Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO/TS 13004:2013)

ISO/TS 13004:2013 describes a method for substantiating a selected sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5 or 35 kGy that achieves a sterility assurance level (SAL) of 10−6 or less for radiation sterilization of health care products. ISO/TS 13004:2013 also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.

Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Bestätigung der gewählten Sterilisationsdosis: Methode VDmaxSD (ISO/TS 13004:2013)

1.1   Einschlussklauseln
Diese Technische Spezifikation beschreibt ein Verfahren zur Bestätigung einer ausgewählten Sterilisations-dosis von (17,5; 20; 22,5; 27,5; 30; 32,5 oder 35) kGy, bei der ein Sterilitätssicherheits¬niveau (SAL) von höchstens 106 für die Strahlensterilisation von Produkten für die Gesundheitsvorsorge erzielt wird. Die vorliegende Technische Spezifikation legt weiterhin ein Verfahren zur Sterilisationsdosis¬überprüfung fest, auf dessen Grundlage die fortgesetzte Wirksamkeit der bestätigten Sterilisationsdosis nachgewiesen werden kann.
ANMERKUNG   Die Auswahl und Bestätigung der Sterilisationsdosis dient der Erfüllung der Anforderungen an die Festlegung der Sterilisationsdosis im Rahmen der Verfahrensdefinition nach ISO 11137 1.
1.2   Ausschlussklauseln
Dieses Verfahren gilt ausschließlich für die Bestätigung einer ausgewählten Sterilisationsdosis von (17,5; 20; 22,5; 27,5; 30; 32,5 oder 35) kGy und wird nicht für die Bestätigung weiterer Sterilisationsdosen angewendet. Das Verfahren wird nicht für die Bestätigung einer ausgewählten Sterilisationsdosis genutzt, wenn die durchschnittliche Keimbelastung der gesamten Produkteinheit den für die ausgewählte Sterilisationsdosis festgelegten Grenzwert überschreitet (siehe Tabelle 3).
ANMERKUNG   Die Verfahren für die Bestätigung ausgewählter Sterilisationsdosen von 25 kGy und 15 kGy werden nicht von dieser Technischen Spezifikation abgedeckt; sie werden in ISO 11137 2 beschrieben.
1.3   Anwendung
Wird die Entscheidung getroffen, dieses Verfahren zur Festlegung der Sterilisationsdosis anzuwenden, müssen die hier angegebenen Anforderungen (muss) und Anleitungen (sollte) befolgt werden.

Stérilisation des produits de santé - Irradiation - Justification de la dose de stérilisation choisie: méthode VDmaxSD (ISO/TS 13004:2013)

Sterilizacija izdelkov za zdravstveno nego - Sevanje - Utemeljitev izbrane doze sterilizacije: metoda VDmaxSD (ISO/TS 13004:2013)

Standard CEN ISO/TS 13004 opisuje metodo za utemeljitev izbrane doze sterilizacije 17,5, 20, 22,5, 27,5, 30, 32,5 ali 35 kGy za doseganje ravni zagotavljanja sterilnosti (SAL) 10–6 ali manj za sterilizacijo zdravstvenih pripomočkov s sevanjem. Ta tehnična specifikacija določa tudi metodo za revizijo odmerka sterilizacije, ki se uporablja za dokaz stalne učinkovitosti utemeljenega odmerka sterilizacije.

General Information

Status
Published
Publication Date
27-May-2014
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
28-May-2014
Completion Date
28-May-2014

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SLOVENSKI STANDARD
SIST-TS CEN ISO/TS 13004:2014
01-oktober-2014
Sterilizacija izdelkov za zdravstveno nego - Sevanje - Utemeljitev izbrane doze
sterilizacije: metoda VDmaxSD (ISO/TS 13004:2013)

Sterilization of health care products - Radiation - Substantiation of selected sterilization

dose: Method VDmaxSD (ISO/TS 13004:2013)

Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Bestätigung der

gewählten Sterilisationsdosis: Methode VDmaxSD (ISO/TS 13004:2013)

Stérilisation des produits de santé - Irradiation - Justification de la dose de stérilisation

choisie: méthode VDmaxSD (ISO/TS 13004:2013)
Ta slovenski standard je istoveten z: CEN ISO/TS 13004:2014
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
13.280 Varstvo pred sevanjem Radiation protection
SIST-TS CEN ISO/TS 13004:2014 en

