SIST EN 60601-2-43:2010/A2:2020
(Amendment)Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures (IEC 60601-2-43:2010/A2:2019)
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures (IEC 60601-2-43:2010/A2:2019)
2020-01-08 CV: BT decision (D164/C119) to proceed to publication without link to legislation
2019-11-07 mah: consultant assessment missing: blocked.
2019-11-12 - JO: BT document to remove link to the MDD under review
Appareils électromédicaux - Partie 2-43: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X lors d’interventions
Medicinska električna oprema - 2-43. del: Posebne zahteve za osnovno varnost in bistvene lastnosti rentgenske opreme za interventne postopke - Dopolnilo A2 (IEC 60601-2-43:2010/A2:2019)
General Information
Relations
Overview
Standard: EN 60601-2-43:2010/A2:2020
Title: Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X‑ray equipment for interventional procedures
Organization: CLC / CENELEC (adoption of IEC 60601-2-43:2010/A2:2019)
EN 60601-2-43:2010/A2:2020 defines the basic safety and essential performance requirements for both fixed and mobile X‑ray equipment declared by manufacturers as suitable for radioscopically guided interventional procedures. Amendment A2 clarifies scope (including mobile X‑ray), aligns selected subclauses with IEC 60601-2-54, and adds requirements and recommendations for dose display, dose mapping and other radiation‑safety features.
Key topics and technical requirements
- Scope and applicability: Covers interventional X‑ray equipment (fixed and mobile); cone‑beam CT mode is covered by this standard rather than IEC 60601‑2‑44. The standard supersedes selected subclauses of IEC 60601‑2‑54 where cited.
- Radiation protection / dosimetry: Introduction of terms and requirements for DOSE MAP, SKIN DOSE, SKIN DOSE MAP and dosimetric indications. Requires population of specified radiation dose data elements and inspection/functional verification.
- Dose displays: Requirement for a dose area product display unit and recommendations for a DOSE MAP to present spatial dose distribution.
- Radioscopy features: Requirements for pulse repetition frequency during radioscopy, management of radioscopy image storage, and display functions such as Last Image Hold (LIH).
- User information and accompanying documents: New statements required in accompanying documents (e.g., humidity preconditioning treatment, enclosure protection, dosimetric indications, examination protocols).
- Mechanical and thermal safety: Clarifications on mechanical hazards of support systems and recommendations for protection of gantry enclosures.
- Normative references and collateral standards: Specifies applicable collateral standards and cross‑references (e.g., IEC 60601‑1 family, IEC 60601‑2‑54, IEC 60529).
Applications and who uses this standard
- Manufacturers of X‑ray systems for interventional cardiology, interventional radiology and hybrid operating rooms - for design, testing and labeling to meet essential performance and safety.
- Test laboratories and conformity assessors - to verify compliance, perform functional and dosimetric tests, and inspect accompanying documentation.
- Clinical engineers and hospital procurement teams - to specify equipment features (dose monitoring, LIH, dose area product display, dose maps) and ensure safe clinical use.
- Radiation safety officers and regulatory bodies - for acceptance testing, dose documentation and regulatory conformity in EU jurisdictions (Annex ZZ relates to EU directives).
Related standards
- IEC 60601‑1 (general medical electrical safety)
- IEC 60601‑2‑54 (X‑ray equipment for radiography and radioscopy) - cited subclauses apply as indicated
- IEC 60601‑1‑2 (EMC), IEC 60529 (IP Code), IEC 60580 (dose area product meters), IEC 61910‑1, IEC 62220‑1‑1
Keywords: EN 60601-2-43, X‑ray equipment, interventional procedures, medical electrical equipment, radiation protection, dose map, radioscopy, IEC 60601-2-54.
