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EN ISO 15747:2019 Standard

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  Keywords:

#document #plastic #parenterals #requirements #ml

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 25th of March 2020

  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 12342:1998 +A1:2009

Medical devices Directive (93/42/EEC)

Breathing tubes intended for use with anaesthetic apparatus and ventilators

EN ISO 25539-2:2009

Medical devices Directive (93/42/EEC)

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)

EN ISO 21534:2009

Medical devices Directive (93/42/EEC)

Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)

EN ISO 21535:2009

Medical devices Directive (93/42/EEC)

Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:20...

EN ISO 21536:2009

Medical devices Directive (93/42/EEC)

Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2...

EN ISO 21649:2009

Medical devices Directive (93/42/EEC)

Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)

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