BRITISH STANDARD
`
`BSEN
`62274:2005
`
`Medical electrical
`equipinent- Safety of
`radiotherapy record
`and verify systeins
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`The European Standard EN 62274:2005 has the status of a
`British Standard
`
`res 11.040.60
`
`NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW
`
`British Standards
`
`JUBILANT EXHIBIT 1029
`Jubilant v. Bracco, IPR2018-01449
`
`

`

`National foreword
`
`This British Standard is the official English language version of
`EN 62274:2005. It is identical with IEC 62274:2005.
`The UK participation in its preparation was entrusted by Technical Committee
`CH/62, Electromedical equipment in medical practice, to Subcommittee
`CH/62/3, Equipment for radiotherapy, nuclear medicine and radiation
`dosimetry, which has the responsibility to:
`
`aid enquirers to understand the text;
`
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`present to the responsible international/European committee any
`enquiries on the interpretation, or proposals for change, and keep UK
`interests informed;
`
`monitor related international and European developments and
`promulgate them in the UK
`
`A list of organizations represented on this subcommittee can be obtained on
`request to its secretary.
`Cross-references
`The British Standards which implement international or European
`publications referred to in this document may be found in the BSI Catalogue
`under the section entitled "International Standards Correspondence Index", or
`by using the "Search" facility of the BSI Electronic Catalogue or of British
`Standards Online.
`This publication does not purport to include all the necessary provisions of a
`contract. Users are responsible for its correct application.
`Compliance with a British Standard does not of itself confer immunity
`from legal obligations.
`
`Summary of pages
`This document comprises a front cover, an inside front cover, the EN title page,
`pages 2 to 18, an inside back cover and a back cover.
`The BSI copyright notice displayed in this document indicates when the
`document was last issued.
`
`Amendments issued since publication
`
`Amd. No.
`
`Date
`
`Comments
`
`BS EN 6227 4:2005
`
`This British Standard was
`published under the authority
`of the Standards Policy and
`Strategy Committee
`on 28 December 2005
`
`© BSI 28 December 2005
`
`ISBN O 580 47175 6
`
`

`

`EUROPEAN STANDARD
`
`NORME EUROPEENNE
`
`EN 62274
`
`EUROPAISCHE NORM
`
`June 2005
`
`ICS 11.040.60
`
`English version
`
`Medical electrical equipment-
`Safety of radiotherapy record and verify systems
`(IEC 62274:2005)
`
`Appareils electromedicaux -
`Securite des systemes d'enregistrement
`et de verification de radiotherapie
`(CEI 62274:2005)
`
`Medizinische elektrische Gerate -
`Sicherheit van Aufzeichnungs(cid:173)
`und Verifikationssystemen
`fur die Strahlentherapie
`(IEC 62274:2005)
`
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`This European Standard was approved by CENELEC on 2005-06-01. CENELEC members are bound to
`comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
`Standard 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 Central Secretariat or to any CENELEC member.
`
`This European Standard 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 Central Secretariat has the same status as the official versions.
`
`CENELEC members are the national electrotechnical committees of Austria, Belgium, Cyprus, Czech
`Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
`Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden,
`Switzerland and United Kingdom.
`
`CENELEC
`
`European Committee for Electrotechnical Standardization
`Comite Europeen de Normalisation Electrotechnique
`Europaisches Komitee fOr Elektrotechnische Normung
`
`Central Secretariat: rue de Stassart 35, B - 1050 Brussels
`
`© 2005 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
`
`Ref. No. EN 62274:2005 E
`
`