Frequently Asked Questions
SIST EN 60601-2-43:2010/A2:2020 is a amendment published by the Slovenian Institute for Standardization (SIST). Its full title is "Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures (IEC 60601-2-43:2010/A2:2019)". This standard covers: 2020-01-08 CV: BT decision (D164/C119) to proceed to publication without link to legislation 2019-11-07 mah: consultant assessment missing: blocked. 2019-11-12 - JO: BT document to remove link to the MDD under review
2020-01-08 CV: BT decision (D164/C119) to proceed to publication without link to legislation 2019-11-07 mah: consultant assessment missing: blocked. 2019-11-12 - JO: BT document to remove link to the MDD under review
SIST EN 60601-2-43:2010/A2:2020 is classified under the following ICS (International Classification for Standards) categories: 11.040.50 - Radiographic equipment; 13.280 - Radiation protection; 37.040.25 - Radiographic films. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN 60601-2-43:2010/A2:2020 has the following relationships with other standards: It is inter standard links to SIST EN IEC 60601-2-43:2023. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 60601-2-43:2010/A2:2020 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/295. 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 SIST EN 60601-2-43:2010/A2:2020 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 SIST standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2020
Medicinska električna oprema - 2-43. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti rentgenske opreme za interventne postopke - Dopolnilo A2 (IEC
60601-2-43:2010/A2:2019)
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and
essential performance of X-ray equipment for interventional procedures (IEC 60601-2-
43:2010/A2:2019)
Appareils électromédicaux - Partie 2-43: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils à rayonnement X lors d’interventions
Ta slovenski standard je istoveten z: EN 60601-2-43:2010/A2:2020
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 60601-2-43:2010/A2
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2020
ICS 11.040.50; 37.040.25
English Version
Medical electrical equipment - Part 2-43: Particular requirements
for the basic safety and essential performance of X-ray
equipment for interventional procedures
(IEC 60601-2-43:2010/A2:2019)
Appareils électromédicaux - Partie 2-43: Exigences To be completed
particulières pour la sécurité de base et les performances (IEC 60601-2-43:2010/A2:2019)
essentielles des appareils à rayonnement X lors
d'interventions
(IEC 60601-2-43:2010/A2:2019)
This amendment A2 modifies the European Standard EN 60601-2-43:2010; it was approved by CENELEC on 2019-11-20. 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
© 2020 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-43:2010/A2:2020 E
European foreword
The text of document 62B/1137/FDIS, future IEC 60601-2-43/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 60601-2-43:2010/A2:2020.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2020-10-03
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2023-04-03
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, and supports essential requirements of EU
Directive(s).
For the relationship with EU Directive(s), see informative Annex ZZ, included in EN 60601-2-43:2010.
Endorsement notice
The text of the International Standard IEC 60601-2-43:2010/A2:2019 was approved by CENELEC as
a European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 60601-1-8 NOTE Harmonized as EN 60601-1-8
IEC 60601-1-9 NOTE Harmonized as EN 60601-1-9
IEC 60601-1-10 NOTE Harmonized as EN 60601-1-10
IEC 60601-1-12 NOTE Harmonized as EN 60601-1-12
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.
The Annex ZA of EN 60601-1:2006 is applicable, except as follows:
Publication Year Title EN/HD Year
Amendment
IEC 60529 1989 Degrees of protection provided by EN 60529 1991
enclosures (IP Code)
+EN 1993
60529:1991/corrige
ndum May 1993
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
IEC 60601-1-3 2008 Medical electrical equipment - Part 1-3: EN 60601-1-3 2008
General requirements for basic safety and
essential performance - Collateral
Standard: Radiation protection in
diagnostic X-ray equipment
+EN 60601-1-2010
3:2008/corrigendum
Mar. 2010
+A11 2016
Addition
IEC 60580 2000 Medical electrical equipment - Dose area EN 60580 2000
product meters
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
+A12 2014
+EN 60601-2010
1:2006/corrigendum
Mar. 2010
+AC 2014
+A11 2011
Publication Year Title EN/HD Year
IEC 60601-2-54 2009 Medical electrical equipment - Part 2-54: EN 60601-2-54 2009
Particular requirements for the basic safety
and essential performance of X-ray
equipment for radiography and radioscopy
IEC 61910-1 2014 Medical electrical equipment - Radiation EN 61910-1 2014
dose documentation - Part 1: Radiation
dose structured reports for radiography
and radioscopy
IEC 62220-1 2003 Medical electrical equipment - EN 62220-1 2004
Characteristics of digital X-ray imaging
devices -- Part 1: Determination of the
detective quantum efficiency
IEC 62220-1-1 2015 Medical electrical equipment - EN 62220-1-1 2015
Characteristics of digital X-ray imaging
devices - Part 1-1: Determination of the
detective quantum efficiency - Detectors
used in radiographic imaging
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
IEC 60601-2-43 ®
Edition 2.0 2019-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
A MENDMENT 2
AM ENDEMENT 2
Medical electrical equipment –
Part 2-43: Particular requirements for the basic safety and essential
performance of X-ray equipment for interventional procedures
Appareils électromédicaux –
Partie 2-43: Exigences particulières pour la sécurité de base et les
performances essentielles des appareils à rayonnement X lors d’interventions
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-7349-4
– 2 – IEC 60601-2-43:2010/AMD2:2019
IEC 2019
FOREWORD
This amendment has been prepared by subcommittee 62B: Diagnostic imaging equipment, of
IEC technical committee 62: Electrical equipment in medical practice.
