BS EN 62304:2006+A1:2015

This standard BS EN 62304:2006+A1:2015 Medical device software. Software life-cycle processes is classified in these ICS categories:

• 35.080 Software
• 11.040.01 Medical equipment in general
• 35.240.80 IT applications in health care technology

1.1 * Purpose

This standard defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes.

1.2 * Field of application

This standard applies to the development and maintenance of medical device software when software is itself a medical device or when software is an embedded or integral part of the final medical device.

NOTE 1 This standard can be used in the development and maintenance of software that is itself a medical device. However, additional development activities are needed at the system level before this type of software can be placed into service. These system activities are not covered by this standard, but can be found in IEC 82304-1² [22].

This standard describes processes that are intended to be applied to software which executes on a processor or which is executed by other software (for example an interpreter) which executes on a processor.

This standard applies regardless of the persistent storage device(s) used to store the software (for example: hard disk, optical disk, permanent or flash memory).

This standard applies regardless of the method of delivery of the software (for example: transmission by network or email, optical disk, flash memory or EEPROM). The method of software delivery itself is not considered medical device software.

This standard does not cover validation and final release of the medical device, even when the medical device consists entirely of software.

NOTE 2 If a medical device incorporates embedded software intended to be executed on a processor, the requirements of this standard apply to the software, including the requirements concerning software of unknown provenance (see 8.1.2).

NOTE 3 Validation and other development activities are needed at the system level before the software and medical device can be placed into service. These system activities are not covered by this standard, but can be found in related product standards (e.g., IEC 60601-1, IEC 82304-1, etc.).

1.3 Relationship to other standards

This medical device software life cycle standard is to be used together with other appropriate standards when developing a medical device. Annex C shows the relationship between this standard and other relevant standards.

1.4 Compliance

Compliance with this standard is defined as implementing all of the processes, activities, and tasks identified in this standard in accordance with the software safety class.

NOTE The software safety classes assigned to each requirement are identified in the normative text following the requirement.

Compliance is determined by inspection of all documentation required by this standard including the risk management file, and assessment of the processes, activities and tasks required for the software safety class.

NOTE 1 This assessment could be carried out by internal or external audit.

NOTE 2 Although the specified processes, activities, and tasks are performed, flexibility exists in the methods of implementing these processes and performing these activities and tasks.

NOTE 3 Where any requirements contain “as appropriate” and were not performed, documentation for the justification is necessary for this assessment.

NOTE 4 The term “conformance” is used in ISO/IEC 12207 where the term “compliance” is used in this standard.

NOTE 5 For compliance of legacy software see 4.4.