Dosimetry and related protocols in
medical applications of ionizing
radiation
ISO/TC 085/SC 02/WG 22
Date: Doc. Number: 2014-01-27
N 0020
Assistant:
Malika BELKEBIR
Direct line :
[email protected]
Your contact:
Laurence THOMAS
Direct line : +33 1 41 62 83 70
[email protected]
ISO/NWIP 19461 Measurement for the
clearance of waste contaminated with
radioisotopes for medical application
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For information
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Association Française de Normalisation 11, rue Francis de Pressensé F-93571 La Plaine Saint-Denis Cedex
http://www.afnor.fr SIRET 775 724 818 00205
NEW WORK ITEM PROPOSAL
Closing date for voting
2013-12-07
Date of circulation
2013-09-07
Secretariat
AFNOR
Reference number
(to be given by the Secretariat)
ISO/TC 85 / SC 2 N 1359
Proposal for new PC
A proposal for a new work item within the scope of an existing committee shall be submitted to the secretariat of that committee with a copy to
the Central Secretariat and, in the case of a subcommittee, a copy to the secretariat of the parent technical committee. Proposals not within the
scope of an existing committee shall be submitted to the secretariat of the ISO Technical Management Board.
The proposer of a new work item may be a member body of ISO, the secretariat itself, another technical committee or subcommittee, or
organization in liaison, the Technical Management Board or one of the advisory groups, or the Secretary-General.
The proposal will be circulated to the P-members of the technical committee or subcommittee for voting, and to the O-members for information.
IMPORTANT NOTE: Proposals without adequate justification risk rejection or referral to originator.
Guidelines for proposing and justifying a new work item are contained in Annex C of the ISO/IEC Directives, Part 1.
Proposal (to be completed by the proposer)
Title of the proposed deliverable.
(in the case of an amendment, revision or a new part of an existing document, show the reference number and current title)
English title
Radiological protection - Measurement for the clearance of waste contaminated with radioisotopes for
medical application
French title
Radioprotection - Mesurage pour la libération des déchets contaminés par des radioisotopes lors des
applications médicales
(if available)
Scope of the proposed deliverable.
This project contains the measurement method, procedure and condition to decide the storage time for clearance level based
on the duration of storage for decay derived from initial activity concentration of the waste and half-lives of radioisotopes
contained in the waste stream, and IAEA limiting values for clearance.
The main subjects of the proposal are;
- Terms and definitions,
- Measurement method and procedure,
- Determination of decay storage time for clearance of each kind of radioactive wastes and radionuclides,
- Requirements (half-lives of radioisotopes, initial condition and activity concentration and storage condition), and
- Correction factors, documentation and reporting, specification of measurement, uncertainty, record keeping, quality
assurance and control.
FORM 4 (ISO) v. 2012
Page 1 of 3
New work item proposal
Purpose and justification of the proposal.
The amount of disposable radioactive wastes in the hospital have been increased due to development of medical diagnosis
and therapy rapidly. It contains very short lived radioisotopes, and generated mainly caused by PET/CT using F-18, Tc99m, etc,.
IAEA proposed criteria for clearance level of waste to cope with the above situation witch are based on the individual
(10μSv/y) and collective dose (1man-Sv/y), and concentration of each nuclides (IAEA Safety Series No 111-P-1.1,
Application of exemption principles to the recycle and reuse of materuials from nuclear facilities, 1992, IAEA RS-G-1.7,
Application of the concepts of exclusion, exemption and clearance, 2004).
However, IAEA criteria require evaluation of dose or concentration on a case by case, it is not easy to apply IAEA methods
practically. Therefore, the most countries apply simpler way depend on storage time.
That is, the most advanced countries apply the method of introducing minimum storage time for decay to the wastes
containing only very short lived radioisotopes instead of direct application of IAEA criteria. Therefore, it is needed to
decide minimum storage time depend on suitable measurement for each radionuclide and waste
With regard to the above situation, this project proposes measuring method, procedure and condition to decide of storage
time for clearance level of radioactive waste contaminated with radioisotopes in the hospital.
If a draft is attached to this proposal,:
Please select from one of the following options (note that if no option is selected, the default will be the first
option):
Draft document will be registered as new project in the committee's work programme (stage 20.00)
Draft document can be registered as a Working Draft (WD – stage 20.20)
Draft document can be registered as a Committee Draft (CD – stage 30.00)
Draft document can be registered as a Draft International Standard (DIS – stage 40.00)
Is this a Management Systems Standard (MSS)?
