IEC 60601-2-54:2009/AMD1:2015
(Amendment)Amendment 1 - Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
Amendment 1 - Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
Amendement 1 - Appareils électromédicaux - Partie 2-54: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X utilisés pour la radiographie et la radioscopie
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IEC 60601-2-54 ®
Edition 1.0 2015-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –
Part 2-54: Particular requirements for the basic safety and essential performance
of X-ray equipment for radiography and radioscopy
Appareils électromédicaux –
Partie 2-54: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils à rayonnement X utilisés pour la radiographie et la
radioscopie
IEC 60601-2-54:2009-06/AMD1:2015-04(en-fr)
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IEC 60601-2-54 ®
Edition 1.0 2015-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –
Part 2-54: Particular requirements for the basic safety and essential performance
of X-ray equipment for radiography and radioscopy
Appareils électromédicaux –
Partie 2-54: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils à rayonnement X utilisés pour la radiographie et la
radioscopie
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-2567-7
– 2 – IEC 60601-2-54:2009/AMD1:2015
© IEC 2015
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:
CDV Report on voting
62B/929/CDV 62B/956/RVC
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.
_____________
© IEC 2015
INTRODUCTION TO AMENDMENT 1
The purpose of this first amendment to IEC 60601-2-54:2009 is to introduce changes to
reference the first amendment (2012) to IEC 60601-1:2005. As neither IEC 60601-2-54:2009
nor this amendment refers to specific elements of IEC 60601-1-2, the introduction of a dated
reference to the latter document has been removed. In addition, a number of technical errors
have been corrected.
FOREWORD
Replace, in the existing second paragraph, the phrase "IEC 60601-2-28:1993 (currently under
revision)" with "parts of IEC 60601-2-28:1993".
201.1 Scope, object and related standards
Amend the footnote to read as follows:
1)
The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance
201.1.3 Collateral standards
Replace the existing second sentence of the second paragraph with the following:
IEC 60601-1-8, IEC 60601-1-10, IEC 60601-1-11 and IEC 60601-1-12 do not apply.
201.2 Normative references
Add the following new reference:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012
Delete the following reference:
IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance– Collateral standard: Electromagnetic compatibility –
Requirements and tests
Replace the existing reference to IEC 60601-1-3 with the following:
IEC 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
IEC 60601-1-3:2008/AMD1:2013
– 4 – IEC 60601-2-54:2009/AMD1:2015
© IEC 2015
201.3 Terms and definitions
Replace, in the introductory paragraph, the reference to "IEC 60601-1:2005" by
"IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012".
201.4.3 ESSENTIAL PERFORMANCE
201.4.3.101 * Additional ESSENTIAL PERFORMANCE requirements
Replace the existing title with the following:
201.4.3.101 * Additional potential ESSENTIAL PERFORMANCE requirements
Replace, in the first sentence, the term "ESSENTIAL PERFORMANCE" by "potential ESSENTIAL
PERFORMANCE".
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements
Amend the existing title of the table to read as follows:
Table 201.101 – Distributed potential ESSENTIAL PERFORMANCE requirements
201.7 ME EQUIPMENT identification, marking and documents
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
201.7.2.101 BEAM LIMITING DEVICE
Replace the existing third dash with the following:
QUALITY EQUIVALENT FILTRATION of all materials together that are permanently fixed and
–
intercept the X-RAY BEAM.
CCOMPANYING DOCUMENTS
201.7.9 A
201.7.9.2 Instructions for use
Add the following new subclause:
201.7.9.2.17 ME EQUIPMENT emitting radiation
Replacement:
For X-RAY EQUIPMENT the instructions for use shall provide information as required in 203.5.
© IEC 2015
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
201.9.2 HAZARDS associated with moving parts
Replace the existing title with the following:
201.9.2 MECHANICAL HAZARDS associated with moving parts
Add the following header:
201.9.2.2 TRAPPING ZONE
201.9.2.2.4 GUARDS and protective measures
Replace the existing title with the following:
201.9.2.2.4 GUARDS and other RISK CONTROL measures
201.9.2.2.4.4 Protective measures
Replace the existing title with the following:
201.9.2.2.4.4 Other RISK CONTROL measures
201.9.2.3 Other HAZARDS associated with moving parts
Replace the existing title with the following:
201.9.2.3 Other MECHANICAL HAZARDS associated with moving parts
201.9.2.3.1 Unintended movement
Add the following new paragraph between the penultimate paragraph and the compliance
statement:
The configurations shall be considered in the USABILITY ENGINEERING PROCESS.
Replace the final paragraph (compliance statement) by the following:
Compliance is checked by functional tests and by inspection of the instructions for use and
the USABILITY ENGINEERING FILE.
201.11 Protection against excessive temperatures and other HAZARDS
201.11.101 Protection against excessive temperatures of X-RAY TUBE ASSEMBLIES
Add the following note after the first paragraph:
NOTE Examples of such means are covers, handles for operation etc.
202 Electromagnetic compatibility – Requirements and tests
Replace the dated reference by an undated reference in the first paragraph as follows:
– 6 – IEC 60601-2-54:2009/AMD1:2015
© IEC 2015
IEC 60601-1-2 applies, except as follows.
202.101 Immunity testing of ESSENTIAL PERFORMANCE
Add the following two new paragraphs before the existing first paragraph:
The MANUFACTURER may minimize the test requirements of the additional potential ESSENTIAL
PERFORMANCE requirements listed in Table 201.101 to a practical level through the RISK
MANAGEMENT PROCESS.
When selecting the requirements to be tested, the MANUFACTURER needs to take into account
the sensitivity to the EMC environment, probability of EMC condition and severity, and
probability and contribution to unacceptable RISK through the RISK MANAGEMENT PROCESS.
Add, after the last paragraph, the following new text:
ME EQUIPMENT being tested shall not be modified to perform this immunity test.
Compliance is checked by the inspection of RISK MANAGEMENT FILE.
203 Radiation protection in diagnostic X-ray equipment
Replace, in the first paragraph, the reference to "IEC 60601-1-3:2008" by
"IEC 60601-1-3:2008 and IEC 60601-1-3:2008/AMD1:2013".
203.6 RADIATION management
203.6.4 Indication of operational states
203.6.4.5 *Dosimetric indications
Replace, in the third paragraph, the second, third and fourth dashes with the following:
– The value of the cumulative REFERENCE AIR KERMA resulting from RADIOSCOPY and
RADIOGRAPHY since the last reset operation shall be
• continuously displayed at the working position of the OPERATOR in mGy together with
this unit and updated at least once every 5 s; or
• displayed not later than 5 s after the interruption or termination of LOADING.
– The values for the REFERENCE AIR KERMA RATE and the cumulative REFERENCE AIR KERMA
shall be clearly distinguishable from each other.
203.7 RADIATION QUALITY
203.7.1 HALF-VALUE LAYERS and TOTAL FILTRATION in X-RAY EQUIPMENT
Add the following note after the first paragraph:
NOTE An appropriate permanently mounted FILTER, not remova
...
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