International Standard
ISO/TS 10993-19:2020
Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
Reference number
ISO/TS 10993-19:2020
Edición 2
2020-03
International Standard
Vista previa
ISO/TS 10993-19:2020
75138
No disponible en español
Publicado (Edición 2, 2020)
Esta norma se revisó y confirmó por última vez en 2023. Por lo tanto, esta versión es la actual.

ISO/TS 10993-19:2020

ISO/TS 10993-19:2020
75138
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Formato
CHF 96
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Resumen

This document provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physical, i.e. physico‑chemical, morphological and topographical (PMT) properties of materials in finished medical devices. Such an assessment is limited to those properties that are relevant to biological evaluation and the medical device's intended use (clinical application and duration of use) even if such properties overlap with clinical effectiveness.

This document does neither address the identification or quantification of degradation products nor the evaluation of the physico-chemical properties of the degraded materials, which are covered in ISO 10993‑9, ISO 10993‑13, ISO 10993‑14 and ISO 10993‑15.

Chemical characterization of materials is covered by ISO 10993‑18.

The ISO 10993 series is not applicable when the material or device is not in contact with the body directly or indirectly.

Informaciones generales

  •  : Publicado
     : 2020-03
    : Norma Internacional confirmada [90.93]
  •  : 2
     : 13
  • ISO/TC 194
    11.100.20 
  • RSS actualizaciones

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