Wednesday 20 August 2008 _______________ OFFICIAL JOURNAL ___________________ (Section One)  
MINISTRY OF ENERGY  
Draft Amendment to Mexican Official Standard No NOM-013-NUCL-1995, Radiologica l Safety Requirements for 
patients who have been administered radioactive material.  
In the margin, there is a seal with the national emblem, which bears the words: Estados Unidos Mexicanos - 
Secretaría de Energía.  
DRAFT AMENDMENT TO OFFICIAL MEXICAN STANDARD NO NOM-013-NUCL-1995, RADIOLOGICAL 
SAFETY REQUIREMENTS FOR PATIENTS WHO HAVE BEEN ADMINISTERED RADIOACTIVE 
MATERIAL.  
JUAN EIBENSCHUTZ HARTMAN, Chairman of the Na tional Advisory Committee for Standardisation of 
Nuclear Safety and Safeguards and Director-General of the National Committee for Nuclear Safety and 
Safeguards, pursuant to the provisions of Articles 33 fraction X of the Organic Law on Federal Public 
Administration; 4 of the Federal Law on Administrative Procedure; 1 and 38  fractions II and III, 40 fractions I, 
III and XI, 41, 46, 47 and 51 of the Federal Law on Metrol ogy and Standardisation; 1,  4 and 18 fraction III, 19, 
21 and 50, I, II, III and XI of the Law Regulating Article 27 of the Constitution on Nuclear Material; 1, 2, 3, 4, 
18, 37, 162, 164 and 170 of the General Regulation on Radiological Safety; 1, 2 and 3 fraction VI(b), and 34 
fractions XVI, XVII, XIX, XXII and XXIV of the Rules of Pr ocedure of the Ministry of  Energy; 28 and 33 of the 
Federal Law on Metrology and Standa rdisation, hereby orders the publication in the Official Journal of the 
Federation of the draft amendment to  Mexican Official Standard No NOM-0 13-NUCL-1995 Radiological Safety 
Requirements for the release of pat ients who have been administered radioactive material, which will 
subsequently be referred to as "PROY- NOM-013-NUCL- 2008, Radiological Safety Requirements for the 
release of patients who have been administered radioactive material".  
This draft Mexican Official Standard is published in accord ance with the provisions laid down in Article 47 
fraction I of the Federal Law on Metrology and Standardi sation. Interested parties must submit any comments 
within 60 calendar days of the date of publication to the National Advisory  Committee for Standardisation of 
Nuclear Safety and Safeguards, at Dr José María Barragán 779, colonia Narvarte, código postal 03020, 
México, D.F., telephone: 5095 3246, fax: 5590 6103, e-mail: ccnn_snys@cnsns.gob.mx.  
Within the deadline referred to above, the regulation st atement on the impact of the draft standard will be 
available for public consultation at the committee's headquarters.  
Mexico, Distrito Federal, 12 June 2008 – Chairman of t he National Advisory Committee on Standardisation 
of Nuclear Safety and Safeguards and Director-General  of the National Committee for Nuclear Safety and 
Safeguards – Juan Eibensch utz Hartman – Signature.  
FOREWORD  
The following services, institutions and businesses shall take part in the drawing up of this draft 
amendment:  
Secretaría de la Defensa Nacional (Ministry of Defence).  
– Hospital Central Militar (Central Military Hospital).  
Secretaría de Energía (Ministry of Energy).  
– Unidad de Asuntos Jurídicos (Legal Affairs Unit) / Dirección de Estudios y Consultas (Study and 
Consultation Department).  
Secretaría de Medio Ambiente y Recursos Naturales (Ministry for the Environment and Natural Resources).  
– Dirección General de Gestión Integral de Materiales y Actividades Riesgosas (Directorate-General of 
Integrated Management of Hazardous Materials and Activities)  
Secretaría del Trabajo y Previsión Social (Ministry of Labour and Social Welfare).  
– Dirección General de Seguridad y Salud en el Trabajo (Directorate-General for Health and Safety at 
Work).  
Secretaría de Salud (Ministry of Health).  – Commission Federal para la Proteccion contra Riesgos Sanitarios (Federal Committee for Protection 
against Health Risks)  
Asociación Mexicana de Física Médica, A. C.  
Calidad XXI, S.A. de C.V.  
Centro de Diagnóstico Integral, XIMAG.  
Centro Médico Nacional 20 de Noviembre, ISSSTE.  
Federación Mexicana de Profesionales Técnicos en Radiología e Imagen, A.C.  
Hospital de Especialidades del Centro Médico Nacional la Raza, IMSS.  
Hospital de Oncología, Centro Médico Nacional Siglo XXI, IMSS.  
Hospital General de México, Secretaría de Salud.  
Hospital Regional Adolfo López Mateos, ISSSTE.  
Instituto Nacional de Ciencias Médicas y Nutrición, Salvador Zubirán.  
Instituto Nacional de In vestigaciones Nucleares.  
Oncología, Radioterapia y Radiocirugía, S.A. de C.V.  
Sociedad Mexicana de Medicina Nuclear, A.C.  
Sociedad Mexicana de Seguridad Radiológica, A.C.  
DRAFT AMENDMENT TO MEXICAN OFFICIAL ST ANDARD NO NOM-013-NUCL-2008, RADIOLOGICAL 
SAFETY REQUIREMENTS FOR THE RELEA SE OF PATIENTS WHO HAVE BEEN 
ADMINISTERED RADIOACTIVE MATERIAL.  
TABLE OF CONTENTS  
0. Introduction  
1. Objective  
2. Scope  
3. References  
4. Definitions  
5. Requirements  
Annex A (Normative) Information for family members of patients who have been administered 
radioactive material  
Annex B (Normative) Information for patients who hav e received therapy with radioactive material  
 
