WORLD TRADE  
ORGANIZATION  G/TBT/N/DOM/64 
3 September 2009 
 (09-4109) 
Committee on Technical Barriers to Trade Original:   Spanish 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   DOMINICAN REPUBLIC
 
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible:  
Dirección General de Normas y Sistemas de Calidad , DIGENOR  
(Directorate-General of Standards and Quality Systems) 
Edificio de Oficinas Gubernamentale s "Juan Pablo Duarte", piso 11 
Avenida México, esquina Leopoldo Navarro Santo Domingo, Dominican Republic Tel.: +1-809-686-2205 Fax: +1-809-688-3843 E-mail: direcciongeneral@gob.do
 
Website: http://www.digenor.gob.do  
Name and address (including telephone  and fax numbers, e-mail and website 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be  indicated if different from above:  
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):   International 
Classification for Standards (ICS) code 11.100.99 
5. Title, number of pages and langua ge(s) of the notified document:  NORDOM 11:  
32-003 - Medicina de Laboratorio.  Normas  nacionales para el manejo de sustancias 
peligrosas en los laboratorios de salud  (Dominican Standard (NORDOM) 11:32-003 - 
Laboratory medicine.  National standards fo r the handling of hazardous substances in 
health laboratories) (28 pages, in Spanish). 
6. Description of content:   Definitions;  abbreviations;  in ternal, external and international 
transport;  packaging;  marking and labelling;  storage;  waste disposal. 
7. Objective and rationale, including the nature of urgent problems where applicable:  
To standardize the handling process for hazar dous substances commonly used in health 
laboratories, with a view to protecting the h ealth of internal and external users, the 
community and the environment. G/TBT/N/DOM/64 
Page 2  
 
  8. Relevant documents:  
6.1  Boquet, E., et al., Mejoría Continua de la Calidad.  Guía para los Laboratorios 
Clínicos de América Latina  (Ongoing quality improvement.  Guide for clinical laboratories 
in Latin America).  Editorial Panamericana, Mexico, 1995.  
6.2 Bollmann, L.C.M., Normas de seguridad.  Almacenam iento de productos químicos.  
Servicios de higiene y seguridad en el trabajo  (Safety standards.  Chemical storage.  
Occupational health and safety services).  Faculty of Exact and Natural Sciences, 
University of Buenos Aires, Argentina, 1995.  
Burnett, David, Acreditación del Laboratorio Clínico (Clinical laboratory accreditation). 
Editorial Reverté S.A., Barcelona, 1998.  6.3 Ministry of the Environment, Housi ng and Territorial Development, Colombia, 
Guías de manejo seguro y gestión ambiental para 25 sustancias químicas (Guidelines on 
safe handling and environmental manageme nt for 25 chemical substances), 
http://www.minambiente.gov.co/prensa/publi cacionesIguias ambientales/6 otros sect 
ores/44 guias para manejo seguro y gestion ambiental 25 sust quim.pdf  
 6.5 Department of Consumer and Business Services, Oregon Occupational Safety and 
Health Division (OSHA), Diccionario de términos de higiene y seguridad en el trabajo  
(Dictionary of occupational health and safety terms), http://www.orosha.org/pdf/dictionary/ 
spanish-english.pdf  
 6.6 Resolución de la Secretaría General T écnica, relativa al Acuerdo Multilateral 
M-143 en virtud de la Sección 1.5.1 del Acu erdo Europeo sobre Trans porte de Mercancías 
Peligrosas por Carretera (ADR) (Technical General Secretariat Resolution on the 
Multilateral Agreement M-143 under section 1.5.1 of the European Agreement concerning 
the International Carriage of Dangerous Goods by Road (ADR), Madrid, Spain, 
1 March 2004.  
6.7 IATA – Dangerous Goods Regulations, 47
th edition (in Spanish).  Entry into force 
1 January 2006.  6.8 ISO 15190:2003 "Medical laboratories - Requirements for safety".  
6.9 Montero Campos, M., Manual de Bioseguridad de lo s Laboratorios del Instituto 
Costarricense de Investigación y Nutrición en Salud  (Biosecurity manual of the 
laboratories of the Costa Rican Health Research and Nutrition Institute), 1997.  6.10 World Health Organization (WHO), La boratory Biosafety Manual (second edition), 
Geneva, 1994. 
 
