Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards (ISO 11139:2018)

This International Standard defines terms in the field of sterilization of healthcare products used in the standards developed by ISO/TC 198 "Sterilization of healthcare products", CEN/TC 204 "Sterilization of medical devices", and CEN/TC 102 "Sterilizers and associated equipment for processing of medical devices".

Sterilisation von Produkten für die Gesundheitsfürsorge - Vokabular, das bei der Sterilisation und zugehöriger Ausrüstung sowie in Prozessnormen verwendet wird (ISO 11139:2018)

Dieses Dokument definiert Begriffe aus dem Bereich der Sterilisation von Produkten für die Gesundheitsfürsorge einschließlich der zugehörigen Ausrüstung und Verfahren.

Stérilisation des produits de santé - Vocabulaire des termes utilisés dans les normes de procédés de stérilisation et les équipements connexes (ISO 11139:2018)

Le présent document définit les termes employés dans le domaine de la stérilisation des produits de santé, y compris les équipements et processus connexes.

Sterilizacija izdelkov za zdravstveno nego - Slovar izrazov, ki se uporabljajo pri sterilizaciji in ustrezni opremi ter pri procesnih standardih (ISO 11139:2018)

Ta mednarodni standard določa pogoje na področju sterilizacije izdelkov za zdravstveno nego, ki se uporabljajo v standardih ISO/TC 198 Sterilizacija izdelkov za zdravstveno nego, CEN/TC 204 Sterilizacija medicinskih pripomočkov ter CEN/TC 102 Sterilizatorji in povezana oprema za obdelavo medicinskih pripomočkov.

General Information

Status
Published
Public Enquiry End Date
19-Oct-2017
Publication Date
13-Nov-2018
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
19-Oct-2018
Due Date
24-Dec-2018
Completion Date
14-Nov-2018

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SLOVENSKI STANDARD
SIST EN ISO 11139:2018
01-december-2018

Sterilizacija izdelkov za zdravstveno nego - Slovar izrazov, ki se uporabljajo pri

sterilizaciji in ustrezni opremi ter pri procesnih standardih (ISO 11139:2018)

Sterilization of health care products - Vocabulary of terms used in sterilization and

related equipment and process standards (ISO 11139:2018)
Sterilisation von Produkten für die Gesundheitsfürsorge - Vokabular, das bei der

Sterilisation und zugehöriger Ausrüstung sowie in Prozessnormen verwendet wird (ISO

11139:2018)

Stérilisation des produits de santé - Vocabulaire des termes utilisés dans les normes de

procédés de stérilisation et les équipements connexes (ISO 11139:2018)
Ta slovenski standard je istoveten z: EN ISO 11139:2018
ICS:
01.040.11 Zdravstveno varstvo Health care technology
(Slovarji) (Vocabularies)
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11139:2018 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11139:2018
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SIST EN ISO 11139:2018
EN ISO 11139
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2018
EUROPÄISCHE NORM
ICS 01.040.11; 11.080.01
English Version
Sterilization of health care products - Vocabulary of terms
used in sterilization and related equipment and process
standards (ISO 11139:2018)

Stérilisation des produits de santé - Vocabulaire des Sterilisation von Produkten für die

termes utilisés dans les normes de procédés de Gesundheitsfürsorge - Vokabular, das bei der

stérilisation et les équipements connexes (ISO Sterilisation und zugehöriger Ausrüstung sowie in

11139:2018) Prozessnormen verwendet wird (ISO 11139:2018)
This European Standard was approved by CEN on 1 September 2018.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11139:2018 E

worldwide for CEN national Members.
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SIST EN ISO 11139:2018
EN ISO 11139:2018 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 11139:2018
EN ISO 11139:2018 (E)
European foreword

This document (EN ISO 11139:2018) has been prepared by Technical Committee ISO/TC 198

"Sterilization of health care products" in collaboration with Technical Committee CEN/TC 102

“Sterilizers and associated equipment for processing of medical devices” the secretariat of which is held

by DIN.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by March 2019, and conflicting national standards shall

be withdrawn at the latest by March 2019.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

According to CEN Internal Regulations, terms and definition are always developed for a specific subject

of the relevant standard/specification of the relevant working group. The working group uses the

advice of the terminology working group to ensure that new terms and definitions are in line with the

regulations and not in conflict with existing terms and definitions. Whenever possible, terms and

definitions can be taken form the terminology standard EN ISO 11139.

