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.
ISO 14607:2007 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