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`EN 6227 4:2005
`
`- 2 -
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`Foreword
`
`The text of document 62C/381/FDIS, future edition 1 of IEC 62274, prepared by SC 62C "Equipment
`for radiotherapy, nuclear medicine and radiation dosimetry" des IEC TC 62 "Electrical equipment in
`medical practice", was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC
`as EN 6227 4 on 2005-06-01.
`
`The following dates were fixed:
`
`-
`
`latest date by which the EN has to be implemented
`at national level by publication of an identical
`national standard or by endorsement
`
`(dop)
`
`2006-03-01
`
`latest date by which the national standards conflicting
`with the EN have to be withdrawn
`
`(dow)
`
`2008-06-01
`
`In this standard, the following print types are used:
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`requirements proper: roman type;
`
`test specifications: italic type;
`
`notes and explanatory matter: small roman type;
`
`TERMS USED THROUGHOUT THIS PARTICULAR STANDARD THAT ARE DEFINED IN CLAUSE 3, OR IN OTHER
`STANDARDS: SMALL CAPITALS.
`
`-
`
`-
`
`Annex ZA has been added by CENELEC.
`
`Endorsement notice
`
`The text of the International Standard IEC 62274:2005 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 60601-1-6
`
`NOTE Harmonized as EN 60601-1-6:2004 (not modified).
`
`!EC 60601-2-11
`
`NOTE
`
`Harmonized as EN 60601-2-11:1997 (not modified).
`
`IEC 60601-2-17
`
`NOTE
`
`Harmonized as EN 60601-2-17:2004 (not modified).
`
`!EC 62083
`
`NOTE
`
`Harmonized as EN 62083:2001 (not modified}.
`
`

`

`EN 6227 4:2005
`
`t
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`- 3 -
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`CONTENTS
`
`INTRODUCTION ................................................................................................................... .4
`1
`Scope and object. ........................................................................................................... 5
`
`2
`
`3
`
`4
`
`5
`6
`
`7
`8
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`9
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`Normative references ..................................................................................................... 6
`
`Terms and definitions ..................................................................................................... 7
`
`General requirements for tests ........................................................................................ 7
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`ACCOMPANYING DOCUMENTS ............................................................................................. 7
`Requirements for safety .................................................................................................. 8
`
`TREATMENT machine set-up verification ......................................................................... 11
`
`TREATMENT recording and reporting ............................................................................... 12
`
`Accuracy ...................................................................................................................... 12
`
`10 Abnormal operation and fault conditions ........................................................................ 12
`11
`Human errors in software design ................................................................................... 12
`
`12 Change in software versions ......................................................................................... 13
`
`13 Human errors in use ..................................................................................................... 13
`
`Bibliography ......................................................................................................................... 16
`
`Annex (normative) Hardware safety .................................................................................... 14
`
`Annex ZA (normative) Normative references to international publications with their
`corresponding European publications .................................................................................... 18
`Table 1 - Clauses and subclauses in this standard that require the provision of
`information in the ACCOMPANYING DOCUMENTS and the technical description .............................. 8
`
`

