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AAMI TIR32 - MEDICAL DEVICE SOFTWARE RISK MANAGEMENT Organization: AAMI
Date: 2004-01-01
Description: The report provides guidance for those new to the concepts of software system safety in the medical device industry and as an aide-memoire for medical device and software designers more familiar with the topic.
AAMI HE74 - HUMAN FACTORS DESIGN PROCESS FOR MEDICAL DEVICES Organization: AAMI
Date: 2001-01-01
Description: Practice differences occur because of the wide variety and complexity of medical devices, which range from simple syringes to complex imaging systems, and which may be used in hospitals, clinics, or the home by various professionals and laypersons.
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. This TIR may provide useful information and recommendations to • people responsible for determining the appropriate content and size of a validation effort; • people responsible for performing the analyses and evaluations that drive the content or size determination; • people responsible for planning and executing the validation activities; • people responsible for reviewing and approving the adequacy of the validation effort; and • people responsible for auditing, inspecting, and evaluating the validation for compliance to regulation.
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). The assessment of the eventual further software applications associated with the PPMD is beyond the scope of this Standard.
DSF/IEC/FDIS 82304-1 - HEALTH SOFTWARE -- PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY Organization: DS
Description: 1.1 Purpose This Part of 82304 applies to the SAFETY and SECURITY of HEALTH SOFTWARE PRODUCTS designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, and its primary focus is on the requirements for MANUFACTURERS. 1.2 Field of application This document covers the entire lifecycle including design, development, VALIDATION, installation, maintenance, and disposal of HEALTH SOFTWARE PRODUCTS. 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: 1.1 Purpose This Part of 82304 applies to the SAFETY and SECURITY of HEALTH SOFTWARE PRODUCTS designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, and its primary focus is on the requirements for MANUFACTURERS. 1.2 Field of application This document covers the entire lifecycle including design, development, VALIDATION, installation, maintenance, and disposal of HEALTH SOFTWARE PRODUCTS. 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.
SEPT - UL 1998 CHECKLIST - SOFTWARE ENGINEERING PROCESS TECHNOLOGY-EVIDENCE PRODUCT CHECKLIST FOR ANSI/UL 1998-2004 STANDARD FOR SOFTWARE IN PROGRAMMABLE COMPONENTS - REVISION 1 - REVISION 1 Organization: SEPT
Date: 2012-01-10
Description: A general software configuration of a microprocessor based programmable component typically includes the operating system or executive software, communication software, micro-controller, input/output hardware, and any generic software libraries, database management or user interface software.
SEPT - UL 1998 CHECKLIST* - * IN EDITABLE MICROSOFT WORD - SOFTWARE ENGINEERING PROCESS TECHNOLOGY-EVIDENCE PRODUCT CHECKLIST FOR ANSI/UL 1998-2004 STANDARD FOR SOFTWARE IN PROGRAMMABLE COMPONENTS - REVISION 1 - REVISION 1; INCLUDES ACCESS TO ADDITIONAL CONTENT Organization: SEPT
Date: 2012-01-10
Description: A general software configuration of a microprocessor based programmable component typically includes the operating system or executive software, communication software, micro-controller, input/output hardware, and any generic software libraries, database management or user interface software.
DSF/PRCEN ISO/TS 29321 - HEALTH INFORMATICS - APPLICATION OF CLINICAL RISK MANAGEMENT TO THE MANUFACTURE OF HEALTH SOFTWARE (ISO/TS 29321:2008) Organization: DS
Description: It is acknowledged that, on the boundary, there are health software products that are encompassed by medical device regulations in some countries but not in others.
CTA-CEB18 - RECOMMENDED PRACTICE FOR TRANSMITTER CONTROL AND STATUS INDICATION IN TRANSMITTING PORTABLE ELECTRONIC DEVICES (T-PEDS) - FORMERLY CEA-CEB18 Organization: CTA
Date: 2007-01-01
Description: It is understood that a majority of currently available Bluetooth devices are class 3 and operate at milliwatts to of power, while class 1 devices operating at 1 watt may increasingly find their way into commercially available products.

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