6.11 WHO, Laboratory Biosafety Manual (third edition), Geneva, 2005. 
6.12 Patino Reyes, Nancy, El laboratorio de toxicología  (The toxicology laboratory), 
Department of Toxicology, Faculty of Medicine, National University, Bogotá, http://www.revmed.unal.edu.co/r evistafm/v51nl/v51nla6.html
 
 
6.13 Ministry of Health of Peru, Manual de Normas de Bioseguridad  (Biosecurity 
standards manual), Lima, 1997.   G/TBT/N/DOM/64 
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  6.14 Office of Health, Occupational Sa fety and Environmental Protection, 
University of Puerto Rico  in Cayey, Puerto Rico, 
http://www.cayey.upr.edu/OSSOPA/P lan_de_Higiene_Quimica 2006.pdf  
 6.15 Ramírez Díaz, Luz María, Almacenamiento y manejo de reactivos y productos 
químicos  (Storage and handling of reag ents and chemical products), 
http://www.mollabs.com/archivos/sep30 2005/12-13.pdf
 
 6.16 Regulación para el transporte sin riesgo de mercancías peligrosas por vía aérea  
(Regulations on the safe transport of hazardous goods by air), Edition 1, May 2006, Civil 
aviation authority, El Salvador (electronic copy). 
 6.17 Ley General de Salud, 42–01 (General Law on Health No. 42-01), Dominican 
Republic.  
6.18 Ministry of Public Health and Social Welfare/Laboratory and Blood Bank 
Department, Dominican Republic, Normas para las Buenas Prác ticas de Laboratorios de 
Salud (Standards for good practices in health laboratories), National standards series 
No. 12, 1999.  
6.19 Normas Nacionales de Bioseguridad para Laboratorio .  Directrices y Requisitos 
Generales para la Bioseguridad en los Laboratorios / SESPASIDIGENOR 2004  (National 
biosecurity standards for laboratories.  Gene ral guidelines and requirements for biosecurity 
in laboratories/SESPASIDIGENOR 2004), National Directorate for Laboratories, Ministry of Public Health and Social Welfare, Dominican Republic.  
6.20 Executive Commission for Health Sector Reform (CERSS), Agenda Estratégica 
Nacional  (National strategic agenda), Dominican Republic. 
 6.21 Executive Commission for Health Sector Reform (CERSS), El Modelo 
Dominicano de Prestación de Servicios de Salud  (The Dominican model for the provision 
of health services), Dominican Republic, April 2005. 
 6.22 Executive Commission for Health Sector Reform (CERSS), Una Reforma para 
estar en Salud  (A reform to promote health), Dominican Republic, 2004. 
 
6.23 Reglamento para la habilitación y funci onamiento de los Laboratorios Clínicos y 
de Salud Pública  (Regulations on the approval and functi oning of clinical and public health 
laboratories), Ministry of Public Health a nd Social Welfare, Dominican Republic, 2004. 
 6.24 Reglamento para la habilitación y funcionam iento de Bancos de  Sangre y Servicios 
de Transfusión  (Regulations on the approval a nd functioning of blood banks and 
transfusion services), Ministry of Public Health and Social Welfare, Dominican Republic, 
2004.  6.25 Reglamentos Generales de la Ley de Salud  (General regulations under the Law on 
Health), Ministry of Public Health and Social Welfare, Dominican Republic, 2004. 
 
6.26 Reglamentos Generales de la Ley de Salud II  (General regulations under the 
Law on Health II), Ministry of Public Hea lth and Social Welfare, Dominican Republic, 
2005.  G/TBT/N/DOM/64 
Page 4  
 
  6.27 Norma para el manejo de residuos sólidos communes  (Standard for common solid 
residue management), Ministry of the Envi ronment and Natural Resources, Dominican 
Republic, 2001.  6.28 Norma ambiental para la gestión integral de desechos infecciosos  (Environmental 
standard for integrated infectious waste ma nagement), Ministry of the Environment and 
Natural Resources, Dominican Republic, 2003.  6.29 Norma ambiental para la ges tión de desechos radioactivos (Environmental 
standard for radioactive waste management),  Ministry of the Environment and Natural 
Resources, Dominican Republic, 2003. 
9. Proposed date of adoption: 
Proposed date of entry into force:   28 November 2008 
28 May 2009 
10. Final date for comments:   - 
11. Texts available from:  National enquiry point [ X] or address, telephone and fax 
numbers and e-mail and website addresses, if available, of other body: 
Dirección General de Normas y Sistemas de Calidad (DIGENOR) 
Edificio de Oficinas Gubernamentale s "Juan Pablo Duarte", piso 11 
Avenida México, esquina Leopoldo Navarro 
Santo Domingo, Dominican Republic Tel.: +1-809-686-2205 Fax: +1-809-688-3843 E-mail: cendoc@digenor.gob.do
 
Website: http://www.digenor.gob.do