Yes
No
Indication(s) of the preferred type or types of deliverable(s) to be produced under the proposal.
International Standard
Technical Specification
Proposed development track
 1 (24 months)
Publicly Available Specification
2 (36 months - default)
Technical Report
3 (48 months)
Known patented items (see ISO/IEC Directives, Part 1 for important guidance)
Yes
No
If "Yes", provide full information as annex
A statement from the proposer as to how the proposed work may relate to or impact on existing work, especially
existing ISO and IEC deliverables. The proposer should explain how the work differs from apparently similar work,
or explain how duplication and conflict will be minimized.
The NWIP contains measurement method and procedure for the clearance of waste contaminated with radioisotopes for
medical appliaction. This kind of standard has not been published as ISO and IEC standard. Therefore, it does not relate to
or impact on existing work, and not be duplicated and conflicted with others.
A listing of relevant existing documents at the international, regional and national levels.
IAEA Safety Series No 111-P-1.1, Application of exemption principles to the recycle and reuse of materials from nuclear
facilities, 1992
IAEA RS-G-1.7, Application of the concepts of exclusion, exemption and clearance, 2004
Draft ISO 19017 Guide for Gamma Spectrometry Measurement of Radioactive Waste (developed within
ISO/TC85/SC5/WG13)
A simple and concise statement identifying and describing relevant affected stakeholder categories (including small
and medium sized enterprises) and how they will each benefit from or be impacted by the proposed deliverable(s)
The NWIP can be applied in field of radioactive waste control in the hospital. This standard is expected to simplfy the
radiation work for disposal of radioactive waste. Therefore, their radiation working time and radiation exposur will be
reduced.
FORM 4 (ISO) v. 2012
Page 2 of 3
New work item proposal
Liaisons:
Joint/parallel work:
A listing of relevant external international organizations
or internal parties (other ISO and/or IEC committees) to
be engaged as liaisons in the development of the
deliverable(s).
Possible joint/parallel work with:
IAEA
IEC
(please specify committee ID)
CEN
(please specify committee ID)
Other
(please specify)
A listing of relevant countries which are not already P-members of the committee.
None
Preparatory work (at a minimum an outline should be included with the proposal)
A draft is attached
An outline is attached
An existing document to serve as initial basis
The proposer or the proposer's organization is prepared to undertake the preparatory work required
Proposed Project Leader (name and e-mail address)
Changbum KIM, Professional Engineer
Korea Institute of Nuclear Safety, 19 Gusung-dong Yusunggu, 305-338 Daejeon (Korea)
[email protected]
Yes
No
Name of the Proposer
(include contact information)
Seong, Si-Heon
Administrator
Korean Agency for Technology and Standards
Supplementary information relating to the proposal
This proposal relates to a new ISO document;
This proposal relates to the amendment of existing ISO document
This proposal is for the revision of an existing ISO document;
This proposal relates to the adoption as an active project of an item currently registered as a Preliminary Work Item;
This proposal relates to the re-establishment of a cancelled project as an active project.
Other:
Annex(es) are included with this proposal (give details)
FORM 4 (ISO) v. 2012
Page 3 of 3
New Work Item Proposal
Measurements for the clearance of waste contaminated with radioisotopes for medical
application
CONTENTS
Forward
Introduction
1. Scope
2. Normative references
3. Terms, definitions and symbols
4. Fundamentals
4.1 Radioisotopes for in-vivo, in-vitro and research
4.2 Classification and characteristics of radioactive waste
4.3 Clearance level
5. Measurement method and procedure
6. Requirements
6.1 Initial condition
6.2 Storage of radioactive waste
6.3 Disposal method
7. Uncertainty
8. Quality control
9. Documentation and reporting
Annex A (informative) Example of the procedure for clearance of radioactive waste
Bibliography
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
The main task of technical committees is to prepare International Standards. Draft International
Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies
casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO XXXXX was prepared by Technical Committee ISO/TC 85, Nuclear energy, nuclear technologies, and
radiological protection, Subcommittee SC 2, Radiological protection, Working Group WG XX.
ISO XXXXX consists of the following parts, under the general title Measurements for the clearance of
waste contaminated with radioisotopes for medical application.
⎯Part 1: Radioactive waste for in-vivo and in-vitro
⎯Part 2: Radioactive waste for research
Annex A of this part of ISO XXXXX is for information only.