The text of this amendment is based on the following documents:
FDIS Report on voting
62B/1137/FDIS 62B/1146/RVD
Full information on the voting for the approval of this amendment can be found in the report
on voting indicated in the above table.
The committee has decided that the contents of this amendment and the base publication will
remain unchanged until the stability date indicated on the IEC website under
"http://webstore.iec.ch" in the data related to the specific publication. At this date, the
publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
___________
INTRODUCTION to Amendment 2
The purpose of this second amendment to IEC 60601-2-43:2010 is to introduce changes as
follows:
– scope clarification with regards to MOBILE X-ray equipment and applicability of
IEC 60601-2-54 subclauses;
– reference to IEC 60601-2-54:2009/AMD2:2018 for common subclauses;
– alignment of 201.7.9.1 with IEC 60601-2-54:2009/AMD2:2018 – 201.7.9.1 is no longer
modified;
– inclusion of adapted requirements or recommendations from
IEC 60601-2-54:2009/AMD2:2018 for
• management of radioscopy image storage in 203.6.1.101,
• display of last image hold (LIH RADIOGRAM) in 203.6.7.101, and
• graphical indication of the boundaries of the X-RAY FIELD in 203.8.102.2;
– inclusion of a recommendation for protection of gantry enclosures in 201.11.6.5.103;
– inclusion of a requirement for X-RADIATION pulse repetition frequency during radioscopy
in 203.6.3.103;
IEC 60601-2-43:2010/AMD2:2019 – 3 –
IEC 2019
– inclusion of a recommendation for a DOSE MAP in 203.6.4.5 with additional definitions
in 201.3;
– inclusion of a requirement for display unit of dose area product in 203.6.4.5;
– addition of a number of technical clarifications.
__________
201.1.1 Scope
Replace the first sentence of the first existing paragraph by the following new sentence:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of both
FIXED and MOBILE X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for
RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, hereafter referred to as
INTERVENTIONAL X-RAY EQUIPMENT.
Replace the third existing note, including the footnote, by the following new note and footnote:
NOTE 3 INTERVENTIONAL X-RAY EQUIPMENT, when used for cone-beam CT mode, is covered by this standard and
not by IEC 60601-2-44 [2] . No additional requirements for operation in cone-beam CT mode were identified for this
standard (see also Note 4 in 203.6.4.5).
__________
2) Figures in square brackets refer to the Bibliography.
Add, after the fourth existing note, the following new paragraph:
The subclauses of this standard supersede IEC 60601-2-54 subclauses. IEC 60601-2-54
applies only with regards to the cited subclauses; non-cited subclauses of IEC 60601-2-54 do
not apply.
201.1.3 Collateral standards
Replace, in the second existing paragraph, the second sentence, including its corresponding
footnotes, modified by IEC 60601-2-43:2010/AMD1:2017, by the following new sentence and
footnotes:
6 7 8 9 10
IEC 60601-1-8 , IEC 60601-1-9 , IEC 60601-1-10 , IEC 60601-1-11 , IEC 60601-1-12 do
not apply.