`

`EN 6227 4:2005
`
`-4-
`
`INTRODUCTION
`
`A RADIOTHERAPY RECORD AND VERIFY SYSTEM (RVS) is a PEMS (PROGRAMMABLE ELECTRICAL
`MEDICAL SYSTEM) or a subsystem that is used to help prevent erroneous set-up of a medical
`ELECTRON ACCELERATOR, GAMMA BEAM THERAPY EQUIPMENT, or other RADIOTHERAPY TREATMENT
`machine and to record all TREATMENT sessions. This is accomplished through verification of
`the set-up and preventing machine operation if the set-up does not match predetermined
`settings. Inaccuracies in the data or errors in the record and verify process may represent
`SAFETY HAZARDS to PATIENTS. This standard defines requirements to be complied with by
`MANUFACTURERS in the design and construction of an RVS
`in order to provide protection
`against the occurrence of such hazards.
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`- 5 -
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`EN 6227 4:2005
`
`MEDICAL ELECTRICAL EQUIPMENT -
`SAFETY OF RADIOTHERAPY RECORD
`AND VERIFY SYSTEMS
`
`1 Scope and object
`
`1.1 Scope
`
`This International Standard applies to the design and manufacture and some installation
`aspects of a RECORD AND VERIFY SYSTEM (RVS) for use in RADIOTHERAPY in human medical
`practice that
`
`a) provides, defines, or displays treatment machine set up data; imports data either through
`input by the OPERATOR or directly from other devices,
`b) may control the ability of that equipment to operate;
`c)
`records data of all TREATMENT sessions; and
`d)
`is intended to be:
`1)
`for NORMAL USE, under the authority of appropriately licensed or QUALIFIED PERSONS, by
`OPERATORS having the required skills and training;
`2) maintained in accordance with the recommendations given in the INSTRUCTIONS FOR
`USE; and
`3) used within the environmental and electrical supply conditions specified
`technical description.
`
`the
`
`in
`
`This standard does not address dynamic beam deliveries.
`
`NOTE This may be addressed in a future version of this standard.
`
`It does, however, address certain specific aspects of the connection of the RVS to a network
`or to other radiotherapy equipment, and the communication protocol to be used.
`
`1.2 Object
`
`This standard applies to any RVS and establishes the requirements for features, associated
`documentation, and testing of the software. Requirements for SAFETY of hardware are not
`included in this standard, as these vary with the nature of the hardware (see 1.3.1 and
`Annex A concerning hardware requirements).
`
`An RVS developed by a USER exclusively for the USER'S own use is not within the scope of this
`standard, but it is highly recommended that the principles of this standard be applied in its
`creation and use. If this technology is provided to another USER under conditions in which the
`developers do not directly control its use, and is represented as being suitable for use, then
`the developers assume the role of MANUFACTURER and this standard applies.
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`EN 6227 4:2005
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`- 6 -
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`1.3 Relationship to other standards
`
`1.3.1
`
`Hardware SAFETY standards
`
`Requirements for SAFETY of hardware, such as for protection against electric shock, fire, and
`for ELECTROMAGNETIC COMPATIBILITY, are not included in this document. SAFETY requires that
`these subjects be addressed by the MANUFACTURER separately through compliance with an
`appropriate standard, depending upon the nature and environment of the hardware used for
`the RVS (see Annex A for hardware SAFETY standards).
`
`1.3.2
`
`Software SAFETY standards
`
`All clauses and subclauses of the collateral standard IEC 60601-1-4 (see 4.1) apply.
`
`In applying IEC 60601-1-4, the MANUFACTURER shall consider hazards that could occur due to
`use errors associated with the RVS.
`
`NOTE
`
`IEC 60601-1-6 describes a process for the risk management of use errors.
`
`1.3.3
`
`IEC 61217
`
`IEC 61217, Radiotherapy equipment - Co-ordinates, movements and scales, applies. The
`means of applying IEC 61217 are specified in appropriate subclauses of this standard.
`
`1.3.4 Other standards
`
`Because an RVS is likely to contain PATIENT-related information and other medical data,
`standards related to confidentiality of PATIENT information and security of electronic records
`may apply. Where there is an apparent conflict between any of these standards and a
`requirement of this standard, the MANUFACTURER shall resolve the conflict in a way that best
`meets the intent of each standard, and shall explain the implementation in the ACCOMPANYING
`DOCUMENTS.
`
`2 Normative references
`
`The following referenced documents are indispensable for the application 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.
`
`IEC 60601-1, Medical electrical equipment - Part 1: General requirements for safety
`
`I EC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for safety -
`Collateral standard: Electromagnetic compatibility - Requirements and tests
`
`IEC 60601-1-4: 1996, Medical electrical equipment - Part 1-4: General requirements for safety
`- Collateral Standard: Programmable electrical medical systems
`Amendment 1 (1999)1)
`
`IEC 60601-2-29, Medical electrical equipment - Part 2-29: Particular requirements for the
`safety of radiotherapy simulators
`
`IEC TR 60788, Medical electrical equipment - Glossary of defined terms
`
`1) A consolidated edition 1.1 exists including IEC 60601-1-4:1996 and its Amendment 1 (1999).
`
`

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`EN 6227 4:2005
`
`IEC 60950-1, Information technology equipment- Safety- Part 1: General requirements
`
`IEC 61000 (all parts), Electromagnetic compatibility (EMC)
`
`IEC 61217, Radiotherapy equipment - Co-ordinates, movements and scales
`
`3 Terms and definitions
`
`For the purpose of this document, the terms and definitions given in IEC 60601-1, IEC 60601-1-2,
`IEC 60601-1-4, IEC 60601-2-29 and IEC 60788 and the following apply.
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`3.1
`RECORD AND VERIFY SYSTEM
`RVS
`PROGRAMMABLE ELECTRICAL MEDICAL SYSTEM or subsystem including its associated peripherals,
`that is used to compare the set-up of a RADIOTHERAPY TREATMENT machine to predetermined
`set-up conditions prior to the start of a proposed RADIOTHERAPY TREATMENT and each
`TREATMENT session, and record actual TREATMENT sessions. It also provides a means of
`preventing the machine operation if the actual set-up is not the same as the pre-set intended
`set-up, within USER defined tolerances.
`
`4 General requirements for tests
`
`4.1 Testing during development
`
`Compliance with IEC 60601-1-4 requires identification of HAZARDS, assessment of their RISKS,
`and appropriate verification and validation of RISK controls. Demonstration of compliance with
`the requirements of this standard shall be included as part of the above processes, with
`explicit reference to each requirement. The MANUFACTURER shall retain compliance data as a
`permanent record. Each test shall include a protocol containing all the necessary input data,
`sufficient detail to provide for exact reproducibility, and the expected result.
`
`4.2 Testing during installation
`
`The MANUFACTURER shall provide an installation test document as part of the technical
`description that includes a demonstration that the RVS performs according to the operational
`description provided in the ACCOMPANYING DOCUMENTS as required in Clause 5.
`
`5 ACCOMPANYING DOCUMENTS
`
`The technical description and the INSTRUCTIONS FOR USE shall contain the information as
`required by this standard (see Table 1 for references).
`
`

