loading
AAMI 14971 - Medical devices— Application of risk management to medical devices
January 1, 2019 - AAMI

This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical...

CLSI AUTO16 - Next-Generation In Vitro Diagnostic Instrument Interface
April 1, 2019 - CLSI

This standard specifies requirements for the data exchange associated with the analytical workflow between medical laboratory in vitro diagnostic (IVD) instruments and the systems managing their work. This data exchange includes test orders and test results for both patients and QC specimens...

DS/EN IEC 62087-7 - Audio, video, and related equipment – Methods of measurement for power consumption Part 7: Computer monitors
February 18, 2019 - DS

This part of IEC 62087 specifies the determination of the power consumption of computer monitors including, but is not limited to, those with CRT, LCD, PDP or OLED technologies. Computer monitors that include touch screen functionality are included in the scope of this document. This...

IEC/IEEE 82079-1 - Preparation of information for use (instructions for use) of products – Part 1: Principles and general requirements
May 1, 2019 - IEC

This part of 82079 International Standard provides principles and general requirements for information for the use of products. Information for use is: • necessary for the safe use of a product; • helpful for the efficient and effective use of a product; and • often necessary to fulfil market,...

IEEE 82079-1 - Preparation of information for use (instructions for use) of products - Part 1: Principles and general requirements
May 1, 2019 - IEEE

This part of 82079 International Standard provides principles and general requirements for information for the use of products. Information for use is: • necessary for the safe use of a product; • helpful for the efficient and effective use of a product; and • often necessary to fulfil market,...

AAMI HIT1000-3 - Safety and effectiveness of health IT software and systems - Part 3: Application of risk management
January 1, 2019 - AAMI

This part of AAMI HIT1000 (Part 3: Application of risk management) identifies the core concepts and principles needed to maintain safe and effective health IT software and systems in order to estimate and evaluate the associated risks, to control these risks, and to monitor the...

AAMI TIR97 - Principles for medical device security - Postmarket risk management for device manufacturers
January 1, 2019 - AAMI

This TIR provides guidance for addressing postmarket security risk management within the risk management framework defined by ANSI/AAMI/ISO 14971. While it is based on the ANSI/AAMI/ISO 14971 framework for medical device risk management, most concepts are applicable to any healthcare product...

NEMA UTN P1 - Electric Utility Communications Networks
January 1, 2019 - NEMA

Introduction The past two decades have witnessed a revolution in the electric industry with the emergence of distributed energy resources (DER), advances in sensors, data networks, software technologies and the emergence of the Internet of Things. These new technologies and solutions...

IEC 62087-7 - Audio, video, and related equipment - Methods of measurement for power consumption Part 7: Computer monitors
December 1, 2018 - IEC

This part of IEC 62087 specifies the determination of the power consumption of computer monitors including, but is not limited to, those with CRT, LCD, PDP or OLED technologies. Computer monitors that include touch screen functionality are included in the scope of this document. This...

IETF RFC 8497 - Marking SIP Messages to Be Logged
November 1, 2018 - IETF

SIP networks use signaling monitoring tools to diagnose user-reported problems and to perform regression testing if network or user agent (UA) software is upgraded. As networks grow and become interconnected, including connection via transit networks, it...

Advertisement