Nederlandse
voornorm
NVN-ISO/TS 20225 (en)
Benamingen voor medische apparatuur
met als doel een gereglementeerde
gegevensuitwisseling
(ISO/TS 20225:2001,IDT)
Global medical device nomenclature for the purpose of regulatory data
exchange (ISO/TS 20225:2001,IDT)
Vervangt ENV 13004:1999
Als Nederlandse voornorm is aanvaard:
- ISO/TS 20225:2001,IDT
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Normcommissie 301 002 "Medische hulpmiddelen"
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maart 2002
ICS 01.040.11; 11.040.01
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ISO/TS
20225
TECHNICAL
SPECIFICATION
First edition
2001-11-01
Nomenclature globale des dispositifs médicaux destinée à l'échange de
données réglementtaires
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Global medical device nomenclature for the
purpose of regulatory data exchange
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Reference number
ISO/TS 20225:2001(E)
© ISO 2001
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ISO/TS 20225:2001(E)
PDF disclaimer
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that a problem relating to it is found, please inform the Central Secretariat at the address given below.
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© ISO 2001
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic
or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body
in the country of the requester.
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© ISO 2001 – All rights reserved
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ISO/TS 20225:2001(E)
Foreword
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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.
In other circumstances, particularly when there is an urgent market requirement for such documents, a technical
committee may decide to publish other types of normative document:
or
an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in an
ISO working group and is accepted for publication if it is approved by more than 50 % of the members of the
parent committee casting a vote;
—
an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical
committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting a
vote.
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An ISO/PAS or ISO/TS is reviewed after three years with a view to deciding whether it should be confirmed for a
further three years, revised to become an International Standard, or withdrawn. In the case of a confirmed ISO/PAS
or ISO/TS, it is reviewed again after six years at which time it has to be either transposed into an International
Standard or withdrawn.
Attention is drawn to the possibility that some of the elements of this Technical Specification may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
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ISO/TS 20225 was prepared by the European Committee for Standardization (CEN) in collaboration with Technical
Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices, in
accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
Throughout the text of this document, read "...this Report..." to mean "...this Technical Specification...".
© ISO 2001 – All rights reserved
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iii
ISO/TS 20225:2001(E)
Foreword
This CEN Report was prepared by CEN/TC 257, Symbols and information
provided with medical devices and nomenclature for regulatory data
exchange, the secretariat of which is held by SFS, in collaboration with
ISO/TC 210, Quality management and corresponding general aspects for
medical devices.
This is a first edition, so no other documents are superseded.
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This document was prepared by CEN/TC 257/SC1, Identification, coding,
Nomenclature and regulatory data sets for medical devices, in collaboration
with ISO/TC 210, Quality management and corresponding general aspects for
medical devices
Annex A is for information only.
This CEN Report contains a Bibliography.
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© ISO 2001 – All rights reserved
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ISO/TS 20225:2001(E)
Introduction
This technical report contains the Nomenclature for medical devices for the
purpose of regulatory data exchange. Whereas the nomenclature may be
useful for other purposes, it is designed and was developed for regulatory
data exchange, such as vigilance reporting, tracking of medical device safety.
It may also have other applications such as regulatory registrations.
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Generic device groups have been identified for those devices which are
characterised as devices in regulations of all the various jurisdictions as the
laws relevant to medical devices define them. However, some jurisdictions
may not consider a particular device to be a medical device for their
respective jurisdiction.
Simply because the device is listed in this
nomenclature does not necessarily mean it is a medical device in every
jurisdiction.
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This technical report includes the complete nomenclature at the time of
publication. Medical devices are listed alphabetically by their generic device
group name with the respective code and definition. Additionally, synonyms
for medical devices make reference to the appropriate generic device group.
For details of the complete structure, please refer to EN ISO 15225
Specification for a nomenclature system for medical devices for the purpose
of regulatory data exchange. It is anticipated that the report will be available in
due course from standards organisations as an image file on digital media.
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A Maintenance Agency is being established to meet the need for timely
consideration of new terms and definitions or revisions of current terms and
definitions. New terms will be accepted periodically as required and the list in
this report may not be fully up to date. Please refer to supplements issued
periodically by the Agency to ensure that you have the most up to date
version.
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The nomenclature will also be available in an electronic format, for example in
digital format as an image file. The electronic format will conform to EN ISO
15225, however it will be updated more frequently than this report.