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

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SIST-TS CEN ISO/TS 13004:2014
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SIST-TS CEN ISO/TS 13004:2014
TECHNICAL SPECIFICATION
CEN ISO/TS 13004
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
May 2014
ICS 11.080.01
English Version
Sterilization of health care products - Radiation - Substantiation
of selected sterilization dose: Method VDmaxSD (ISO/TS
13004:2013)

Stérilisation des produits de santé - Irradiation - Justification Sterilisation von Produkten für die Gesundheitsfürsorge -

de la dose de stérilisation choisie: méthode VDmaxSD Strahlen - Bestätigung der gewählten Sterilisationsdosis:

(ISO/TS 13004:2013) Methode VDmaxSD (ISO/TS 13004:2013)

This Technical Specification (CEN/TS) was approved by CEN on 27 May 2014 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit their

comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available

promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS)

until the final decision about the possible conversion of the CEN/TS into an EN is reached.

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, 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: Avenue Marnix 17, B-1000 Brussels

© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 13004:2014 E

worldwide for CEN national Members.
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SIST-TS CEN ISO/TS 13004:2014
CEN ISO/TS 13004:2014 (E)
Contents Page

Foreword ..............................................................................................................................................................3

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SIST-TS CEN ISO/TS 13004:2014
CEN ISO/TS 13004:2014 (E)
Foreword

The text of ISO/TS 13004:2013 has been prepared by Technical Committee ISO/TC 198 “Sterilization of

health care products” of the International Organization for Standardization (ISO) and has been taken over as

CEN ISO/TS 13004:2014 by Technical Committee CEN/TC 204 “Sterilization of medical devices” the

secretariat of which is held by BSI.

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

rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

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

countries are bound to announce this Technical Specification: 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

Endorsement notice

The text of ISO/TS 13004:2013 has been approved by CEN as CEN ISO/TS 13004:2014 without any

modification.
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SIST-TS CEN ISO/TS 13004:2014
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SIST-TS CEN ISO/TS 13004:2014
TECHNICAL ISO/TS
SPECIFICATION 13004
First edition
2013-05-01
Sterilization of health care products —
Radiation — Substantiation of selected
sterilization dose: Method VD
max
Stérilisation des produits de santé — Irradiation — Justification de la
dose de stérilisation choisie: méthode VD
max
Reference number
ISO/TS 13004:2013(E)
ISO 2013
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SIST-TS CEN ISO/TS 13004:2014
ISO/TS 13004:2013(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2013

All rights reserved. Unless otherwise specified, 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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2013 – All rights reserved
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SIST-TS CEN ISO/TS 13004:2014
ISO/TS 13004:2013(E)
Contents Page

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

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

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

1.1 Inclusions ..................................................................................................................................................................................................... 1

1.2 Exclusions .................................................................................................................................................................................................... 1

1.3 Application ................................................................................................................................................................................................. 1

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

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

4 Definition and maintenance of product families for sterilization dose substantiation and

sterilization dose auditing ......................................................................................................................................................................... 5

4.1 General ........................................................................................................................................................................................................... 5

4.2 Defining product families .............................................................................................................................................................. 5

4.3 Designation of product to represent a product family ........................................................................................ 6

4.4 Maintaining product families ..................................................................................................................................................... 7

4.5 Consequence of failure of sterilization dose substantiation or sterilization dose audit ......... 8

5 Selection and testing of product for substantiating and auditing a selected

sterilization dose.................................................................................................................................................................................................. 8

5.1 Nature of product ................................................................................................................................................................................. 8

5.2 Sample item portion (SIP) ............................................................................................................................................................. 9

5.3 Manner of sampling .........................................................................................................................................................................10

5.4 Microbiological testing ..................................................................................................................................................................11

5.5 Irradiation ................................................................................................................................................................................................11

6 Method VD — Substantiation of a selected sterilization dose of 17,5, 20, 22,5, 27,5,

max

30, 32,5, or 35 kGy ...........................................................................................................................................................................................11

6.1 Rationale....................................................................................................................................................................................................11

6.2 Procedure for Method VD for multiple production batches ..........................................................12

max

6.3 Procedure for Method VD for a single production batch ..................................................................17

max

7 Maintaining process effectiveness ..................................................................................................................................................21

7.1 General ........................................................................................................................................................................................................21

