DIN EN ISO 10993-7:2024-08
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/DIS 10993-7:2024); German and English version prEN ISO 10993-7:2024 / Note: Date of issue 2024-07-19*Intended as replacement for DIN EN ISO 10993-7 (2022-09).
| Fecha edición: |
2024-08-01
En Vigor
|
|---|---|
| Idiomas disponibles: | Alemán, Inglés |
| Resumen: | This document specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in 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 or components that have neither direct nor indirect patient contact (e. g., in vitro diagnostic devices) are out of scope of this document. This document does not apply to devices that have been demonstrated to not absorb or retain EO or its degradation product ECH, such as medical devices made exclusively of metal alloys and glass, see Annex C.5. NOTE This document does not specify limits for ethylene glycol (EG). No device limits are specified for EG because the risk assessment in Annex F indicates that calculated allowable levels are higher than those likely to occur in a medical device. |
| Keywords: | Biological analysis and testing|Biological tests|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: |
Normas citadas
Libros relacionados
Normas relacionadas
Colecciones temáticas relacionadas