For more information regarding this process, other information such as a
current list of database licensees and official translations, or advice and help
with new terms, contact the Global Medical Device Nomenclature
Maintenance Agency. Find details about the Agency on:
< http://www.bsi-global.com/gmdn >
or contact your local standards authority.
© ISO 2001 – All rights reserved
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ISO/TS 20225:2001(E)
1
Scope
This Report lists terms, definitions and codes for medical devices; the listing is
structured such that it can be used for the purpose of regulatory data
exchange.
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© ISO 2001 – All rights reserved
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ISO/TS 20225:2001(E)
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Listing of the Global Medical Device Nomenclature
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© ISO 2001 – All rights reserved
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30368 Immunochemistry reagents, fertility/pregnancy hormones/proteins, 17-ketogenic steroid kit. A kit is one or more items provided as a single unit for use in
combination to achieve the intended use of the device.
30369 Immunochemistry reagents, fertility/pregnancy hormones/proteins, 17-ketosteroid kit. A kit is one or more items provided as a single unit for use in combination
to achieve the intended use of the device.
17-ketogenic steroid kit
17-ketosteroid kit
38540 Clinical chemistry reagents, enzymes, 5' nucleotidase kit. A kit is one or more items provided as a single unit for use in combination to achieve the intended use
of the device.
41689 Immunochemistry reagents, drugs of abuse/toxicology, toxicology, calibrator for 5-aminolevulinate dehydratase. A calibrator is any substance, material or article
intended by its manufacturer to be used to establish the measurement relationships of a device.
41690 Immunochemistry reagents, drugs of abuse, toxicology, toxicology, control for 5-aminolevulinate dehydratase. A control is a substance, material or article
intended by its manufacturer to be used to verify the performance characteristics of the device.
30438 Immunochemistry reagents, drugs of abuse/toxicology, toxicology, kit for 5-aminolevulinate dehydratase. A kit is one or more items provided as a single unit for
use in combination to achieve the intended use of the device.
38171 Immunochemistry reagents, tumour markers, calibrator for 5-HIAA. A calibrator is any substance, material or article intended by its manufacturer to be used to
establish the measurement relationships of a device.
38170 Immunochemistry reagents, tumour markers, other tumour markers, control for 5-HIAA. A control is a substance, material or article intended by its manufacturer
to be used to verify the performance characteristics of the device.
30298 Immunochemistry reagents, tumour markers, kit for 5-HIAA. A kit is one or more items provided as a single unit for use in combination to achieve the intended
use of the device.
30862 Synonym for: Analyser, haematology, cell-differential
30267 Synonym for: Alpha1-acid glycoprotein kit
41506 Synonym for: Training aid, communication, abacus
32234 Synonym for: Binder, abdominal
39431 Synonym for: Haemoglobin subtype kit
41262 Haematology/histology/cytology, immunohaematology, ABO typing, ABO cells, calibrator for ABO grouping cells. A calibrator is any substance, material or
article intended by its manufacturer to be used to establish the measurement relationships of a device.
41263 Haematology/histology/cytology, immunohaematology, ABO typing, ABO cells, control for ABO grouping cells. A control is a substance, material or article
intended by its manufacturer to be used to verify the performance characteristics of the device.
5'-nucleotidase kit
5-aminolevulinate dehydratase calibrator
5-aminolevulinate dehydratase control
5-aminolevulinate dehydratase kit
5-hydroxyindoleacetic acid calibrator
5-hydroxyindoleacetic acid control
5-hydroxyindoleacetic acid kit
5 part differential low/medium end blood cell
counter
a1-acid glycoprotein
Abacus
Abdominal binder
Abnormal hemoglobin quantitation
ABO grouping cell calibrator
ABO grouping cell control
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38635 Synonym for: Binocular vision test unit
4-dot binocular vision test
© ISO 2001 – All rights reserved
30861 Synonym for: Analyser, haematology, cell-differential
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2,4-dinitrophenylhydrazine, lactate dehydrogenase 31371 Synonym for: Lactate dehydrogenase kit
39922 Synonym for: Nitrogen kit
30324 Immunochemistry reagents, fertility function hormones/proteins, 17 OH progesterone kit. A kit is one or more items provided as a single unit for use in
combination to achieve the intended use of the device.
17-hydroxyprogesterone kit
2,4-dinitrofluorobenzene (spectroscopic), nitrogen
(amino-nitrogen)
30367 Immunochemistry reagents, fertility/pregnancy hormones/proteins, 17-hydroxy-ketosterone kit. A kit is one or more items provided as a single unit for use in
combination to achieve the intended use of the device.
