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ISO 17327-1:2018

Current
Current

The latest, up-to-date edition.

Non-active surgical implants — Implant coating — Part 1: General requirements
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English

Published date

02-16-2018

ISO 17327-1:2018 specifies general requirements for implant coatings, comprising both surface coatings and surface modifications, applied to non-active surgical implants. This document specifies requirements concerned with generic coating properties including chemical and phase compositions, surface texture, coating coverage integrity, dissolvability, coating thickness, adhesion strength, abrasion resistance, porosity and pore size, and surface wettability.

ISO 17327-1:2018 is applicable to surface coatings, which are defined as layers of material with any different property than the natural surface of the substrate which are intentionally added to the substrate.

ISO 17327-1:2018 is applicable to surface modifications, which are defined as intentional conversion or reconstruction of the surface of the original substrate to form a new surface material consisting of components of the substrate's own material and possibly foreign material and forming a surface layer with different properties.

Since the pertinent properties of a coating and their needed level of characterization are highly dependent on the intended application of the implant, the generic nature of the general requirements in this document is not intended to either override or replace the provisions of application-specific performance standards.

ISO 17327-1:2018 is not applicable to surfaces modified by texturing with the exclusive intention to change the roughness of the surface or the strength of the raw material.

ISO 17327-1:2018 is not applicable to natively passivated metal surfaces. While this document is applicable to intentionally passivated metal surfaces, well-established materials passivated by conventional techniques, such as nitric acid immersion, are usually non-hazardous and can be described in a very basic manner.

ISO 17327-1:2018 is not applicable to implant coatings utilizing viable tissue.

ISO 17327-1:2018 is not applicable to laminates, i.e. composite materials made of multiple layers, e.g. vascular prosthesis constructed of different expanded polytetrafluoroethylene layers, except the exposed surface of the laminate, which can be an implant coating (see 3.1, note 2 to entry).

ISO 17327-1:2018 is not applicable to coverings, e.g. covered stents.

NOTE 1 ISO 17327-1:2018 does not contain requirements on biocompatibility. Nevertheless, this is a critical property of the device and coating and needs to be addressed during risk assessment.

NOTE 2 ISO 17327-1:2018 supplements applicable non-active surgical implant standards and ISO 14630.

NOTE 3 ISO 17327-1:2018 does not require that manufacturers have a quality management system in place. However, the application of a quality management system, such as that described in ISO 13485, could be appropriate to help ensure that the implant achieves its intended performance.

NOTE 4 Although fully porous implants are not coatings, some of the considerations in this document can also be applied to them.

DevelopmentNote
Supersedes ISO/DIS 17327-1. (02/2018)
DocumentType
Standard
Pages
15
PublisherName
International Organization for Standardization
Status
Current

Standards Relationship
IS/ISO 17327 : Part 1 : 2018 Identical
BS ISO 17327-1:2018 Identical
NEN ISO 17327-1 : 2018 Identical

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 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 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/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 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements
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 13179-1:2014 Implants for surgery Plasma-sprayed unalloyed titanium coatings on metallic surgical implants Part 1: General requirements
ASTM F 1926/F1926M : 2014 : REDLINE Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings
NFS 94 069 : 1994 XP MATERIALS FOR SURGICAL IMPLANTS - DEFINING AND CHARACTERIZATION OF THE THICKNESS OF THE COATINGS OBTAINED BY PLASMA PROJECTION FOR BIOMEDICAL APPLICATIONS
ASTM F 1854 : 2015 : REDLINE Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants

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