Introduction
This part of ISO XXXXX addresses method of radioactivity measurement, procedure of determining
storage period and condition for the clearance of waste contaminated with radioisotopes for medical
application based on the initial condition of each type of waste and equation of obtaining radioactivity
from counting measurement using the detector. From the equation, the appropriate duration of storage
for the radioactive waste before final disposal can be evaluated.
The amounts of radioactive wastes which are disposed after their use in the hospital have been
increased rapidly due to the development of various technologies applied for the diagnosis and radiation
treatment using the nuclear medicine. Most of the nuclear medicines are radioisotopes with short halflife such as 18F or 99mTc used in PET/CT diagnosisetc, but their types and numbers used in the hospital
are so numerous that the disposal of the remaining radioisotopes after use of the nuclear medicine
becomes a serious concern.
IAEA proposed criteria for the clearance level of radioactive waste depending on the individual dose (10
μSv/y),the collective dose (1 man-Sv/y) and the concentration of each nuclides (IAEA Safety Series No
111-P-1.1, Application of exemption principles to the recycle and reuse of materials from nuclear
facilities, 1992, IAEA RS-G-1.7, Application of the concepts of exclusion, exemption and clearance, 2004)
and methods of determining the clearance level from the criteria by evaluating of dose or concentration
of the radioactive waste on a case by case basis.
However, IAEA methods is so complicate for the practical application that the most countries use an
alternative method of determining the minimum storage time based on the measurement of
radioactivity and the radioactive decay for the mainly short-lived radioactive wastes instead of direct
application of IAEA criteria. Therefore, the measurement of radioactivity becomes more significant in
obtaining the accurate minimum storage time for each radioactive waste before its disposal.
By taking the current situation regarding the clearance level into account, this document proposes
measurement methods of establishing an appropriate clearance level for the radioactive wastes
contaminated with radioisotopes after their use in the hospital.
1. Scope
This part of ISO XXXXX establishes method of radioactivity measurement and determination of storage
periods of the radioactive wastes produced as a result of the medical application of the radioisotopes
based on the counting measurement using the detector and decay correction from initial activity
concentration of the radioisotopes contained in the waste stream.It provides a set of control and
measurement for the self-clearance of the radioactive wastes by which the hospital can assure to meet
the clearance level. This International Standard may also be of use for the guidance to the regulatory
body.
2. Normative references
The following normative document contains provisions which, through reference in this text, constitute
provisions of this part of ISO XXXXX.
2.1 IAEA Safety Series No 111-P-1.1, Application of exemption principles to the recycle and reuse of
materials from nuclear facilities, 1992
2.2 IAEA RS-G-1.7, Application of the Concepts of Exclusion, Exemption and Clearance
2.3 ISO 11932, Activity measurements of solid materials considered for recycling, reuse or disposal as
non-radioactive waste
3. Terms, definitions and symbols
3.1 Clearance level
3.2 Decay
3.3 Medical application
3.4 Waste
3.5 In-vivo and in –vitro
3.6 Radioactive waste
3.7 Storage container
3.8 Unsealed source
3.9 Radio isotopes
3.10 Multi-channel analyzer
3.11 Gamma counter
3.12 Solution
3.13 Detergent
3.14 Calibration factor
4. Fundamentals
4.1 Radioisotopes for in-vivo, in-vitro and research
This part introduces the usage, kind and specification of radioisotopes used in the in –vivo, in-vitro and
research briefly.
4.2 Classification and characteristics of radioactive waste
This part addresses
-
The characteristics of the radioisotope used in medical application,
-
Types and characteristics of radioactive waste and
-
Classification of radioactive waste by types and radioisotopes
4.3 Clearance level
This part specifies the clearance level referenced to the IAEA RS-G-1.7 “Application of the concepts of
exclusion, exemption and clearance”.
5. Measurement method and procedure
This part addresses method of radioactivity measurement and procedure of determining storage timed
for the radioactive waste used for the medical purposes in the hospital.
Since there are several types, shapes and volumes of the containers used as nuclear medicines in the
hospitals, it is not practically possible to measure the activities of the radioisotopes left over in all the
containers after use in order to classify as a radioactive waste. Therefore, it is reasonable to select the
containers being mostly used and measure the activities of the remaining radioisotopes using the
certified reference materials (CRM) disseminated by the national standard laboratory. The radioactive
solutions being used mostlyinclude125I, 18F, 32P, 35S, 51Cr, 67Ga, 85Sr, 123I, 124I, 131I, 166Ho and 201Tl. The
measurement protocol is as follows;
1) Currently, the container of125I is a small tube and the activity of the remaining solution has been
measured using gamma counter. For the measurement of activity of 125I, the same size and
shape of125I CRM, specially manufactured by the primary standard institution, will be used. The
number of count measurement can be more than five. The specific activity of the sample is
given by the following equation.
