ISO TR 15499 Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process - Second Edition
Список продуктов
Данный раздел/документ содержится в продуктах:
Данный раздел/документ содержится в продуктах:
- Техэксперт: Машиностроительный комплекс
- Картотека зарубежных и международных стандартов
- CEN CEN/TR 13931 Rotodynamic pumps - Forces and moments on flanges - Centrifugal, mixed flow and axial flow horizontal and vertical shafts pumps - Incorporating Corrigendum June 2010
- CEN EN ISO 9908 Technical specifications for centrifugal pumps - Class III - Incorporates Amendment A1: 2011
- ISO 1940-1 CORR 1 Mechanical vibration — Balance quality requirements for rotors in a constant (rigid) state — Part 1: Specification and verification of balance tolerances TECHNICAL CORRIGENDUM 1 - Second Edition
- CEN EN ISO 9908 Technical specifications for centrifugal pumps - Class III - Incorporates Amendment A1: 2011
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- CEN CEN/TR 13931 Rotodynamic pumps - Forces and moments on flanges - Centrifugal, mixed flow and axial flow horizontal and vertical shafts pumps - Incorporating Corrigendum June 2010
- CEN EN ISO 9908 Technical specifications for centrifugal pumps - Class III - Incorporates Amendment A1: 2011
- ISO 1940-1 CORR 1 Mechanical vibration — Balance quality requirements for rotors in a constant (rigid) state — Part 1: Specification and verification of balance tolerances TECHNICAL CORRIGENDUM 1 - Second Edition
- CEN EN ISO 9908 Technical specifications for centrifugal pumps - Class III - Incorporates Amendment A1: 2011
- 23.080
- CEN CEN/TR 13931 Rotodynamic pumps - Forces and moments on flanges - Centrifugal, mixed flow and axial flow horizontal and vertical shafts pumps - Incorporating Corrigendum June 2010
- CEN EN ISO 9908 Technical specifications for centrifugal pumps - Class III - Incorporates Amendment A1: 2011
- ISO 1940-1 CORR 1 Mechanical vibration — Balance quality requirements for rotors in a constant (rigid) state — Part 1: Specification and verification of balance tolerances TECHNICAL CORRIGENDUM 1 - Second Edition
- CEN EN ISO 9908 Technical specifications for centrifugal pumps - Class III - Incorporates Amendment A1: 2011
- CEN CEN/TR 13931 Rotodynamic pumps - Forces and moments on flanges - Centrifugal, mixed flow and axial flow horizontal and vertical shafts pumps - Incorporating Corrigendum June 2010
- CEN CEN/TR 13931 Rotodynamic pumps - Forces and moments on flanges - Centrifugal, mixed flow and axial flow horizontal and vertical shafts pumps - Incorporating Corrigendum June 2010
- ISO GUIDE 31 Reference Materials - Contents of Certificates and Labels - Second Edition
- CEN EN 16480 Pumps - Minimum required efficiency of rotodynamic water pumps
- CEN EN ISO 5198 Centrifugal, Mixed Flow and Axial Pumps - Code for Hydraulic Performance Tests - Precision Class
- BSI BS EN 13275 Cryogenic Vessels - Pumps for Cryogenic Service
- CEN EN ISO 9908 Technical specifications for centrifugal pumps - Class III - Incorporates Amendment A1: 2011
- ISO 1940-1 CORR 1 Mechanical vibration — Balance quality requirements for rotors in a constant (rigid) state — Part 1: Specification and verification of balance tolerances TECHNICAL CORRIGENDUM 1 - Second Edition
- CEN EN ISO 9908 Technical specifications for centrifugal pumps - Class III - Incorporates Amendment A1: 2011
- BSI BS EN 13275 Cryogenic Vessels - Pumps for Cryogenic Service
- CEN EN ISO 5198 Centrifugal, Mixed Flow and Axial Pumps - Code for Hydraulic Performance Tests - Precision Class
- CEN EN 16480 Pumps - Minimum required efficiency of rotodynamic water pumps
- CEN EN 16480 Pumps - Minimum required efficiency of rotodynamic water pumps
- CEN EN ISO 5198 Centrifugal, Mixed Flow and Axial Pumps - Code for Hydraulic Performance Tests - Precision Class
- BSI BS EN 13275 Cryogenic Vessels - Pumps for Cryogenic Service
- CEN EN ISO 9908 Technical specifications for centrifugal pumps - Class III - Incorporates Amendment A1: 2011
