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Norm

ÖNORM EN ISO 10993-18

Ausgabedatum: 2020 11 15

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)

This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biologica...
Weiterlesen
ZURÜCKGEZOGEN : 2021 02 16
Herausgeber:
Austrian Standards International
Format:
Digital | 82 Seiten
Sprache:
Englisch
Standards mitgestalten:
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.
ÖNORM EN ISO 10993-18
2021 02 15
Biologische Beurteilung von Medizinprodukten - Teil 18: Chemische Charakterisierung von Werkstoffen ...
Norm
ÖNORM EN ISO 10993-18
2020 11 15
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device mate...
Norm
ÖNORM EN ISO 10993-18
2009 09 15
Biologische Beurteilung von Medizinprodukten - Teil 18: Chemische Charakterisierung von Werkstoffen ...
Norm
ÖNORM EN ISO 10993-18
2005 10 01
Biologische Beurteilung von Medizinprodukten - Teil 18: Chemische Charakterisierung von Werkstoffen ...
Norm
Historie aufklappen
Norm
ISO 10993-17:2002
Ausgabedatum : 2002 11 27
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
Norm
ISO 14971:2019
Ausgabedatum : 2019 12 10
Medical devices — Application of risk management to medical devices
Norm
ÖNORM EN ISO 10993-18
Ausgabedatum : 2021 02 15
Biologische Beurteilung von Medizinprodukten - Teil 18: Chemische Charakterisierung von Werkstoffen für Medizinprodukte im Rahmen eines Risikomanagementsystems (ISO 10993-18:2020)
Norm
ISO 10993-18:2020
Ausgabedatum : 2020 01 13
Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process