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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>11.040.40 Implants for surgery, prosthetics and orthotics>PD ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices General requirements
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immediate downloadReleased: 2021-03-15
PD ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices General requirements

PD ISO/TS 37137-1:2021

Biological evaluation of absorbable medical devices General requirements

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Standard number:PD ISO/TS 37137-1:2021
Pages:22
Released:2021-03-15
ISBN:978 0 539 02157 8
Status:Standard
DESCRIPTION

PD ISO/TS 37137-1:2021


This standard PD ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices is classified in these ICS categories:
  • 11.040.40 Implants for surgery, prosthetics and orthotics

This document specifies the requirements for the evaluation of absorbable medical devices during a biological risk assessment based on ISO 10993-1, including a clarification of the terms "absorb", "degrade" and other related terms (see Annex A).


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