Need help?

EN ISO 15747:2019 Standard

wave
Save  

  Keywords:

#document #plastic #parenterals #requirements #ml

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Plastic containers for intravenous injections (ISO 15747:2018)

  Purpose

This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals. This document is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions. NOTE In some countries, national or regional pharmacopoeias or other government regulations are legally binding and these requirements take precedence over this document.

  Publication

Wednesday 25th of March 2020

  Related Standards

EN 60601-2-43:2010

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment fo...

EN ISO 15223-1:2016

Medical devices Directive (93/42/EEC)

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requir...

EN ISO 14408:2009

Medical devices Directive (93/42/EEC)

Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2005)

EN 14561:2006

Medical devices Directive (93/42/EEC)

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments use...

EN 14562:2006

Medical devices Directive (93/42/EEC)

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for in...

EN 14563:2008

Medical devices Directive (93/42/EEC)

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activi...

  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 ISO 15747:2019 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