G/TBT/N/MEX/353  
2 March  2017 
(17-1261) Page: 1/3 
Committee on Technical  Barriers to Trade  Original:  Spanish  
 
  NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6.  
 
1. Notifying Member : MEXICO  
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible : Secretaría de Salud  (Ministry of Heal th) 
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:  
Comité Consultivo Nacional de Normalización de Innovación  
Desarrollo, Tecnologías e Información en Salud  (National Advisory Committee on 
Standardization for Innovation, Development, Technology and Information in Health Care)  
Lieja número 7, 1er. piso  
Colonia Juárez, Delegación Cuauhtém oc 
Código Postal 06696, Ciudad de México  
Tel.: (55) 55 53 69 30 and 52 86 17 20  
Fax: 52 86 17 26  
Email: jose.meljem@salud.gob.mx   
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) : 
Haemodialysis infrastructure  
5. Title, number of pages and language(s) of the notified document : Proyecto de 
modificación de la Norma Oficial Mexicana NOM -003-SSA3 -2010, para la práctica de la 
hemodiálisis, para quedar como Norma Oficial Mexicana NOM -003-SSA3 -2016, para la 
práctica de hemodiálisis  (Draft amendment to Mexican Official Standard NOM -003-SSA3 -
2010 on  the practice of haemodialysis, which is to become Mexican Official Standard NOM -
003-SSA3 -2016 on the practice of haemodialysis) (14 pages, in Spanish)  
6. Description of content : Chronic and acute kidney failure may be treated in a number of 
ways: with ex tracorporeal renal replacement therapy, otherwise known as haemodialysis ; 
with related therapies, such as haemofiltration and haemodiafiltration ; or with any form of 
continuous renal replacement therapy . These treatments, supplemented by other medical 
and nutritional measures, can significantly improve the prognosis for kidney failure, alter 
the course of the condition, and improve quality of life for patients.  
The notified Standard establishes the criteria and minimum requirements governing 
professional an d technical personnel, infrastructure, equipment and specific procedures in 
medical establishments in the public, social and private sectors, where haemodialysis, 
continuous renal replacement therapies, and related therapies take place.  
It should be noted that in all cases, the scientific and ethical principles guiding medical 
practice must be taken into account, in particular the principle of the prescriptive freedom 
of the nephrologist and other doctors, who, together with the support of nursing staff and  
technicians, must provide their services ensuring the highest levels of quality and safety, 
using the means and resources available, for the benefit of the patient.  G/TBT/N/MEX/353  
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  7. Objective and rationale, including the nature of urgent problems where 
applicable : The Standard establishes the minimum infrastructure, equipment and safety 
requirements to be met by establishments where haemodialysis, continuous renal 
replacement therapies, and related therapies take place . It applies to hospitals, fixed 
independent units or units not connected to a hospital, which use portable or other types 
of equipment to provide therapy . The Standard also establishes a profile for the personnel 
in charge of carrying out the procedure.  
The Standard is mandatory for all establishments pro viding haemodialysis, continuous 
renal replacement therapies, and related therapies in the public, social and private sectors.  
8. Relevant documents:  
 3.1 Mexican Official Standard NOM -001-SEDE -2012: Instalaciones Eléctricas 
(utilización)  (Electrical inst allations (use))  
 3.2 Mexican Official Standard NOM -004-SSA3 -2012: Del expediente clínico (Medical 
records)  
 3.3 Mexican Official Standard NOM -010-SSA2 -2010: Para la prevención y el control 
de la infección por Virus de la Inmunodeficiencia Humana  (Prevention  and control of 
infection from the Human Immunodeficiency Virus)  
 3.4 Mexican Official Standard NOM -016-SSA3 -2012: Que establece los requisitos 
mínimos de infraestructura y equipamiento de hospitales y consultorios de atención 
médica especializada  (Minimum requirements for infrastructure and equipment in 
specialized hospitals and medical practices)  
 3.5 Mexican Official Standard NOM -017-SSA2 -2012: Para la vigilancia 
epidemiológica  (Epidemiological surveillance)  
 3.6 Mexican Official Standard NOM -030-SSA3 -2013: Que establece las 
características arquitectónicas para facilitar el acceso, tránsito, uso y permanencia 
de las personas con discapacidad en establecimientos para la atención médica 
ambulatoria y hospitalaria del Sistema Nacional de Salud (Architectural de sign 
features to ensure disabled people can access, move around in, use and stay in 
outpatient and hospital facilities within the national health system)  
 3.7 Mexican Official Standard NOM -045-SSA2 -2005: Para la vigilancia 
epidemiológica, prevención y contr ol de las infecciones nosocomiales  
(Epidemiological surveillance, prevention and control of nosocomial infections)  
 3.8 Mexican Official Standard NOM -087-SEMARNAT -SSA1 -2002: Protección 
ambiental - Salud ambiental - Residuos peligrosos biológico -infecciosos - 
Clasificación y especificaciones de manejo  (Environmental protection - 
Environmental health - Hazardous bio -infectious residues - Classification and 
handling specifications)  
9. Proposed date of adoption : Once published as a final standard.  
Proposed date  of entry into force : 60 calendar days after publication in the Official 
Journal.  
10. Final date for comments : 60 calendar days after publication in the Official Journal (2 0 
January 2 017).  
11. Texts available from : National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
Secretaría de Economía  (Ministry of the Economy)  
Subsecretaría de Competitividad y Normatividad  (Under -Secretariat of Competitiveness 
and Standardization)  
Dirección Gen eral de Normas  (General Directorate of Standards)  
Tel.: (+52) 55 5729 9100, Ext. 43217  
Fax: (+52) 55 5520 9715  
Website: http://www.economia -noms.gob.mx/?P=144  
Email: normasomc@economia.gob.mx  and/or sofia.pacheco@economia.gob.mx  G/TBT/N/MEX/353  
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  Text available online at: 
http://www.dof.gob .mx/nota_detalle.php?codigo=5469489&fecha=20/01/2017  
https://members.wto.org/crnattachments/2017/TBT/MEX/17_0493_00_s.pdf