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DIN CEN ISO/TS 11137-4:2023-10

Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020); German version CEN ISO/TS 11137-4:2023

Fecha edición: 2023-10-01
En Vigor
Idiomas disponibles: Alemán
Resumen: This document provides additional guidance to that given in ISO 11137?3 on meeting the requirements specified in ISO 11137?1, ISO 11137?2 and ISO/TS 13004 for the establishment and control of a radiation sterilization process using gamma, electron beam, and Xirradiation.

Keywords: Checks|Definitions|Dose|Dosimeters|Dosimetry|Electron beams|Gamma-radiation|Health protection|Inspection|Ionizing radiation|Irradiation|Irradiation apparatus|Medical devices|Medical equipment|Medical products|Medical sciences|Medical technology|Performance|Personnel|Phototherapy|Process control|Product information|Public health|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
CTN:

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Idéntica CEN ISO/TS 11137-4:2023

Idéntica ISO/TS 11137-4:2020

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