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SAE JA1003 - SOFTWARE RELIABILITY PROGRAM IMPLEMENTATION GUIDE Organization: SAE
Date: 2004-01-01
Description: Thus, it is important to use methods and techniques that provide evidence that the software component has been designed, implemented, tested, installed, and, as necessary, updated without faults that might result in undesirable system failures.
AAMI TIR45 - GUIDANCE ON THE USE OF AGILE PRACTICES IN THE DEVELOPMENT OF MEDICAL DEVICE SOFTWARE Organization: AAMI
Date: 2012-01-01
Description: The following groups are the intended audience for this TIR: • Medical device manufacturers who are planning to use AGILE techniques • Manufacturers who are currently practicing AGILE and are entering the regulated medical device space • Software development teams, including software test and quality groups • Software definers, including marketing, sales, and other representatives of the customer • Senior management, project managers, quality managers • Quality systems and regulatory affairs personnel • Internal and external auditors • Regulating bodies, agencies, and organizations responsible for overseeing the safety and effectiveness of medical devices Exclusions This TIR is not intended to be used as an educational tool or tutorial for the following: • AGILE development practice • Quality system regulations This TIR should be regarded as a reference and as a guidance intended to provide recommendations for complying with international standards and FDA guidance documents when using AGILE practices in the development of medical device software.
AAMI TIR36 - VALIDATION OF SOFTWARE FOR REGULATED PROCESSES Organization: AAMI
Date: 2007-01-01
Description: It does not apply to • software used as a component, part, or accessory of a medical device, or • software that is itself a medical device.
DS/CEN/TS 15127-1 - HEALTH INFORMATICS - TESTING OF PHYSIOLOGICAL MEASUREMENT SOFTWARE - PART 1: GENERAL Organization: DS
Date: 2005-09-08
Description: The means to specify test data sets, documenting the creation of the test data, and the use of the test data for the testing, possibly for certification purposes, of medical software which is designed to process data in the form of one or more arrays of acquired patient and associated data.
NBN - CEN/TS 15127-1 - HEALTH INFORMATICS - TESTING OF PHYSIOLOGICAL MEASUREMENT SOFTWARE - PART 1: GENERAL Organization: NBN
Date: 2005-07-01
Description: 1.1 In scopeThe means to specify test data sets, documenting the creation of the test data, and the use of the test data for the testing, possibly for certification purposes, of medical software which is designed to process data in the form of one or more arrays of acquired patient and associated data.
VDI 5703 - SYSTEMATICAL DEVELOPMENT FOR A MODEL-BASED TESTING OF MEDICAL DEVICES Organization: VDI
Date: 2015-09-01
Description: The scope of this VDI Standard is meant for the development of model-based tests (e.g. on the basis of physical, chemical, biological, or numeric models), which are applied in order to ensure warranty of safety and function, product design and development, certification, reimbursement by public health insurances or product monitoring of medical products, • for materials, components, or complete products, • by manufacturers and users of medical devices, research institutions, test institutes and other authorities.
ANS 10.7 - NON-REAL-TIME, HIGH-INTEGRITY SOFTWARE FOR THE NUCLEAR INDUSTRY-DEVELOPER REQUIREMENTS Organization: ANS
Date: 2013-01-01
Description: For complex software, hand calculations and code-to-code comparisons may not be adequate to verify and validate the software. This may include software used for nuclear design and analysis; analysis of postulated accidents and assignment of safety classification levels to systems, structures, and components at nuclear facilities; computational fluid dynamics (CFD); thermal hydraulics; structural mechanics; complex Monte Carlo simulations; radiation dosimetry; and nuclear medical applications.
CENELEC - EN 61508-3 - FUNCTIONAL SAFETY OF ELECTRICAL/ELECTRONIC/PROGRAMMABLE ELECTRONIC SAFETY-RELATED SYSTEMS - PART 3: SOFTWARE REQUIREMENTS Organization: CENELEC
Date: 2010-05-01
Description: This part of the IEC 61508 series a) is intended to be utilized only after a thorough understanding of IEC 61508-1 and IEC 61508-2; b) applies to any software forming part of a safety-related system or used to develop a safety-related system within the scope of IEC 61508-1 and IEC 61508-2. Such software is termed safety-related software (including operating systems, system software, software in communication networks, human-computer interface functions, and firmware as well as application software); c) provides specific requirements applicable to support tools used to develop and configure a safety-related system within the scope of IEC 61508-1 and IEC 61508-2; d) requires that the software safety functions and software systematic capability are specified; NOTE 1 If this has already been done as part of the specification of the E/E/PE safety-related systems (see 7.2 of IEC 61508-2), then it does not have to be repeated in this part.
IEC 61508-3 - FUNCTIONAL SAFETY OF ELECTRICAL/ELECTRONIC/PROGRAMMABLE ELECTRONIC SAFETY-RELATED SYSTEMS – PART 3: SOFTWARE REQUIREMENTS - EDITION 2.0 Organization: IEC
Date: 2010-04-01
Description: This part of the IEC 61508 series a) is intended to be utilized only after a thorough understanding of IEC 61508-1 and IEC 61508-2; b) applies to any software forming part of a safety-related system or used to develop a safety-related system within the scope of IEC 61508-1 and IEC 61508-2. Such software is termed safety-related software (including operating systems, system software, software in communication networks, human-computer interface functions, and firmware as well as application software); c) provides specific requirements applicable to support tools used to develop and configure a safety-related system within the scope of IEC 61508-1 and IEC 61508-2; d) requires that the software safety functions and software systematic capability are specified; NOTE 1 If this has already been done as part of the specification of the E/E/PE safety-related systems (see 7.2 of IEC 61508-2), then it does not have to be repeated in this part.
