Verkkokauppa
SFS-EN ISO 10993-14:en
Biological evaluation of medical devices. Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
Soveltamisala
Suomenkielistä soveltamisalaa ei ole saatavissa.
This part of ISO 10993 specifies two methods of obtaining solutions of degradation products from ceramics (including glasses) for the purposes of quantification. It also gives guidance on the analysis of these solutions in order to identify the degradation products. Because of the generalized nature of this part of ISO 10993, product specific standards, when available, that address degradation product formation under more relevant conditions of use, should be considered first. This part of ISO 10993 considers only those degradation products generated by a chemical dissociation of ceramics during in vitro testing. No degradation induced by mechanical stress or external energy is covered. It is noted that while ISO 6872 and ISO 9693 cover chemical degradation tests, they do not address the analysis of degradation products. Because of the range of ceramics used in medical devices and the different requirements for accuracy and precision of the results, no specific analytical techniques are identified. Further, this part of ISO 10993 provides no specific requirements for acceptable levels of degradation products. Although these materials are intended for biomedical applications, the biological activity of these degradation products is not addressed in this part of ISO 10993.
Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
This part of ISO 10993 specifies two methods of obtaining solutions of degradation products from ceramics (including glasses) for the purposes of quantification. It also gives guidance on the analysis of these solutions in order to identify the degradation products. Because of the generalized nature of this part of ISO 10993, product specific standards, when available, that address degradation product formation under more relevant conditions of use, should be considered first. This part of ISO 10993 considers only those degradation products generated by a chemical dissociation of ceramics during in vitro testing. No degradation induced by mechanical stress or external energy is covered. It is noted that while ISO 6872 and ISO 9693 cover chemical degradation tests, they do not address the analysis of degradation products. Because of the range of ceramics used in medical devices and the different requirements for accuracy and precision of the results, no specific analytical techniques are identified. Further, this part of ISO 10993 provides no specific requirements for acceptable levels of degradation products. Although these materials are intended for biomedical applications, the biological activity of these degradation products is not addressed in this part of ISO 10993.
Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
Sisällysluettelo
Sidokset
Velvoittavat viittaukset
ISO 10993-1:2003 Biological evaluation of medical devices -- Part 1: Evaluation and testing
ISO 10993-9:1999 Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products
ISO 3310-1:2000 Test sieves -- Technical requirements and testing -- Part 1: Test sieves of metal wire cloth
ISO 10993-9:1999 Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products
ISO 3310-1:2000 Test sieves -- Technical requirements and testing -- Part 1: Test sieves of metal wire cloth
Tekninen komitea
Direktiivi
93/42/EEC Lääkinnälliset laitteet
98/79/EC In vitro diagnostiset lääkinnälliset laitteet
2007/47/EC Aktiiviset implantoitavat lääkinnälliset laitteet
http://ec.europa.eu »
98/79/EC In vitro diagnostiset lääkinnälliset laitteet
2007/47/EC Aktiiviset implantoitavat lääkinnälliset laitteet
http://ec.europa.eu »
Vahvistuspäivä
12.10.2009
Julkaisupäivä
30.10.2009
Painos
2
Sivumäärä
16
Julkaisun kieli
englanti