17-hydroxyketosterone kit
ISO/TS 20225:2001(E)
38956 Synonym for: Free tyrosine kit
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41265 Haematology/histology/cytology, immunohaematology, ABO typing, calibrator for ABO sera. A calibrator is any substance, material or article intended by its
manufacturer to be used to establish the measurement relationships of a device.
41266 Haematology/histology/cytology, immunohaematology, ABO typing, control for ABO sera. A control is a substance, material or article intended by its
manufacturer to be used to verify the performance characteristics of the device.
30597 Haematology/histology/cytology, immunohaematology, ABO typing, kit for ABO sera. A kit is one or more items provided as a single unit for use in combination
to achieve the intended use of the device.
32677 Synonym for: Metreurynter
38811 Synonym for: Prosthesis, external, arm, transhumeral
ABO serum calibrator
ABO serum control
ABO serum kit
Abortion system, metreurynter-balloon
Above-elbow prosthesis
38669 Synonym for: Prosthesis, external, leg, trans-femoral
38933 Synonym for: Absorbent, carbon dioxide
36051 An absorbent material, e.g. soda lime, placed into an anaesthesia system carbon dioxide absorber to remove carbon dioxide from the exhaled gases in the
patient breathing circuit by chemical reaction. This device is single use.
17803 A device that is a chemical product used for the treatment of infectious liquid body spills, e.g. blood, vomit or urine, from human beings or animals. It is provided
in liquid (sprays), powder, or granulated form; it absorbs, encapsulates, and disinfects the waste to render it harmless. The liquid waste is solidified as a final
product and can thereafter be treated as ordinary waste.
33531 A device made of paper or cotton used to absorb moisture from the oral cavity during dental procedures. This device is single use.
38777 A non-medicated absorbent point used in endodontic procedures that has been sterilized once in a manner approved by the manufacturer.
42418 A device designed as a container used to hold an appropriate absorbent and which is installed into a circuit or system where one or more undesirable elements
are extracted using this device. This will typically be a gas, e.g. carbon dioxide removal from an anaesthesia breathing circuit.
Template for: Absorber, carbon dioxide, reusable
Absorber, carbon dioxide, single use
Absorber, halogenated vapour
17616 Synonym for: Absorber, <specify>
31241 Synonym for: Absorber, carbon dioxide, <specify>
42415 A container used for the removal of carbon dioxide gas. It will typically be used in an anaesthesia system breathing circuit. This device can be reusable
(refillable with a carbon dioxide absorbent) or single use (a prepackaged disposable container). Its design will be compatible to the parent device with which it is
to be used.
Template for: Absorber, carbon dioxide, reusable
Absorber, carbon dioxide, single use
37022 A refillable container used in an anaesthesia system breathing circuit for the removal of exhaled carbon dioxide. This device is refilled with an appropriate
carbon dioxide absorbent and can be reused after the required hygienic procedures have been followed.
42414 A prepackaged container in an anaesthesia system breathing circuit for carbon dioxide absorbent. It is installed within the breathing circuit to remove exhaled
carbon dioxide. This device is single use.
Absorbent, carbon-dioxide
Absorbent, carbon dioxide
Absorbent, infectious waste
Absorbent, saliva
Absorbent point, dental
Absorber, <specify>
Absorber, anaesthesia unit
Absorber, carbon-dioxide
Absorber, carbon dioxide, <specify>
Absorber, carbon dioxide, reusable
Absorber, carbon dioxide, single use
© ISO 2001 – All rights reserved
40532 A device designed to absorb (to draw into itself) another product that usually is not desired and needs to be removed. When the absorbent is saturated, it will
usually be discarded.
Template for: Absorbent, carbon dioxide
Absorbent, infectious waste
Absorbent, saliva
Absorbent, <specify>
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35702 A strip of dental material coated with abrasive particles on one or both sides used for modifying the surface of a tooth or restoration.
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Above-knee prosthesis
30596 Haematology/histology/cytology, immunohaematology, ABO typing, ABO cells, kit for ABO grouping cells. A kit is one or more items provided as a single unit
for use in combination to achieve the intended use of the device.
