ГОСТ ISO 10993-4-2020. Межгосударственный стандарт. Изделия медицинские. Оценка биологического действия медицинских изделий. Часть 4. Исследования изделий, взаимодействующих с кровью

Международные стандарты

[1]

ISO 3826-3, Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features (Контейнеры складные пластмассовые для человеческой крови и ее компонентов. Часть 3. Системы упаковки крови со встроенными элементами)

[2]

ISO 5840 (all parts), Cardiovascular implants - Cardiac valve prostheses (Сердечно-сосудистые имплантаты. Протезы клапанов сердца)

[3]

ISO 5841-3, Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers (Имплантаты для хирургии. Кардиостимуляторы. Часть 3. Низкопрофильные соединители [IS-1] для имплантируемых кардиостимуляторов)

[4]

ISO 7198, Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (Имплантаты для сердечно-сосудистой системы. Сосудистые протезы. Трубчатые сосудистые графты и заплаты)

[5]

ISO 7199, Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (Сердечно-сосудистые имплантаты и искусственные органы. Системы газообмена с кровью (оксигенаторы))

[6]

ISO 10993 (all parts), Biological evaluation of medical devices (Изделия медицинские. Оценка биологического действия медицинских изделий)

[7]

ISO 12891-1, Retrieval and analysis of surgical implants - Part 1: Retrieval and handling (Извлечение и анализ хирургических имплантатов. Часть 1. Извлечение и порядок обращения)

[8]

ISO 14708-2, Implants for surgery - Active implantable medical devices - Part 2: Cardiac Pacemakers (Имплантаты для хирургии. Активные имплантируемые медицинские устройства. Часть 2. Электрокардиостимуляторы)

[9]

ISO 14708-5, Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices (Имплантаты для хирургии. Активные имплантируемые медицинские устройства. Часть 5. Устройства, поддерживающие систему кровообращения)

[10]

ISO 15674, Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags (Имплантаты сердечно-сосудистые и искусственные органы. Кардиотомические/венозные системы резервуаров (с/без фильтра) с твердой оболочкой и мягкие венозные резервуары)

[11]

ISO 15675, Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters (Имплантаты сердечно-сосудистые и искусственные органы. Системы искусственного кровообращения. Фильтры для линий артериальной крови)

[12]

ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories (Общие требования к компетентности испытательных и калибровочных лабораторий)

[13]

ISO 8637, Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (Сердечно-сосудистые имплантаты и искусственные органы. Гемодиализаторы, гемодиафильтры, гемофильтры и гемоконцентраторы)

Национальные стандарты

[14]

Guidelines for blood/material interactions. Report of the National Heart, Lung, and BloodInstitute Working Group, U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health. NIH Publication No. 85-2185, revised September 1985. Available from Biomaterials Program, Bioengineering Research Group, Division of Heart and Vascular Diseases, NHLBI, Two Rockledge Center, 6701 Rockledge Drive, Bethesda, MD 20892, USA

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Harker L.A., Ratner B.D., Didisheim P. eds. Cardiovascular Biomaterials and Biocompatibility. Supplement to Cardiovasc. Pathol. 2 (3). Suppl, Jul - Sept 1993, pp. 1S - 224S

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ANSI/AAMI RD16. Hemodialyzers, hemodiafilters, and hemoconcentrators. In: International Organization for Standardization and Association for the Advancement of Medical Instrumentation, editor. Cardiovascular implants and artificial organs. American National Standards Institute; 2007. p. 30

[17]

ASTM F756-13, Standard practice for assessment of hemolytic properties of materials

[18]

ASTM F1984-99, Standard practice for testing whole blood complement activation in serum by solid materials

[19]

ASTM F2065-00E1, Standard practice for testing for alternative pathway complement activation in serum by solid materials

[20]

ASTM E2524-08(2013), Standard test method for analysis of hemolytic properties of nanoparticles

[21]

GB/T 16175, Biological evaluation test methods for medical organic silicon materials

[22]

MHLW Notification by Director, OMDE, Yakushokuki-hatsu 0301 No. 20, March 1, 2012, Basic Principles of Biological Safety Evaluation Required for Application for Approval to Market Medical Devices

[23]

