© International Electrotechnical Commission, 2004
DRAFT INTERNATIONAL STANDARD IEC/DIS 62304
ISO/TC 210 Secretariat: ANSI
Voting begins on Voting terminates on
2004-12-03 2005-05-06

Medical device software - Software life cycle processes
Logiciels de dispositifs médicaux - Procédés relatifs au cycle de durée de
vie des logiciels

CONTENTS Page
Foreword....................................................................
........................................................................ 4
Introduction
............................................................................
............................................................ 6
1 Scope
............................................................................
.............................................................. 9
1.1 Purpose
............................................................................
................................................... 9
1.2 Field of application
............................................................................
................................... 9
1.3 Relationship to other standards
............................................................................
................ 9
1.4 Compliance
............................................................................
.............................................. 9
2 Normative references
............................................................................
........................................ 9
3 Definitions
............................................................................
.......................................................10
4 General
requirements................................................................
...................................................14
4.1 Quality management
system......................................................................
..........................14
4.2 RISK MANAGEMENT
............................................................................
....................................14
4.3 Software safety
classification..............................................................
.................................14
5 Software development
PROCESS.....................................................................
...............................15
5.1 Software development planning
............................................................................
...............15
5.2 Software requirements analysis
............................................................................
...............17
5.3 Software ARCHITECTURE
............................................................................
...........................19
5.4 Software detailed design
............................................................................
.........................19
5.5 Software coding
............................................................................
......................................20
5.6 Software integration and integration testing
.........................................................................21
5.7 SOFTWARE SYSTEM testing
............................................................................
........................22
5.8 Software release
............................................................................
.....................................23
6 Software Maintenance
PROCESS.....................................................................
...............................24
6.1 Establish software maintenance plan
............................................................................
.......24
6.2 Problem and modification analysis
............................................................................
...........25
6.3 Modification implementation
............................................................................
....................26
7 Software RISK MANAGEMENT
PROCESS.....................................................................
........................26
7.1 Analysis of software contributing to hazardous situations
.....................................................26
7.2 RISK CONTROL measures
............................................................................
..........................27
7.3 VERIFICATION of RISK CONTROL measures
............................................................................
..27
7.4 RISK MANAGEMENT of software changes
............................................................................
....28
8 Software configuration management
PROCESS.....................................................................
..........28
8.1 Configuration identification
............................................................................
......................28
8.2 Change control
............................................................................
........................................29
8.3 Configuration status
accounting..................................................................
.........................29
9 Software problem resolution PROCESS
............................................................................
...............30
9.1 Prepare PROBLEM
REPORTS.....................................................................
..............................30
9.2 Advise relevant parties
............................................................................
............................30
9.3 Investigate the problem
............................................................................
...........................30
9.4 Evaluate the problem's relevance to
SAFETY......................................................................
...30
9.5 Track and report
status......................................................................
..................................30
9.6 Resolve the
problem.....................................................................
.......................................30
9.7 Maintain
records.....................................................................
.............................................31
9.8 Analyse problems for trends
............................................................................
....................31
9.9 VERIFY software problem resolution
............................................................................
.........31

62304 © IEC 2004 - 3 - 62A/xxx/CDV
9.10 Test documentation contents
............................................................................
...................31
Annex A (informative) Rationale for the requirements of this standard
.................................................32
Annex B (informative) Guidance on the provisions of this standard
......................................................35
Annex C (informative) Relationship to other standards
........................................................................48
Annex D (informative)
Implementation..............................................................
...................................62
Bibliography
............................................................................
..........................................................64
Index of defined terms
............................................................................
............................................65
FIGURES
Figure 1 - Overview of software development PROCESSES and
ACTIVITIES.............................................. 7
Figure 2 - Overview of software maintenance PROCESSES and
ACTIVITIES.............................................. 7
Figure B.1 - Example of partitioning of SOFTWARE ITEMS
......................................................................39
Figure C.1 - Relationship of key MEDICAL DEVICE standard to IEC
62304..............................................48
Figure C.2 - Software as part of the V-model
............................................................................
..........51
Figure C.3 - Application of IEC 62304 with IEC 61010-1
.....................................................................59
TABLES
Table A.1 - Summary of requirements by software safety
class...........................................................34
Table C.1 - Relationship with ISO 13485
............................................................................
................49
Table C.2 - Relationship between the requirement of ISO 14971 and IEC
62304.................................50
Table C.4 - Relationship with IEC 60601-1-4
............................................................................
..........56
Table D.1 - Checklist for small companies without certified QM
system...............................................63