1.1 This part of the IEC 61508 series a) is intended to be utilized only after a thorough understanding of IEC 61508-1 and IEC 61508-2; b) applies to any software forming part of a safety-related system or used to develop a safety-related system within the scope of IEC 61508-1 and IEC 61508-2. Such software is termed safety-related software (including operating systems, system software, software in communication networks, human-computer interface functions, and firmware as well as application software); c) provides specific requirements applicable to support tools used to develop and configure a safety-related system within the scope of IEC 61508-1 and IEC 61508-2; d) requires that the software safety functions and software systematic capability are specified; NOTE 1 If this has already been done as part of the specification of the E/E/PE safety-related systems (see 7.2 of IEC 61508-2), then it does not have to be repeated in this part. NOTE 2 Specifying the software safety functions and software systematic capability is an iterative procedure; see Figures 3 and 6. NOTE 3 See Clause 5 and Annex A of IEC 61508-1 for documentation structure. The documentation structure may take account of company procedures, and of the working practices of specific application sectors. NOTE 4 Note: See 3.5.9 of IEC 61508-4 for definition of the term "systematic capability". e) establishes requirements for safety lifecycle phases and activities which shall be applied during the design and development of the safety-related software (the software safety lifecycle model). These requirements include the application of measures and techniques, which are graded against the required systematic capability, for the avoidance of and control of faults and failures in the software; f) provides requirements for information relating to the software aspects of system safety validation to be passed to the organisation carrying out the E/E/PE system integration; g) provides requirements for the preparation of information and procedures concerning software needed by the user for the operation and maintenance of the E/E/PE safety-related system; h) provides requirements to be met by the organisation carrying out modifications to safety-related software; i) provides, in conjunction with IEC 61508-1 and IEC 61508-2, requirements for support tools such as development and design tools, language translators, testing and debugging tools, configuration management tools; NOTE 4 Figure 5 shows the relationship between IEC 61508-2 and IEC 61508-3. j) Does not apply for medical equipment in compliance with the IEC 60601 series.