ASTM 2382, Standard test method for assessment of intravascular medical device materials on partial thromboplastin time (PTT)

[24]

ASTM F2888-13, Standard test method for platelet leukocyte count - An in-vitro measure for haemocompatibility assessment of cardiovascular materials

[25]

Anticoagulant Sodium Citrate Solution U.S.P. In: Larry Callahan, editor. USP 28: (USP Citric Acid RS); Assay. U.S. Pharmacopeia; 2006 d. p 168; PF 31(3), p. 731

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NIH. Public Health Service Policy on Humane Care and Use of Laboratory Animals; Health Research Extension Act of 1985: Public Law 89-544. In: Office of Extramural Research; OLAW, editor. Office of Laboratory Animal Welfare; 2002. (a/k/a OLAW, 2002)

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USDA. 9 CFR: Code of Federal Regulations: Chapter 1; Subchapter A - Animal Welfare. In: Animal Welfare Information Center U, editor. Government Printing Office; 2004

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NIH. Evaluation of hemodialyzers and dialysis membranes. Report of a Study Group for the Artificial Kidney-Chronic Uremia Program NIAMDD-1977. Chapter two. In vitro characterization of hemodialyzers. Artif. Organs. 1977, 1 (2) pp. 59 - 77

[29]

ASTM F1830-97, Standard practice for selection of blood for in vitro evaluation of blood pumps

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ASTM F1841-97, Standard practice for assessment of haemolysis in continuous flow blood pumps

Руководящие документы Департамента по продуктам питания и лекарственным средствам (FDA) США

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CDRH. Class II special controls guidance document for certain percutaneous transluminal coronary angioplasty (PTCA) catheters - Document No. 1605. In: Office of Device Evaluation (ODE); Division of Cardiovascular Devices; Interventional Cardiology Devices Branch, editor. DRAFT guidance for industry and FDA staff: FDA; 2008. p. 34

[32]

CDRH. Class II special controls guidance document: indwelling blood gas analyzers - Document No. 1126. In: Office of Device Evaluation (ODE); Division of Cardiovascular and Respiratory Devices; Anesthesiology and Respiratory Devices Branch, editor. Final guidance for industry and FDA staff: FDA; 2001. p. 16

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CDRH. Coronary drug-eluting stents: nonclinical and clinical studies. In: Center for Devices and Radiological Health (CDRH); Center for Drug Evaluation and Research (CDER); and Office of Combination Products (OCP), editor. DRAFT guidance for industry: FDA; 2008. p. 89

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CDRH. Coronary drug-eluting stents: nonclinical and clinical studies - Companion Document No. 6255. In: Center for Devices and Radiological Health (CDRH); Center for Drug Evaluation and Research (CDER); and Office of Combination Products (OCP), editor. DRAFT guidance for industry: FDA; 2008. p. 32

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CDRH. Guidance for annuloplasty rings 510(k) submissions - Document No. 1358. In: Office of Device Evaluation (ODE); Division of Cardiovascular and Respiratory Devices; Circulatory Support and Prosthetic Devices Branch, editor. Final guidance for industry and FDA staff: FDA; 2001. p. 17

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CDRH. Guidance for cardiopulmonary bypass arterial line blood filter 510(k) submissions - Document No. 1622. In: Office of Device Evaluation (ODE); Division of Cardiovascular Respiratory and Neurology Devices; Circulatory Support and Prosthetic Devices Branch, editor. Final guidance for industry and FDA staff: FDA; 2000. p. 8

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CDRH. Guidance for cardiopulmonary bypass oxygenators 510(k) submissions - Document No. 1361. In: Office of Device Evaluation (ODE); Division of Cardiovascular and Respiratory Devices; Circulatory Support and Prosthetic Devices Branch, editor. Final guidance for industry and FDA staff: FDA; 2000. p. 23

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G95-1. 1997 Blue Book Memorandum: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" (Replaces #G87-1 #8294). FDA <http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080735.htm>. Accessed 04/15/2010

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УДК 615.46:002:006.354

МКС 11.020

IDT

Ключевые слова: изделия медицинские, гемосовместимость, система свертывания, система комплемента, гемолиз, тромбоз, тромбоэмболия, активация тромбоцитов, гематология