17/30250386 DC : 0
NA
Status of Standard is Unknown
BS ISO 17327-1 - NON-ACTIVE SURGICAL IMPLANTS - IMPLANT COATING - PART 1: GENERAL REQUIREMENTS
Hardcopy , PDF
English
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General Requirements
Annex A (informative) - Coating technology examples
Annex B (informative) - Examples of intended functions
of implant coatings
Annex C (informative) - Referenced standards for implant
coatings or implants with coatings
Bibliography
BS ISO 17327-1.
| Committee |
CH/150
|
| DocumentType |
Draft
|
| Pages |
23
|
| PublisherName |
British Standards Institution
|
| Status |
NA
|
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO 25539-2:2012 | Cardiovascular implants — Endovascular devices — Part 2: Vascular stents |
| ISO 4287:1997 | Geometrical Product Specifications (GPS) — Surface texture: Profile method — Terms, definitions and surface texture parameters |
| ISO 13779-4:2002 | Implants for surgery — Hydroxyapatite — Part 4: Determination of coating adhesion strength |
| ISO 14577-4:2016 | Metallic materials — Instrumented indentation test for hardness and materials parameters — Part 4: Test method for metallic and non-metallic coatings |
| 2007/47/EC : 2007 COR 1 2015 | DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE) |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| ASTM F 1377 : 2013 : REDLINE | Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075) |
| ISO 13779-3:2008 | Implants for surgery — Hydroxyapatite — Part 3: Chemical analysis and characterization of crystallinity and phase purity |
| ISO 14242-2:2016 | Implants for surgery — Wear of total hip-joint prostheses — Part 2: Methods of measurement |
| ISO 25539-1:2017 | Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses |
| ISO 14630:2012 | Non-active surgical implants — General requirements |
| ISO 13779-2:2008 | Implants for surgery — Hydroxyapatite — Part 2: Coatings of hydroxyapatite |
| ISO/TR 14283:2004 | Implants for surgery — Fundamental principles |
| NFS 94 072 : 1998 | MATERIALS FOR SURGICAL IMPLANTS - DETERMINATION OF TENSILE ADHERENCE OF PHOSPHOCALCIC COATINGS FOR BIOMEDICAL APPLICATIONS |
| ISO 12417-1:2015 | Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements |
| ISO/TS 12417:2011 | Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products |
| ISO 25539-3:2011 | Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects — Good clinical practice |
| ISO 14243-2:2016 | Implants for surgery — Wear of total knee-joint prostheses — Part 2: Methods of measurement |
| ISO 13179-1:2014 | Implants for surgery — Plasma-sprayed unalloyed titanium coatings on metallic surgical implants — Part 1: General requirements |
| ISO 9277:2010 | Determination of the specific surface area of solids by gas adsorption — BET method |
| ASTM F 1926/F1926M : 2014 : REDLINE | Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings |
| ASTM F 1854 : 2015 : REDLINE | Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants (Withdrawn 2024) |
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