NEN-EN 13795-1
Single-use and reusable surgical coverings, used as medical devices in healthcare facilities, for patients, clinical staff and equipment - Part 1: Information to be supplied, manufacturing and processing requirements and general guidance
inactive
| Organization: | NEN |
| Publication Date: | 1 January 2000 |
| Status: | inactive |
| Page Count: | 19 |
| ICS Code (Hospital equipment): | 11.140 |
scope:
This standard specifies information to be supplied to users and third party verifiers, in addition to the usual labeling of medical devices (see EN 980 and EN 1041), concerning manufacturing and processing requirements. This standard gives general guidance on the characteristics of single-use and reusable surgical gowns, surgical drapes and clean air suits used as medical devices for patients, clinical staff and equipment. It is intended to prevent the transmission of infective agents between patients and clinical staff during surgical and other invasive procedures.
Document History
June 1, 2017
Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
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...
July 1, 2009
Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products
This standard specifies information to be supplied to users and third party verifiers, in addition to the usual labelling of medical devices (see EN 980 and EN 1041), concerning manufacturing and...
December 1, 2002
Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products
This standard specifies information to be supplied to users and third party verifiers, in addition to the usual labeling of medical devices (see EN 980 and EN 1041), concerning manufacturing and...
March 1, 2001
Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products
This standard specifies information to be supplied to users and third party verifiers, in addition to the usual labeling of medical devices (see EN 980 and EN 1041), concerning manufacturing and...
NEN-EN 13795-1
January 1, 2000
Single-use and reusable surgical coverings, used as medical devices in healthcare facilities, for patients, clinical staff and equipment - Part 1: Information to be supplied, manufacturing and processing requirements and general guidance
This standard specifies information to be supplied to users and third party verifiers, in addition to the usual labeling of medical devices (see EN 980 and EN 1041), concerning manufacturing and...