ISO 11139 mentions a „White Paper“ in the ISO Foreword. CEN does not endorse this „White Paper“ for

the following reasons:

 there was no official standardisation request for the preparation of such a document,

 the document has not been developed according to CEN Internal Regulations and
 the document is outside the scope of EN ISO 11139.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
Endorsement notice

The text of ISO 11139:2018 has been approved by CEN as EN ISO 11139:2018 without any modification.

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SIST EN ISO 11139:2018
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SIST EN ISO 11139:2018
INTERNATIONAL ISO
STANDARD 11139
First edition
2018-08
Sterilization of health care products —
Vocabulary of terms used in
sterilization and related equipment
and process standards
Stérilisation des produits de santé — Vocabulaire des termes utilisés
dans les normes de procédés de stérilisation et les équipements
connexes
Reference number
ISO 11139:2018(E)
ISO 2018
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SIST EN ISO 11139:2018
ISO 11139:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
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SIST EN ISO 11139:2018
ISO 11139:2018(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

Annex A (informative) Summary of standards in which each term is included in their

respective Clause 3 ..........................................................................................................................................................................................33

Bibliography .............................................................................................................................................................................................................................45

© ISO 2018 – All rights reserved iii
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SIST EN ISO 11139:2018
ISO 11139:2018(E)
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 of the voluntary nature of standards, 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 198, Sterilization of health care products.

This first edition of ISO 11139 cancels and replaces ISO/TS 11139:2006, which has been technically

revised.
The main changes compared with the previous edition are as follows:

— all the terms and definitions have been reviewed based on existing documents in the field and future

needs, and have been revised accordingly for consistency of use;
NOTE This vocabulary is now the source document for these terms.
— additional terms and definitions have been added.

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 www .iso .org/members .html.
iv © ISO 2018 – All rights reserved
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SIST EN ISO 11139:2018
ISO 11139:2018(E)
Introduction

This document provides the fundamental vocabulary for sterilization of health care products and

associated equipment. It provides the foundation for other standards on cleaning, disinfecting,

sterilizing, and aseptic processing of health care products together with associated equipment and

ancillary products used in ensuring effective application of these processes. This document is intended

to help the user to understand the vocabulary of cleaning, disinfecting, sterilizing, and aseptically

processing health care products, in order to be able to implement the related standards effectively.

This document contains the terms and definitions that apply to all standards on cleaning, disinfecting,

sterilizing, and aseptic processing of health care products together with associated equipment

and ancillary products developed by ISO/TC 198 and other European standards in the same field of

application.
The terms and definitions are arranged in alphabetical order in English.

ISO/TC 198 has produced a white paper describing the principles used to develop this compilation

of terms and definitions and proposals on its use in the development of new and revised standards

for disinfecting, sterilizing, and aseptic processing of health care products together with associated

equipment and ancillary products. This white paper is available through the International Organization

for Standardization.

The Bibliography includes the standards referenced in Annex A. If a term has been dropped in a current

revision, reference has not been made.
© ISO 2018 – All rights reserved v
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SIST EN ISO 11139:2018
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SIST EN ISO 11139:2018
INTERNATIONAL STANDARD ISO 11139:2018(E)
Sterilization of health care products — Vocabulary of terms
used in sterilization and related equipment and process
standards
1 Scope

This document defines terms in the field of the sterilization of health care products including related

equipment and processes.
2 Normative references
There are no normative references in this document.
3 Terms and definitions

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1

measure of microbiological lethality delivered by a moist heat disinfection process expressed in terms

of the equivalent time in seconds at 80 °C with reference to a microorganism with a z value of 10 K

3.2
absolute pressure
pressure for which the zero value is associated with absolute vacuum
3.3
absorbed dose

quantity of ionizing radiation energy imparted per unit mass of a specified material

