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DS/EN 62304/A1 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES Organization: DS
Date: 2015-11-05
Description: The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes.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.This standard does not cover validation and final release of the medical device, even when the medical device consists entirely of software.
CEI EN 62304 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES Organization: CEI
Date: 2015-08-01
Description: 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.
AAMI 62304 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES Organization: AAMI
Date: 2006-01-01
Description: 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 EDICAL DEVICE.
CEI - EN 62304/A1 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES Organization: CEI
Date: 2016-04-01
Description: * Field of application Replace the entire existing text of this subclause with the following: 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.
CENELEC - EN 62304 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES - INCORPORATING CORRIGENDUM NOVEMBER 2008; INCORPORATES AMENDMENT A1: 2015 Organization: CENELEC
Date: 2006-07-01
Description: 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.
AAMI HE74 - HUMAN FACTORS DESIGN PROCESS FOR MEDICAL DEVICES Organization: AAMI
Date: 2001-01-01
Description: By providing a structured approach to user interface design, this document can help manufacturers develop safe and usable medical devices. This document includes an overview of the human factors engineering (HFE) discipline, a discussion of the benefits of HFE, a review of the HFE process and associated analysis and design techniques, and a discussion of implementation issues and relevant national and international standards and regulations (see annex B).
CEI 62-236 - MEDICAL PLANTAR PRESSURE MEASUREMENT DEVICES (PPMDS): MEASURING PERFORMANCE Organization: CEI
Date: 2015-01-01
Description: NOTE 1 The above technical assessment partly takes into account the appropriateness of the acquisition software associated with the PPMD, since the measured quantities shall be read through it (i.e. data from the PPMD shall be obtained only by means of interfaces delivered by the Manufacturer and Operating Systems declared by the Manufacturer).
DSF/IEC/FDIS 82304-1 - HEALTH SOFTWARE -- PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY Organization: DS
Description: In each referenced standard, the term “medical device” or “medical device software” is to be substituted by the term “HEALTH SOFTWARE” or “HEALTH SOFTWARE PRODUCT”, as appropriate.
DS/IEC 82304-1 - HEALTH SOFTWARE – PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY Organization: DS
Date: 2016-11-10
Description: In each referenced standard, the term “medical device” or “medical device software” is to be substituted by the term “HEALTH SOFTWARE” or “HEALTH SOFTWARE PRODUCT”, as appropriate.
ISO/IEC DIS 82304-1 - HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY Organization: ISO
Date: 2015-07-31
Description: Specifically, IEC 82304-1 does not apply to: a) medical electrical equipment or systems covered by the IEC 60601/IEC 80601 series; b) in vitro diagnostic equipment covered by the IEC 61010 series; c) implantable devices covered by the ISO 14708 series NOTE This standard also applies to HEALTH SOFTWARE PRODUCTS (e.g., medical apps, health apps) intended to be used in combination with mobile computing platforms.

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