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CEI EN 62304 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES Organization: CEI
Date: 2015-08-01
Description:   Field of application This standard applies to the development and maintenance of MEDICAL DEVICE SOFTWARE. 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.
IEEE 1028 - SOFTWARE REVIEWS AND AUDITS - IEEE COMPUTER SOCIETY DOCUMENT Organization: IEEE
Date: 2008-06-16
Description: This standard provides definitions, requirements, and procedures that are applicable to the reviews of software development products throughout the software life cycle.Users of this standard shall specify where and when this standard applies and any intended deviations from this standard.
DS/IEC/TR 80002-1 - MEDICAL DEVICE SOFTWARE - PART 1: GUIDANCE ON THE APPLICATION OF ISO 14971 TO MEDICAL DEVICE SOFTWARE Organization: DS
Date: 2009-10-29
Description: This technical report provides guidance for the application of the requirements contained in ISO 14971:2007, Medical devices- Application of risk management to medical devices to MEDICAL DEVICE SOFTWARE with reference to IEC 62304:2006, Medical device software- Software life cycle processes.
DSF/IEC 80002-1 - MEDICAL DEVICE SOFTWARE - GUIDANCE ON THE APPLICATION OF ISO 14971 TO MEDICAL DEVICE SOFTWARE Organization: DS
Description: This technical report provides guidance for the application of the requirements contained in ISO 14971:2007, Medical devices- Application of risk management to medical devices to MEDICAL DEVICE SOFTWARE with reference to IEC 62304:2006, Medical device software- Software life cycle processes.
NEN - NPR-IEC/TR 80002-1 - MEDICAL DEVICE SOFTWARE - PART 1: GUIDANCE ON THE APPLICATION OF ISO 14971 TO MEDICAL DEVICE SOFTWARE Organization: NEN
Date: 2009-11-01
Description: This technical report provides guidance for the application of the requirements contained in ISO 14971:2007, Medical devices- Application of risk management to medical devices to MEDICAL DEVICE SOFTWARE with reference to IEC 62304:2006, Medical device software- Software life cycle processes.
AAMI TIR80002-1 - MEDICAL DEVICE SOFTWARE - PART 1: GUIDANCE ON THE APPLICATION OF ISO 14971 TO MEDICAL DEVICE SOFTWARE Organization: AAMI
Date: 2009-01-01
Description: This technical report provides guidance for the application of the requirements contained in ISO 14971:2007, Medical devices— Application of risk management to medical devices to MEDICAL DEVICE SOFTWARE with reference to IEC 62304:2006, Medical device softwareSoftware life cycle processes.
IEC/TR 80002-1 - MEDICAL DEVICE SOFTWARE – PART 1: GUIDANCE ON THE APPLICATION OF ISO 14971 TO MEDICAL DEVICE SOFTWARE - EDITION 1.0 Organization: IEC
Date: 2009-09-01
Description: This technical report provides guidance for the application of the requirements contained in ISO 14971:2007, Medical devices— Application of risk management to medical devices to MEDICAL DEVICE SOFTWARE with reference to IEC 62304:2006, Medical device softwareSoftware life cycle processes.
IEEE 1012 - SYSTEM, SOFTWARE, AND HARDWARE VERIFICATION AND VALIDATION - IEEE COMPUTER SOCIETY Organization: IEEE
Date: 2016-01-01
Description: A description of system life cycle processes may be found in ISO/IEC/IEEE 15288:2015(E) [B16], 1 and a description of software life cycle processes may be found in ISO/IEC 12207:2008 [B11].
DS/IEC/TR 80002-3 - MEDICAL DEVICE SOFTWARE - PART 3: PROCESS REFERENCE MODEL OF MEDICAL DEVICE SOFTWARE LIFE CYCLE PROCESSES Organization: DS
Date: 2014-06-23
Description: They have been aligned with the software development life cycle processes of ISO/IEC 12207:2008 and are presented herein in full compliance with ISO/IEC 24774:2010.
DSF/IEC/FDIS 82304-1 - HEALTH SOFTWARE -- PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY Organization: DS
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; or c) implantable devices covered by the ISO 14708 series. NOTE – This document also applies to HEALTH SOFTWARE PRODUCTS (e.g. medical apps, health apps) intended to be used in combination with mobile computing platforms. 1.3 Compliance Compliance with this document is determined by inspection of all documentation required by this document.