`

`EN 6227 4:2005
`
`- 8 -
`
`Table 1 - Clauses and subclauses in this standard that require the provision of
`information in the ACCOMPANYING DOCUMENTS and the technical description
`
`Check reference
`
`Instructions for use
`
`Technical description
`
`6.5
`
`6.9
`
`6.9
`
`7.2
`
`7.3
`
`9
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`10.1
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`2
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`11
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`12
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`17
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`18
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`19
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`20
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`21
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`22
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`23
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`6.3
`
`6.4 a)
`
`6.4 b)
`
`6.6
`
`6.7
`
`6.8
`
`7.4
`
`10.2
`
`11
`
`12 a)
`
`12 b)
`
`12 d)
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`13
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`A.1.4
`
`A.3
`
`NOTE The check reference is given as an aid for checking the availability of
`compliance documentation.
`
`6 Requirements for safety
`
`6.1 RADIATION quantities
`
`All values of RADIATION quantities requested, displayed or printed shall include their units.
`Units of RADIATION should conform to the SI convention. Units (e .g. "monitor units" (MU))
`describing dose delivery shall be consistent with those used by the TREATMENT machine.
`
`Compliance is checked by inspection of the DISPLAY and output information.
`
`6.2 Date and time
`
`When the date is displayed or printed, correct interpretation shall not depend upon the
`OPERATOR'S interpretation of format, and a DISPLAY of the year shall be in four digits.
`
`

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`- 9 -
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`EN 6227 4:2005
`
`Examples (acceptable): '03 Apr 2005', '03/04/2005 (dd/mm/yyyy)', '2005/04/03 (yyyy/mm/dd)'
`Examples (not acceptable): '03/04/05', 03/04/2005, '03 Apr 05'.
`
`When the time is requested, displayed or printed, it shall be represented on a 24-hour clock
`basis, or if a 12-hour clock is used it shall be unambiguously indicated whether it is a.m or
`p.m. Measurements of time shall include units (hr, min, sec.).
`
`When time is entered, displayed or printed, each denomination of time shall be labelled. To
`prevent confusion with numbers, single-letter abbreviations of time denomination shall not be
`used (e.g. h,m,s). Acceptable examples: 2,05 min; 1 hour 33 minutes; 1 :43:15 (hr:min:sec).
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`Time-sensitive functions shall be performed correctly at transitions such as year boundaries,
`leap years, etc.
`
`Compliance is checked by testing and by inspection of the DISPLAY and output information.
`
`6.3 Coordinate systems and scales
`
`It shall be possible for the OPERATOR to perform all RVS functions with the scales and
`coordinates of RADIOTHERAPY TREATMENT EQUIPMENT displayed according to the IEC 61217
`convention. If, in addition, any convention other than IEC 61217 is employed for scales and
`coordinates, the conventions shall be identified. The units shall be the same as are used in
`the RADIOTHERAPY TREATMENT EQUIPMENT.
`
`The method and format of DISPLAY of scales shall be explained in the INSTRUCTIONS FOR USE.
`
`Compliance is checked by testing and by inspection of the DISPLAY, output information and
`ACCOMPANYING DOCUMENTS.
`
`6.4 Protection against unauthorized use
`
`Means shall be provided to prevent unauthorised changes. Where changes to the data are
`permitted by authorised persons, means shall be provided to prevent a person making
`changes he/she is not authorised to make.
`NOTE Password protection is a normal way of implementing this requirement. If password protection is used, then
`there should be means for setting a person's authority or individual authorisation for specific functions.
`Compliance is checked by testing, and by inspection of the ACCOMPANYING DOCUMENTS and
`INSTRUCTIONS FOR USE.
`
`Where network connection is permitted by the design, the following requirements apply.
`a) Access to the RVS shall be provided only to EQUIPMENT or individuals who are authorized
`(for example, by a password under the control of the USER).
`b) Access to TREATMENT prescriptions and other data containing the PATIENT identification
`information through the network shall be restricted to prevent unauthorized access.
`c) The MANUFACTURER shall recommend some means of virus protection in the INSTRUCTIONS
`FOR USE.
`Compliance is checked by testing and by inspection of the ACCOMPANYING DOCUMENTS.
`
`

