UNE-EN 13795-2:2025
Current
The latest, up-to-date edition.
Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
Hardcopy , PDF
English, Spanish, Castilian
24-09-2025
This document specifies information to be supplied to users and third-party verifiers in addition to the usual labelling of medical devices (see EN ISO 20417 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.
| Committee |
CTN 111
|
| DocumentType |
Standard
|
| Pages |
33
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN 13795-2:2025 | Identical |
| EN 13795-2:2025 | Equivalent |
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