AAMI HE74 - HUMAN FACTORS DESIGN PROCESS FOR MEDICAL DEVICES Organization: AAMI
Date: 2001-01-01
Description: This document addresses the needs of a diverse group of professionals who handle the planning, funding, management, and performance of research, design, and testing activities related to the safety and usability of medical devices, including: a) Company, department, project, and product managers; b) Design and engineering professionals (e.g., human factors engineers, industrial designers, technical writers, information designers, software developers, mechanical engineers, electrical engineers, packaging engineers); c) Medical researchers and other interested clinicians; and d) Marketers and other business professionals in the medical device industry.
IEC TR 62366-2 - MEDICAL DEVICES – PART 2: GUIDANCE ON THE APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES - EDITION 1.0 Organization: IEC
Date: 2016-04-01
Description: This technical report also can be useful for other healthcare products (e.g. drug packaging and drug LABELLING, drug-MEDICAL DEVICE combination products and health IT software). Purpose The intent of this technical report is to provide guidance related to: • the essential elements of a USABILITY ENGINEERING PROCESS as required by IEC 62366-1:2015, including: – USER research techniques, – analysis techniques, – design techniques, and – MEDICAL DEVICE USABILITY EVALUATION approaches (e.g.
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).
IEC 61223-3-1 - EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-1: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHIC AND RADIOSCOPIC SYSTEMS - EDITION 1.0 Organization: IEC
Date: 1999-03-01
Description: Nor does it consider: c) aspects of mechanical and electrical safety, d) aspects of mechanical, electrical and software performance unless they are essential to the performance of the tests directly affecting image quality and PATIENT dose.
WILEY - DESIGN AND DEVELOP - DESIGN AND DEVELOPMENT OF MEDICAL ELECTRONIC INSTRUMENTATION: A PRACTICAL PERSPECTIVE OF THE DESIGN CONSTRUCTION AND TEST OF MEDICAL DEVICES Organization: WILEY
Date: 2005-01-01
Description: Walking you through the building blocks of implementing medical devices, Design and Development of Medical Electronic Instrumentation addresses the practical aspects of amplifying, processing, simulating, and evoking biopotentials.
DIN - VDI 5703 - SYSTEMATICAL DEVELOPMENT FOR A MODEL-BASED TESTING OF MEDICAL DEVICES Organization: DIN
Date: 2015-09-01
Description: Nicht betrachtet werden in dieser Richtlinie: • empirische Untersuchungen am Menschen (klinische Prüfungen) • Software • Kombinationsprodukte in Verbindung mit Pharmaka oder Zellen (ATMPs)
UL 2900-2-1 BULLETIN - UL STANDARD FOR SAFETY TECHNICAL PANEL FOR SOFTWARE CYBERSECURITY FOR NETWORK-CONNECTABLE PRODUCTS - COMMENTS DUE: JANUARY 16, 2017 Organization: UL
Date: 2016-12-16
Description: It applies to, but is not limited to, the following key components: a) Medical devices; b) Accessories to medical devices; c) Medical device data systems; d) In vitro diagnostic devices; e) Health information technology; and f) Wellness devices.
ARMY - DA PAM 73-1 - TEST AND EVALUATION IN SUPPORT OF SYSTEMS ACQUISITION Organization: ARMY
Date: 1997-02-28
Description: This category includes systems that contain Materiel System Computer Resources, which are the computer hardware, software, and firmware specifically designed, configured, and acquired as an integral element of the system and needed so that the system can fully perform its mission.
ISO DIS 11608-4 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 4: NEEDLE-BASED INJECTION SYSTEMS CONTAINING ELECTRONICS Organization: ISO
Date: 2016-02-11
Description: This part of ISO 11608 specifies reference requirements and test methods for needle-based injection systems (NIS) containing electronics (with or without software) intended to be used with needles and with replaceable or non-replaceable containers.
IEC 61223-2-6 - EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS – PART 2-6: CONSTANCY TESTS – IMAGING PERFORMANCE OF COMPUTED TOMOGRAPHY X-RAY EQUIPMENT - EDITION 2.0 Organization: IEC
Date: 2006-11-01
Description: It is not intended to consider: – aspects of mechanical and electrical safety nor – aspects of mechanical, electrical and software performance, unless they are essential for performing the CONSTANCY TESTS and directly affect image quality, PATIENT dose and positioning.
DS/EN 61223-2-6 - EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 2-6: CONSTANCY TESTS - IMAGING PERFORMANCE OF COMPUTED TOMOGRAPHY X-RAY EQUIPMENT Organization: DS
Date: 2007-06-26
Description: It is not intended to consider:- aspects of mechanical and electrical safety nor- aspects of mechanical, electrical and software performance, unless they are essential forperforming the CONSTANCY TESTS and directly affect image quality, PATIENT dose andpositioning.

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