WORLD TRADE  
ORGANIZATION  G/TBT/N/DOM/63 
2 September 2009 
 (09-4099) 
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 language(s) of the notified document:  NORDOM 11:32-002 
- Medicina de laboratorio.  Normas nacional es para el manejo de muestras para el 
diagnostico y sustancias infecciosas en los laboratorios de salud  (Dominican Standard 
(NORDOM) 11:32-002 - Laboratory medicine.  National standards on the handling of 
diagnostic samples and infectious substances in h ealth laboratories) (23 pages, in Spanish). 
6. Description of content:   Definitions;  abbreviations;  exemptions;  internal, external and 
international transport;  processing of samples;  packaging, marking and labelling;  spillage 
control;  storage;  waste disposal. 
7. Objective and rationale, including the nature of urgent problems where applicable:  
To standardize the process of handling diagno stic samples and infectious substances in 
health laboratories.  Establishes standards relating to the handling of such samples and 
substances (with regard to sample-taking, iden tification, analytical processes, packaging, 
labelling, transport, storage and disposal), so that they can be used to obtain reliable and 
timely results. 
 G/TBT/N/DOM/63 
Page 2  
 
  8. Relevant documents:  
6.1 Alonso Urmeneta, B. et al., Manual Práctico de Microbiología (Practical 
microbiology manual).  Masón, second edition, 1999. 
6.2 Bioseguridad.  Especímenes para Diagnóstico.   Transporte Terrestre.  Norma IRAM 
80058-1 (Biosecurity.  Diagnostic specimens.  Land transport.  IRAM standard 
80058-1), second edition, 15 May 2003.  Arge ntine Standards Institute, Argentina. 
6.3  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. 
6.4  Cuba, Ministry of Public Health, Buenas Prácticas de Laboratorio Clínico,  
Regulación 3-95 (Good clinical laboratory practices, Regulation No. 3-95). 
6.5  Envío y recepción de muestras de sangre hacia o desde el exterior del país, 
Resolución 54/98 (Sending blood samples to and receiving blood samples from other 
countries, Resolution No. 54/98).  Ministry of Health and Social Action, Argentina (www.msal.gov.ar). 
6.6  Envío y recepción de materiales biológicos.  Resolución 481/99  (Sending and 
receiving biological materials, Resolution No. 481/99).  Ministry of Health and Social Action, Argentina (www.msal.gov.ar). 
6.7  NTP 628:  Riesgo biológico en el transpor te de muestras y ma teriales infecciosos 
(NTP No. 628:  Biological risks in the transporting of samples and infectious 
materials).  Ministry of Labour and Social Affairs, Spain.  
6.8  Resolución de la Secretaría General Técn ica, relativa al Acuerdo Multilateral M-143 
en virtud de la Sección 1.5.1 del Acuer do Europeo sobre Trans porte de Mercancías 
Peligrosas por Carretera (A DR), relativo al transporte de mu estras para diagnóstico 
(Technical General Secretariat Resolu tion on the Multilateral Agreement M-143 
under section 1.5.1 of the European Agreem ent concerning the International Carriage 
of Dangerous Goods by Road (ADR) relating to the carriage of diagnostic 
specimens), Madrid, Spain, 1 March 2004. 
6.9  Fernández Espina, Camilo, El aseguramiento de calidad en el laboratorio clínico  
(Quality assurance in the clinical laboratory).  Acta Bioquímica Clínica Latinoamericana 1999, Vol.  XXXIII, pp. 49 - 68 
6.10 Fernandez Espina, Camilo, Gestión de calidad en el laboratorio clínico  (Quality 
management in the clinical laboratory).  Editorial Médica Panamericana, first edition, 
Madrid, 2005. 
6.11  IATA – Dangerous Goods Regulations, 47
th edition (in Spanish).  Entry into force 
1 January 2006. 
6.12  ISO 15190:2003 "Medical laboratories - Requirements for safety". 
6.13  ISO 15189:2003 "Medical laboratories - Particular requirements for quality and 
competence". 
6.14  Lucero, N., Acerca de la recepción y envío de mu estras.  III.  Envases para material 
biológico infeccioso y/o perecedero (Receiving and sending samples.  III.  Containers 
for infectious and/or perishable biol ogical material).  Bulletin No. 129, 1998, 
Argentine Microbiology Association. 
6.15  Lucero, N. et al., Transporte de materiales infecciosos (Transport of infectious  G/TBT/N/DOM/63 
 Page 3 
 
