SR EN 13795-2:2019
Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
This European Standard 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 European Standard 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 European Standard specifies test methods for evaluating the identified characteristics of clean air suits and sets performance requirements for these products.
Status :
Valid
Approval date : 9/30/2019
Number of pages : 32
ICS : 11.140 Hospital equipment
Technical Committee : 377 - Medical devices
- Replaces SR EN 13795+A1:2013
- Normative reference SR EN 29073-3:1998
- Normative reference SR EN ISO 9073-10:2005
- Normative reference SR EN ISO 13938-1:2002
- Normative reference SR EN ISO 139:2005
- Normative reference SR EN ISO 10993-1:2010
- Normative reference SR EN ISO 22612:2005
- Normative reference SR EN ISO 139:2005/A1:2011
- Normative reference SR EN ISO 11737-1:2018