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Normas DIN – AENOR
DIN 58341:2019-09

DIN 58341:2019-09

Requirements for the validation of cleaning and disinfection processes / Note: Date of issue 2019-08-23

Exigences pour la validation des procédés d'entretien et de désinfection / Attention: Date de parution 2019-08-23

Anforderungen an die Validierungen von Reinigungs- und Desinfektionsverfahren / Achtung: Erscheinungsdatum 2019-08-23

Fecha Anulación:
2020-07 /Withdrawn
Relación con otras normas DIN:

Reemplazada por: DIN 58341:2020-07

Resumen:
This standard specifies requirements for the quality of the preparation, performance and documentation of the validation of manual and mechanical cleaning procedures as well as manual chemical and thermal disinfection procedures. It applies to reprocessable non-critical, semi-critical and critical medical devices used in health care facilities for which a validated procedure is required for cleaning and disinfection. NOTE Requirements for the validation of manual procedures for the cleaning and disinfection of thermolabile endoscopes could differ from this standard. In addition to installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ), this standard also deals with requalification without special cause. This standard applies to cleaning and disinfection procedures according to DIN EN ISO 15883-2 and DIN EN ISO 15883-4. This document is to be applied together with DIN EN ISO 15883-1 and E DIN EN ISO 15883-5. Requirements for the processing steps following the cleaning and disinfection process as well as given prerequisites (e. g. packaging, sterilisation) are not covered by this standard.
Keywords:
Accessories, Chemical, Cleaning, Cleaning equipment, Cleaning work, Cleanings, Definitions, Desinfection methods, Disinfection, Disinfectors, Drying, Efficiency, Equipment, Experts, Flushing, Functions, Hygiene, Manual, Mechanical, Medical devices, Medical products, Medical sciences, Preparation, Public health, Quality, Quality management, Specification (approval), Technical knowledge, Thermal, Training, Validation, Working substances
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