Medical electrical equipment - Safety of radiotherapy record and verify systems

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 in the technical description. 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.

Medizinische elektrische Geräte - Sicherheit von Aufzeichnungs- und Verifikationssystemen für die Strahlentherapie

Appareils électromédicaux - Sécurité des systèmes d'enregistrement et de vérification de radiothérapie

S'applique à la conception et à la fabrication ainsi qu'à certains aspects d'installation d'un système d'enregistrement et de vérification (SEV) utilisé en radiothérapie dans la pratique médicale chez l'homme a) qui fournit, définit, ou affiche des données concernant la configuration des paramètres de la machine de traitement; qui importe des données, soit par entrées de la part de l'opérateur, soit directement à partir d'autres dispositifs, b) qui peut contrôler la capacité de fonctionnement de cet équipement; c) qui enregistre des données de toutes les séances de traitement; et d) qui est prévu: 1) pour une utilisation normale, sous l'autorité de personnes qualifiées ou munies de la licence appropriée, par des opérateurs possédant les compétences et la formation nécessaires; 2) pour être entretenu conformément aux recommandations données dans les instructions d'utilisation; et 3) pour être utilisé dans les conditions d'environnement et d'alimentation électrique spécifiées dans la description technique.

Medicinska električna oprema – Varnost radioterapevtskih zapisovalno-preverjalnih sistemov (IEC 62274:2005)

General Information

Status
Published
Publication Date
31-Dec-2005
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
01-Jan-2006
Due Date
01-Jan-2006
Completion Date
01-Jan-2006

Buy Standard

Standard
SIST EN 62274:2006
English language
21 pages
sale 10% off
Preview
sale 10% off
Preview

e-Library read for
1 day

Standards Content (sample)

SLOVENSKI SIST EN 62274:2006
STANDARD
januar 2006
Medicinska električna oprema – Varnost radioterapevtskih zapisovalno-
preverjalnih sistemov (IEC 62274:2005)
(istoveten EN 62274:2005)

Medical electrical equipment - Safety of radiotherapy record and verify systems IEC

62274:2005)
ICS 11.040.50; 11.040.60 Referenčna številka
SIST EN 62274:2006(en)

© Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno

---------------------- Page: 1 ----------------------
EUROPEAN STANDARD EN 62274
NORME EUROPÉENNE
EUROPÄISCHE NORM June 2005
ICS 11.040.60
English version
Medical electrical equipment –
Safety of radiotherapy record and verify systems
(IEC 62274:2005)
Appareils électromédicaux – Medizinische elektrische Geräte –
Sécurité des systèmes d'enregistrement Sicherheit von Aufzeichnungs-
et de vérification de radiothérapie und Verifikationssystemen
(CEI 62274:2005) für die Strahlentherapie
(IEC 62274:2005)

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
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für 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
---------------------- Page: 2 ----------------------
EN 62274:2005 - 2 -
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 62274 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:
- 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).
IEC 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).
IEC 62083 NOTE Harmonized as EN 62083:2001 (not modified).
__________
---------------------- Page: 3 ----------------------
- 3 - EN 62274:2005
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

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.

NOTE Where an international publication has been modified by common modifications, indicated by (mod), the relevant

EN/HD applies.
Publication Year Title EN/HD Year
IEC 60601-1 1988 Medical electrical equipment EN 60601-1 1990
Part 1: General requirements for safety + corr. July 1994
A1 1993
+ corr. July 1994
A2 1995
A13 1996
IEC 60601-1-2 2001 Medical electrical equipment EN 60601-1-2 2001
Part 1-2: General requirements for safety -
Collateral standard: Electromagnetic
compatibility - Requirements and tests
IEC 60601-1-4 1996 Medical electrical equipment EN 60601-1-4 1996
Part 1-4: General requirements for safety -
Collateral standard: Programmable
electrical medical systems
A1 1999 A1 1999

IEC 60601-2-29 1999 Part 2-29: Particular requirements for the EN 60601-2-29 1999

safety of radiotherapy simulators
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
IEC 60950-1 2001 Information technology equipment - Safety EN 60950-1 2001
(mod) Part 1: General requirements + corr. April 2004
+ A11 2004
IEC 61000-2-4 2002 Electromagnetic compatibility (EMC) EN 61000-2-4 2002
Part 2-4: Environment - Compatibility
levels in industrial plants for low-frequency
conducted disturbances
IEC 61217 1996 Radiotherapy equipment - Coordinates, EN 61217 1996
movements and scales
---------------------- Page: 4 ----------------------
NORME CEI
INTERNATIONALE
IEC
62274
INTERNATIONAL
Première édition
STANDARD
First edition
2005-05
Appareils électromédicaux –
Sécurité des systèmes d'enregistrement
et de vérification de radiothérapie
Medical electrical equipment –
Safety of radiotherapy record
and verify systems
 IEC 2005 Droits de reproduction réservés  Copyright - all rights reserved

Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in any

utilisée sous quelque forme que ce soit et par aucun procédé, form or by any means, electronic or mechanical, including

électronique ou mécanique, y compris la photocopie et les photocopying and microfilm, without permission in writing from

microfilms, sans l'accord écrit de l'éditeur. the publisher.