Specific activityA
=
Then, the time taken from the current magnitude of specific activity to that of the clearance
level ACL (usually 100 Bq/g) is obtained from the relation of decay correction ACL = A (1/2)n as n
= ln (ACL / A) / ln (0.5). The storage time can be determined as the multiplication of safety factor
(1.2) to this time n, i.e.
.
2) For the activity measurement of the other radioactive remnants, it can be recommended to use
Marinelli beaker type CRM and multichannel analyzer (MCA) with the following procedure. The
remaining solution of the several radioisotopes will be collected with the container into the
aqueous solution of the other Marinelli beaker whose dimension is same with that of CRM. The
bottles containing the remaining radioisotopes will be submerged into the solution and the
radioisotopes will be mixed with the solution. Since the radioisotopes are not soluble, the total
activity of the remnants in the solution will not change. The reason for submerging the several
types of bottles of the radioisotopes into the aqueous solution is because the CRM is a
homogenous radioactive material. In order to measure the total activity of the Marinelli beaker
containing several kinds of radioisotopes accurately, this beaker should be approximated as
homogeneous as it can be and using the aqueous solution is one of the best option to
accomplish this purpose.
The measurement of the total activity of the Marinelli beaker is analogous to the activity
measurement of125I with the difference of using Marinelli beaker type CRM and MCA for the
activity measurement. The uncertainty budget is also similar to that of 1).
The storage time may also be determined by the same process as in 1).
6. Requirements
6.1 Initial condition
This part addresses the initial condition of the radioactive waste to be stored for clearance level in the
hospital. The initial condition may contain kind, content, shape, hot spot and residual activity of each
types of the radioactive waste.
6.2 Storage of radioactive waste
This part addresses the specification of storage container and facility, procedure for storing the
radioactive waste, determination of storage periods of the radioactive waste, and sign and marking.
6.3 Disposal method
This part addresses statement concerning disposal method of the radioactive waste; confirmation of the
condition of the radioactive waste and procedure for disposal. Disposal of the radioactive waste shall be
separated for storage or incineration as other ordinary industry waste.
7
Uncertainty
The uncertainty budget for the determination of storage period consists of the uncertainty of measuring
devices, the uncertainty of count measurement, the uncertainty of used certified reference
material(CRM) for the measurement, the efficiency of the detector and the uncertainty of the safety
factor.
8
Quality control
Quality assurance program of this part may refer to ISO 9001.
9
Documentation and reporting
All the information regarding the radioactive waste shall be recorded from generation to final disposal
and reported properly. This part addresses the all the items to be recorded and reported including
standard format and content of the documents.
Annex A. (Informative)
Example of the procedure for clearance of radioactive waste
1.0 Purpose
The purpose of this annex is to establish and generalize the procedure for the clearance of the
radioactive waste from the medical application of the radioisotopes in the hospital by adopting the
developed procedure to the clearance of the radioactive wastes generated by some of the radionuclides
currently used as nuclear medicines in the Seoul National University Hospital and Korea Cancer Center
Hospital.
2.0 Scope of application
2.1 This procedure shall be applied to the following radionuclides appeared in Table 1.
-I-125, I-131, Mo-99, Tc-99m, Sr-89, Ga-67, Tl-201
2.2 This procedure shall be applied to the process from the generation of the radioactive waste as a
result of the use of radioactive isotope to the stage of clearance.
2.3 The types of the radioactive waste to be released from the regulatory control under this procedure
are as follows.
- Bead
- Coating tube, PPT
- Vial (I-125, I-131, Tc-99m, Sr-89, Ga-67, Tl-201, etc.)
- Mo-99 column
- Syringes
- Other contaminated materials
3.0 Definition of terms
Definitions of terms used in this procedure are as follows.
3.1 “Collection” refers to collecting waste furnished in the facilities.
3.2 “Collection bag” refers to the bags used for collecting waste in the facilities.
3.3 “Collection container” refers to the containers furnished in the facilities; collection bag is put into
the collection container after use.
3.4 “Storage” refers to storing the radioactive waste in a certain facility, which is segregated for the
purpose of decaying the radioactivity of the waste until the point of clearance.
4.0 Tasks
4.1 President of hospital
He or she shall preside over all the activities related to the process of clearing the radioactive waste and
will be responsible for all aspects of management.
