Verkkokauppa
SFS-EN ISO 10993-18:2020:en
Biological evaluation of medical devices. Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
Soveltamisala
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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.
Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
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.
Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
Sisällysluettelo
Sidokset
Velvoittavat viittaukset
ISO 10993-17:2002 Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances
ISO 10993-1:2018 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
ISO 14971:2019 Medical devices -- Application of risk management to medical devices
ISO 10993-1:2018 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
ISO 14971:2019 Medical devices -- Application of risk management to medical devices
Tekninen komitea
Direktiivi
90/385/EEC Aktiiviset implantoitavat lääkinnälliset laitteet
93/42/EEC Lääkinnälliset laitteet
2007/47/EC Aktiiviset implantoitavat lääkinnälliset laitteet
2017/745
http://ec.europa.eu »
93/42/EEC Lääkinnälliset laitteet
2007/47/EC Aktiiviset implantoitavat lääkinnälliset laitteet
2017/745
http://ec.europa.eu »
Vahvistuspäivä
12.06.2020
Julkaisupäivä
16.06.2020
Painos
3
Sivumäärä
77
Julkaisun kieli
englanti