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DIN EN ISO 10993-7:2022-09
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008 + Cor 1:2009 + Amd 1:2019); German version EN ISO 10993-7:2008 + AC:2009 + A1:2022 / Note: To be replaced by DIN EN ISO 10993-7 (2024-08).
| Fecha edición: |
2022-09-01
En Vigor
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|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This part of ISO 10993 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 this document is applied, are also included in the informative annexes. EO-sterilized devices that have no patient contact (e. g., in vitro diagnostic devices) are not covered by this part of ISO 10993. |
| Keywords: | Biological analysis and testing|Biological tests|CE marking|Chemical residues|Definitions|Dental equipment|Ethylene oxide|Evaluations|Gas chromatography|Gaseous|Health protection|Limits (mathematics)|Mathematical calculations|Measurement|Measuring techniques|Medical devices|Medical equipment|Medical products|Medical sciences|Methods of analysis|Quality assurance|Quality assurance systems|Residual content|Residue|Residues|Specification (approval)|Sterile technology|Sterilization (hygiene)|Sterilizing gases|Surgical equipment|Surgical implants|Surgical instruments|Testing|Validation |
| ICS: | 11.100.20 - Evaluación biológica de productos sanitarios |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 10993-7:2008/A1:2022 Idéntica ISO 10993-7:2008/Amd 1:2019 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 10993-7:2009-02 Reemplaza a DIN EN ISO 10993-7 Berichtigung 1:2011-06 Reemplaza a DIN EN ISO 10993-7/A1:2018-08 |
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