BS EN 62304-2006 医疗器械软件.软件使用周期过程

标准号：BS EN 62304-2006
中文标准名称：医疗器械软件.软件使用周期过程
英文标准名称：Medical device software - Software life-cycle processes
标准类型：C30
发布日期：2006/11/30 12:00:00
实施日期：2006/11/30 12:00:00
中国标准分类号：C30
国际标准分类号：11.040.01;35.080;35.240.80
引用标准：ISO 14971
适用范围：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 DEVICESOFTWARE life cycle PROCESSES.This standard applies to the development and maintenance of MEDICAL DEVICE SOFTWARE.This standard applies to the development and maintenance of MEDICAL DEVICE SOFTWARE whensoftware is itself a MEDICAL DEVICE or when software is an embedded or integral part of the finalMEDICAL DEVICE.This standard does not cover validation and final release of the MEDICAL DEVICE, even when theMEDICAL DEVICE consists entirely of software.This MEDICAL DEVICE SOFTWARE life cycle standard is to be used together with other appropriatestandards when developing a MEDICAL DEVICE. HAnnex C shows the relationship between this standardand other relevant standards.Compliance with this standard is defined as implementing all of the PROCESSES, ACTIVITIES, and TASKSidentified 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 therequirement.Compliance is determined by inspection of all documentation required by this standard including theRISK MANAGEMENT FILE, and assessment of the PROCESSES, ACTIVITIES and TASKS required for thesoftware safety class. See HAnnex D.