What is ISO/TS 37137-1 about?
ISO/TS 37137-1 is one of a series of documents for the biological evaluation of absorbable medical devices that specifies the requirements for the evaluation of absorbable medical devices during a biological risk assessment based on ISO 109931, including a clarification of the terms "absorb", "degrade" and other related terms (see Annex A).
Biological evaluation is the assessment of a medical device, medical device component, or material to determine if either the medical device material or the medical device design, or both is likely to result in an unacceptable adverse systemic and/or local effect on the surrounding cells and/or tissues
An understanding of the potential clinical impact of degradation is needed and the effect of degradation on the potential for adverse effects (systemic and local) shall be discussed in the biological risk assessment.
Who is ISO/TS 37137-1 for?
ISO/TS 37137-1 on the biological evaluation of absorbable medical devices is useful for-
- Manufacturers of absorbable medical devices
- Biomedical laboratories
Why should you use ISO/TS 37137-1?
Absorbable implants are intentionally designed to degrade and therefore release degradation products into the patient, a feature making these products fundamentally different from other medical devices that are not intended to be absorbed by the patient’s body.
ISO/TS 37137-1 guideline provides minimum requirements for the evaluation of absorbable medical devices during a biological risk assessment to support the safety of such absorbable medical devices through the device lifetime.
