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Resumen

This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally stepwise approach to the chemical characterization which can include one or more of the following:

— the identification of its materials of construction (medical device configuration);

— the characterization of the materials of construction via the identification and quantification of their chemical constituents (material composition);

— the characterization of the medical device for chemical substances that were introduced during manufacturing (e.g. mould release agents, process contaminants, sterilization residues);

— the estimation (using laboratory extraction conditions) of the potential of the medical device, or its materials of construction, to release chemical substances under clinical use conditions (extractables);

— the measurement of chemical substances released from a medical device under its clinical conditions of use (leachables).

This document can also be used for chemical characterization (e.g. the identification and/or quantification) of degradation products. Information on other aspects of degradation assessment are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15.

The ISO 10993 series is applicable when the material or medical device has direct or indirect body contact (see ISO 10993-1 for categorization by nature of body contact).

This document is intended for suppliers of materials and manufacturers of medical devices, to support a biological evaluation.

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Informaciones generales

  • Estado
     : Publicado
    Fecha de publicación
     : 2020-01
    Etapa
    : Norma Internacional publicada [60.60]
  • Edición
     : 2
    Número de páginas
     : 66
  • Comité Técnico :
    ISO/TC 194
    ICS :
    11.100.20 
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  2. Tienda
  3. Standards catalogue
  4. ICS
  5. 11
  6. 11.100
  7. 11.100.20
  8. ISO 10993-18:2020