__________
6 IEC 60601-1-8, Medical electrical equipment – Part 1-8: General requirements for basic safety and essential
performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems
7 IEC 60601-1-9, Medical electrical equipment – Part 1-9: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for environmentally conscious design
8 IEC 60601-1-10, Medical electrical equipment – Part 1-10: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers
9 IEC 60601-1-11, Medical electrical equipment – Part 1-11: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical
systems used in the home healthcare environment
10 IEC 60601-1-12, Medical electrical equipment – Part 1-12: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical
systems intended for use in the emergency medical services environment
– 4 – IEC 60601-2-43:2010/AMD2:2019
IEC 2019
201.2 Normative references
Add, immediately after the instruction "Amendment", the following new reference:
IEC 60529:1989, Degrees of protection provided by enclosures (IP Code)
IEC 60529:1989/AMD1:1999
IEC 60529:1989/AMD2:2013
Replace, under "Addition", the existing reference to IEC 60580 and the one to
IEC 60601-2-54, modified by IEC 60601-2-43:2010/AMD1:2017, by the following new
references:
IEC 60580:2000, Medical electrical equipment – Dose area product meters
IEC 60601-2-54:2009, Medical electrical equipment – Part 2-54: Particular requirements for
the basic safety and essential performance of X-ray equipment for radiography and
radioscopy
IEC 60601-2-54:2009/AMD1:2015
IEC 60601-2-54:2009/AMD2:2018
201.3 Terms and definitions
Replace the first existing paragraph, modified by IEC 60601-2-43:2010/AMD1:2017, by the
following new paragraph:
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012, IEC 60601-1-3:2008 and IEC 60601-1-3/AMD1:2013,
IEC 60601-2-54:2009, IEC 60601-2-54:2009/AMD1:2015 and IEC 60601-2-
54:2009/AMD2:2018, IEC TR 60788:2004, IEC 61910-1:2014, IEC 62220-1-1:2015 and the
following apply.
Add, after the existing definition 201.3.204, added by IEC 60601-2-43:2010/AMD1:2017, the
following new terms and definitions:
201.3.205
DOSE MAP
representation of the spatial distribution of a RADIATION dose quantity
201.3.206
SKIN DOSE
estimated ABSORBED DOSE to the skin at a specific point
201.3.207
SKIN DOSE MAP
DOSE MAP of the SKIN DOSE
201.4.102 RADIATION dose documentation
Add, at the end of the paragraph, modified by IEC 60601-2-43:2010/AMD1:2017, but before
the compliance statement, the following new paragraph:
The data elements shall be populated with the specified data.
Replace the existing compliance statement by the following new compliance statement:
Compliance is checked by appropriate inspection and functional test.
IEC 60601-2-43:2010/AMD2:2019 – 5 –
IEC 2019
201.5 General requirements for testing of ME EQUIPMENT
Replace the existing text by the following new text:
Clause 5 of the general standard applies, except as follows:
201.5.7 Humidity preconditioning treatment
Addition:
For INTERVENTIONAL X-RAY EQUIPMENT that is to be used only in controlled environments, as
specified in the ACCOMPANYING DOCUMENTS, no humidity preconditioning treatment is required.
The ACCOMPANYING DOCUMENTS shall include the time period that the room environmental
operating conditions need to be maintained prior to powering the system on.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
201.7.2.104 Marking of compliance
Replace, in the second existing paragraph, the reference "IEC 60601-2-43:2010" by
"IEC 60601-2-43:2010, IEC 60601-2-43:2010/AMD1:2017, IEC 60601-2-43:2010/AMD2:2019".
201.7.2.105 Protection against ingress of liquids
Replace, in the existing paragraph, the reference "IEC 60529" by "IEC 60529:1989,
IEC 60529:1989/AMD1:1999 and IEC 60529:1989/AMD2:2013".
201.7.9.1 General
Replace the existing text by the following new text:
Subclause 201.7.9.1 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD2:2018 applies.
