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СтандартыBSI

BS ISO 17327-1:2018

Действует
Non-active surgical implants. Implant coating. General requirements — 24 стр.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

ISO 25539-3:2011
Действует
Cardiovascular implants -- Endovascular devices -- Part 3: Vena cava filters — 100 стр.
ASTM F1609-08(2014)
Заменен
Standard Specification for Calcium Phosphate Coatings for Implantable Materials — 4 стр.
ISO 4287:1997/Amd.1:2009
Действует
Geometrical Product Specifications (GPS) -- Surface texture: Profile method -- Terms, definitions and surface texture parameters -- Amendment 1: Peak count number — 6 стр.
ASTM F1160-14(2017)e1
Действует
Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings — 9 стр.
ASTM C633-13(2017)
Заменен
Standard Test Method for Adhesion or Cohesion Strength of Thermal Spray Coatings — 8 стр.
ISO/IEC 17025:2017
Действует
General requirements for the competence of testing and calibration laboratories — 38 стр.
ISO 14155:2011
Действует
Clinical investigation of medical devices for human subjects -- Good clinical practice — 66 стр.
ISO 25539-2:2012
Действует
Cardiovascular implants -- Endovascular devices -- Part 2: Vascular stents — 98 стр.
ISO 14577-4:2007
Заменен
Metallic materials -- Instrumented indentation test for hardness and materials parameters -- Part 4: Test method for metallic and non-metallic coatings — 32 стр.
ASTM F1147-05(2017)e1
Заменен
Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings — 8 стр.
ISO/TR 14283:2004
Заменен
Implants for surgery -- Fundamental principles — 22 стр.
ASTM F1044-05(2017)e1
Действует
Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings — 6 стр.
ASTM F1978-18
Заменен
Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser — 5 стр.
BS ISO 14242-2:2016
Действует
Implants for surgery. Wear of total hip-joint prostheses. Methods of measurement — 14 стр.
ISO 12417-1:2015
Действует
Cardiovascular implants and extracorporeal systems -- Vascular device-drug combination products -- Part 1: General requirements — 56 стр.
BS ISO 14243-2:2016
Действует
Implants for surgery. Wear of total knee-joint prostheses. Methods of measurement — 12 стр.
ISO 13485:2003
Заменен
Medical devices -- Quality management systems -- Requirements for regulatory purposes — 64 стр.
ASTM F2024-10(2016)
Заменен
Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings — 4 стр.
ASTM F1854-15
Отменен
Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants (Withdrawn 2024) — 10 стр.
ASTM F1377-13
Заменен
Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075) — 3 стр.
ISO 4288:1996/Cor.1:1998
Действует
Geometrical Product Specifications (GPS) - Surface texture: Profile method - Rules and procedures for the assessment of surface texture; Technical Corrigendum 1 — 1 стр.
ASTM F1926/F1926M-14
Заменен
Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings — 5 стр.
ASTM F1580-12
Заменен
Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants — 4 стр.
BS ISO 13179-1:2014
Действует
Implants for surgery. Plasma-sprayed unalloyed titanium coatings on metallic surgical implants. General requirements — 16 стр.
ISO 25539-1:2003/Amd.1:2005
Заменен
Cardiovascular implants -- Endovascular devices -- Part 1: Endovascular prostheses -- Amendment 1: Test methods — 50 стр.
ISO 10993-18:2005
Действует
Biological evaluation of medical devices -- Part 18: Chemical characterization of materials — 24 стр.
ISO 14630:2012
Действует
Non-active surgical implants -- General requirements — 20 стр.