`

`EN 6227 4:2005
`
`- 10 -
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`6.5 Correctness of data transfer
`
`The MANUFACTURER shall identify RVS data transfer protocols in the technical description.
`
`Data transferred from and to the TREATMENT machines or other devices, excluding hardcopy
`devices, shall include a protection against data transmission errors. Means shall be provided
`to warn the OPERATOR that expected data have not been transferred.
`
`Examples: DICOM 3 or FTP, each of which includes error detection, or a proprietary format
`that includes a checksum of each input or output data set.
`
`Compliance is checked by inspection of the protocol specifications and by inspection of the
`ACCOMPANYING DOCUMENTS.
`
`6.6 Data acceptance
`
`Means shall be provided such that the TREATMENT machine set-up data and other patient
`TREATMENT data shall be available
`for TREATMENT use only after the OPERATOR has
`acknowledged that they have been reviewed for correctness and completeness.
`
`Compliance is checked by testing and by inspection of ACCOMPANYING DOCUMENTS.
`
`Where design allows, machine set-up data and other patient TREATMENT data shall be
`reviewed or approved by entry of an authorised identification:
`
`a) any modification to the data shall result in invalidation of the authorised identification;
`b) after modification of the approved data a new authorised identification shall be required;
`c)
`the RVS shall provide a means for preserving the history and the record of the authorised
`identification; and
`d) the INSTRUCTIONS FOR USE shall describe how these features are to be properly and safely
`used.
`
`Compliance is checked by testing and by inspection of ACCOMPANYING DOCUMENTS.
`
`6.7 Deleting and editing data
`
`Means shall be provided to restrict the ability to edit TREATMENT history data to persons who
`are authorised to carry out this function. A record of the change details shall be retained. The
`fact that the TREATMENT history has been modified shall be apparent to a person using it, e.g.
`by a visual indicator.
`
`Compliance is checked by testing.
`
`6.8 Backing up data
`
`Means shall be provided for backing-up data onto a separate medium from the primary
`storage, such that it can be restored in the case of a failure of the primary data storage device.
`
`NOTE Usually a backup provides a means to restore data in the case of system failure.
`
`Compliance is checked by testing and by inspection of ACCOMPANYING DOCUMENTS.
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`EN 6227 4:2005
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`6.9 Archiving data
`
`Means shall be provided for archiving sets of data for long term storage, such that the data
`can be accessed at a later date.
`
`NOTE Archiving is the process of moving or copying sets of data from the primary storage to a separate storage
`media. Standardising the archiving process is highly desirable. By using established standards such as DICOM or
`HL7, archiving would be vendor and media independent.
`
`Compliance is checked by testing and by inspection of ACCOMPANYING DOCUMENTS.
`
`7 TREATMENT machine set-up verification
`
`7 .1 Prevention of TREATMENT
`
`The RVS shall provide a means by which the operation of the TREATMENT machine shall be
`prevented in the event that the machine set-up does not correspond to the prescribed data
`within prescribed tolerances.
`
`Compliance is checked by testing.
`
`7 .2 Override
`
`If an override capability is provided, the USER shall:
`
`-
`-
`
`acknowledge the override parameters;
`provide authorised identification.
`
`The fact that an override has been made shall be recorded.
`
`Compliance is checked by testing
`
`7 .3 Transfer of prescribed TREATMENT data
`
`If the design of the RVS allows transfer of the prescribed TREATMENT parameters to the
`TREATMENT machine, the RVS shall prompt the OPERATOR to confirm that the transferred data
`are correct prior to the first use, and after any modification.
`
`NOTE This confirmation may be through not performing the download for the first TREATMENT session after entry
`or modification, so that the OPERATOR is required to set up the machine from a separate source of information. For
`TREATMENT session where this is not possible, confirmation may be implemented by requiring that the OPERATOR
`confirm, prior to the RVS allowing the TREATMENT to proceed, that a new or modified set-up has been verified by
`other means.
`
`Compliance is checked by inspection of the protocol specifications, and by inspection of the
`ACCOMPANY/NG DOCUMENTS.
`
`7 .4 Accompanying information
`
`The ACCOMPANYING DOCUMENTS shall include a caution to the OPERATOR that the correct
`operation of the RVS depends on the connection of the RVS to the radiotherapy system,
`which may
`include
`the RADIOTHERAPY TREATMENT PLANNING SYSTEM
`(RTPS) and
`the
`RADIOTHERAPY SIMULATOR, as well as the TREATMENT machine. Any change to the radiotherapy
`system to which the RVS is connected shall require testing to confirm correct operation.
`
`Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
`
`