201.7.9.101 Additional statements in ACCOMPANYING DOCUMENTS
Table 201.102 – Other subclauses requiring statements in ACCOMPANYING DOCUMENTS
Add, after the last row, the following new rows:
201.5.7 Humidity preconditioning treatment
201.11.6.5.103 ENCLOSURES
203.5.2.4.102 EXAMINATION PROTOCOLS
203.6.4.5 Dosimetric indications
Add, after Table 201.102, the following new note:
NOTE While Table 201.C.102 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD2:2018 lists the following
subclauses "203.6.4.5 Dosimetric indications" and "203.5.2.4.5.101 Dosimetric information for X-RAY EQUIPMENT
specified for RADIOSCOPY and/or SERIAL RADIOGRAPHY", the corresponding requirements for statements in
ACCOMPANYING DOCUMENTS are located in this standard and not in IEC 60601-2-54:2009 and its amendments.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Delete the sentence: "Clause 8 of the general standard applies, except as follows:"
– 6 – IEC 60601-2-43:2010/AMD2:2019
IEC 2019
201.9.8 HAZARDS associated with support systems
Replace the existing title of this subclause by the following new title:
201.9.8 MECHANICAL HAZARDS associated with support systems
201.9.8.3.3 Dynamic forces due to loading from persons
Replace, in the existing paragraph, the reference "IEC 60601-2-54:2009" by "IEC 60601-2-
54:2009 and IEC 60601-2-54:2009/AMD2:2018".
201.10 Protection against unwanted and excessive radiation HAZARDS
Replace the existing paragraph, excluding the note, by the following new paragraph:
Clause 201.10 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD2:2018 applies.
201.11 Protection against excessive temperatures and other HAZARDS
201.11.6.5.103 ENCLOSURES
Add, in the first existing paragraph, the following new sentence to the third dash, modified by
IEC 60601-2-43:2010/AMD1:2017:
For the PATIENT SUPPORT test, testing may be considered sufficient by angulating the PATIENT
SUPPORT 15° from the horizontal position.
Add, in the first existing paragraph, the following item to the dash list:
– X-RAY TUBE ASSEMBLY and associated GANTRY elements should have a minimum degree of
protection of IPX2, except for INTERVENTIONAL X-RAY EQUIPMENT with a FIXED over-table X-
RAY SOURCE ASSEMBLY. The ACCOMPANYING DOCUMENTS shall describe the associated
GANTRY elements that are included within the IPX2 classification. Testing may be
considered sufficient by tilting the C-arm in the least favourable position with a maximum
of 15° in any direction from the vertical position.
Replace, in the second paragraph, the reference "IEC 60529" by "IEC 60529:1989,
IEC 60529:1989/AMD1:1999 and IEC 60529:1989/AMD2:2013".
Replace "NOTE 1" by "NOTE".
Delete the second note.
Add, after 201.11.6.5.103, the following new text:
201.11.8 Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT
Subclause 201.11.8 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD2:2018 applies.
201.12 Accuracy of controls and instruments and protection against
hazardous outputs
Replace, in the note, the reference "under 203.6.4.3 of IEC 60601-2-54:2009" by "under
203.6.4.3 of this document".
IEC 60601-2-43:2010/AMD2:2019 – 7 –
IEC 2019
201.16 ME SYSTEMS
Replace the existing text by the following new text:
Clause 16 of the general standard applies, except as follows:
201.16.8 Interruption of the power supply to parts of an ME SYSTEM
Replacement:
Subclause 201.16.8 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD2:2018 applies.
203.4.1 Statement of compliance
Replace, in the existing paragraph, modified by IEC 60601-2-43:2010/AMD1:2017, the
reference "IEC 60601-2-43:2010" by "IEC 60601-2-43:2010, IEC 60601-2-
43:2010/AMD1:2017 and IEC 60601-2-43:2010/AMD2:2019".
Add, after the existing 203.4.101, the following new text:
203.5.2.1 References in subclauses
Table 2 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS
Amendment:
The row about Clinical protocols, Subclause 5.2.4.4, does not apply.
203.5.2.4 Instructions for use
Add, after the existing 203.5.2.4, the following new subclause:
203.5.2.4.4 Clinical protocols
Subclause 5.2.4.4 of IEC 60601-1-3:2008 does not apply.
