Reference number
ISO 10993-18:2020
International Standard
ISO 10993-18:2020
Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
Edition 2
2020-01
Preview
ISO 10993-18:2020
64750
No disponible en español
Publicado (Edición 2, 2020)
Esta norma tiene 1 modificaciones.

ISO 10993-18:2020

ISO 10993-18:2020
64750
Idioma
Formato
CHF 194
Convertir Franco suizo (CHF) a tu moneda

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.

Informaciones generales

  •  : Publicado
     : 2020-01
    : Norma Internacional publicada [60.60]
  •  : 2
     : 66
  • ISO/TC 194
    11.100.20 
  • RSS actualizaciones

 Modificaciones

Las enmiendas se emiten cuando se decide que puede ser necesario agregar nuevo material a un documento de normalización existente. También pueden incluir correcciones editoriales o técnicas que deban aplicarse al documento existente.

Amendment 1

Determination of the uncertainty factor

Edición 2022

ISO 10993-18:2020/Amd 1:2022
82241
Idioma
Formato
CHF 18
Convertir Franco suizo (CHF) a tu moneda

Ciclo de vida

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