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CEN - EN 13795-2

Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits

active, Most Current
Organization: CEN
Publication Date: 1 April 2019
Status: active
Page Count: 32
ICS Code (Hospital equipment): 11.140
scope:

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.

Document History

EN 13795-2
April 1, 2019
Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
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...
November 1, 2004
Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods
A description is not available for this item.
November 1, 2004
Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods
A description is not available for this item.

References

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