7.2 Determination of bioburden ....................................................................................................................................................22

7.3 Sterilization dose audit .................................................................................................................................................................22

8 Tables of values for SIP equal to 1,0 VD , SIP dose reduction factor and augmentation

max

dose corresponding to applicable values of average bioburden for selected sterilization

doses of 17,5, 20, 22,5, 27,5, 30, 32,5 and 35 kGy ...........................................................................................................27

9 Worked examples .............................................................................................................................................................................................53

9.1 Substantiation of a selected sterilization dose of 17,5 kGy (SIP less than 1,0) ............................53

9.2 Substantiation of a selected sterilization dose of 30 kGy (SIP equal to 1,0) ...................................54

22,5

9.3 Sterilization dose audit for a sterilization dose substantiated using Method VD , the

max

findings from which necessitated augmentation of the sterilization dose ......................................55

Bibliography .............................................................................................................................................................................................................................57

© ISO 2013 – All rights reserved iii
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SIST-TS CEN ISO/TS 13004:2014
ISO/TS 13004:2013(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.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

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:

— 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.

An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed for

a further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or

ISO/TS is confirmed, it is reviewed again after a further three years, at which time it must either be

transformed into an International Standard or be withdrawn.

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/TS 13004 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.

iv © ISO 2013 – All rights reserved
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SIST-TS CEN ISO/TS 13004:2014
ISO/TS 13004:2013(E)
Introduction

This Technical Specification is intended to be used in conjunction with ISO 11137-1, Sterilization of health care

products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization

process for medical devices. One of the activities encompassed within process definition in ISO 11137-1 is

the option to select and substantiate a sterilization dose to be applied to health care products.

ISO 11137-2 includes Method VD for the substantiation of 25 kGy as a sterilization dose (termed

max
25 15

Method VD ) for product with an average bioburden less than or equal to 1 000 and Method VD

max max

for the substantiation of 15 kGy as a sterilization dose for product with an average bioburden less than

or equal to 1,5.

This Technical Specification extends the methods of selection and substantiation of a sterilization dose

specified in ISO 11137-2. It provides a methodology for the substantiation of selected sterilization doses

of 17,5, 20, 22,5, 27,5, 30, 32,5 and 35 kGy, each of which is valid only for a specified upper limit of

average bioburden.

NOTE Selected sterilization doses of 25 kGy and 15 kGy are not included in this Technical Specification. The

seven methods in this Technical Specification follow the same technical steps as the methods given in ISO 11137-2

for selection and substantiation of sterilization doses of 25 kGy and 15 kGy. However, the descriptive text in this

Technical Specification has been modified to better communicate the methods and hence the text occasionally

differs from that in ISO 11137-2.

The method described in this Technical Specification is for substantiation of a selected sterilization dose

−6 20

to achieve a sterility assurance level (SAL) of 10 or less at that dose, (e.g. Method VD for a selected

max

sterilization dose of 20 kGy). The application of the method is not limited by production batch size or

production frequency, and the number of product items irradiated in the verification dose experiment

remains constant. The method is founded on and embodies the following three principles:

— existence of a direct link between the outcome of the verification dose experiment and the attainment

of an SAL of 10 at the selected sterilization dose;

— possession of a level of conservativeness at least equal to that of the standard distribution of

resistances (SDR);

— for a given bioburden, use of a maximal verification dose (VD ) corresponding to substantiation

max
of a selected sterilization dose.
[6]

This approach to sterilization dose substantiation was first outlined by Kowalski and Tallentire and,

[7]

from subsequent evaluations involving computational techniques (Kowalski, Aoshuang and Tallentire )

[8]

and field evaluations (Kowalski et al ), it was concluded that the method is soundly based. An overview

[9][10]

of the method and aspects of putting it into practice are provided in Kowalski and Tallentire.

Application of the Method VD approach to doses other than 25 kGy is discussed in Kowalski and

max
[11][12]
Tallentire.

The method described here and designated Method VD procedurally comprises elements that

max

closely parallel those of dose setting Method 1 described in ISO 11137-2. One key area of difference is the

number of product items used in the verification dose experiment. In the computer evaluations referred

to above, changing the verification SAL value had little effect on the substantiation outcome and this

finding led to a sample size of 10 product items being chosen for subsequent field evaluations and,

ultimately, for inclusion in this document.

