Need help?

EN 13795-2:2019 Standard

wave
Save  

  Keywords:

#standard #european #clean #characteristics #requirements

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 25th of March 2020

  Description:

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

  Purpose

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.

  Publication

Wednesday 25th of March 2020

  Related Standards

EN 80601-2-58:2009

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal d...

EN 1789:2007 +A1:2010

Medical devices Directive (93/42/EEC)

Medical vehicles and their equipment - Road ambulances

EN 1639:2009

Medical devices Directive (93/42/EEC)

Dentistry - Medical devices for dentistry - Instruments

EN 1640:2009

Medical devices Directive (93/42/EEC)

Dentistry - Medical devices for dentistry - Equipment

EN 1641:2009

Medical devices Directive (93/42/EEC)

Dentistry - Medical devices for dentistry - Materials

EN 1642:2011

Medical devices Directive (93/42/EEC)

Dentistry - Medical devices for dentistry - Dental implants

  Stay up to date

CELAB is Notified Body No.2037 for the EMC Directive and Italian office of a Notified Body for the RED Directive.

CELAB performs voluntary inspection activities on technical construction files to check their contents.

CELAB can accomplish all the required tests in order to affix the CE-marking related to EMC, LVD, RED, MDD, machines and many others.

CLICK HERE TO GET TESTS AND INFO ON THE EN 13795-2:2019 STANDARD

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0