What is ISO/TS 17137 about?
ISO/TS 17137 establishes design evaluation requirements and recommendations for absorbable cardiovascular implants used to treat vessels and/or the vascular space within the circulatory system. These recommendations in ISO/TS 17137 includes the heart and all vasculature. ISO/TS 17137 is intended to supplement device-specific standards by providing guidelines specific for either absorbable implants or components, or both.
ISO/TS 17137 is applicable to implants in direct contact with the cardiovascular system, where the intended action is upon the circulatory system.
Note: ISO/TS 17137 does not address the specific evaluation of issues associated with viable tissues, viable cells, and/or implants with non-viable biological materials and their derivatives. Note 2: Procedures and devices used prior to and following the introduction of the absorbable cardiovascular implant (e.g., balloon angioplasty devices) are excluded from the scope of this document if they do not affect the absorption aspects of the implant.
Who is ISO/TS 17137 for?
ISO/TS 17137 on cardiovascular implants is applicable to:
- Prosthetic heart valves
- Protective cases in pacemakers
- Artificial hearts
- Circulatory devices
- Cardiopulmonary bypass system
- Heart valves
- Vascular grafts,
- Stents
Why should you use ISO/TS 17137?
ISO/TS 17137 provides useful requirements of absorbable cardiovascular implants for performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information from the manufacturer.
Degradation and absorption combined with the cardiovascular implant are covered by ISO/TS 17137 and it is useful to wide applications in cardiovascular implants.
ISO/TS 17137 helps in designing absorbable cardiovascular implants which are medical devices with various clinical indications for use in the human cardiovascular blood system. They have a wide range of applications in treatment of cardiovascular diseases and following the appropriate standards and guidelines can improve treatment procedures.
What’s changed since the last update?
PD ISO/TS 17137:2021 supersedes PD ISO/TS 17137:2019, which is withdrawn.
The technical changes compared to the PD ISO/TS 17137:2019 are as follows:
- Considerations have been added to multiple clauses regarding degradation-induced device fracture and the generation of absorbable particulate matter after mechanical attributes are lost
- Clauses about labelling and instructions for use (IFU) have been modified
- Figure 2 has been modified to facilitate translation into multiple languages
- Standards with guidance for characterization of absorbable polymers and metals have been elaborated
- Additional guidance regarding animal and clinical study design, limitations, and assessment has been added.