EN ISO 14607:2009
Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)

Standard No.

EN ISO 14607:2009

Release Date

2009

Published By

European Committee for Standardization (CEN)

Status

Be replaced

Replace By

EN ISO 14607:2018

Latest

EN ISO 14607:2018

Replace

BS EN ISO 14607:2007

Scope

This International Standard specifies particular requirements for mammary implants for clinical practice.

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

EN ISO 14607:2009 history

• 2018 EN ISO 14607:2018 Non-active surgical implants - Mammary implants - Particular requirements
• 2009 EN ISO 14607:2009 Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)
• 2007 EN ISO 14607:2007 Non-active surgical implants - Mammary implants - Particular requirements [Superseded: CEN EN 12180]

EN ISO 14607:2009 Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007) has been changed from BS EN ISO 14607:2007 Non-active surgical implants - Mammary implants - Particular requirements.