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ISO/TS 20225:2001(E)
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40044 Synonym for: Absorbent, saliva
17152 Synonym for: Radionuclide system, diagnostic, bone absorptiometer
17150 Synonym for: Radionuclide system, diagnostic, bone absorptiometer
17151 Synonym for: Radionuclide system, diagnostic, bone absorptiometer
Absorber, saliva, paper
Absorptiometer
Absorptiometer, dual-photon
Absorptiometer, single-photon
17747 Synonym for: X-ray system, diagnostic, bone absorptiometer, dual-energy
Absorptiometer, X-ray, dual-energy
37907 Synonym for: Phantom, diagnostic imaging, <specify>
36489 A therapeutic accelerator where excited particles, usually electrons, are accelerated by using, e.g. microwaves in an evacuated tube which can be released
directly, or can produce x-rays (decelerated radiation), or by using a strong magnetic field to produce a non-linear acceleration path for particles accelerated in
an alternating electric field. The output is used as a treatment beam on the patient, either directly or after passing a suitable target.
Template for: Accelerator system, application program software
Accelerator system, linear
Accelerator system, non-linear
Accelerator system, operating system software
Accelerator system, stereotactic radiosurgery
40886 An individual software program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities
to a medical accelerator system configuration. A basic set of applications programs and routines are included with such computer controlled therapy systems
and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must
be combined specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically
identified by a proprietary name and "version" or "upgrade" number.
35159 A therapeutic system that produces high-energy electrons which in turn can produce high-energy x-rays. It provides a uniform radiation field of uniform intensity
and predictable energy level, in a beam with well-defined dimensions. The principle of operation is linear acceleration of electrons by means of electromagnetic
microwaves. The output is used as a treatment beam on the patient, either directly or after passing a suitable target. It is mostly used in the treatment of cancer.
38799 Synonym for: Heat exchanger, accelerator system
41514 Synonym for: Modulator, accelerator system
33073 A particle therapeutic accelerator system using a strong magnetic field to produce a non-linear acceleration path for particles accelerated in an alternating
electric field. The path is often formed as a spiral or a circle. The output is used as a treatment beam on the patient, either directly or after passing a suitable
target.
40832 Mainframe or personal computer (PC) based operating system software (or firmware) that is specific to the central processing unit incorporated into medical
linear or non-linear accelerator system configurations. This includes the software or firmware based programs and routines supplied by the computer
manufacturer that drive a specific computer in the performance of its tasks and assists the operators, applications programmers and programs with various
supporting functions. A proprietary name and a "version number" are commonly used identify different operating system versions.
18054 A therapeutic radiosurgical stereotactic system based on a linear accelerator. The output is restricted to a narrow high intensity beam. The gantry has the
capability for extended angulation and movement.
15810 Synonym for: Tester, joint movement
40367 Synonym for: Bite block
Accelerator system, <specify>
Accelerator system, application program software
Accelerator system, linear
Accelerator system, linear, heat exchanger
Accelerator system, modulator
Accelerator system, non-linear
Accelerator system, operating system software
Accelerator system, stereotactic radiosurgery
Accelerometer
Accessory, bite block, for endoscope
© ISO 2001 – All rights reserved
33105 Synonym for: Accelerator system, linear
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Accelerator, linear, medical
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Absorptiometry phantom
17748 Synonym for: X-ray system, diagnostic, bone absorptiometer, single-energy
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Absorptiometer, x-ray, single-energy
17540 Synonym for: X-ray system, diagnostic, <specify>
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Absorptiometer, x-ray
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ISO/TS 20225:2001(E)
36096 A canister containing absorbent materials, e.g. activated charcoal, that removes halogenated vapour from a breathing system or exhaled gases.
or
Absorber, halogenated vapour
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34014 Synonym for: Fixation device, internal, spine, construct
34015 Synonym for: Fixation device, internal, spine, construct
34570 Synonym for: Specimen preparatory equipment, sample processor
Accessory, fixation, spinal interlaminal
Accessory, fixation, spinal intervertebral body
Accessory, medical specimen pre-treatment
instrument
31842 Synonym for: Retractor, dental
37274 Synonym for: Infusion pump, <specify>
32970 Synonym for: Traction unit, <specify>
34149 Synonym for: Ventilator accessory, <specify>
40087 Synonym for: Wheelchair accessory, <specify>
40234 Synonym for: Contact lens solution
34011 Synonym for: Contact lens solution
Accessory, traction
Accessory, ventilator
Accessory, wheelchair
Accessory to contact lens - cleaning and wetting
agent
Accessory to contact lens solution
Accessory, retractor, dental
Accessory, pump, infusion
39289 Synonym for: Camera accessory, surgical, <specify>
39284 Synonym for: Endoscope accessory, cleaning brush, reusable
Accessory, cleaning, for endoscope
Accessory, photographic, for endoscope (exclude
light source)
40368 Synonym for: Endoscope accessory, cleaning brush, single use
Accessory, cleaning brush, for endoscope
ISO/TS 20225:2001(E)
37405 Synonym for: Battery, secondary
30437 Immunochemistry reagents, drugs of abuse/toxicology, toxicology, kit for acetaminophene (paracetemol). A kit is one or more items provided as a single unit for
use in combination to achieve the intended use of the device.