International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland

Telephone: +41 22 919 02 11 Telefax: +41 22 919 03 00 E-mail: inmail@iec.ch Web: www.iec.ch

CODE PRIX
PRICE CODE
Commission Electrotechnique Internationale
International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
Pour prix, voir catalogue en vigueur
For price, see current catalogue
---------------------- Page: 5 ----------------------
62274  IEC:2005 – 3 –
CONTENTS

FOREWORD...........................................................................................................................5

INTRODUCTION.....................................................................................................................9

1 Scope and object............................................................................................................11

1.1 Scope....................................................................................................................11

1.2 Object ...................................................................................................................11

1.3 Relationship to other standards .............................................................................13

2 Normative references .....................................................................................................13

3 Terms and definitions .....................................................................................................15

4 General requirements for tests .......................................................................................15

4.1 Testing during development ..................................................................................15

4.2 Testing during installation......................................................................................15

5 ACCOMPANYING DOCUMENTS .............................................................................................15

6 Requirements for safety .................................................................................................17

6.1 RADIATION quantities ..............................................................................................17

6.2 Date and time........................................................................................................17

6.3 Coordinate systems and scales .............................................................................19

6.4 Protection against unauthorized use......................................................................19

6.5 Correctness of data transfer ..................................................................................21

6.6 Data acceptance ...................................................................................................21

6.7 Deleting and editing data.......................................................................................21

6.8 Backing up data ....................................................................................................21

6.9 Archiving data .......................................................................................................23

7 TREATMENT machine set-up verification...........................................................................23

7.1 Prevention of TREATMENT .......................................................................................23

7.2 Override ................................................................................................................23

7.3 Transfer of prescribed TREATMENT data..................................................................23

7.4 Accompanying information ....................................................................................23

8 TREATMENT recording and reporting ................................................................................25

9 Accuracy ........................................................................................................................25

10 Abnormal operation and fault conditions .........................................................................25

10.1 General hardware diagnostics ...............................................................................25

10.2 Data and code.......................................................................................................25

11 Human errors in software design ....................................................................................25

12 Change in software versions...........................................................................................27

13 Human errors in use .......................................................................................................27

Annex A (normative) Hardware safety..................................................................................29

Bibliography..........................................................................................................................33

Index of defined terms ..........................................................................................................35

Table 1 – Clauses and subclauses in this standard that require the provision of

information in the ACCOMPANYING DOCUMENTS and the technical description...........................17

---------------------- Page: 6 ----------------------
62274  IEC:2005 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
SAFETY OF RADIOTHERAPY RECORD
AND VERIFY SYSTEMS
FOREWORD

1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising

all national electrotechnical committees (IEC National Committees). The object of IEC is to promote

international co-operation on all questions concerning standardization in the electrical and electronic fields. To

this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,

Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC

Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested

in the subject dealt with may participate in this preparatory work. International, governmental and non-

governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely

with the International Organization for Standardization (ISO) in accordance with conditions determined by

agreement between the two organizations.

2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international

consensus of opinion on the relevant subjects since each technical committee has representation from all

interested IEC National Committees.

3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC

Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

misinterpretation by any end user.

4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications

transparently to the maximum extent possible in their national and regional publications. Any divergence

between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in

the latter.

5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any

equipment declared to be in conformity with an IEC Publication.

6) All users should ensure that they have the latest edition of this publication.

7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

members of its technical committees and IEC National Committees for any personal injury, property damage or

other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

Publications.

8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is

indispensable for the correct application of this publication.

9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of

patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

International Standard IEC 62274 has been prepared by subcommittee 62C: Equipment for

radiotherapy, nuclear medicine and radiation dosimetry of IEC Technical Committee 62:

Electrical equipment in medical practice.
The text of this standard is based on the following documents:
FDIS Report on voting
62C/381/FDIS 62C/385/RVD

Full information on the voting for the approval of this standard can be found in the report on

voting indicated in the above table.

This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

---------------------- Page: 7 ----------------------
62274  IEC:2005 – 7 –
In this standard, the following print types are used:
– 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.

The committee has decided that the contents of this publication will remain unchanged until

the maintenance result date indicated on the IEC web site 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.
---------------------- Page: 8 ----------------------
62274  IEC:2005 – 9 –
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.
---------------------- Page: 9 ----------------------
62274  IEC:2005 – 11 –
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 in the

technical description.
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.
---------------------- Page: 10 ----------------------
62274  IEC:2005 – 13 –
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

IEC 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)

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
___________

A consolidated edition 1.1 exists including IEC 60601-1-4:1996 and its Amendment 1 (1999).

---------------------- Page: 11 ----------------------
62274  IEC:2005 – 15 –

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.
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).
---------------------- Page: 12 ----------------------
62274  IEC:2005 – 17 –
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
1 6.3
2 6.4 a)
3 6.4 b)
4 6.5
5 6.6
6 6.7
7 6.8 6.9
8 6.9
9 7.2
10 7.3
11 7.4
12 9
14 10.1
15 10.2
16 11
17 12 a)
18 12 b)
20 12 d)
21 13
22 A.1.4
23 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.

---------------------- Page: 13 ----------------------
62274  IEC:2005 – 19 –

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).

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.

---------------------- Page: 14 ----------------------
62274  IEC:2005 – 21 –
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
...

Questions, Comments and Discussion

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