`

`EN 6227 4:2005
`
`- 12 -
`
`8 TREATMENT recording and reporting
`
`For each patient the RVS shall provide a means by which the OPERATOR can retrieve and
`report all recorded TREATMENT machine parameters used in the previous TREATMENT sessions.
`
`NOTE The guides and contents of the record and report may be found in ICRU publications 50 and 62 for photon
`beam therapy and 58 for BRACHYTHERAPY.
`
`Compliance is checked by testing.
`
`9 Accuracy
`
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`The MANUFACTURER shall state the accuracy of the RVS for all of the TREATMENT parameters
`recorded.
`
`Compliance is checked by testing as described in the ACCOMPANYING DOCUMENTS.
`
`10 Abnormal operation and fault conditions
`
`10.1 General hardware diagnostics
`
`Facilities shall be provided so that the correct function of the means referred to in 7 .1 and the
`communication between RVS and TREATMENT machine can be checked. The ACCOMPANYING
`DOCUMENTS shall contain an explanation of the function of these facilities.
`
`If these facilities require actions of the OPERATOR, such actions shall be described in the
`ACCOMPANYING DOCUMENTS together with a recommendation of the frequencies with which
`such checks should be made.
`
`Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
`
`10.2 Data and code
`
`Executable program code, TREATMENT machine set-up data and other patient TREATMENT data
`shall have a checksum or other equivalent protection that ensures that they will not be used if
`modified through a hardware fault, through a virus, accidentally during servicing, or by any
`other unauthorized manner. In the event that an error is detected the MANUFACTURER shall
`provide instructions to the OPERATOR for restoring correct operation, either on the DISPLAY or
`in the INSTRUCTIONS FOR USE.
`
`Compliance is checked by inspection of the DISPLAY or the ACCOMPANYING DOCUMENTS.
`
`11 Human errors in software design
`
`The requirements for software development process and RISK management that are defined in
`IEC 60601-1-4 shall apply. In applying the requirements of IEC 60601-1-4 the term PEMS
`shall include an RVS.
`
`is checked by testing and by examining system documentation
`Compliance
`requirements of /EC 60601-1-4.
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`The MANUFACTURER shall describe, in the INSTRUCTIONS FOR USE, a means by which the USER
`can report errors in the operation that are observed during use or testing.
`
`Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
`
`12 Change in software versions
`
`The following requirements apply when a new version of the software is provided to the USER
`by the MANUFACTURER.
`
`a)
`
`b)
`
`If the installation is not performed by the MANUFACTURER, the INSTRUCTIONS FOR USE shall
`provide clear instructions for the installation of a new version, and for any tests that are
`required to determine that the installation was successful.
`The INSTRUCTIONS FOR USE . shall advise the USER to maintain appropriate records of
`software updates. The MANUFACTURER shall keep records of software updates provided to
`or installed by each USER.
`If use of data from the previous version could cause incorrect results, either:
`1)
`the design shall convert the data to the new format; or
`2)
`the design shall prevent use of the data.
`If installation of a new version of the software may delete machine set-up or other patient
`TREATMENT data, the OPERATOR shall be warned and required to backup the data before
`proceeding with installation of the new version.
`If data created on the currently installed version of the software are to be used on the next
`successive version of software, the INSTRUCTION FOR USE shall provide instructions on how
`to restore data created with the current version onto the next version, unless these
`services are performed solely by the MANUFACTURER.
`e) The INSTRUCTIONS FOR USE shall provide instructions on how to restore the RVS to the
`condition it was in prior to the installation of a new version of software.
