ISO 14607:2007
Withdrawn
Withdrawn
View Superseded by
Non-active surgical implants — Mammary implants — Particular requirements
Available format(s)
Hardcopy , PDF
Language(s)
English, French, Russian
Published date
01-29-2007
Withdrawn date
04-09-2025
Superseded by
US$96.00
Excluding Tax where applicable
ISO 14607:2007 specifies particular requirements for mammary implants for clinical practice.
With regard to safety, ISO 14607:2007 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.
| DevelopmentNote |
Supersedes ISO/DIS 14607. (04/2018)
|
| DocumentType |
Standard
|
| Pages |
28
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| I.S. EN ISO 14607:2009 | Identical |
| BS EN ISO 14607:2007 | Equivalent |
| I.S. EN ISO 14607:2007 | Equivalent |
| DIN EN ISO 14607:2007-05 | Equivalent |
| NS EN ISO 14607 : 2009 | Identical |
| BS EN ISO 14607:2007 | Identical |
| NEN EN ISO 14607 : 2009 | Identical |
| PN EN ISO 14607 : 2009 | Identical |
| DIN EN 12180:2000-04 | Corresponds |
| EN ISO 14607:2018 | Identical |
| DIN EN ISO 14607:2009-08 | Identical |
| DS EN ISO 14607 : 2009 | Identical |
| NBN EN ISO 14607 : 2009 | Identical |
| BS EN ISO 14607:2009 | Identical |
| UNE-EN ISO 14607:2007 | Identical |
| UNE-EN ISO 14607:2009 | Identical |
| NF EN ISO 14607 : 2009 | Identical |
| 04/300654 DC : DRAFT JAN 2004 | BS EN ISO 14630 - NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| I.S. EN 16844:2017+A2:2019 | Aesthetic medicine services - Non-surgical medical treatments |
| ISO/TS 13907:2012 | Soil quality — Determination of nonylphenols (NP) and nonylphenol-mono- and diethoxylates — Method by gas chromatography with mass selective detection (GC-MS) |
| BS EN ISO 14630:2012 | Non-active surgical implants. General requirements |
| 13/30278952 DC : 0 | BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES |
| I.S. EN 16844:2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| I.S. EN ISO 14630:2012 | NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 14630:2012) |
| ISO 16142-1:2016 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| 15/30317874 DC : 0 | BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| BS ISO 16142-1:2016 | Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| 12/30254927 DC : 0 | BS EN 16372 - AESTHETIC SURGERY SERVICES |
| I.S. EN 16372:2014 | AESTHETIC SURGERY SERVICES |
| EN 16844:2017 | Aesthetic medicine services - Non-surgical medical treatments |
| DIN EN ISO 14630:2013-03 | Non-active surgical implants - General requirements (ISO 14630:2012) |
| EN 16372:2014 | Aesthetic surgery services |
| EN ISO 14630:2012 | Non-active surgical implants - General requirements (ISO 14630:2012) |
| BS EN 16372:2014 | Aesthetic surgery services |
| BS EN 16844 : 2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS |
| ISO 14630:2012 | Non-active surgical implants — General requirements |
| UNE-EN 16372:2015 | Aesthetic surgery services |
| UNE-EN ISO 14630:2013 | Non-active surgical implants - General requirements (ISO 14630:2012) |
| ISO 7619-1:2010 | Rubber, vulcanized or thermoplastic — Determination of indentation hardness — Part 1: Durometer method (Shore hardness) |
| ISO 4287:1997 | Geometrical Product Specifications (GPS) — Surface texture: Profile method — Terms, definitions and surface texture parameters |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes |
| ISO 16054:2000 | Implants for surgery — Minimum data sets for surgical implants |
| CR 14060:2000 | Medical device traceability |
| ASTM D 792 : 2013 : REDLINE | Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement |
| ISO/TR 14969:2004 | Medical devices — Quality management systems — Guidance on the application of ISO 13485: 2003 |
| ISO 34-1:2015 | Rubber, vulcanized or thermoplastic — Determination of tear strength — Part 1: Trouser, angle and crescent test pieces |
| ISO 14630:2012 | Non-active surgical implants — General requirements |
| ISO/TR 14283:2004 | Implants for surgery — Fundamental principles |
| 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 14155:2011 | Clinical investigation of medical devices for human subjects — Good clinical practice |
| ISO 37:2017 | Rubber, vulcanized or thermoplastic — Determination of tensile stress-strain properties |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 25178-2:2012 | Geometrical product specifications (GPS) — Surface texture: Areal — Part 2: Terms, definitions and surface texture parameters |
Summarise
US$96.00
Excluding Tax where applicable
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