6. Concordance with international standards  
7. Bibliography  
8. Conformity assessment  
9. Compliance  
10. Entry into force  
 
0. Introduction  
When radioactive material is administered to patients, for either diagnosis or therapy, they experience a 
temporary increase in the amount of radioactive material in the body, and accordingly become sources of 
ionising radiation for a certain length of time. Conseq uently, when they are released, they may cause others, 
in particular their family members, to be exposed unnecessarily.  
It is for this reason, and pursuant to Article 170 of the General Regulation on Radioactive Safety, that general radiological safety requirements regarding  the release of patients who have been administered 
radioactive material are laid down in this standard.  
1. Objective  
To lay down radiation protection requirements fo r patients who have been administered radioactive 
material, with a view to applying the radiological safety  principles required to protect their family members and 
other members of the public.  
2. Scope  
This standard shall apply in all cases where radioactive material is administered to patients in the form of 
open radioactive sources.  
This standard does not lay down the quant ity of radioactive material that is to be administered to patients, 
which is the joint responsibility of the clinical physician treating the patient and the specialist in nuclear 
medicine.  
3. References  
For a broader understanding of this standard, the following Mexican official standard in force should be 
referred to:  
3.1 NOM-008-SCFI-2002 General system of units of measurement.  
4. Definitions  
For the purposes of this standard:  
4.1 Release of a patient means  a situation in which a patient who has been administered radioactive 
material no longer needs to remain in a controlled facility under constant medical supervision, and so is 
allowed to leave.  
4.2 Administration of radioactive material  means the introduction of radioactive material into the body 
by any means, subject to medical prescription.  
5. Requirements  
The following requirements shall apply in all cases in which radioactive material is administered to 
patients.  
5.1 For cases of therapy, patient record s must bear the following information:  
a) Patient's name, age and sex  
b) Diagnosis  
c) Date and time of administration of the radioactive material  
d) Date and time of patient's release  
e) Name and signature of the doctor prescribing the radioactive material  
f) Name and signature of the doctor administering the radioactive material  
g) Radioactive material administered  
h) Activity of the radioactive material administered  
i) Means of administration  
j)  Equivalent dose rate measured at 1.0m from the patient, at the point where the reading is highest, at 
the time of the patient's release.  
5.2 For cases of diagnosis, the following information shall appear in the patient record or in a logbook of 
the radioactive material administered to patients:  a) Patient's name, age and sex 
b) Date of administration of the radioactive material 
c) Name and signature of the doctor prescribing the radioactive material 
d) Name and signature of the doctor administering the radioactive material 
e) Radioactive material administered 
f) Activity of the radioactive material administered 
g) Means of administration. 
5.3 Patients who have been administered radioactive mate rial may only be released if they meet one of 
the following conditions:  
 
