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prEN 13795-2
Edition
02/2025
Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
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Abstract
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.
Status
| Draft - Active |
Origin
| Technical Committee : |
| CEN/TC 205 : Non-active medical devices |
Implementation
| start of the vote on the project | 31/08/2023 | date of ratification (dor) | 06/01/2025 | |||
| end of the vote on the project | 23/11/2023 | date of anouncement (doa) | 05/05/2025 | |||
| start of the vote on the final project | 14/10/2024 | date of publication (dop) | 04/08/2025 | |||
| end of the vote on the final project | 09/12/2024 | date of withdrawal (dow) | 04/08/2025 |
|
Publication Official Journal
of the Grand-Duchy of Luxembourg |
|
| Reference |
Relations
| Relations to older standards |
| ILNAS-EN 13795-2:2019 |
International Classification for Standards (ICS codes) :
| 11.140 : Hospital equipment |
