SIST EN ISO 21535:2024 PDF

Overview - EN ISO 21535:2024 / ISO 21535:2023 (hip-joint replacement implants)

EN ISO 21535:2024 (identical to ISO 21535:2023) defines specific requirements for hip‑joint replacement implants, covering both total and partial hip replacements and components made of metallic and non‑metallic materials. Published by CEN and prepared by ISO/TC 150, the standard addresses safety and intended performance through requirements for design attributes, materials, design evaluation, manufacture, sterilization, packaging, labelling and methods of test. It also recognises that implants with an established and safe history of clinical use can demonstrate conformity by providing clinical evidence rather than full redesign or retesting.

Key topics and technical requirements

• Intended performance and safety: Requirements to demonstrate that implants perform as intended in the clinical environment.
• Design attributes and tolerances: Mechanical and dimensional controls for components (including taper connections and modular interfaces).
• Materials and biocompatibility: Selection and evaluation of metallic and non‑metallic materials used in hip implants, aligned with biological evaluation standards.
• Design evaluation and testing: Mandated tests and methods of test to assess static/fatigue strength, wear, torque/disassembly forces, fretting corrosion and impingement risk.
• Manufacture, sterilization and packaging: Controls to ensure sterility, handling and traceability of implants during distribution.
• Information supplied by the manufacturer: Labelling, instructions and patient/surgeon information required for safe use and post‑market surveillance.
• Clinical evidence option: Pathway for historically marketed implants with sufficient clinical use to demonstrate conformity via documented clinical data.

Applications

EN ISO 21535:2024 is applied to the lifecycle of hip replacement implants - from product design and preclinical testing through manufacturing, regulatory submission and post‑market surveillance. Typical practical uses:

• Developing technical files and design dossiers for CE marking and regulatory submissions (including alignment with Regulation (EU) 2017/745).
• Defining test programs for wear, fatigue and modular connection performance for R&D and validation.
• Preparing labeling, sterilization and packaging specifications for manufacturing and distribution.
• Supporting clinical evaluation and post‑market clinical follow‑up (PMCF) strategies.

Who uses this standard:

• Implant manufacturers and R&D engineers
• Regulatory and quality teams (medical device regulatory affairs)
• Notified bodies and conformity assessment labs
• Biomechanical testing laboratories and clinical evaluators

Related standards

Key referenced documents that work with EN ISO 21535:2024 include (examples):

• ISO 7206 series (hip prosthesis testing and dimensions)
• ISO 14242 series (wear testing of total hip‑joint prostheses)
• ISO 10993-1 (biological evaluation of medical devices)
• ISO 14630 and ISO 21534 (general and joint replacement implant requirements)

Keywords: EN ISO 21535:2024, ISO 21535:2023, hip‑joint replacement implants, non‑active surgical implants, hip replacement standard, implant testing, medical device regulation.