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11.040.01
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35.240.80
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جميع الحقوق محفوظة لهيئة لتقييس لدول مجلس التعاون لدول الخليج العربية.
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All rights reserved to GCC Standardization Organization (GSO). Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either GSO at the address below or GSO's member body in the country of the requester.
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Outreach Dept, Knowledge Management Section
GCC Standardization Organization (GSO)
P.O.Box: 85245 Riyadh 12511
Kingdom of Saudi Arabia
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إدارة التواصل، قسم إدارة المعرفة
هيئة التقييس لدول مجلس التعاون لدول الخليج العربية (GSO)
ص. ب: 85245 الرياض 12511
المملكة العربية السعودية
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Tel: | +966115208000 | :هاتف | ||||||
Fax: | +966115208010 | :فاكس | ||||||
E-Mail: | csc@gso.org.sa | :بريد إلكتروني | ||||||
Website: | www.gso.org.sa | :موقع ويب |
تقديم خليجي |
International Standard IEC 62304 | |
Medical device software — Software life cycle processes Logiciels de dispositifs médicaux — Processus du cycle de vie du logiciel Reference number IEC 62304:2006(en) | First edition 2006-05
© IEC 2006
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FDIS | Report on voting |
62A/523/FDIS | 62A/528/RVD |
Figure 1 — Overview of software development processes and activities |
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Figure 2 — Overview of software maintenance processes and activities |
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[1] | IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | |
[2] | IEC 60601-1-4:1996, Medical electrical equipment - Part 1: General requirements for safety - 4.Collateral standard: Programmable electrical medical systems Amendment 1 (1999) | |
[3] | IEC 61508-3, Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements | |
[4] | IEC 61010-1:2001, Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements | |
[5] | ISO 9000:2005, Quality management systems - Fundamentals and vocabulary | |
[6] | ISO 9001:2000, Quality management systems - Requirements | |
[7] | ISO 13485:2003, Medical devices - Quality management systems - Requirements for regulatory purposes | |
[8] | ISO/IEC 9126-1:2001, Software engineering — Product quality — Part 1: Quality model | |
[9] | ISO/IEC 12207:1995, Information technology – Software life cycle processes Amendment 1 (2002) Amendment 2 (2004) | |
[10] | ISO/IEC 14764:1999, Information technology – Software maintenance | |
[11] | ISO/IEC 90003:2004, Software engineering – Guidelines for the application of ISO 9001:2000 to computer software | |
[12] | ISO/IEC Guide 51:1999, Safety aspects – Guidelines for their inclusion in standards | |
[13] | IEEE 610.12:1990, IEEE standard glossary of software engineering terminology | |
[14] | IEEE 1044:1993, IEEE standard classification for software anomalies | |
[15] | IEC 60601-1-6, Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability |
ICS 11.040.01; 35.240.80 Price based on 151 pages
© IEC 2006all rights reserved
| iso.org |