Manufacturers of health care products who intend to use this specification are reminded that the

requirements contained in ISO 11137 apply to the manufacture and control of production batches

destined for radiation sterilization. In particular, one requirement states that products have to be

manufactured in circumstances such that the bioburden is controlled. Compliance with the requirements

for controlling the quality of raw materials, the manufacturing environment, the health, hygiene and

attire of personnel and for establishing the basic properties of packaging material is essential.

© ISO 2013 – All rights reserved v
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SIST-TS CEN ISO/TS 13004:2014
TECHNICAL SPECIFICATION ISO/TS 13004:2013(E)
Sterilization of health care products — Radiation —
Substantiation of selected sterilization dose: Method
max
1 Scope
1.1 Inclusions

This Technical Specification describes a method for substantiating a selected sterilization dose of 17,5,

20, 22,5, 27,5, 30, 32,5 or 35 kGy that achieves a sterility assurance level (SAL) of 10 or less for radiation

sterilization of health care products. This Technical Specification also specifies a method of sterilization

dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.

NOTE Selection and substantiation of the sterilization dose is used to meet the requirements for establishing

the sterilization dose within process definition in ISO 11137-1.
1.2 Exclusions

This method is for the substantiation of a selected sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5,

or 35 kGy only and is not used to substantiate other sterilization doses. The method is not used for

the substantiation of a selected sterilization dose if the average bioburden of the entire product item

exceeds the limit specified for the selected sterilization dose (see Table 3).

NOTE The methods for substantiation of selected sterilization doses of 25 kGy and 15 kGy are not included in

this Technical Specification; they are described in ISO 11137-2.
1.3 Application

If the decision is made to use this method of sterilization dose establishment, the method is to be followed

according to the requirements (shall) and guidance (should) stipulated herein.
2 Normative references

The following referenced documents are indispensable for the application of this document. For dated

references, only the edition cited applies. For undated references, the latest edition of the referenced

document (including any amendments) applies.

ISO 11137-1:2006, Sterilization of health care products — Radiation — Part 1: Requirements for development,

validation and routine control of a sterilization process for medical devices

ISO 11737-1, Sterilization of medical devices — Microbiological methods — Part 1: Determination of a

population of microorganisms on products

ISO 11737-2, Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility

performed in the definition, validation and maintenance of a sterilization process

3 Terms and definitions

For the purposes of this document, the following abbreviations, terms and definitions apply.

© ISO 2013 – All rights reserved 1
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SIST-TS CEN ISO/TS 13004:2014
ISO/TS 13004:2013(E)
3.1
batch

defined quantity of product, intended or purported to be uniform in character and quality, that has been

produced during a defined cycle of manufacture
[SOURCE: ISO/TS 11139:2006, 2.1]
3.2
bioburden

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

[SOURCE: ISO/TS 11139:2006, 2.2]
3.3
correction
action to eliminate a detected nonconformity

Note 1 to entry: A correction can be made in conjunction with corrective action (3.4).

[SOURCE: ISO 9000:2005, 3.6.6, modified]
3.4
corrective action

action to eliminate the cause of a detected nonconformity or other undesirable situation

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.

Note 3 to entry: There is a distinction between correction and corrective action.

[SOURCE: ISO 9000:2005, 3.6.5]
3.5
dose
absorbed dose

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

Note 1 to entry: The unit of absorbed dose is the gray (Gy), where 1 Gy is equivalent to the absorption of 1 J/kg.

Note 2 to entry: For the purposes of this document, the term dose is used to mean absorbed dose.

[SOURCE: ISO 11137-1:2006, 3.1, modified]
3.6
dose mapping

measurement of dose distribution and variability in material irradiated under defined conditions

[SOURCE: ISO 11137-1:2006, 3.10]
3.7
false positive

test result interpreted as growth arising from product, or portion thereof, tested when either growth

resulted from extraneous microbial contamination or turbidity occurred from interaction between the

product, or portion thereof, and the test medium
[SOURCE: ISO 11137-2:2012, 3.1.3]
2 © ISO 2013 – All rights reserved
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SIST-TS CEN ISO/TS 13004:2014
ISO/TS 13004:2013(E)
3.8
health care product(s)

medical device(s), including in vitro diagnostic medical device(s), or medicinal product(s), including

biopharmaceutical(s)
[SOURCE: ISO/TS 11139:2006, 2.20]
3.9
medical device

instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software,

material, or other related article intended by the manufacturer to be used, alone or in combination, for

human beings for one or more of the specific purpose(s) of:
— diagnosis, prevention, monitoring, treatment, or alleviation of disease;