 
  materials).  Bulletin No. 139, 1999, Argentine Microbiology Association. 
6.16 Lucero N., Acerca de la recepción y envío de muestras.  I.  Bioseguridad y Control de 
Calidad del Diagnóstico de Laboratorio  (Receiving and sending samples.  
I. Biosecurity and laboratory diagnostic quality control).  Bulletin No. 125, 1997, 
Argentine Microbiology Association. 
6.17  Munitis, M.C., H.A.  Micucci, Sugerencias para una legislación especial para los 
pequeños generadores de residuos de establecimientos de salud (Suggestions for 
special legislation concerning small generators of health-care waste).  Acta Bioquímica Clínica Latinoamericana, 2000, Volume 34, No. 2, pp. 209 - 230. 
6.18  Munitis, M.C., H.A.  Micucci, Efluentes líquidos de establ ecimientos de salud.  
Estado actual y propuesta de gestión  (Liquid effluent from health-care 
establishments.  Current situation and management proposal).  Acta Bioquímica 
Clínica Latinoamericana, 2000, Volume 36, No. 2, pp. 83 – 101. 
6.19  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. 
6.20  Moran Villatoro, L., Obtención de muestras sanguíneas de calidad analítica 
(Obtaining blood samples of analytical quality).  Editorial Médica Panamericana, first edition, 2001. 
6.21 National Committee for Clinical Laborat ory Standards, NCCLS Approved Standard 
LA4-A4.  Blood Collection on Filter Pa per for Neonatal Screening Programs, 
Villanova, PA, 2003. 
6.22  Niño H., and L.  Barrera, Garantía de Calidad en el Laboratorio Clínico  (Quality 
assurance in the clinical laboratory), Colombia, 1993. 
6.23 World Health Organization (WHO), La boratory Biosafety Manual (second edition), 
Geneva, 1994. 
6.24   WHO, Laboratory Biosafety Manual (third edition), Geneva, 2005. 
6.25  Pan American Health Organization (PA HO)/WHO, Guidelines for the Safe Transport 
of Infectious Substances and Di agnostic Specimens, Geneva, 1997. 
6.26  PAHO/WHO, Guidance on Regulations for th e Transport of Infectious Substances.  
Communicable Disease Surveillance and Response.  September 2005. 
6.27  Ministry of Health of Peru, Manual de Normas de Bioseguridad  (Biosecurity 
standards manual), Lima, 1997. 
6.28  Ministry of Health of Peru, Manual de Procedimientos par a la Obtención y Envío de 
Muestras  (Manual of procedures for obtaining and sending samples), Lima, 1997. 
6.29 Reglamento Técnico MERCOSUR para el Transporte de Sustancias Infecciosas y 
Muestras para Diagnóstico  (MERCOSUR Technical Regulation on the transport of 
infectious substances and diagnostic sampl es), Resolution No. 145/03, Ministry of 
Health and Social Action, Argentina ( www.msal.gov.ar
). 
6.30 Reglamento General para el Transporte de Mercancías Peligrosas por Carretera  
(General regulations on the transport of hazardous goods by road), Resolution No. 195/97.  Department of Public Works and Transport, Ministry of the Economy, 
Argentina. G/TBT/N/DOM/63 
Page 4  
 
  6.31  Reglamento de Salud Ambiental  (Environmental health regulations). 
6.32  Ley General de Salud, 42 – 01 (General Law on Health No. 42-01), Dominican 
Republic. 
6.33  Normas Nacionales de Bioseguridad para Laboratorio .  Directrices y Requisitos 
Generales para la Bioseguridad en los Laboratorios /SESPASIDIGENOR 2004  
(National biosecurity standards for laborat ories.  General guidelines and requirements 
for biosecurity in laboratories/SESPASIDIGENOR 2004), National Directorate for Laboratories, Ministry of Public Health  and Social Welfare, Dominican Republic. 
6.34  Ley sobre el SIDA, 55 - 93  (Law on AIDS No. 55-93), Dominican Republic. 
6.35  Reglamento para la habilitación y funcionam iento de los Laboratorios Clínicos y de 
Salud Pública  (Regulations on the approval and functioning of clinical and public 
health laboratories), Ministry of Public  Health and Social Welfare, Dominican 
Republic, 2004. 
6.36  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. 
6.37 Reglamentos Generales de la Ley de Salud  (General regulations under the Law on 
Health), Ministry of Public Health and Social Welfare, Dominican Republic, 2004. 
6.38 Reglamentos Generales de la Ley de Salud II  (General regulations under the Law on 
Health II), Ministry of Public Health a nd Social Welfare, Dominican Republic, 2005. 
6.39 VIH Virus Inmunodeficiencia Hum ana.  Normas de Bioseguridad  (HIV – Human 
immunodeficiency virus.  Biosecurity standards), Ministry of Public Health and Social Welfare, Dominican Republic, 1995. 
6.40 Normas sobre los Residuos Infecciosos  (Standards on infectious residues), Ministry of 
the Environment and Natural Resources, Dominican Republic, 2001. 
6.41 Norma para el manejo de residuos sólidos communes  (Standard on common solid 
residue management), Ministry of th e Environment and Natural Resources, 
Dominican Republic, 2001. 
6.42 Reglamento sobre el manejo de desechos hospitalarios  (Regulations on hospital 
waste management), Ministry of Public Health and Social Welfare, Dominican 
Republic. 
6.43 Sistemas de diagnósticos in Vitro.  Enva ses para el transporte de muestras médicas y 
biológicas.  Requisitos ensayos UNE EN 82  (In vitro diagnostic systems.  Containers 
for transporting medical and biological sa mples.  Testing requirements UNE EN 82), 
Spanish Standardization and Certificati on Association (AENOR), Madrid, 1996. 
6.44 Terragno, Raquel, Acerca de la recepción y envío de muestras.  II.  El laboratorio de 
referencia (Receiving and sending samples.  II.  The reference laboratory), Bulletin 
No. 126, 1997, Argentine Microbiology Association. 
6.45 Terragno, Raquel, Transporte de Especi menes para Diagnóstico (Transporting 
diagnostic specimens).  Acta Bioquímica Clínica Latinoamericana, 2005, Volume 39, No. 2, pp. 217 – 23. 
  G/TBT/N/DOM/63 
 Page 5 
 
 
  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 [ ] 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