`
`c)
`
`d)
`
`Compliance is checked by testing (b and c), and by inspection of the ACCOMPANYING
`DOCUMENTS (a, b, C, d, e).
`
`13 Human errors in use
`
`The INSTRUCTIONS FOR USE shall provide comprehensive instructions to the USER of all
`information needed for safe operation, including, but not limited to, the specific information in
`other clauses and subclauses of this standard.
`
`The INSTRUCTIONS FOR USE shall provide a cautionary notice to the USER that the USER should
`ensure that individuals authorized to enter and accept machine set-up or other patient
`TREATMENT data are appropriately trained for the functions they perform.
`
`Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
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`Annex A
`(normative)
`
`Hardware safety
`
`A.1
`
`Hardware safety standards
`
`A.1.1
`
`General requirements
`
`This standard is concerned principally with operational features and other aspects of RVS
`software required for safe operation. It shall be supplemented by, or be supplemental to , an
`appropriate hardware SAFETY standard,
`to which
`the MANUFACTURER shall additionally
`demonstrate compliance . Below are general descriptions of some of the available standards,
`and some comments about their applicability. The list is not meant to be comprehensive, and
`it is the responsibility of the MANUFACTURER to identify and select appropriate standards,
`including
`their most recent revisions and amendments . The MANUFACTURER may use
`standards other than those listed where analysis shows them to be also appropriate.
`
`The MANUFACTURER shall state in the technical description all hardware SAFETY standards with
`which the RVS complies .
`
`A.1.2
`
`IEC 60950-1: SAFETY of INFORMATION TECHNOLOGY EQUIPMENT
`
`This standard applies to a range of INFORMATION TECHNOLOGY EQUIPMENT as identified in its
`Subclause 1.1.1, EQUIPMENT covered by this standard. If an RVS uses general-purpose
`computer hardware and peripherals, and is not used with direct connections to a PATIENT, then
`IEC 60950-1 is a pertinent standard.
`
`A.1.3
`
`IEC 60601-1: MEDICAL ELECTRICAL EQUIPMENT - Part 1: General requirements
`for SAFETY
`
`IEC 60601-1 is the General Standard for the Safety of medical electrical equipment. If the
`RVS hardware is used in the presence of patients , or is integrated with hardware used in the
`presence of patients , then IEC 60601-1 may be an appropriate standard to use for hardware
`safety considerations .
`
`A.1.4
`
`IEC 61000 series of standards:
`Requirements for ELECTROMAGNETIC COMPATIBILITY (EMC) testing
`
`This is a family of generic standards containing general requirements for ELECTROMAGNETIC
`COMPATIBILITY e.g. immunity, emissions, environment, testing and measurement.
`
`A.1.5
`
`IEC 60601-1-2 (collateral standard to 60601-1):
`ELECTROMAGNETIC COMPATIBILITY - Requirements and tests
`
`This standard address ELECTROMAGNETIC COMPATIBILITY test requirements and/or methods for
`INFORMATION TECHNOLOGY EQUIPMENT and for MEDICAL ELECTRICAL EQUIPMENT. Applicability will
`depend on the nature of the hardware and the environment in which it is to be used . In most
`cases, an RVS will use general-purpose commercial computer hardware for use in an
`environment appropriate to such EQUIPMENT, and the computer MANUFACTURER may have
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`EN 6227 4:2005
`
`certified the EQUIPMENT to one of these standards. If the computer is of custom construction,
`or is integrated with EQUIPMENT that has connections to a PATIENT, further analysis will likely
`be required to determine which standards apply.
`
`Compliance is checked by testing and inspection as required by the appropriate standards,
`and by inspection of the ACCOMPANYING DOCUMENTS for identification of the standards.
`
`A.2 Completeness of hardware safety
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`Demonstration of hardware safety shall include, but not necessarily be limited to, the following
`potential hazards: electric