BS EN ISO 14607:2009
Non-active surgical implants - Mammary implants - Particular requirements
- Standard No.
- BS EN ISO 14607:2009
- Release Date
- 2009
- Published By
- British Standards Institution (BSI)
- Status
- Replace By
- BS EN ISO 14607:2018
- Latest
- BS EN ISO 14607:2018
- Replace
- BS EN ISO 14607:2007
- Scope
- This International Standard specifies particular requirements for mammary implants for clinical practice. With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.
BS EN ISO 14607:2009 Referenced Document
- ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
- ISO 14155-1:2003 Clinical investigation of medical devices for human subjects - Part 1: General requirements
- ISO 14155-2 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plants
- ISO 14630 Non-active surgical implants - General requirements*， 2012-12-01 Update
- ISO 34-1:2004 Rubber, vulcanized or thermoplastic - Determination of tear strength - Part 1: Trouser, angle and crescent test pieces
- ISO 37 Rubber, vulcanized or thermoplastic - Determination of tensile stress-strain properties*， 2017-11-01 Update
BS EN ISO 14607:2009 history
- 2018 BS EN ISO 14607:2018 Non-active surgical implants. Mammary implants. Particular requirements
- 2009 BS EN ISO 14607:2009 Non-active surgical implants - Mammary implants - Particular requirements
- 2008 BS EN ISO 14607:2008 Non-active surgical implants - Mammary implants - Particular requirements
- 2008 BS EN ISO 14607:2007 Non-active surgical implants - Mammary implants - Particular requirements
- 2000 BS EN 12180:2000 Non-Active Surgical Implants - Body Contouring Implants - Specific Requirements for Mammary Implants
