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prEN IEC 62304:2019

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This document applies to the development and maintenance of HEALTH SOFTWARE by a MANUFACTURER. MEDICAL DEVICE SOFTWARE is a subset of HEALTH SOFTWARE. Therefore, this standard applies to: – Non-MEDICAL DEVICE HEALTH SOFTWARE, – MEDICAL DEVICE software that is embedded or an integral part of the final MEDICAL DEVICE, – Software as a Medical Device, i.e., MEDICAL DEVICE SOFTWARE where the software is itself a 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 82304-1 [6]. This document 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 document applies regardless of the persistent storage device(s) used to store the software (for example: hard disk, optical disk, permanent or flash memory). This document applies regardless of the method of delivery of the software (for example: transmission by network or email, EEPROM, Smart Drive, Cloud). The method of software delivery itself is not considered HEALTH SOFTWARE. This document does not cover validation and final release of the product, even when the product consists entirely of software. It also does not cover software lifecycle steps after release of the product, including implementation, configuration, integration (with other systems), go-live, clinical use, operations, decommissioning or disposal, other than ACTIVITIES involving maintenance of the software. NOTE 2 If a product incorporates embedded software intended to be executed on a processor, the requirements of this document 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 product 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 [1], IEC 82304-1 [6], etc.).

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