• There are no items in your cart

17/30250386 DC : 0

NA
NA

Status of Standard is Unknown

BS ISO 17327-1 - NON-ACTIVE SURGICAL IMPLANTS - IMPLANT COATING - PART 1: GENERAL REQUIREMENTS
Available format(s)

Hardcopy , PDF

Language(s)

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

View more information
US$23.96
Excluding Tax where applicable

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.