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CEI EN 62304 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES Organization: CEI
Date: 2015-08-01
Description: 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. See Annex D. NOTE 1 This assessment could be carried out by internal or external audit.
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: 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. Text deleted NOTE 1 This assessment could be carried out by internal or external audit.
AAMI 62304 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES Organization: AAMI
Date: 2006-01-01
Description: 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. See Annex D. NOTE 1 This assessment could be carried out by internal or external audit.
DSF/PRCEN ISO/TR 29322 - HEALTH INFORMATICS - GUIDANCE ON THE MANAGEMENT OF CLINICAL RISK RELATING TO THE DEPLOYMENT AND USE OF HEALTH SOFTWARE SYSTEMS (ISO/TR 29322:2008) Organization: DS
Description: This Technical Report however, makes clear that the assessment of risks to patients in the deployment and use of health software, and in decisions taken about those risks, needs to involve appropriate, experienced and knowledgeable clinicians.
DSF/IEC 80002-1 - MEDICAL DEVICE SOFTWARE - GUIDANCE ON THE APPLICATION OF ISO 14971 TO MEDICAL DEVICE SOFTWARE Organization: DS
Description: This technical report is aimed at RISK MANAGEMENT practitioners who need to perform RISK MANAGEMENT when software is included in the MEDICAL DEVICE/SYSTEM, and at software engineers who need to understand how to fulfil the requirements for RISK MANAGEMENT addressed in ISO 14971.
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 is aimed at RISK MANAGEMENT practitioners who need to perform RISK MANAGEMENT when software is included in the MEDICAL DEVICE/SYSTEM, and at software engineers who need to understand how to fulfil the requirements for RISK MANAGEMENT addressed in ISO 14971.
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 is aimed at RISK MANAGEMENT practitioners who need to perform RISK MANAGEMENT when software is included in the MEDICAL DEVICE/SYSTEM, and at software engineers who need to understand how to fulfill the requirements for RISK MANAGEMENT addressed in ISO 14971.
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 is aimed at RISK MANAGEMENT practitioners who need to perform RISK MANAGEMENT when software is included in the MEDICAL DEVICE/SYSTEM, and at software engineers who need to understand how to fulfil the requirements for RISK MANAGEMENT addressed in ISO 14971.
EUROCAE ED 153 - GUIDELINES FOR ANS SOFTWARE SAFETY ASSURANCE Organization: EUROCAE
Date: 2009-08-01
Description: Therefore, it is necessary to offer guidance on how to assure that the risk associated with deploying the software is reduced to a tolerable level.
DSF/IEC/FDIS 82304-1 - HEALTH SOFTWARE -- PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY Organization: DS
Description: Where the HEALTH SOFTWARE PRODUCT is subject to regulatory requirements, external assessment may take place.
DS/IEC 82304-1 - HEALTH SOFTWARE – PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY Organization: DS
Date: 2016-11-10
Description: Where the HEALTH SOFTWARE PRODUCT is subject to regulatory requirements, external assessment may take place.
ISO - ISO/IEC DIS 82304-1 - HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY Organization: ISO
Date: 2015-07-31
Description: Where the HEALTH SOFTWARE PRODUCT is subject to regulatory requirements, external assessment of all documentation required by this standard is possible.
ISO - ISO DIS 25119-3 - TRACTORS AND MACHINERY FOR AGRICULTURE AND FORESTRY - SAFETY-RELATED PARTS OF CONTROL SYSTEMS - PART 3: SERIES DEVELOPMENT, HARDWARE AND SOFTWARE Organization: ISO
Date: 2017-01-04
Description: Machine specific standards (type-C standards) can identify performance levels and/or categories or they should be determined by the manufacturer of the machine based on risk assessment. It is not applicable to non-E/E/PES systems (e.g. hydraulic, mechanic or pneumatic).