203.5.2.4.5.102 Test for dosimetric information
Replace, in the last paragraph, "NOTE 2" by "NOTE".
Add, after the existing 203.5.2.4.101, the following new subclause:
203.5.2.4.102 EXAMINATION PROTOCOLS
Subclause 203.5.2.4.101 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD2:2018
applies.
NOTE The numbering of the cited subclause from IEC 60601-2-54 is different.
Add, after the existing 203.6, the following new text:
203.6.1 General
Additional subclauses:
– 8 – IEC 60601-2-43:2010/AMD2:2019
IEC 2019
203.6.1.101 Management of RADIOSCOPY image storage
NTERVENTIONAL X-RAY EQUIPMENT shall provide the capability to store a RADIOSCOPY REPLAY
I
IMAGE SEQUENCE for display. This capability may be limited to storage of images as follows:
RADIOSCOPY;
– at pulse rates up to 10 pulses per second, the last 30 s of
– for pulse rates greater than 10 pulses per second, the last 300 images;
RADIOSCOPY, the last 10 s of RADIOSCOPY.
– for continuous
This requirement does not apply to MOBILE X-RAY EQUIPMENT with a maximum FOCAL SPOT TO
less than 45 cm and that is specified for extremities use only in its
IMAGE RECEPTOR DISTANCE
INTENDED USE.
NOTE The storage is not required to be a permanent storage.
Compliance is checked by functional test.
203.6.1.102 Management of EXAMINATION PROTOCOLS
Subclause 203.6.1.102 of IEC 60601-2-54:2009 and IEC 60601-2-54:2009/AMD2:2018
applies.
203.6.2 Initiation and termination of the IRRADIATION
Replace, in the existing paragraph, the reference "IEC 60601-2-54:2009" by "IEC 60601-2-
54:2009 and IEC 60601-2-54:2009/AMD2:2018".
203.6.3 RADIATION dose and RADIATION QUALITY
203.6.3.2 Reproducibility of the RADIATION output
Replace, in the existing paragraph, the reference "IEC 60601-2-54:2009" by "IEC 60601-2-
54:2009 and IEC 60601-2-54:2009/AMD2:2018".
Add, after the existing 203.6.3.102, the following new subclause:
203.6.3.103 * X-RADIATION pulse repetition frequency during RADIOSCOPY
If the RADIOSCOPY pulse rate is selectable, the minimum pulse rate shall be less than or equal
to 4 pulses per second.
203.6.4.3 Indication of LOADING FACTORS and MODES OF OPERATION
Replace, in the existing par
...
SIST EN 60601-2-43:2010/A2:2020は、医療電気機器に関する規格の一部であり、特に介入手技のためのX線機器における基本的な安全性と必須性能に関する特定要件を定めています。この規格は、医療現場においてX線装置が安全かつ効果的に運用されるための基盤を提供するものであり、その重要性は計り知れません。 この規格の主な強みは、医療従事者や患者に対する安全性の向上を目指している点です。特に、X線機器の使用に伴うリスクを最小限に抑えるための詳細な要件が含まれており、技術者による適切な評価とともに、装置の設計や使用方法のガイドラインが整備されています。また、IEC 60601-2-43:2010/A2:2019に基づく規格であるため、国際的にも通用する基準となっており、国内外の医療機関にとっても非常に価値のあるものとなっています。 さらに、この規格の適用範囲は、介入手技に特化しているため、特定の医療行為において必要なパフォーマンスを保証するための重要な要素となります。2020年1月8日の決定を受けて、立法にリンクすることなく出版されることが確定し、業界全体における今後の標準化への影響も期待されます。これにより、医療機器の規制環境はより明確となり、医療現場における実践がさらに強化されます。 総じて、SIST EN 60601-2-43:2010/A2:2020は、医療機器の基本的な安全性を確保し、患者ケアの質を向上させるための非常に重要な規格であり、その relevancyは今後も持続していくと考えられます。安全かつ効果的な医療の実現に向けた、X線機器に特化したこの規格の制定は、業界の標準を進化させるための重要な一歩と言えるでしょう。
