DIN EN 13795-2:2025-03
Surgical clothing and drapes - Requirements and test Methods - Part 2: Clean air suits; German version EN 13795-2:2025
| Fecha edición: |
2025-03-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This document specifies information to be supplied to users and third party verifiers in addition to the usual labelling of medical devices (see EN 1041 and EN ISO 15223-1), concerning manufacturing and processing requirements. This document gives information on the characteristics of single-use and reusable clean air suits used as medical devices for clinical staff, intended to prevent the transmission of infective agents between clinical staff and patients during surgical and other invasive procedures. This document specifies test methods for evaluating the identified characteristics of clean air suits and sets performance requirements for these products. |
| Keywords: | Accessories|CE marking|Clean air|Clinics|Cover cloths|Data of the manufacturer|Definitions|Enterprises|Equipment for single use|Ergonomics|Health protection|Hygiene|Information|Instructions for use|Medical devices|Medical equipment|Medical personnel|Medical products|Medical sciences|Medical technology|Occupational safety|Operation shirt|Patients|Personnel|Production|Products|Public health|Reusability|Reuse|Specification (approval)|Sterility|Surgery|Surgical equipment|Testing|Textiles|Work clothes |
| ICS: | 11.140 - Equipamiento de hospital |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN 13795-2:2025 |
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Reemplazo Normas |
Reemplaza a DIN EN 13795-2:2019-06 Reemplaza a DIN EN 13795-2:2023-10 |
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