Verkkokauppa
SFS-EN ISO 10993-7:en
Biological evaluation of medical devices. Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
Soveltamisala
Suomenkielistä soveltamisalaa ei ole saatavissa.
ISO 10993-7:2008 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released. Additional background, including guidance and a flowchart showing how the standard is applied are also included in informative annexes.
EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by ISO 10993-7:2008.
Tämän julkaisun valmistelusta Suomessa vastaa Palvelualojen työnantajat PALTA ry, puh. 040 579 4393.
ISO 10993-7:2008 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released. Additional background, including guidance and a flowchart showing how the standard is applied are also included in informative annexes.
EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by ISO 10993-7:2008.
Tämän julkaisun valmistelusta Suomessa vastaa Palvelualojen työnantajat PALTA ry, puh. 040 579 4393.
Sisällysluettelo
Sidokset
Velvoittavat viittaukset
ISO 10993-10:2002 Biological evaluation of medical devices -- Part 10: Tests for irritation and delayed-type hypersensitivity
ISO 10993-10:2021 Biological evaluation of medical devices — Part 10: Tests for skin sensitization
ISO 10993-12:2007 Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials
ISO 10993-10:2021 Biological evaluation of medical devices — Part 10: Tests for skin sensitization
ISO 10993-12:2007 Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials
Tekninen komitea
Direktiivi
90/385/EEC Aktiiviset implantoitavat lääkinnälliset laitteet
93/42/EEC Lääkinnälliset laitteet
http://ec.europa.eu »
93/42/EEC Lääkinnälliset laitteet
http://ec.europa.eu »
Vahvistuspäivä
09.03.2009
Julkaisupäivä
27.03.2009
Painos
2
Sivumäärä
92
Julkaisun kieli
englanti