- ISO 1940-1 CORR 1 Mechanical vibration — Balance quality requirements for rotors in a constant (rigid) state — Part 1: Specification and verification of balance tolerances TECHNICAL CORRIGENDUM 1 - Second Edition
- CEN EN ISO 9908 Technical specifications for centrifugal pumps - Class III - Incorporates Amendment A1: 2011
- BSI BS EN 13275 Cryogenic Vessels - Pumps for Cryogenic Service
- CEN EN ISO 5198 Centrifugal, Mixed Flow and Axial Pumps - Code for Hydraulic Performance Tests - Precision Class
- CEN EN ISO 5198 Centrifugal, Mixed Flow and Axial Pumps - Code for Hydraulic Performance Tests - Precision Class
- BSI BS EN 13275 Cryogenic Vessels - Pumps for Cryogenic Service
- CEN EN ISO 9908 Technical specifications for centrifugal pumps - Class III - Incorporates Amendment A1: 2011
- ISO 1940-1 CORR 1 Mechanical vibration — Balance quality requirements for rotors in a constant (rigid) state — Part 1: Specification and verification of balance tolerances TECHNICAL CORRIGENDUM 1 - Second Edition
- CEN EN ISO 9908 Technical specifications for centrifugal pumps - Class III - Incorporates Amendment A1: 2011
- BSI BS EN 13275 Cryogenic Vessels - Pumps for Cryogenic Service
- BSI BS EN 13275 Cryogenic Vessels - Pumps for Cryogenic Service
- CEN EN ISO 9908 Technical specifications for centrifugal pumps - Class III - Incorporates Amendment A1: 2011
- ISO 1940-1 CORR 1 Mechanical vibration — Balance quality requirements for rotors in a constant (rigid) state — Part 1: Specification and verification of balance tolerances TECHNICAL CORRIGENDUM 1 - Second Edition
- CEN EN ISO 9908 Technical specifications for centrifugal pumps - Class III - Incorporates Amendment A1: 2011
- CEN EN ISO 9908 Technical specifications for centrifugal pumps - Class III - Incorporates Amendment A1: 2011
- ISO 1940-1 CORR 1 Mechanical vibration — Balance quality requirements for rotors in a constant (rigid) state — Part 1: Specification and verification of balance tolerances TECHNICAL CORRIGENDUM 1 - Second Edition
- ISO 1940-1 CORR 1 Mechanical vibration — Balance quality requirements for rotors in a constant (rigid) state — Part 1: Specification and verification of balance tolerances TECHNICAL CORRIGENDUM 1 - Second Edition
- ASME B73.1 Specification for Horizontal End Suction Centrifugal Pumps for Chemical Process
- ASME B16.42 Ductile Iron Pipe Flanges and Flanged Fittings Classes 150 and 300
- ASME COMPANION GUIDE V2 Companion Guide to the ASME Boiler and Pressure Vessel and Piping Codes - Volume 2 - Fourth Edition
- ASME PVHO-1 Safety Standard for Pressure Vessels for Human Occupancy - Includes Interpretations Volumes 1, 3, 4 and 6
- CEN CEN/TR 13931 Rotodynamic pumps - Forces and moments on flanges - Centrifugal, mixed flow and axial flow horizontal and vertical shafts pumps - Incorporating Corrigendum June 2010
- Картотека зарубежных и международных стандартов
Ссылается на
- В списке элементов: 15
- ISO 13485 Medical devices Quality management systems Requirements for regulatory purposes - Troisieme EditionТребования Систем управления качеством медицинских устройств в регулирующих целях - Выпуск Troisieme
Карточка документа - ISO 10993-12 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - Fourth EditionБиологическая оценка медицинских устройств - Часть 12: Подготовка пробы и справочные материалы - Четвертый Выпуск
На основе ISO 10993-12 разработан ГОСТ ISO 10993-12-2015 (IDT)ГОСТ ISO 10993-12-2015 (IDT) - ISO 10993-13 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices - Second EditionБиологическая оценка медицинских устройств — Часть 13: Идентификация и определение количества продуктов ухудшения от полимерных медицинских устройств - Второй Выпуск
На основе ISO 10993-13 разработан ГОСТ ISO 10993-13-2016 (IDT)ГОСТ ISO 10993-13-2016 (IDT) - ISO 10993-1 CORR 1 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process TECHNICAL CORRIGENDUM 1 - Fourth EditionБиологическая оценка медицинских устройств — Часть 1: Оценка и проверяющий в управлении рисками обрабатывает TECHNICAL CORRIGENDUM 1 - Четвертый Выпуск
