ГОСТ ISO 10555-1-2021 Катетеры внутрисосудистые однократного применения стерильные. Часть 1. Общие требования (с Поправкой)

[1]

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[2]

ISO 3105, Glass capillary kinematic viscometers - Specifications and operating instructions

[3]

ISO 80369-1, Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements

[4]

ISO 80369-7, Small bore connectors for liquids and gases in healthcare applications - Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications

[5]

ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

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ISO 11135-1, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

[7]

ISO 11137-1, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

[8]

ISO 11607-1, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

[9]

ISO 11607-2, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes

[10]

ISO/TS 12417, Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products

[11]

ISO 14971, Medical devices - Application of risk management to medical devices

[12]

ISO 17665-1, Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

[13]

IEC 80369-6, Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications

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ASTM F640-12, Standard Test Methods for Determining Radiopacity for Medical Use

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Iserson K.V., J.-F.-B.Charriere. The man behind the "French" gauge. 1987 Nov. (abstract only)

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Casey R.G., Joseph-Frederic-Benoit Charriere. Master cutler and instrument designer. 2003 Mar. (abstract only)

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The Seldinger technique. Reprint from Acta Radiologica 1953. AJR Am.J.Roentgenol. 1984 Jan, 142 (1) pp.5-7

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Nabil Kibriya, Rebecca Hall, Steven Powell, Thien How, Richard G. McWilliams. French Sizing of Medical Devices is not Fit for Purpose. Cardiovascular and Interventional Radiology, January 2013