La norme SIST EN 60601-2-43:2010/A2:2020 aborde des exigences particulières pour la sécurité de base et la performance essentielle des équipements à rayons X utilisés dans les procédures interventionnelles. Cette norme s'inscrit dans le cadre plus large de la norme IEC 60601, qui est reconnue mondialement pour sa rigueur et son approche systématique concernant la sécurité des équipements médicaux. L'une des forces majeures de cette norme réside dans son étendue, qui couvre de manière exhaustive les différents aspects de sécurité et de performance des dispositifs à rayons X. Elle définit clairement les exigences spécifiques nécessaires non seulement pour protéger les patients, mais également le personnel médical durant les procédures. Par exemple, les spécifications relatives à l’exposition aux rayonnements, à l’ergonomie des équipements, et à la maintenance sont bien détaillées, ce qui facilite leur application pratique dans un environnement clinique. Un autre point fort de cette norme est son actualisation constante pour s'adapter aux évolutions technologiques et aux nouvelles pratiques médicales. La révision de 2020, avec l'ajout de l'amendement A2, montre un engagement à intégrer des recommandations basées sur les évaluations de consultants experts, assurant ainsi la pertinence et la conformité des exigences de sécurité face aux innovations dans le domaine des équipements de radiologie. En termes de pertinence, la norme SIST EN 60601-2-43:2010/A2:2020 est cruciale pour les fabricants d’équipements médicaux, les professionnels de la santé et les organismes de réglementation. Elle garantit non seulement la sécurité des dispositifs à rayons X, mais renforce également la confiance des utilisateurs et des patients dans le cadre des interventions chirurgicales. En établissant des critères clairs et rigoureux, cette norme contribue à l'amélioration continue de la qualité des soins médicaux, ce qui est essentiel dans le contexte actuel du secteur de la santé. En résumé, la norme SIST EN 60601-2-43:2010/A2:2020 représente une référence indispensable pour assurer la sécurité et l’efficacité des équipements à rayons X utilisés dans les procédures interventionnelles, en intégrant des exigences précises qui répondent aux défis contemporains de l'industrie médicale. Son adoption est primordiale pour toute organisation impliquée dans le développement, l'utilisation, ou la réglementation de ce type d'équipement.
SIST EN 60601-2-43:2010/A2:2020 표준은 의료 전기 장비의 안전 및 필수 성능에 관한 구체적인 요구사항을 명시한 문서로, 특히 중재 절차에 사용되는 X선 장비에 중점을 두고 있습니다. 이 표준의 범위는 의료 분야에서의 X선 장비의 기본 안전성과 필수 성능을 보장하는 데 중요한 역할을 합니다. SIST EN 60601-2-43:2010/A2:2020의 주요 강점 중 하나는 중재 절차에서 사용되는 X선 장비의 안전성을 강화하는 상세한 요구사항을 제공한다는 점입니다. 이는 환자와 의료진의 안전을 모두 고려한 설계 기준을 포함하고 있어, 의료 환경에서의 사고를 예방하고, 장비의 신뢰성을 증대시킵니다. 또한, 이 표준은 국제 전기 기술 위원회(IEC) 기준을 따르고 있어, 글로벌 시장에서의 일관성을 유지하고, 다른 국가의 기준과도 호환성을 높입니다. 이 표준은 2020년 1월 8일에 출판 결정을 진행하면서, MDD와의 연관성을 제거한 점이 인상적입니다. 이러한 결정은 전통적인 의학 장비 규제와의 혼란을 최소화하고, 최신 의료 기술에 대한 반영을 목표로 하고 있습니다. 또한, 최근의 버전 업데이트를 통해, 시대의 변화에 맞춰 기술적 요구사항을 지속적으로 개선하려는 노력이 돋보입니다. SIST EN 60601-2-43:2010/A2:2020은 의료 기기의 안전성과 성능 개선뿐만 아니라, 사용자 경험을 고려한 설계 및 운용 기준을 제공함으로써, 전체 의료 서비스를 향상시키는 데 기여하고 있습니다. 이는 이러한 X선 장비가 중재 절차에서 점점 더 보편화되고 있는 현재의 상황에서 더욱 중요한 이슈가 되고 있습니다. 표준의 적시성과 유용성은 의료 분야의 발전에 긍정적인 영향을 미치고 있으며, 관련 산업의 지속 가능한 성장을 뒷받침하고 있습니다.