DSF/PREN ISO 25119-3 - TRACTORS AND MACHINERY FOR AGRICULTURE AND FORESTRY -- SAFETY-RELATED PARTS OF CONTROL SYSTEMS -- PART 3: SERIES DEVELOPMENT, HARDWARE AND SOFTWARE Organization: DS
Description: Machine specific standards (type-C standards) can identify performance levels and/or categories or they should be determined by the manufacturer of the machine based on risk assessment. It is not applicable to non-E/E/PES systems (e.g. hydraulic, mechanic or pneumatic).
DS/CEN ISO/TS 14441 - HEALTH INFORMATICS - SECURITY AND PRIVACY REQUIREMENTS OF EHR SYSTEMS FOR USE IN CONFORMITY ASSESSMENT Organization: DS
Date: 2014-01-20
Description: This Technical Specification includes a cross-mapping of 82 security and privacy requirements against the Common Criteria categories in ISO/IEC 15408 (all parts). The point-of-service (POS) clinical software is typically part of a larger system, for example, running on top of an operating system, so it must work in concert with other components to provide proper security and privacy.
DSF/FPREN 16590-3 - TRACTORS AND MACHINERY FOR AGRICULTURE AND FORESTRY - SAFETY-RELATED PARTS OF CONTROL SYSTEMS - PART 3: SERIES DEVELOPMENT, HARDWARE AND SOFTWARE (ISO 25119-3:2010 MODIFIED) Organization: DS
Description: Machine specific standards (type-C standards) can identify performance levels and/or categories or they should be determined by the manufacturer of the machine based on risk assessment. It is not applicable to non-E/E/PES systems (e.g. hydraulic, mechanic or pneumatic).
DIN EN 16590-3 - TRACTORS AND MACHINERY FOR AGRICULTURE AND FORESTRY - SAFETY-RELATED PARTS OF CONTROL SYSTEMS - PART 3: SERIES DEVELOPMENT, HARDWARE AND SOFTWARE (ISO 25119-3:2010 MODIFIED) Organization: DIN
Date: 2015-04-01
Description: Machine specific standards (type-C standards) can identify performance levels and/or categories or they should be determined by the manufacturer of the machine based on risk assessment. It is not applicable to non-E/E/PES systems (e.g. hydraulic, mechanic or pneumatic).
NBN - EN 16590-3 - TRACTORS AND MACHINERY FOR AGRICULTURE AND FORESTRY - SAFETY-RELATED PARTS OF CONTROL SYSTEMS - PART 3: SERIES DEVELOPMENT, HARDWARE AND SOFTWARE (ISO 25119-3:2010 MODIFIED) Organization: NBN
Date: 2014-05-23
Description: Machine specific standards (type-C standards) can identify performance levels and/or categories or they should be determined by the manufacturer of the machine based on risk assessment.It is not applicable to non-E/E/PES systems (e.g. hydraulic, mechanic or pneumatic).
NBN - EN 16590-3 - TRACTORS AND MACHINERY FOR AGRICULTURE AND FORESTRY - SAFETY-RELATED PARTS OF CONTROL SYSTEMS - PART 3: SERIES DEVELOPMENT, HARDWARE AND SOFTWARE (ISO 25119-3:2010 MODIFIED) Organization: NBN
Date: 2014-05-23
Description: Machine specific standards (type-C standards) can identify performance levels and/or categories or they should be determined by the manufacturer of the machine based on risk assessment.It is not applicable to non-E/E/PES systems (e.g. hydraulic, mechanic or pneumatic).
ISO - ISO/IEC DIS 27019 - INFORMATION TECHNOLOGY - SECURITY TECHNIQUES - INFORMATION SECURITY MANAGEMENT GUIDELINES BASED ON ISO/IEC 27002 FOR PROCESS CONTROL SYSTEMS SPECIFIC TO THE ENERGY UTILITY INDUSTRY Organization: ISO
Date: 2017-01-06
Description: This International Standard also includes a requirement to adapt the risk assessment and treatment processes described in ISO/IEC 27001:2013 to the energy utility industry sector specific guidance provide in this document

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