a) They produce an equivalent dose rate below 0.05mSvh-1 (5mRh-1) at a distance of one metre, or  
b) The residual activity of the radioactive ma terial administered is less than 1110MBq (30 mCi). 
5.4 Patients who do not meet one of the conditions in  5.3 must remain in hospital under medical 
supervision.  
5.5 Verbal instructions must be given by the doctor specialising in nuclear medicine or the radiological 
safety officer to patients who have received diagnosis with:  
• a quantity of any beta emitter radioactive material, or 
• a quantity lower than 1110 MBq (30 mCi) of  any gamma emitter radioactive material. 
 
5.6 Patients who have received therapy with a quantit y of more than 1110 MBq (30 mCi) of any gamma 
emitter radioactive material, and who at the time of rele ase meet one of the conditions laid down in 5.3, must 
be provided with Annexes A and B of this standard. Pati ents must sign a confirmation of receipt of these 
annexes and this confirmation must remain  in their record for at least two years.  
5.7 Breastfeeding women who, on medical advice, have to  be administered radioactive material must stop 
breastfeeding until the specialist says it is safe to resume.  ANNEX A (NORMATIVE)  
INDICATIONS FOR FAMILY MEMBERS OF PA TIENTS WHO HAVE BEEN ADMINISTERED 
RADIOACTIVE MATERIAL  
Patient's name:  
Name of hospital where the radioactive material is administered:  
Name of the doctor responsible for administering the radioactive material. 
Telephone: 
Name of the doctor prescribing the radioactive material:  
Date on which the radioactive material was administered __/ ____ / ____     Radionuclide: _____________  
Activity: ______________(Bq) ___________ (mCi).  
Equivalent dose rate at a distance of 1m at the time of the patient's release _____ mSvh-1________ (mRh-1) 
Person measuring the equivalent dose rate at a distance of  1m from the patient at the time of the patient's 
release, specialist in nuclear medicine ( ); or the radiological safety officer ( ):  
Name Signature  
THE FOLLOWING PRECAUTIONS MUST BE OBSERVED:  
a) Persons under 45 years of age must not come within one metre of the patient. 
b) Pregnant women, breastfeeding women and children  must avoid contact with, or proximity to, the 
patient and must spend as little time as possible with the patient, even at a distance of more than one 
metre. 
For further informati on, please contact:______________________________________________________  
IT IS NOT NECESSARY TO OBSERVE ANY SPECIAL RADIOLOGICAL 
SAFETY PRECAUTIONS AFTER: 
 ________ / ________ / ________  ANNEX B (REGULATORY)  
INDICATIONS FOR PATIENTS WHO HAVE RECEIVED THERAPY WITH RADIOACTIVE MATERIAL  
Patient: ______________________________________________________________________________  
has been administered radioactive material as part of the treatment of his/her  medical condition, as 
prescribed by Dr_______________________________________________________________________  
1.     The radioactive material is expelled within a matter of days, via the uri ne, faeces, sweat and saliva. 
For your safety and for the safety of those aroun d you, the following steps are recommended, as a 
minimum:  
DURING THE FIRST THREE DAYS:  
a) Keep at least one metre away from breastfeedin g mothers, children and pregnant women and spend 
as little time with them as possible. 
b) Sleep alone in a bed, though you may share a bedroom with others. 
c) Wash your clothes separately from th ose of the rest of your family. 
d) Avoid sexual relations. 
e) After using the toilet, flus h at least three times. 
f) Take the medicine as indicated by your doctor and attend medical appointments. 
g) Drink sufficient liquids. 
h) If you feel pain in your neck or any other discomfort please call your doctor.  
i) In the event of vomiting or any other eventual ity requiring medical attention, please contact  
your telephone helpdesk ______________________ , and speak to Dr _______________________  
for further instructions.  
j) Avoid public places and public transport.  
6. Concordance with international standards  
No concordance with international standards can be established, because no references were available 
when this standard was drawn up.  
7. Bibliography  
7.1 The International Commission on Radiological Protection. 2004. Release of Patients after Therapy with 
Unsealed Radionuclides. (ICRP Publicat ion 94)/Annals of the ICRP) 2004.  
7.2 The International Commission on Radiological Prot ection. 1977. The Handlin g, Storage, Use and 
Disposal of Unsealed Radionuclides in Hospitals and Medical Research Establishments. 46p. (ICRP 
Publication 25)/Annals of the ICRP 1 (2)1977. 
7.3 The International Commission on Radiological Pr otection. 1977. Recommend ations of the ICRP: 
Adopted January 17, 1977. 46p. (ICRP Public ation 26)/Annals of the ICRP 1 (3)1977.  
 