DS/IEC 82304-1 - HEALTH SOFTWARE – PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY Organization: DS
Date: 2016-11-10
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; or c) implantable devices covered by the ISO 14708 series. NOTE – This document also applies to HEALTH SOFTWARE PRODUCTS (e.g. medical apps, health apps) intended to be used in combination with mobile computing platforms. 1.3 Compliance Compliance with this document is determined by inspection of all documentation required by this document.
CENELEC - EN 82304-1 - HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY Organization: CENELEC
Date: 2017-09-01
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; or c) implantable devices covered by the ISO 14708 series. NOTE This document also applies to HEALTH SOFTWARE PRODUCTS (e.g. medical apps, health apps) intended to be used in combination with mobile computing platforms.
ISO - 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.
NEN - NPR-IEC/TR 80002-3 - MEDICAL DEVICE SOFTWARE - PART 3: PROCESS REFERENCE MODEL OF MEDICAL DEVICE SOFTWARE LIFE CYCLE PROCESSES (IEC 62304) Organization: NEN
Date: 2014-06-01
Description: They have been aligned with the software development life cycle processes of ISO/IEC 12207:2008 and are presented herein in full compliance with ISO/IEC 24774:2010.
IEC TR 80002-3 - MEDICAL DEVICE SOFTWARE – PART 3: PROCESS REFERENCE MODEL OF MEDICAL DEVICE SOFTWARE LIFE CYCLE PROCESSES (IEC 62304) - EDITION 1.0 Organization: IEC
Date: 2014-06-01
Description: They have been aligned with the software development life cycle processes of ISO/IEC 12207:2008 and are presented herein in full compliance with ISO/IEC 24774:2010.
ISO - ISO DIS 20730-1 - ROAD VEHICLES - VEHICLE ROADWORTHINESS INTERFACE FOR ELECTRONIC PERIODICAL TECHNICAL INSPECTION (EPTI) - PART 1: COMMUNICATION REQUIREMENTS Organization: ISO
Date: 2018-05-08
Description: The standard specifies: — Terminology; — Communication establishment between the ePTI external test equipment and the vehicle's ePTIrelevant systems; — Usage of a credentials based authentication and authorisation mechanism between the ePTI external test equipment and the vehicle; — Protection against tampering of the defined ePTI methods; — Definition of ePTI relevant use cases: — ePTI external test equipment discovers available data identifier as specified in ISO 20730-3, — ePTI external test equipment queries ePTI-relevant system’s information, including software identification, software integrity, current and/or stored values — ePTI external test equipment activates ePTI-relevant system’s actuators or routines.
MODUK - DEF STAN 05-96 - GUIDANCE ON QUALITY SYSTEM REQUIREMENTS FOR THE IMPLEMENTATION OF DEF STAN 05-95/ISSUE 2 - INTERIM ISSUE 1 (01.94); Organization: MODUK
Date: 1994-01-01
Description: Lack of reliance on the software for contract achievement or for demonstrating product performance may allow the contractor and purchaser to agree that control of such software should be exercised in accordance with the contractor's approved quality system (eg under ISO 9001, ISO 9000-3). Where the contractor is developing non-deliverable software under the contract but it is felt that the specific requirements of Def Stan 05-95/2 are inappropriate or unnecessary then the contractor should obtain the agreement of the purchasing authority prior to its exemption from the requirements of the Standard.
DS/EN 12681-2 - FOUNDING – RADIOGRAPHIC TESTING – PART 2: TECHNIQUES WITH DIGITAL DETECTORS Organization: DS
Date: 2017-11-09
Description: The classes AA and BA reflect the quality requirements of current automated and semi-automated radiographic inspection systems with DDAs (computer based flaw recognition or visual inspection) and mini or micro focus tubes (spot size ≤ 1 mm) with reduced requirements to the unsharpness.
DSF/FPREN 12681-2 - FOUNDING – RADIOGRAPHIC TESTING – PART 2: TECHNIQUES WITH DIGITAL DETECTORS Organization: DS
Description: The classes AA and BA reflect the quality requirements of current automated and semi-automated radiographic inspection systems with DDAs (computer based flaw recognition or visual inspection) and mini or micro focus tubes (spot size ≤ 1 mm) with reduced requirements to the unsharpness.

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