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Homepage>PD ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices General requirements
sklademVydáno: 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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Označení normy:PD ISO/TS 37137-1:2021
Počet stran:22
Vydáno: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).