DIN EN ISO 14160:2021-11
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020); German version EN ISO 14160:2021
| Fecha edición: |
2021-11-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This document specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin. |
| Keywords: | Animal|Animal products|Aseptic|Bacterial count|Biological hazards|Calibration|CE marking|Certification|Characterisations|Checks|Chemical|Chemicals|Clearing|Compatibility|Contamination|Definitions|Derivatives|Developments|Disposable|Disposables|Efficiency|Equipment for single use|Evaluations|Fabrics|Germicides|Germs|Guide books|Incubation|Information|Insulations|Kinetics|Liquid|Liquid materials|Liquids|Loading|Media|Medical devices|Medical products|Methods|Microbiological|Micro-organisms|Netting|Neutralization|Performance|Personnel|Production|Products|Public health|Screening-method|Sterile equipment|Sterilization (hygiene)|Surveillance (approval)|Training|Use|Validation |
| ICS: | 11.080.01 - Esterilización y desinfeccion en general |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 14160:2021 Idéntica ISO 14160:2020 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 14160:2011-10 Reemplaza a DIN EN ISO 14160:2018-05 |
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