The SIST EN 60601-2-43:2010/A2:2020 standard is a critical document that delineates the particular requirements for the basic safety and essential performance of X-ray equipment utilized in interventional medical procedures. This standard falls within the broader category of medical electrical equipment and specifically addresses the safety protocols necessary to ensure that X-ray machines are operated safely and effectively in clinical settings. One of the strengths of this standard is its comprehensive scope, which not only outlines safety requirements but also addresses essential performance criteria that manufacturers and healthcare providers must adhere to. This dual focus helps in minimizing risks associated with X-ray procedures, thereby enhancing patient safety during interventional treatments. Furthermore, the inclusion of updates in the amendment (A2:2020) demonstrates a commitment to keeping the standard relevant in light of ongoing advancements in medical technology. Additionally, the standard stands out due to its international recognition, as it is based on the IEC 60601-2-43 framework, ensuring that it aligns with global best practices and facilitates international trade. This widespread applicability enhances its relevance for manufacturers and healthcare institutions striving for compliance in multiple markets. Overall, the SIST EN 60601-2-43:2010/A2:2020 standard serves as a vital resource for ensuring the safety and effectiveness of X-ray equipment in interventional procedures. Its well-defined requirements not only protect patients but also support the operational integrity of healthcare providers, making it an indispensable element of medical equipment safety standards.
Die Norm SIST EN 60601-2-43:2010/A2:2020 befasst sich mit den grundlegenden Anforderungen an die Sicherheit und die essenzielle Leistung von Röntgengeräten für interventionelle Verfahren. Diese Norm ist ein wichtiger Bestandteil der internationalen Normenreihe IEC 60601, die sich mit der Sicherheit von medizinischen elektrischen Geräten beschäftigt. Der Anwendungsbereich dieser Norm erstreckt sich auf alle Röntgengeräte, die in interventionellen Maßnahmen eingesetzt werden. Dies umfasst nicht nur die technischen Anforderungen, sondern auch spezifische Sicherheitsaspekte, die die Gesundheit von Patienten und medizinischem Personal schützen sollen. Durch die Betrachtung von Faktoren wie Strahlenschutz und Gerätedesign leistet die Norm einen wesentlichen Beitrag zur Verbesserung der Patientensicherheit und zur Gewährleistung einer effektiven Leistung der Geräte. Ein herausragendes Merkmal der SIST EN 60601-2-43:2010/A2:2020 ist ihre umfassende Herangehensweise an die Risikobewertung von Röntgengeräten. Die Norm definiert spezifische Testmethoden und Kriterien, die es Herstellern ermöglichen, sicherzustellen, dass ihre Geräte sowohl den allgemeinen als auch den speziellen Sicherheitsanforderungen entsprechen. Dies fördert nicht nur die Sicherheit im klinischen Alltag, sondern stärkt auch das Vertrauen der Anwender in die angebotenen Technologien. Die Relevanz dieser Norm ist besonders im Kontext der ständig wachsenden Anforderungen im Gesundheitswesen zu sehen. Die technologische Entwicklung in der Medizintechnik erfordert umfassende Standards, um die Sicherheit und Leistungsfähigkeit von Geräten in interventionellen Verfahren zu gewährleisten. Die Norm trägt dazu bei, dass solche Anforderungen systematisch und nachvollziehbar adressiert werden, was die Qualität der Patientenversorgung verbessert. Zusammenfassend lässt sich sagen, dass die SIST EN 60601-2-43:2010/A2:2020 eine entscheidende Rolle in der Standardisierung von Röntgengeräten spielt. Ihre Stärken liegen in der umfassenden Handhabung von Sicherheits- und Leistungsanforderungen sowie im kontinuierlichen Bestreben, die Qualität im Gesundheitswesen zu optimieren.
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