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ISO 13485 is a voluntary standard that contains section 7.3 Design and Development recommending which procedures should be put in place by manufacturers in order to have a quality system that will comply with MDD 93/42/EEC and the MDR.
High-Level Data Link Control (HDLC) is a communication protocol used for transmitting data between devices in telecommunication and networking.Developed by the International Organization for Standardization (ISO), it is defined in the standard ISO/IEC 13239:2002.
A design history file is a compilation of documentation that describes the design history of a finished medical device.The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient.
ISO 13485:2016 is the medical industry's equivalent of ISO 9001. ISO 13485:2016 is a stand-alone standard. Because ISO 13485 is relevant to medical device manufacturers (unlike ISO 9001, which is applicable to any industry), and because of the differences between the two standards relating to continual improvement, compliance with ISO 13485 ...
The general standard IEC 60601-1 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance – gives general requirements of the series of standards. 60601 is a widely accepted benchmark for medical electrical equipment and compliance with IEC60601-1 has become a requirement for the commercialisation of electrical medical equipment in many ...
The International Organization for Standardization (ISO / ˈ aɪ s oʊ /; [3] French: Organisation internationale de normalisation; Russian: Международная организация по стандартизации) is an independent, non-governmental, international standard development organization composed of representatives from the national standards organizations of member ...
This part of the standard is aimed at operators of automation solutions and defines requirements for how security during the operation of plants is to be considered (see ISO/IEC 27001). IEC 62443-2-3 Patch management in the IACS environment Technical Report, Edition 1.0, June 2015 [5] IEC 62443-2-4 Requirements for IACS service providers
Much of the preparatory work that led into the adoption of RM-ODP as an ISO standard was carried out by the Advanced Networked Systems Architecture (ANSA) project. This ran from 1984 until 1998 under the leadership of Andrew Herbert (now MD of Microsoft Research in Cambridge), and involved a number of major computing and telecommunication companies.