ISO 5840:2005 PDF

Scope: This International Standard is applicable to all devices intended for implantation in human hearts, as a heart valve substitute. This International Standard is applicable to both newly developed and modified heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted. This International Standard outlines an approach for qualifying the design and manufacture of a heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests may include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests may also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished heart valve substitute. This International Standard imposes design specifications and minimum performance specifications for heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification. This International Standard excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices.

ISO 5840:2005 Referenced Document

ISO 10993-1:1997 Biological evaluation of medical devices - Part 1: Evaluation and testing
ISO 10993-2:1992 Biological evaluation of medical devices; part 2: animal welfare requirements
ISO 11135:1994 Medical devices; validation and routine control of ethylene oxide sterilization
ISO 11607:2003 Packaging for terminally sterilized medical devices
ISO 13485 *， 2018-05-15 Update
ISO 14155-1:2003 Clinical investigation of medical devices for human subjects - Part 1: General requirements
ISO 14971:2000 Medical devices - Application of risk management to medical devices

2005 ISO 5840:2005 Cardiovascular implants - Cardiac valve prostheses
1996 ISO 5840:1996 Cardiovascular implants - Cardiac valve prostheses
1989 ISO 5840:1989 Cardiovascular implants; cardiac valve prostheses
1984 ISO 5840:1984 Implants for surgery — Cardiovascular implants — Cardiac valve prostheses