3.4
access device
means by which entry to restricted parts of equipment is achieved
Note 1 to entry: This can be by dedicated key, code, or tool.
3.5
action level
value from monitoring that necessitates immediate intervention
3.6
active ingredient

chemical or biological component that is included in the formulation of a health care product to achieve

the intended purpose
3.7
aeration

part of the sterilization cycle during which the sterilizing agent and/or its reaction products desorb

from the health care product until predetermined levels are reached
© ISO 2018 – All rights reserved 1
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SIST EN ISO 11139:2018
ISO 11139:2018(E)
3.8
air break
physical separation in water supply pipes to prevent back flow from equipment
3.9
air detector

device designed to detect the presence of non-condensable gases in the chamber or in a stream of steam

and condensate
3.10
airlock

enclosure with interlocked doors designed to maintain pressure control between adjacent areas

3.11
alert level

value from monitoring providing early warning of deviation from specified conditions

3.12
analyte
chemical substance that is the subject of chemical analysis
3.13
aseptic presentation

transfer of sterile contents from its sterile barrier system using conditions and procedures that

minimize the risk of microbial contamination
3.14
aseptic processing

handling of sterile product, containers, and/or devices in a controlled environment in which the air

supply, materials, equipment, and personnel are regulated to maintain sterility
3.15
aseptic processing area
APA
facilities for aseptic processing, consisting of several zones
3.16
aseptic technique

conditions and procedures used to minimize the risk of the introduction of microbial contamination

3.17
assurance of sterility

qualitative concept comprising all activities that provide confidence that product is sterile

3.18
automatic controller

device that directs the equipment sequentially through required stages of the cycle in response to

programmed cycle parameters
3.19
bacterial challenge test

technical operation performed to evaluate the capability of a filter to retain

microorganisms from a liquid bacterial suspension under specified conditions
3.20
bacteriostasis/fungistasis test

technical operation performed to detect the presence of substances that inhibit microbial multiplication

2 © ISO 2018 – All rights reserved
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SIST EN ISO 11139:2018
ISO 11139:2018(E)
3.21
batch

defined quantity of a product intended or purported to be uniform in character and quality produced

during a specified cycle of manufacture
3.22
bedpan washer-disinfector

washer-disinfector for human waste containers that additionally empties and flushes

3.23
bioburden

population of viable microorganisms on or in a product and/or sterile barrier system

3.24
bioburden correction factor

numerical value applied to a viable count to compensate for incomplete removal of microorganisms

from a product and/or failure to culture microorganisms
3.25
bioburden estimate
value established by applying a correction factor to a bioburden count
3.26
bioburden spike

individual bioburden value that is significantly greater than other bioburden values in a set

3.27
bio-decontamination
removal and/or reduction of biological contaminants to an acceptable level
3.28
biological contaminant
cell or biological entity other than the intended components present in product

EXAMPLE Viruses, bacteria, fungi, protozoa, multicellular parasites, contaminating eukaryotic cells,

aberrant proteins known as prions, endotoxins, or active DNA/RNA.
Note 1 to entry: This can include extrinsic and/or intrinsic contaminants.

Note 2 to entry: A biological entity is a functional assembly of biological molecules or structures, and could be an

enzyme complex, a membranous structure, ribosomes, etc., or a combination thereof, that is kept assembled to

maintain its biological functionality.
3.29
biological indicator

test system containing viable microorganisms providing a specified resistance to a specified

sterilization process
3.30
block

group of channels comprising part of an endoscope with specified lengths, diameters, and

interconnections
3.31
calibration

operation that, under specified conditions, in a first step, establishes a relation between the quantity

values with measurement uncertainties provided by measurement standards and corresponding

indications with associated measurement uncertainties and, in a second step, uses this information to

establish a relation for obtaining a measurement result from an indication

[SOURCE: ISO/IEC Guide 99:2007, 2.39, modified — The notes to entry have been deleted.]

