М.: Российский институт стандартизации, 2025. — 4 с. Утвержден и введен в действие приказом Федерального агентства по техническому регулированию и метрологии от 7 апреля 2025 г. № 258-ст. Дата введения 1 июня 2025 г. Стандарт распространяется на устройства, предназначенные для вывода текстовой, графической и иной информации из электронных вычислительных машин (ЭВМ), в том числе...
М.: Российский институт стандартизации, 2025. — 4 с. Утвержден и введен в действие приказом Федерального агентства по техническому регулированию и метрологии от 7 апреля 2025 г. № 257-ст. Дата введения 1 июня 2025 г. Стандарт устанавливает термины и определения понятий, применяемых в области мониторов, предназначенных для отображения графической информации, выводимой из...
М.: Российский институт стандартизации, 2025. — 8 с. Утвержден и введен в действие приказом Федерального агентства по техническому регулированию и метрологии от 3 апреля 2025 г. № 252-ст. Дата введения 1 июня 2025 г. Стандарт распространяется на устройства, предназначенные для ввода-вывода информации (числовой, текстовой, графической, звуковой, видео) для электронных...
М.: Российский институт стандартизации, 2025. — 7 с. Утвержден и введен в действие приказом Федерального агентства по техническому регулированию и метрологии от 1 апреля 2025 г. № 239-ст. Дата введения 1 июня 2025 г. Стандарт устанавливает термины и определения (буквенные обозначения) понятий, применяемых в области печатающих устройств, предназначенных для ввода и вывода...
М.: Российский институт стандартизации, 2025. — 7 с. Утвержден и введен в действие приказом Федерального агентства по техническому регулированию и метрологии от 7 апреля 2025 г. № 256-ст. Дата введения 1 июня 2025 г. Стандарт распространяется на устройства , предназначенные для печати графической информации, выводимой из электронных вычислительных машин (ЭВМ), в том числе...
М.: Российский институт стандартизации, 2025. — 4 с. Утвержден и введен в действие приказом Федерального агентства по техническому регулированию и метрологии от 7 апреля 2025 г. № 255-ст. Дата введения 1 июня 2025 г. Стандарт устанавливает термины и определения понятий, применяемых в области печатающих устройств, предназначенных для печати графической информации, выводимой из...
М.: Российский институт стандартизации, 2025. — 6 с. Утвержден и введен в действие приказом Федерального агентства по техническому регулированию и метрологии от 8 апреля 2025 г. № 259-ст. Дата введения 1 июня 2025 г. Стандарт устанавливает основные параметры иерархической классификации и систему условных обозначений, применяемых в области вычислительной техники. Стандарт...
ISO, 2007. — 24 p. This part of ISO 22442 specifies requirements for controls on the sourcing, collection and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin, other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in...
Standards Australia, 2001. — 123 p. The Guidelines provide a generic framework for managing risk in the health sector. They provide a reference point for boards of management, senior executives with clinical and corporate governance responsibilities, together with risk management and clinical staff. These guidelines are based on AS/NZS 4360:1999 Risk management.
Standards Australia, 2008. — 17 p. The purpose of this document is to define a Service and assist in the development of a standard approach towards identifying and specifying Services that support messaging in healthcare.
Standards Australia International, 2001. — 71 p. This International Standard specifies requirements for a quality management system where an organization (a) needs to demonstrate its ability to consistently provide product that meet customer and applicable regulatory requirements, and (b) aims to enhance customer satisfaction through the effective application of the system,...
Standards Australia/Standards New Zealand, 2004. — 60 p. This Standard specifies procedures required to develop equipment management programs for medical devices. These include procedures for procurement, acceptance, fault management, routine testing and disposal of medical devices.
Pharmacy Guild of Australia, 2011. — 19 p. This Standard provides guidance for the design and implementation of a pharmacy quality management system. A structured management system will support the provision of consistent and high quality pharmacy health services that in turn will contribute to positive health outcomes for all Australians.
ASTM, 2009. — 11 p. This document provides guidance on the implementation of risk assessment and risk control for Process Analytical Technology (PAT) processes within the pharmaceutical industry. Wherever possible, other appropriate standards on risk assessment/management have been referenced and acknowledged. Where practical, further details of methods and additional...
