. /.WORLD TRADE
ORGANIZATIONG/TBT/N/MEX/66
12 August 2003
(03-4190)
Committee on Technical Barriers to Trade Original:  Spanish
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1. Member to Agreement notifying:   MEXICO
If applicable, name of local government involved (Articles 3.2 and 7.2):           
2. Agency responsible:   Ministry of Health
Name and address (including telephone and fax numbers, e-mail and web-site
addresses, if available) of  agency or authority designated to handle comments
regarding the notification shall be indicated if different from above:    National Enquiry
Point (General Directorate of Standards/Ministry of the Economy Enquiry Point).        
3. Notified under Article 2.9.2 [  X ], 2.10.1 [    ], 5.6.2 [    ], 5.7.1 [    ], other:           
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable):   Needleless transfusion
equipment with filter
5. Title, number of pages and language(s) of the notified document:   Draft Amendment to
Mexican Official Standard NOM-015-SSA1-1993 "Establishing Sanitary Specifications for
Needleless Transfusion Equipment With Filter"  (37 pages, in Spanish).
6. Description of content:   This draft Mexican Official Standard establishes the minimum
operating and safety standards for needleless transfusion equipment with filter used by the
medical services in Mexico for administering blood or blood components as well as the test
methods for checking the equipment.
The purpose of this draft Mexican Official Standard is to minimize, during the
administration of blood or blood component, the risks of:
- Contamination;
- gaseous embolism;
- interaction between the administering equipment and the fluids passing
through it;
- the potential release of harmful substances from the materials used to
manufacture the equipment and their transfer into the bloodstream.
This draft Mexican Official Standard must be observed in all of the industries,
laboratories and establishments engaged in the manufacturing of this product in Mexico andshall apply, in respect of the product, to the purchase, inclusion, reception inspection,
complaints, sampling and supply processes, without undermining such other activities as
may be carried out by the health authorities.G/TBT/N/MEX/66
Page 2
6. Description of content:  (cont'd)
The tests provided for in this draft re lating to systematic and intracutaneous
injections, the identification of materials used to manufacture the transporting tube, the
haemolytic index, heavy metals and acidity and alkalinity limits do not necessarily have tobe carried out as a matter of routine, provided that the manufacturers do not make
significant changes to the manufacturing process or to the raw materials used when the
product was approved, in accordance with the product records and validation studies, so that
the manufacturers, suppliers or distributors must provide the corresponding quality
certificates issued by accredited laboratories.
Pursuant to this draft, purchasers shall be entitled to carry out all of the tests on a
particular batch as they deem necessary, or to conduct the mentioned tests as and when they
decide.
This standard is partially equivalent to International Standard ISO 1135-4
"Transfusion Equipment for Medical Use, Part 4 Transfusion Sets for Single Use."
7. Objective and rationale, including the na ture of urgent problems where applicable:
The purpose of this draft is to establish the minimum operating and safety
specifications, test methods and labelling requirements for needleless transfusion equipment
with filter for the administration of blood or blood components used by the medical services
in Mexico, in order to control the quality of the equipment, protect public health and safety
and provide information to the consumer or user.
8. Relevant documents:   Diario Oficial de la Federación  (Official Journal) of 7 August 2003.
9. Proposed date of adoption:
Proposed date of entry into force: }  Not applicable        
10. Final date for comments:     6 October 2003        
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax
numbers, e-mail and web-site addresses, if available of the other body:
Web site:  www.economia.gob.mx/?P=85 (Standards catalogue);
E-mail:  cidgn@economia.gob.mx