ISO 21535:2007 PDF

Scope: This International Standard provides specific requirements for hip joint replacement implants. With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer, and methods of test.

ISO 21535:2007 Referenced Document

ISO 14630 Non-active surgical implants - General requirements*， 2012-12-01 Update
ISO 21534:2007 Non-active surgical implants - Joint replacement implants - Particular requirements
ISO 7206-1 Implants for surgery - Partial and total hip joint prostheses - Part 1: Classification and designation of dimensions*， 2008-04-01 Update
ISO 7206-2:1996 Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic, ceramic and plastics materials
ISO 7206-4 Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of endurance properties and performance of stemmed femoral components AMENDMENT 1*， 2010-01-01 Update
ISO 7206-6:1992 Implants for surgery; partial and total hip joint prostheses; part 6: determination of endurance properties of head and neck region of stemmed femoral components

2023 ISO 21535:2023 Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants
2016 ISO 21535:2007/Amd 1:2016 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants; Amendment 1
2007 ISO 21535:2007 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
2002 ISO 21535:2002 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants