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sklademVydáno: 2021-03-15
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).