4.2 Radiation safety officer
a. He or she shall establish, direct, and proctors the plans for the clearance of the radioactive waste, and
will report the results of clearance to the President of Hospital.
b. He or she shall assure the details related to the clearance of radioactive waste and maintain
appropriate records.
5.0 Collection of radioactive waste
5.1 Radioactive waste generated from the use of radioisotope shall be put into collection bags furnished
in the facilities at the time of generation.
5.2 A collection bag for the radioactive waste shall be checked for leakage before it is used, and the date
of the commencement of its use shall be recorded.
6.0 Methods of collecting waste
6.1 When the radioactive waste is collected, the waste shall be classified by the radionuclides and types.
6.2 When only a small amount of the radioactive waste is generated, the waste can be stored together
with the waste of the radionuclides whose storage period is similar while the period is categorized in
Table 1. Note that in this case, the longest storage period of the radionuclide shall be applied.
7.0 Collection bag and collection container for radioactive waste
7.1 Collection bag and collection container for the radioactive waste shall be made of substances that
are spill-proof or non-corrodible.
7.2 The size of the collection bag shall be large enough to be able to be used for a long time, and the
collection container shall be sufficiently large to contain many collection bags.
7.3 The collection container shall not be easily overturned, and shall have a cover so that the container
can be closed when it is not in use.
7.4 On a collection bag, a sign such as “Attached Tag 1” shall be affixed and on a collection container a
sign such as “Attached Tag 2” shall be affixed.
8.0 Categorization of collection container
8.1 Taking the types of the radioactive wastes into account, an adequate quantity of collection
containers shall be furnished in the facilities.
8.2 The code number categorized in Table 1 shall be assigned to the collection containers, and the
number shall be marked firmly in order not to be erased easily.
9.0 Storage of collection bag of radioactive waste
9.1 When the bag is filled up with radioactive waste, the opening of the collection bag shall be sealed
and the date of sealing, anticipated date of clearance, volume, and surface dose rate shall be recorded
on the “Attached Tag 1”after measurement of the total radioactivity of the bag. The tag shall then be
attached onto the collection bag.
9.2 The sealed collection bags will be delivered to the waste storage facilities and stored according to
the type of radioactive waste.
9.3 Collection bags will be stored according to the order of its generation so that FIFO (first-in, first-out)
is possible.
10.0 Clearance of waste
10.1 When the storage period of the radioactive waste designated in Table 2 according to the type of
the radioactive waste draws to a close, a plan named “Plan for Clearance of Radioactive Waste” for the
radioactive waste subject to be cleared shall be submitted to the President of hospital. If there is no
request for supplementing the plan for clearance from the President, the waste can be cleared after one
month following the submission of the plan.
10.2 For the clearance, the surface dose rate shall be measured to ensure that the dose rate be less or
equal to the level of natural radioactivity. In measuring the dose rate, the caution is required that the
detector be not affected by the radioactive waste in the vicinity.
10.3 For the clearance, tags of collection bags shall be removed.
11.0 Records related to clearance
Records related to the clearance shall be made using the tag in Table 3 and shall be kept for 5 years from
the date of clearance.
[Table 1]Methods of assigning codes for each type of radionuclide and waste
Code classification of
Radionuclide
Type of Waste
Assorted code number
radionuclide
I-125
I
Vial
1
I-131
E
Syringe
2
Mo-99
M
Tube
3
Tc-99m
T
Bead
4
Ga-67
G
Column
5
Sr-89
S
Cup
6
Tl-201
L
Solid waste
7
Example) In case of Sr-89 syringe; S-2
In case of I-125 tube; I-3
[Table 2]Date when clearance is possible by type of nuclide and waste
Code classification
Nuclide
Type of Waste
Storage period
I-4
I-125
Bead
22 months
I-1
I-125
Vial
8 months
T-2
Tc-99m
Syringe
1 week
Remark
[Table 3]Form for Record of Clearance
Content: vial
Bibliography
note
Attached Tag 2. Sign for collection container
Code Number: I-1
Confirmation
Surface Dose: (Measurement Date: )
method
Volume:
Surface dose
Anticipated Date:
Date
Clearance:
clearance
Surface dose
Date of Seal:
Date
Date of Generation:
Volume
Content
(Types of waste)
Radionuclide
Source of generation
Date of generation
Serial number
Attached Tag 1. Sign for collection bag
Code Classification: I-1-97-001
seal