DIN EN ISO 11137-3:2017-11
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017); German version EN ISO 11137-3:2017
| Fecha edición: |
2017-11-01
En Vigor
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|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | ISO 11137-3 gives guidance on meeting the requirements in ISO 11137-1 and ISO 11137-2 and in ISO/TS 13004 relating to dosimetry and its use in development, validation and routine control of a radiation sterilization process. |
| Keywords: | Acceptance (approval)|Biological hazards|Calibration|Characterisations|Checks|Clearing|Containers|Definitions|Dose|Dose distribution|Dosimeters|Dosimetry|Efficiency|Elections|Electron beams|Evaluations|Gamma-irradiation facility|Gamma-radiation|Germicides|Guide books|Health protection|Hygiene|Inspection|Ionizing radiation|Irradiation apparatus|Jets|Maintenance|Medical devices|Medical equipment|Medical products|Medical sciences|Medical technology|Methods|Performance|Personnel|Phototherapy|Plant|Product information|Qualifications|Quality management|Radiation|Ray treatment|Routine tests|Specification (approval)|Sterilization by irradiation|Sterilization (hygiene)|Surveillance (approval)|Validation|Verification|X-rays |
| ICS: | 11.080.01 - Esterilización y desinfeccion en general, 11.080.99 - Otras normas relativas a esterilización y desinfección |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 11137-3:2017 Idéntica ISO 11137-3:2017 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 11137-3:2006-07 Reemplaza a DIN EN ISO 11137-3:2015-08 |
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