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WTO notification · TBT

EgyptUpdated: check whether it is now adopted or in force

Medical equipment – Egypt

Official title

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 issued an addendum on 25 March 2026 to the earlier TBT notification G/TBT/N/EGY/177. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 10 January 2018. The comment period closed on 11 March 2018.

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Published here:

Updated here:

At a glance

Products

ICS 11.040.20 (Transfusion, infusion and injection equipment)

Notifying member
Egypt
Status
Updated: check whether it is now adopted or in force
Objectives
  • Protection of human health or safety
Area
TBT: Technical product rulesTechnical barriers to trade
Notification type
Regular notification
Document symbol
G/TBT/N/EGY/177Latest notice: G/TBT/N/EGY/177/Add.2
ICS classification
  • 11.040.20 Transfusion, infusion and injection equipment
Keywords
Human health

Key dates

Distributed by the WTO
Comment deadline
Closed on 11 March 2018
Proposed adoption
Proposed entry into force

How to comment

The comment period closed on 11 March 2018. You can still raise concerns about the measure with your country's WTO TBT enquiry point, quoting the document symbol G/TBT/N/EGY/177/Add.2; it can take them up with Egypt.

Find your country's enquiry point on WTO ePing (opens in a new tab)

What the notification says

Latest notice (⁨G/TBT/N/EGY/177/Add.2⁩, 25 March 2026)

The Egyptian Standard ES 5526-4 for ' Transfusion Equipment for Medical Use — Part 4: Transfusion sets for single use, gravity feed'

Products covered:(ICS: 11.040.20) Transfusion, infusion and injection equipment. This addendum concerns the notification of the Ministerial Decree No.58 /2026 (2page, in Arabic) that gives the producers and importers a six-month transitional period to abide by the Egyptian Standard ES 5526-4 ' Transfusion Equipment for Medical Use — Part 4: Transfusion sets for single use, gravity feed' (25 pages, in Arabic). It should be noted that the Ministerial Decree No. 1002/2017 (3 pages, in Arabic) which was formerly notified in G/TBT/N/EGY/177 dated 10 January 2018, mandated among others the earlier version of this standard. Worth mentioning is that this standard is technically identical with ISO 1135-4:2025. Producers and importers are kept informed of any amendments in the Egyptian standards through the publication of administrative orders in the official gazette. Proposed date of adoption: 22 February 2026. Proposed date of entry into force: The day following the date of publication in the official gazette. Agency or authority designated to handle comments and text available from: National Enquiry Point Egyptian Organization for Standardization and Quality 16 Tadreeb El-Modarrebeen St., Ameriya, Cairo - Egypt E-mail: eos@eos.org.eg/eos.tbt@eos.org.eg Website: Tel: + (202) 22845528 Fax: + (202) 22845504

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

Notices on this measure

Every notice about this measure published here, newest first. Each one is the notifying member's own text.

  1. AddendumG/TBT/N/EGY/177/Add.2

    The Egyptian Standard ES 5526-4 for ' Transfusion Equipment for Medical Use — Part 4: Transfusion sets for single use, gravity feed'

    Products covered:(ICS: 11.040.20) Transfusion, infusion and injection equipment. This addendum concerns the notification of the Ministerial Decree No.58 /2026 (2page, in Arabic) that gives the producers and importers a six-month transitional period to abide by the Egyptian Standard ES 5526-4 ' Transfusion Equipment for Medical Use — Part 4: Transfusion sets for single use, gravity feed' (25 pages, in Arabic). It should be noted that the Ministerial Decree No. 1002/2017 (3 pages, in Arabic) which was formerly notified in G/TBT/N/EGY/177 dated 10 January 2018, mandated among others the earlier version of this standard. Worth mentioning is that this standard is technically identical with ISO 1135-4:2025. Producers and importers are kept informed of any amendments in the Egyptian standards through the publication of administrative orders in the official gazette. Proposed date of adoption: 22 February 2026. Proposed date of entry into force: The day following the date of publication in the official gazette. Agency or authority designated to handle comments and text available from: National Enquiry Point Egyptian Organization for Standardization and Quality 16 Tadreeb El-Modarrebeen St., Ameriya, Cairo - Egypt E-mail: eos@eos.org.eg/eos.tbt@eos.org.eg Website: Tel: + (202) 22845528 Fax: + (202) 22845504

  2. AddendumG/TBT/N/EGY/177/Add.1

    The Egyptian Standard ES 5526-3 'Transfusion Equipment for Medical Use —Part 3: Blood-Taking Sets for Single Use'

    Products covered: (ICS: 11.040.20) Transfusion, infusion and injection equipment. This addendum concerns the notification of the Ministerial Decree No. 372 /2025 (1 page, in Arabic) that gives the producers and importers a six-month transitional period to abide by the Egyptian Standard ES 5526-3 'Transfusion Equipment for Medical Use —Part 3: Blood-Taking Sets for Single Use' (23 pages, in Arabic). It should be noted that the Ministerial Decree No. 1002/2017 (3 pages, in Arabic) which was formerly notified in G/TBT/N/EGY/177 dated 10 January 2018, mandated among others the earlier version of this standard. Worth mentioning is that this standard is technically identical with ISO 1135-3:2016. Producers and importers are kept informed of any amendments in the Egyptian standards through the publication of administrative orders in the official gazette. Proposed date of adoption: 22 October 2025. Proposed date of entry into force: The day following the date of publication in the official gazette. Agency or authority designated to handle comments and text available from: National Enquiry Point Egyptian Organization for Standardization and Quality 16 Tadreeb El-Modarrebeen St., Ameriya, Cairo - Egypt E-mail: eos@eos.org.eg/eos.tbt@eos.org.eg Website: Tel: + (202) 22845528 Fax: + (202) 22845504

  3. Regular notificationG/TBT/N/EGY/177

    Comment deadline: Closed on 11 March 2018

    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).

    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

Sources

Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.

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