Accumulator
Acetaminophene kit
39916 Synonym for: Alpha-ketobutyric acid kit
39757 Synonym for: Stain, light microscopy, <specify>
39911 Synonym for: Ascorbic acid kit
33271 Synonym for: Delta-aminolaevulinic acid kit
31398 Synonym for: Cholesterol kit
31392 Synonym for: Folate kit
39764 Synonym for: Stain, light microscopy, <specify>
Acid, alpha-ketobutyric and NADH (U.V.),
hydroxybutyric dehydrogenase
Acid, aniline, fuchsin
Acid, ascorbic, 2,4-dinitrophenylhydrazine
(spectrophotometric)
Acid, delta-aminolevulinic, ion-exchange columns
with colorimetry
Acid, ferric ion-sulfuric, cholesterol
Acid, folic, radioimmunoassay
Acid, fuchsin
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31605 Synonym for: Cholinesterase kit
Acetylcholine choride, specific reagent, pseudo
cholinesterase
© ISO 2001 – All rights reserved
36402 Synonym for: Optometer
Accommodometer
Acetylcholine chloride, specific reagent for pseudo 39080 Synonym for: Cholinesterase kit
cholinesterase
40371 Synonym for: Ventilator accessory, <specify>
Accessory to continuous ventilator (respirator)
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39763 Synonym for: Stain, light microscopy, cytology/histology
31435 Synonym for: Albumin kit
33529 Synonym for: Lactate kit
38950 Synonym for: Nitrous/nitrosonaphthol acid kit, 5-hydroxyindole
39733 Synonym for: Stain, light microscopy, cytology/histology
39920 Synonym for: Malic acid kit
40065 Synonym for: Periodic acid kit
31400 Synonym for: Chloride kit
Acid, hematein
Acid, hydroxyazobenzene-benzoic, albumin
Acid, lactic, enzymatic method
Acid, nitrous and nitrosonaphthol, 5-hydroxyindole
acetic acid/serotonin
Acid, osmic
Acid, oxalacetic and nadh oxidation (U.V.), malic
dehydrogenase
Acid, periodic
Acid, phosphoric-thungstic (spectrophotometric),
chloride
33289 Synonym for: Pyruvate kit
39930 Synonym for: Trifluoroacetic acid, vitamin A, hexane extraction
40173 Synonym for: Uric acid kit
31352 Synonym for: Uric acid kit
39860 Synonym for: Uric acid kit
40084 Synonym for: Uric acid kit
39859 Synonym for: Uric acid kit
39861 Synonym for: Electrode, ion selective, uric acid
38953 Synonym for: Uric acid kit
31351 Synonym for: Vanilmandelic acid kit
31353 Synonym for: Vanilmandelic acid kit
32395 Synonym for: Stain, light microscopy, haematology
31439 Synonym for: Acid phosphatase kit
33164 Synonym for: Acid phosphatase kit
39001 Synonym for: Acid phosphatase kit
31437 Synonym for: Acid phosphatase kit
31429 Synonym for: Acid phosphatase kit
31431 Synonym for: Acid phosphatase kit
Acid, pyruvic, enzymatic (U.V.)
Acid, trifluoroacetic, vitamin A, hexane extraction
Acid, uric, acid reduction of ferric ion
Acid, uric, phosphotungstate reduction
Acid, uric, uricase (colorimetric)
Acid, uric, uricase (colorimetric)
Acid, uric, uricase (gasometric)
Acid, uric, uricase (oxygen rate)
Acid, uric, uricase (U.V.)
