for compliance and risk reduction. For professionals engaged in the medical electrical equipment sector, adherence to this standard ensures alignment with the latest European and international safety expectations.
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2021
Medicinska električna oprema - 1-3. del: Splošne zahteve za osnovno varnost in
bistvene lastnosti - Spremljevalni standard: Varstvo pred sevanjem pri rentgenski
diagnostični opremi - Dopolnilo A2 (IEC 60601-1-3:2008/A2:2021)
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/A2:2021)
Medizinische elektrische Geräte - Teil 1-3: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Strahlenschutz
von diagnostischen Röntgengeräten (IEC 60601-1-3:2008/A2:2021)
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 (IEC 60601-1-3:2008/A2:2021)
Ta slovenski standard je istoveten z: EN 60601-1-3:2008/A2:2021
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 60601-1-3:2008/A2
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2021
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/A2:2021)
Appareils électromédicaux - Partie 1-3: Exigences Medizinische elektrische Geräte - Teil 1-3: Allgemeine
générales pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles - Norme collatérale: Radioprotection dans les wesentlichen Leistungsmerkmale - Ergänzungsnorm:
appareils à rayonnement X de diagnostic Strahlenschutz von diagnostischen Röntgengeräten
(IEC 60601-1-3:2008/A2:2021) (IEC 60601-1-3:2008/A2:2021)
This amendment A2 modifies the European Standard EN 60601-1-3:2008; it was approved by CENELEC on 2021-03-02. 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-1-3:2008/A2:2021 E
European foreword
The text of document 62B/1176/CDV, future IEC 60601-1-3/A2, 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 EN 60601-1-3:2008/A2:2021.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2021–12–02
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2024–03–02
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 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.
Endorsement notice
The text of the International Standard IEC 60601-1-3:2008/A2:2021 was approved by CENELEC as a
European Standard without any modification.
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod), the
relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cenelec.eu.
Replace the existing reference to EN 60601-1 with the following:
Publication Year Title EN/HD Year
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- - + corrigendum 2010
Mar.
+ A1 2012 + A1 2013
- - + A12 2014
+ A2 2020 - -
IEC 60601-1-3 ®
Edition 2.0 2021-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 2
AM ENDEMENT 2
Medical electrical equipment –
Part 1-3: General requirements for basic safety and essential performance –
Collateral Standard: Radiation protection in diagnostic X-ray equipment
Appareils électromédicaux –
Partie 1-3: Exigences générales pour la sécurité de base et les pe
...
Frequently Asked Questions
EN 60601-1-3:2008/A2:2021 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: 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
EN 60601-1-3:2008/A2:2021 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/A2:2021 has the following relationships with other standards: It is inter standard links to EN 60601-1-3:2008. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 60601-1-3:2008/A2:2021 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.
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