— diagnosis, monitoring, treatment, alleviation of or compensation for an injury;

— investigation, replacement, modification, or support of the anatomy or of a physiological process;

— supporting or sustaining life;
— control of conception;
— disinfection of medical devices;

— providing information for medical purposes by means of in vitro examination of specimens derived

from the human body;

and which does not achieve its primary intended action in or on the human body by pharmacological,

immunological or metabolic means, but which may be assisted in its function by such means

Note 1 to entry: This definition from ISO 13485 has been developed by the Global Harmonization Task Force

(GHTF 2002)
[SOURCE: ISO 13485:2003, 3.7, modified]
3.10
Method VD
max

procedure for sterilization dose substantiation that uses the maximal verification dose for a given

bioburden, consistent with the attainment of a SAL of 10 at a selected sterilization dose

Note 1 to entry: The substantiation method is generally referred to as Method VD , where SD takes the value

max
of the selected sterilization dose.
3.11
microorganism
entity of microscopic size, encompassing bacteria, fungi, protozoa and viruses

Note 1 to entry: A specific standard might not require demonstration of the effectiveness of the sterilization

process in inactivating all types of microorganisms, identified in the definition above, for validation and/or

routine control of the sterilization process.
[SOURCE: ISO/TS 11139:2006, 2.26]
3.12
packaging system
combination of the sterile barrier system and protective packaging
[SOURCE: ISO/TS 11139:2006, 2.28]
© ISO 2013 – All rights reserved 3
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SIST-TS CEN ISO/TS 13004:2014
ISO/TS 13004:2013(E)
3.13
positive test of sterility

test result for which there is detectable microbial growth from product, or portion thereof, subjected to

a test of sterility
[SOURCE: ISO 11137-2:2012, 3.1.8]
3.14
product
result of a process

Note 1 to entry: For the purposes of sterilization standards, product is tangible and can be raw material(s),

intermediate(s), sub-assembly(ies) or health care product(s)
[SOURCE: ISO 9000:2005, 3.4.2, modified]
3.15
sample item portion
SIP
defined portion of a health care product that is tested
[SOURCE: ISO 11137-2:2012, 3.1.9]
3.16
sterile barrier system

minimum package that prevents ingress of microorganisms and allows aseptic presentation of product

at the point of use
[SOURCE: ISO/TS 11139:2006, 2.44]
3.17
sterility
state of being free from viable microorganisms

Note 1 to entry: In practice, no such absolute statement regarding the absence of microorganisms can be proven

[see sterilization (3.19)].
[SOURCE: ISO/TS 11139:2006, 2.45]
3.18
sterility assurance level
SAL

probability of a single viable microorganism occurring on an item after sterilization

−6 −3

Note 1 to entry: The term SAL takes a quantitative value, generally 10 or 10 . When applying this quantitative

value to assurance of sterility, an SAL of 10 has a lower value but provides a greater assurance of sterility than

an SAL of 10 .
[SOURCE: ISO/TS 11139:2006, 2.46]
3.19
sterilization
validated process used to render product free from viable microorganisms

Note 1 to entry: In a sterilization process, the nature of microbial inactivation is exponential and thus the survival

of a microorganism on an individual item can be expressed in terms of probability. While this probability can be

reduced to a very low number it can never be reduced to zero [see sterility assurance level (3.18)].

[SOURCE: ISO/TS 11139:2006, 2.47]
4 © ISO 2013 – All rights reserved
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ISO/TS 13004:2013(E)
3.20
sterilization dose
dose selected to achieve the specified requirements for sterility
[SOURCE: ISO 11137-1:2006, 3.40, modified]
3.21
sterilization dose audit

exercise undertaken to confirm the appropriateness of an established sterilization dose

[SOURCE: ISO 11137-2:2012, 3.2.12]
3.22
test of sterility

technical operation performed as part of development, validation or requalification to determine the

presence or absence of viable microorganisms on product or portion thereof
[SOURCE: ISO/TS 11139:2006, 2.54]
3.23
verification dose

dose predicted to give a predetermined SAL greater than or equal to 10 used in establishing the

sterilization dose
Note 1 to entry: For the purpose of this Technical Specification, thi
...

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