Acid, vanilmandelic, diazo, p-nitroaniline/vanillin
Acid, vanilmandelic, electrophoretic separation
Acid hematin
Acid phosphatase, beta glycerophosphate
Acid phosphatase, cytochemical
Acid phosphatase, disodium phenylphosphate
Acid phosphatase, naphthyl phosphate
Acid phosphatase, nitrophenylphosphate
Acid phosphatase, thymol blue monophosphate
© ISO 2001 – All rights reserved
38978 Synonym for: Chloride kit
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Acid, phosphoric-tungstic (spectrophotometric),
chloride
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Dit document is een voorbeeld van NEN / This document is a preview by NEN
7
ISO/TS 20225:2001(E)
39003 Synonym for: Acid phosphatase kit
38498 Clinical chemistry reagents, enzymes, acid phosphatase kit. A kit is one or more items provided as a single unit for use in combination to achieve the intended
use of the device. Acid phosphatase is a Group of isoenzymes (registry no. EC 3.1.3.2) catalysing hydrolysis of phosphate esters in acid medium; tartrate
addition inhibits the activity of prostate isoenzyme, but not the others.
39851 Synonym for: Acid phosphatase kit
32507 Infectious immunology, bacteriology (infect. immunology), other bacteriology immunoassays, kit for acinetobacter calcoaceticus. A kit is one or more items
provided as a single unit for use in combination to achieve the intended use of the device.
41214 Synonym for: Ear simulator, acoustic coupler
42303 Synonym for: Chamber, patient, audiometric, room
34367 Synonym for: Stimulator, evoked response, auditory
15894 Synonym for: Chamber, patient, audiometric, room
39761 Synonym for: Stain, light microscopy, microbiology
16353 Synonym for: Curing unit, dental laboratory
34767 Synonym for: Dental material, denture base, polymer based
34764 Synonym for: Crown/bridge material, polymer based
34761 Synonym for: Artificial teeth, resin
Acid phosphatase kit
Acid phosphatase (prostatic), tartrate inhibited
Acinetobacter calcoaceticus kit
Acoustic coupler
Acoustic room
Acoustic stimulator
Acoustical room
Acridine orange
Acrylic curing unit, dental
Acrylic denture base resin
Acrylic resin, crown
Acrylic resin teeth
38553 Haematology/histology/cytology, haemostasis reagents (coagulation), general coagulation tests, kit for activated partial thromboplastin time. A kit is one or more
items provided as a single unit for use in combination to achieve the intended use of the device.
30592 Synonym for: Activated partial thromboplastin time kit
41695 Haematology, histology, cytology haemostasis, reagents (coagulation), special coagulation tests, calibrator for APC resistance. A calibrator is any substance,
material or article intended by its manufacturer to be used to establish the measurement relationships of a device.
41694 Haematology, histology, cytology haemostasis, reagents (coagulation), special coagulation tests, control for APC resistance. A control is a substance, material
or article intended by its manufacturer to be used to verify the performance characteristics of the device.
30560 Haematology/histology/cytology haemostasis, reagents (coagulation), special coagulation tests, kit for APC resistance. A kit is one or more items provided as a
single unit for use in combination to achieve the intended use of the device.
39829 Synonym for: Activated whole blood clotting time kit
33155 A collection of items for use in combination to determine the time it takes a sample of whole blood to coagulate from the onset of the clotting process.
38732 Synonym for: Orthodontic appliance system
31790 Synonym for: Light, dental, polymerization activator
34541 Synonym for: Endotherapy device, <specify>
31660 A component or sub-system of, or accessory for, a contrast medium injector system that enables the timing of an injection to be coordinated with one or more
physiological parameter. Typically the signals used to trigger the injection are obtained from an external monitoring system such as an electrocardiograph
(ECG), patient monitor, or electroencephalograph (EEG). see: Contrast medium injector system, <specify>.
Activated partial thromboplastin time kit
Activated partial thromboplastin time rapid test
Activated protein C resistance calibrator
Activated protein C resistance control
Activated protein C resistance kit
Activated whole blood clotting time
Activated whole blood clotting time kit
Activator, orthodontic
Activator, ultraviolet, for polymerization
Active treatment device, endotherapy
Actuator, contrast medium injecting
© ISO 2001 – All rights reserved
32392 Synonym for: Activated partial thromboplastin time kit
Activated partial thromboplastin
8
37702 Synonym for: Analyser, haematology, coagulation
ACT meter
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Acid phosphatase, thymolphthalein
monophosphate
ISO/TS 20225:2001(E)
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Dit document is een voorbeeld van NEN / This document is a preview by NEN
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