PD ISO/TS 37137-1:2021 PDF

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 understandi...