© ISO 2018 – All rights reserved 3
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SIST EN ISO 11139:2018
ISO 11139:2018(E)
3.32
calorifier

closed vessel, at a pressure greater than atmospheric, in which water is indirectly heated by the flow of

heated fluid through a heat exchanger
3.33
carrier

supporting material on or in which test microorganisms are deposited

3.34
cell-based

containing or consisting of prokaryotic or eukaryotic cells or cell derived biological entities

Note 1 to entry: A biological entity is a functional assembly of biological molecules or structures, and could be an

enzyme complex, a membranous structure, ribosomes, etc., or a combination thereof that is kept assembled to

maintain its biological functionality.
3.35
cell-processing area
CPA

area for processing cell-based materials consisting of different zones for processing and, where

applicable, for containment
3.36
chamber
part of equipment in which a load is processed
3.37
chamber pre-heating

process that raises the temperature of internal chamber surfaces prior to the commencement of an

operating cycle
3.38
chamber reference temperature
temperature at a specified point within the chamber
3.39
change control

assessment and determination of the appropriateness of a proposed alteration to product, process, or

equipment
3.40
channel separator
device used to keep apart interconnected fluid pathways

EXAMPLE A device inserted in a trumpet valve cylinder where multiple channels meet in order to separate

the air and water pathways in the air/water valve assembly.
3.41
chemical compatibility

capability of process fluids and filter materials to be used together, under the specified process

conditions, without adverse effects on either the fluids or filter materials
3.42
chemical disinfection
disinfection achieved by the action of one or more chemicals
3.43
chemical indicator

test system that reveals change in one or more pre-specified process variables based on a chemical or

physical change resulting from exposure to a process
4 © ISO 2018 – All rights reserved
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SIST EN ISO 11139:2018
ISO 11139:2018(E)
3.43.1
chemical indicator system
combination of a chemical indicator and a specific test load
3.44
chemical indicator endpoint

completion of a specified change after a chemical indicator has been exposed to specified conditions

3.45
clean
visually free of soil and below specified levels of analytes
3.46
cleaning

removal of contaminants to the extent necessary for further processing or for intended use

3.47
cleaning agent

physical or chemical entity, or combination of entities, having activity to render an item clean

3.48
clean-in-place
CIP

cleaning of internal surfaces of parts of equipment or an entire process system, without or with

minimal, disassembly
3.49
clinical use
use of a health care product during a procedure on a patient
3.50
closed system

means to prevent egress of hazardous agents and ingress of extrinsic

contamination
3.51
closure

means used to complete a sterile barrier system where no seal is formed

3.52
closure integrity

characteristics of a closure to minimize the risk of ingress of microorganisms

3.53
colony forming unit
CFU

visible aggregation of microorganisms arising from a single cell or multiple cells

3.54
combination product

entity presented as a single health care product that physically, chemically, or otherwise brings together

or mixes items regulated under separate legislation

Note 1 to entry: The entity could be a combination of medical device and medicinal product or biopharmaceutical

product.
© ISO 2018 – All rights reserved 5
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SIST EN ISO 11139:2018
ISO 11139:2018(E)
3.55
combined standard measurement uncertainty

standard measurement uncertainty that is obtained using the individual standard measurement

uncertainties associated with the input quantities in a measurement model

[SOURCE: ISO/IEC Guide 99:2007, 2.31, modified — The admitted term and the Note 1 to entry have

been deleted.]
3.56
come-down period

time elapsed from the termination of the exposure period to an established null

reaction point
3.57
come-up period

time elapsed from the introduction of the sterilizing agent to the attainment of the

specified conditions
3.58
conditioning

treatment of product prior to the exposure phase to attain a specified temperature, relative humidity,

or other process variable throughout the load
3.59
containment

combination of buildings, engineering functions, equipment, and work practices that allow safe handling

of hazardous biological or chemical substances, and prevent accidental release of these substances to

the external environment
3.60
containment area

designated location consisting of a cell processing area and an associated degowning room

3.61
containment facility

combination of manufacturing rooms including the containment area and associated rooms within a

physical containment barrier

Note 1 to entry: This can include airlocks, access and support rooms, laboratories, and interconnecting corridors.

