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Status : Withdrawn
Standard Type : Main
Document No :
Document Year : 2005
Pages : 13
Edition : 2
Section Volume : Implants for surgery (ISO/TC 150.)
With regard to safety, ISO 14630:2005 gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests required to demonstrate compliance with these requirements. Additional tests are given or referred to in Level 2 and Level 3 StandardDetails.