ASTM, 2010. — 6 p. The purpose of this guide is to establish a framework and context for process understanding for pharmaceutical manufacturing using quality by design (QbD) (Juran, 1992;2 FDA/ICH Q8). The framework is applicable to both active pharmaceutical ingredient (API) and to drug product (DP) manufacturing. High (detailed) level process understanding can be used to...
BSI, 2008. — 54 p. This Publicly Available Specification contains principles and requirements for bodies providing the audit and certification of ship recycling management systems according to management system specifications and standards such as ISO 30000.
BSI, 2008. — 26 p. This Publicly Available Specification specifies requirements for a management system to enable a ship recycling facility to develop and implement procedures, policies and objectives in order to be able to undertake safe and environmentally sound ship recycling operations in accordance with national and international standards. The management system...
BSI, 2003. — 28 p. This Publicly Available Specification identifies the information that may be exchanged in both the production and operation of the assets needed in the transportation process as well as the information needed in the commercial transportation process and the regulatory information relating to each. Asset procurement and operation, as well as commercial...
BSI, 2009. — 20 p. This Technical Specification characterizes the application of ISO 15189 as a system for reducing laboratory error and improving patient safety by applying the principles of risk management, with reference to examination aspects, especially to pre- and post-examination aspects, of the cycle of laboratory medical care. This Technical Specification proposes a...
BSI, 2008. — 50 p. This International Standard specifies the functional requirements for bridge configuration, bridge arrangement, bridge workstations and bridge environment. Guidelines have been drawn up for the methods and solutions to meet the functional requirements.
BSI, 2011. — 94 p. This International Standard provides dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration. As such, this International Standard functions as a recommended practice.
BSI, 2007. — 72 p. This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials.
BSI, 2010. — 30 p. This International Standard provides rules and guidelines for a medical device nomenclature data structure, in order to facilitate cooperation and exchange of data used by regulatory bodies on an international level between interested parties, e.g. regulatory authorities, manufacturers, suppliers, health care providers and end users.
BSI, 2012. — 62 p. This International Standard specifies requirements for quality and competence in medical laboratories. This International Standard can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory...
BSI, 2009. — 96 p. This International Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
BSI, 2004. — 34 p. This International Standard specifies technical requirements for the enhanced functionality of ship's bridge layout and design, with the key navigational functions centralized and integrated, for the purpose of securing safe and efficient operation of the ship, berth–to–berth, regardless of the watchkeeping arrangement in place at a particular time. The...
BSI, 2008. — 36 p. This part of IEC 60092 specifies requirements for all electric propulsion plant and gives the specifications, system design, installation and testing of at least • generators and their prime movers; • switchboards; • transformers/reactors; • semiconductor convertors; • propulsion motors; • excitation systems; • control, monitoring and safety systems; • wires,...
BSI, 2007. — 94 p. This International Standard provides guidelines beyond the requirements given in ISO 9001 in order to consider both the effectiveness and efficiency of a quality management system, and consequently the potential for improvement of the performance of an organization. When compared to ISO 9001, the objectives of customer satisfaction and product quality are...
VDI, 2011. — 18 p. The purpose of the guideline is to provide defintions of terms, establish unified terms and definitions for types of failure on products made from metallic and polymeric materials, allow a systematic procedure of failure analysis; ensure the comparability of the results obtained by different analytical laboratories; emphasise the need for documentation.
VDI, 2004. — 12 p. The purpose of the guideline is to provide defintions of terms; specify designations of, and describe the types of failure; allow a systematic procedure of failure analysis; ensure the comparability of the results obtained by different analytical laboratories; emphasise the need for documentation.
М.: Роспотребнадзор, 2022. — 39 с. Введены взамен MP2.6.1.0066-12 "Применение референтных диагностических уровней для оптимизации радиационной защиты пациента в рентгенологических исследованиях общего назначения; пунктов 6.1 - 6.14 главы 6 MP2.6.1.0097-15 "Оптимизация радиационной защиты пациентов в интервенционной радиологии Настоящие методические рекомендации (далее - МР)...