prEN ISO 22532

SLOVENSKI STANDARD
01-junij-2025
Zdravstvena informatika - Identifikacija medicinskih izdelkov - Temeljno besedišče
(izrazi in definicije) za standarde IDMP (ISO/DIS 22532:2025)
Health informatics - Identification of medicinal products - Core vocabulary (terms and
definitions) for the IDMP Standards (ISO/DIS 22532:2025)
Medizinische Informatik - Identifikation von Arzneimitteln - Kernvokabular (Begriffe und
Definitionen) für die IDMP-Normen (ISO/DIS 22532:2025)
Informatique de santé - Identification des médicaments - Vocabulaire de base (termes et
définitions) pour les normes IDMP (ISO/DIS 22532:2025)
Ta slovenski standard je istoveten z: prEN ISO 22532
ICS:
01.040.11 Zdravstveno varstvo Health care technology
(Slovarji) (Vocabularies)
11.040.01 Medicinska oprema na Medical equipment in general
splošno
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 22532
ISO/TC 215
Health informatics — Identification
Secretariat: ANSI
of medicinal products — Core
Voting begins on:
vocabulary (terms and definitions)
2025-03-10
for the IDMP Standards
Voting terminates on:
ICS: 01.040.11; 35.240.80; 11.120.10
2025-06-02
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 22532:2025(en)
DRAFT
ISO/DIS 22532:2025(en)
International
Standard
ISO/DIS 22532
ISO/TC 215
Health informatics — Identification
Secretariat: ANSI
of medicinal products — Core
Voting begins on:
vocabulary (terms and definitions)
for the IDMP Standards
Voting terminates on:
ICS: 01.040.11; 35.240.80; 11.120.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 22532:2025(en)
ii
ISO/DIS 22532:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 Definitions .1
Bibliography .30

iii
ISO/DIS 22532:2025(en)
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.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of any patent
rights identified during the development of the document will be in the Introduction and/or on the ISO list of
patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment,
as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the
Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health Informatics.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at <>.

iv
ISO/DIS 22532:2025(en)
Introduction
The series of “Identification of Medicinal Products” (IDMP) consists in five international standards and
four technical specifications. When these documents were developed, a special attention was given to use
identical terms and definitions; in the meantime, successive revision of these documents has shown that it
becomes challenging to keep terms and definition perfectly aligned. Further in the meantime new technical
specifications have been developed or are in development, which will inherit IDMP core definitions.
IDMP core definitions are these which are used in at least three of the IDMP series of standards and
technical specifications. The need to group core definitions in one single international standard helps keep
the alignment of core definitions over the time and simplifies the work of all interested parties (standards
developers and implementers) since the core definitions are available in one single place.
If a term can designate more than one concept (homonymy), usually different concepts in different contexts,
the context for the given definition should be stated in conformance with the ISO/IEC Directives, part 2,
16.5.6. In that case the context should precede the definition text enclosed between angle parentheses
(). This indicates that the same term may occur in another context with another definition,
designating another concept, in the same document or in another document.
The International Organization for Standardization (ISO) draws attention to the fact that it is claimed that
conformity with this document may involve the use of a patent.
ISO takes no position concerning the evidence, validity and scope of this patent right.
The holder of this patent right has assured ISO that he/she is willing to negotiate licences under reasonable
and non-discriminatory terms and conditions with applicants throughout the world. In this respect, the
statement of the holder of this patent right is registered with ISO. Information may be obtained from the
patent database available at www.iso.org/patents.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights other than those in the patent database. ISO shall not be held responsible for identifying any or all
such patent rights.
v
DRAFT International Standard ISO/DIS 22532:2025(en)
Health informatics — Identification of medicinal products
— Core vocabulary (terms and definitions) for the IDMP
Standards
1 Scope
This document provides the comprehensive list of terms and definitions (“core definitions”) used in the
IDMP standards and their related standards and technical specifications.
The purpose is to provide a single reference to the core definitions in each of the IDMP standards and related
normative documents, as well as in technical reports.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
3.1 Definitions
3.1.1
adjuvant
component that potentiates the immune response to an antigen and/or modulates it towards the desired
immune response
3.1.2
administrable dose form
pharmaceutical administrable dose form
pharmaceutical dose form for administration to the patient
Note 1 to entry: Transformation of the manufactured items and their corresponding manufactured dose forms may be
necessary before administration.
Note 2 to entry: The administrable dose form is identical to the manufactured dose form in cases where no
transformation of the manufactured item is necessary [i.e. where the manufactured item is equal to the pharmaceutical
product]
— ("administrable dose form", "is a type of", "pharmaceutical dose form")
— ("administrable dose form", "is for", "administration to the patient")
— ("administrable dose form", "is equal to", "manufactured dose form ", "when", "no transformation")

ISO/DIS 22532:2025(en)
3.1.3
allergen
substance used as ingredient or in a device capable of stimulating a type-I hypersensitivity and allergic
reaction
Note 1 to entry: The active allergens are structurally diverse substance derived from biological matrices. In several
instances, if the allergenic protein responsible for the allergenic response has been isolated and characterised in the
majority of patients, then the substance is classified as protein.
— ("allergen", "is a type of", "material")
— ("allergen", "used as", "ingredient or in a device")
— ("allergen", "capable of", "stimulating a type-I hypersensitivity")
— ("allergen", "capable of", "stimulating an allergic reaction")
— ("allergen", "is derived from", "biological matrices")
— ("allergen", "is classified as", "protein")
3.1.4
co-crystals
homogenous (single phase) crystalline structures made up of two or more components in a definite
stoichiometric ratio where the arrangement in the crystal lattice is not based on ionic bonds
Note 1 to entry: Over the last decade, co-crystals have gained considerable attention as alternative solid-state forms
in drug development. By making co-crystals of pharmaceutically interesting substances, their solid state properties
such as solubility, hygroscopicity and stability may be improved as well as manufacturing behaviour (e.g., compaction,
flowability, filterability, etc.). The salt formation is already widely used for this purpose, but with co-crystal formation
this can now be achieved also for substances that lack the possibility of salt formation. A principal tool is the hydrogen
bond, which is responsible for the majority of directed intermolecular interactions in molecular solids. Co-crystals are
multi-component crystals based on hydrogen bonding interactions without the transfer of hydrogen ions to form salts;
this is an important feature, since bronsted acid-base chemistry is not a requirement for the formation of a co-crystal.
— ("co-crystals", "are", "homogenous crystalline structures")
— ("co-crystals", "made up
...