当前位置:首页 / TBT/SPS通报 /Ministerial Decree no 1002/2017 (3 pages, in Arabic), mandating the Egyptian standard: The Egyptian Standard ES 5526-3/2017 for Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (18 pages, in English). The Egyptian Standard ES 5526-4/2017 for Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed (22 pages, in English).

Ministerial Decree no 1002/2017 (3 pages, in Arabic), mandating the Egyptian standard: The Egyptian Standard ES 5526-3/2017 for Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (18 pages, in English). The Egyptian Standard ES 5526-4/2017 for Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed (22 pages, in English).


Egypt
TBT
2018-01-10
2018-03-11

The Ministerial Decree No.1002/2017 gives the producers and importers a transitional period of 6 months to abide by the Egyptian standard ES 5526-3/2017, ES 5526-4/2017 This standards specifies:

  • Requirements for types of blood-taking sets for medical use in order to ensure functional inter changeability of transfusion equipment. It is applicable to sterilized blood-taking sets intended for single use only.
  • Requirements for single use transfusion gravity sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment.

Worth mentioning is that those standards comply with ISO 1135-3:2016 and ISO 1135-4:2015


G/TBT/N/EGY/177
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11.040.20 - Transfusion, infusion and injection equipment

Protection of human health or safety (TBT)

ICS 11.040.20 (Transfusion, infusion and injection equipment)

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