ISO 14607:2018
Non-active surgical implants - Mammary implants - Particular requirements

Standard No.

ISO 14607:2018

Release Date

2018

Published By

International Organization for Standardization (ISO)

Latest

ISO 14607:2018

Scope

This document specifies particular requirements for mammary implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization, and information supplied by the manufacturer.

ISO 14607:2018 Referenced Document

• ASTM D2240-15 Standard Test Method for Rubber Property&x2014;Durometer Hardness*， 2024-04-20 Update
• ASTM D412-16 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension*， 2024-04-20 Update
• ASTM D624-00 Standard Test Method for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic Elastomers*， 2024-04-20 Update
• ASTM D792-13 Standard Test Methods for Density and Specific Gravity lpar;Relative Densityrpar; of Plastics by Displacement*， 2024-04-20 Update
• ASTM F703-18 Standard Specification for Implantable Breast Prostheses
• ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
• ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
• ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
• ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
• ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
• ISO 14630:2012 Non-active surgical implants - General requirements
• ISO 14971:2007 Medical devices - Application of risk management to medical devices
• ISO 16054:2000 Implants for surgery - Minimum data sets for surgical implants
• ISO 25178-2:2012 Geometrical product specifications (GPS) - Surface texture: Areal - Part 2: Terms, definitions and surface texture parameters
• ISO 34-1:2015 Rubber, vulcanized or thermoplastic - Determination of tear strength - Part 1: Trouser, angle and crescent test pieces
• ISO 37:2017 Rubber, vulcanized or thermoplastic - Determination of tensile stress-strain properties
• ISO 4287:1997 Geometrical Product Specification (GPS) - Surface texture: Profile method - Terms, definitions and surface texture parameters
• ISO 7619-1:2010 Rubber, vulcanized or thermoplastic - Determination of indentation hardness - Part 1: Durometer method (Shore hardness)
• ISO/TR 14283:2018 Implants for surgery — Essential principles of safety and performance
• ISO/TR 14969:2004 Medical devices - Quality mangement systems - Guidance on the application of ISO 13485: 2003

ISO 14607:2018 history

• 2018 ISO 14607:2018 Non-active surgical implants - Mammary implants - Particular requirements
• 2007 ISO 14607:2007 Non-active surgical implants - Mammary implants - Particular requirements
• 2002 ISO 14607:2002 Implants for surgery - Specific requirements for mammary implants