7.4 National Council on Radiation Protection and Measurements (EUA). 1970. Precautions in the 
Management of Patients who Have Received Therapeutic Amounts of Radionuclides. (NCRP Report No 37). 
7.5 Nuclear Regulatory Commission. EUA. 1997. Release of Patients Administered Radioactive Materials: 
Regulatory Guide 8.39. Wash ington, D.C, USNRC, 1997. 
7.6 National Council on Radiation Protection and Measurements (EUA). 1995. Dose Limits for Individuals 
who Receive Exposure from Radionuclide Therapy Patients. (NCRP Commentary No. 11). 
7.7  International Atomic Energy Agency. 1997.  Safe ty Series No 115.  International Basic Safety 
Standards for Protection against Ionising Radiation and for Safety of Radiation Sources.  IAEA, Vienna 1997.  
7.8  Mexico, Official Laws 1988.  General Regulation on R adiation Safety. Publis hed in the Official 
Gazette of the Federation on 22 November 1988.  7.9 United States of America, Official  Laws, 2005. Code of Federal Regula tions. Medical us e of Byproduct 
Material. 10CFR35.  
 
7.10 The International Commission on Radiological Protec tion 1987. Protection of the Patient in Nuclear 
Medicine. (ICRP Publicatio n 52) /Annals of ICRP 1987.  
7.11 National Council on Radiation Protection and Measurements (EUA). 1996. Sources and Magnitude of 
Occupational and public exposures from Nuclear Medicine Procedures. (NCRP report No 124).  
8. Conformity assessment  
8.1 Conformity with this Mexican Official Standard shal l be assessed by the Ministry of Energy via the 
National Committee for Nuclear Safety and Safeg uards and/or by the accred ited and authorised persons 
pursuant to the Federal Law on Metrology an d Standardisation and its implementing regulation.  
8.2 The conformity assessment shall include the following:  
 
8.2.1 Information. A documentary review shall be carried out on the information regarding the radioactive 
material administered for therapy and/or diagnosis.  
8.2.2 Patient instructions. It should be verified that instructions for patients who have been administered 
radioactive material for diagnosis are provided by the doctor specialising in nuclear medicine or the 
radiological safety officer. At least two such proc esses must be monitored to check that they are being 
followed correctly.  
8.2.3 Process of patient release. The release of at least two patients who have been administered 
radioactive material for the purposes of therapy must be monitored to ensure that the procedures are being 
followed correctly.  
8.2.4 Verification of equivalent dose rate. The process of verifying the equivalent dose rate at a distance of 
one metre from the patient at the time of the patient's release must be m onitored to ensure that it is being 
carried out correctly.  
9. Compliance  
This standard must be implemented throughout Mexican terri tory. The Ministry of Energy, via the National 
Committee for Nuclear Safety and Safeguards, wi ll be responsible for monitoring compliance.  
10. Entry into force  
This Mexican Official Standard amends and repl aces NOM-013-NUCL-1995, Radiological safety 
requirements for the release of pat ients who have been administered radioactive material, published in the 
Federation Official Gazette on 11 Janu ary 1999 and will enter into forc e 60 calendar days after publication 
as a Mexican Official Standard in  the Federation Official Gazette.  
Mexico, Distrito Federal, 12 June 2008 – Chairman of the National Advisory Committee for Nuclear Safety 
and Safeguards and Director-General of the National Committee nuclear and safeguards committee – Juan 
Eibenschutz H. – Signature.