Note 2 to entry: A containment facility uses a series of barriers (primary, secondary, and tertiary) to minimize

the escape of hazardous agents to facility workers, the general population, and the environment, e.g. isolators (if

necessary, negative pressure type); biological safety cabinets (Class I, II or III); negative air pressure cleanroom;

personnel protective clothing; appropriate work practices; appropriate disposal of hazardous waste; restriction

of access to the facility.
3.62
continuous process machine

equipment that moves one work unit at a time between each step of the process with the product

generally remaining in motion

Note 1 to entry: This is contrasted with batch process equipment, which would expose the entire batch to each

step of the process, one step at a time.
3.63
control
regulation of variables within specified limits
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SIST EN ISO 11139:2018
ISO 11139:2018(E)
3.64
correction
action to eliminate a detected nonconformity

Note 1 to entry: A correction can be made in advance of, in conjunction with, or after a corrective action.

[SOURCE: ISO 9000:2015, 3.12.3, modified — The Note 2 to entry has been deleted.]

3.65
corrective action
action to eliminate the cause of a nonconformity and to prevent recurrence
Note 1 to entry: There can be more than one cause for a nonconformity.

Note 2 to entry: Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent

occurrence.
[SOURCE: ISO 9000:2015, 3.12.2, modified – Note 3 to entry has been deleted]
3.66
coverage factor

number larger than one by which a combined standard measurement uncertainty is multiplied to

obtain an expanded measurement uncertainty
Note 1 to entry: A coverage factor is usually symbolized k.
[SOURCE: ISO/IEC Guide 99:2007, 2.38]
3.67
critical processing zone

location within the aseptic processing area in which product and critical surfaces are exposed to the

environment
3.68
critical surface

surface that might come into direct contact with a product, including its containers or closures, posing

a risk of contamination
3.69
culture collection number

unique identification of a test organism allocated by a recognized culture collection

3.70
culture condition

combination of growth media and manner of incubation used to promote germination, growth, and/or

multiplication of microorganisms

Note 1 to entry: The manner of incubation can include the temperature, time, and any other conditions specified

for incubation.
3.71
cycle complete

message from the automatic controller that the operating cycle has ended successfully

3.72
cycle parameter

value of a cycle variable including its tolerance used for control, monitoring, indication, and recording

of an operating cycle
© ISO 2018 – All rights reserved 7
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SIST EN ISO 11139:2018
ISO 11139:2018(E)
3.73
cycle time

period of time an irradiation container spends in each dwell position in a gamma process,

used as a control parameter for dose
3.74
cycle variable
property used to control, monitor, indicate, or record an operating cycle
3.75
D value
D value

time or dose required under stated conditions to achieve inactivation of 90 % of a population of the test

microorganisms
3.76
dead leg
area of entrapment in vessel or piping that is not easily accessed
3.77
depyrogenation
process used to remove or deactivate pyrogenic substances to a specified level
Note 1 to entry: Pyrogenic substances include bacterial endotoxins.
3.78
desorption

removal of the sterilizing agent from the chamber and the load at the end of the exposure phase

3.79
development
act of elaborating a specification
3.80
dew point

temperature at which the saturation water vapour pressure is equal to the partial pressure of the water

vapour in the atmosphere
3.81
direct support zone
protective area directly surrounding a critical processing zone
3.82
disinfectant
chemical or combination of chemicals used for disinfection
3.83
disinfecting agent
physical or chemical agent used for disinfection
3.84
disinfection

process to inactivate viable microorganisms to a level previously specified as being appropriate for a

defined purpose
3.85
disinfection temperature

minimum temperature on which the evaluation of the disinfection efficacy is based

8 © ISO 2018 – All rights reserved
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SIST EN ISO 11139:2018
ISO 11139:2018(E)
3.86
disinfection time

period for which the process variable(s) is/are maintained at or above that/those specified

Note 1 to entry: Examples of process variables include temperature of the load, disinfectant concentration in the

chamber.
3.87
dose mapping

measurement of dose distribution and variability in material irradiated under specified

conditions
3.88
dose uniformity ratio
ratio of the maximum to the minimum absorbed dose within
...

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