1.

Notifying Member: EGYPT

If applicable, name of local government involved (Articles 3.2 and 7.2):

2.

Agency responsible:

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: http://www.eos.org.eg

Tel.: + (202) 22845528

Fax: + (202) 22845504

3.

Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], Other:

4.

Products covered (HS codes or national tariff lines. ICS numbers may be provided in addition, where applicable): Anaesthetic, respiratory and reanimation equipment (ICS code(s): 11.040.10)

5.

Details of notified document(s) (title, number of pages and languages, means of access): The draft of the Egyptian Standard ES 5824 for" medical electrical equipment- particular requirements for the basic safety and essential performance of infant radiant warmers".; (40 page(s), in Arabic)

Link to notified document(s) and/or contact details for agency or authority which can provide copies upon request:

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: http://www.eos.org.eg

Tel.: + (202) 22845528

Fax: + (202) 22845504

6.

Description of content: The draft of the Egyptian standard ES 5824 specifies the safety requirements for infant radiant warmers, but alternate methods of compliance with a specific clause, by demonstrating equivalent safety, will not be judged as non-compliant, if the manufacturer has demonstrated in his risk management file that the risk presented by the hazard has been found to be of an acceptable level when weighed against the benefit of treatment from the device.

Worth mentioning is that this draft standard is technically identical with IEC 60601-2-21:2020+Amd1/2023.

7.

Objective and rationale, including the nature of urgent problems where applicable: Safety requirements; Quality requirements

8.

Relevant documents:

·_        IEC 60601-2-21:2020+Amd1/2023

·_        Ministerial Decree No. 612/2007

9.

Proposed date of adoption: To be determined

Proposed date of entry into force: To be determined

10.

Provision of comments

Final date for comments: 7 March 2026

[X] 60 days from notification

Contact details of agency or authority designated to handle comments regarding the notification:

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: http://www.eos.org.eg

Tel.: + (202) 22845528

Fax: + (202) 22845504