Карточка документа - ISO 10993-16 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables - Second EditionБиологическая оценка медицинских устройств — Часть 16: Toxicokinetic изучают дизайн для продуктов ухудшения и leachables - Второй Выпуск
На основе ISO 10993-16 разработан ГОСТ ISO 10993-16-2016 (IDT)ГОСТ ISO 10993-16-2016 (IDT) - ISO 10993-9 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products - Second EditionБиологическая оценка медицинских устройств — Часть 9: Зубной мост для идентификации и определения количества потенциальных продуктов ухудшения - Второй Выпуск
На основе ISO 10993-9 разработан ГОСТ ISO 10993-9-2015 (IDT)ГОСТ ISO 10993-9-2015 (IDT) - ISO 10993-7 CORR 1 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals TECHNICAL CORRIGENDUM 1 - Second EditionБиологическая оценка медицинских устройств — Часть 7: остатки TECHNICAL CORRIGENDUM 1 стерилизации Оксида этилена - Второй Выпуск
Карточка документа - ISO 14971 Medical devices — Application of risk management to medical devices - Second edition; Corrected Version 10/01/2007Медицинские устройства — Применение управления рисками к медицинским устройствам - Второй выпуск; Исправленная Версия 10/01/2007
На основе ISO 14971 разработаны ГОСТ Р ИСО 14971-2009 (IDT); ГОСТ ISO 14971-2011 (IDT)ГОСТ ISO 14971-2011 (IDT) - ISO ISO/IEC 17025 CORR 1 General requirements for the competence of testing and calibration laboratories TECHNICAL CORRIGENDUM 1 - Second editionОбщие требования для компетентности лабораторий тестирования и калибровки ТЕХНИЧЕСКОЕ ИСПРАВЛЕНИЕ 1 - Второй выпуск
Карточка документа - ISO 10993-11 Biological evaluation of medical devices Part 11: Tests for systemic toxicity - Second EditionБиологическая оценка Части 11 медицинских устройств: Анализы на системную токсичность - Второй Выпуск
На основе ISO 10993-11 разработаны ГОСТ Р ИСО 10993-11-2009 (IDT); ГОСТ ISO 10993-11-2011 (IDT)ГОСТ ISO 10993-11-2011 (IDT) - ISO TS 10993-19 Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials - First EditionБиологическая оценка Части 19 медицинских устройств: физико-химическая, морфологическая и топографическая характеристика материалов - Первый Выпуск
На основе ISO TS 10993-19 разработаны ГОСТ Р ИСО/ТС 10993-19-2009 (IDT); ГОСТ ISO/TS 10993-19-2011 (IDT)ГОСТ ISO/TS 10993-19-2011 (IDT) - ISO 10993-18 Biological evaluation of medical devices Part 18: Chemical characterization of materials - First EditionБиологическая оценка Части 18 медицинских устройств: Химическая характеристика материалов - Первый Выпуск
На основе ISO 10993-18 разработаны ГОСТ Р ИСО 10993-18-2009 (IDT); ГОСТ ISO 10993-18-2011 (IDT)ГОСТ ISO 10993-18-2011 (IDT) - ISO 10993-17 Biological Evaluation of Medical Devices - Part 17: Establishment of Allowable Limits for Leachable Substances - First EditionБиологическая оценка медицинских устройств - часть 17: учреждение допустимых пределов для веществ Leachable - первый выпуск
На основе ISO 10993-17 разработаны ГОСТ Р ИСО 10993-17-2009 (IDT); ГОСТ ISO 10993-17-2011 (IDT)ГОСТ ISO 10993-17-2011 (IDT) - ISO 10993-14 Biological Evaluation of Medical Devices - Part 14: Identification and Quantification of Degradation Products from Ceramics - First EditionБиологическая оценка медицинских устройств - часть 14: идентификация и определение количества продуктов ухудшения от керамики - первый выпуск
На основе ISO 10993-14 разработаны ГОСТ Р ИСО 10993-14-2009 (IDT); ГОСТ ISO 10993-14-2011 (IDT)ГОСТ ISO 10993-14-2011 (IDT) - ISO 10993-15 Biological Evaluation of Medical Devices - Part 15: Identification and Quantification of Degradation Products from Metals and Alloys - First EditionБиологическая Оценка медицинских устройств - часть 15-Идентификация и количественное определение продуктов деструкции металлов и сплавов - первое издание
На основе ISO 10993-15 разработаны ГОСТ Р ИСО 10993-15-2009 (IDT); ГОСТ ISO 10993-15-2011 (IDT)ГОСТ ISO 10993-15-2011 (IDT)
