Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01)

This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.

Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 2: Festlegung der Sterilisationsdosis (ISO 11137-2:2006, korrigierte fassung 2006-08-01)

Dieser Teil von ISO 11137 legt Verfahren zur Ermittlung der Mindestdosis, die zur Erreichung einer festgelegten Anforderung an die Sterilität erforderlich ist, und Verfahren zur Bestätigung der Anwendung von 25 kGy oder 15 kGy als Sterilisationsdosis zur Erreichung eines Sterilitätssicherheitsniveaus, SAL von 10 6 fest. Dieser Teil von ISO 11137 legt auch Verfahren der Dosisüberprüfung zum Nachweis der fortgesetzten Wirksamkeit der Sterilisationsdosis fest.
Dieser Teil von ISO 11137 definiert Produktfamilien für die Dosisfestlegung und Dosisüberprüfung.

Stérilisation des produits de santé - Irradiation - Partie 2: Établissement de la dose stérilisante (ISO 11137-2:2006, version corrigée 2006-08-01)

L'ISO 11137-2:2006 spécifie des méthodes de détermination de la dose minimale nécessaire pour atteindre une exigence spécifiée de stérilité et des méthodes pour justifier l'utilisation de la dose stérilisante de 25 kGy ou de la dose stérilisante de 15 kGy, pour obtenir un niveau d'assurance de la stérilité, s, de 10-6. Elle spécifie aussi des méthodes d'audit de la dose pour démontrer l'efficacité continue de la dose stérilisante.
L'ISO 11137-2:2006 définit des familles de produits pour l'établissement de la dose et l'audit de la dose.

Sterilizacija izdelkov za zdravstveno nego - Sevanje - 2. del: Določanje odmerka sterilizacije (ISO 11137-2:2006, popravljena verzija 2006-08-01)

General Information

Status
Withdrawn
Publication Date
15-Aug-2007
Withdrawal Date
19-Sep-2012
Technical Committee
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
14-Sep-2012
Due Date
07-Oct-2012
Completion Date
20-Sep-2012

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SLOVENSKI STANDARD
SIST EN ISO 11137-2:2007
01-september-2007
1DGRPHãþD
SIST EN 552:2000
SIST EN 552:2000/A1:2000
SIST EN 552:2000/A2:2001
SIST EN ISO 11137-2:2006
6WHULOL]DFLMDL]GHONRY]D]GUDYVWYHQRQHJR6HYDQMHGHO'RORþDQMHRGPHUND
VWHULOL]DFLMH ,62SRSUDYOMHQDYHU]LMD

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization

dose (ISO 11137-2:2006, corrected version 2006-08-01)

Sterilisation von Produkten für die Gesundheitsfürsorge - Strahlen - Teil 2: Festlegung

der Sterilisationsdosis (ISO 11137-2:2006, korrigierte fassung 2006-08-01)

Stérilisation des produits de santé - Irradiation - Partie 2: Établissement de la dose

stérilisante (ISO 11137-2:2006, version corrigée 2006-08-01)
Ta slovenski standard je istoveten z: EN ISO 11137-2:2007
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11137-2:2007 en,fr,de

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

---------------------- Page: 1 ----------------------
EUROPEAN STANDARD
EN ISO 11137-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2007
ICS 11.080.01 Supersedes EN ISO 11137-2:2006
English Version
Sterilization of health care products - Radiation - Part 2:
Establishing the sterilization dose (ISO 11137-2:2006, corrected
version 2006-08-01)

Stérilisation des produits de santé - Irradiation - Partie 2: Sterilisation von Produkten für die Gesundheitsfürsorge -

Établissement de la dose stérilisante (ISO 11137-2:2006, Strahlen - Teil 2: Festlegung der Sterilisationsdosis (ISO

version corrigée 2006-08-01) 11137-2:2006, korrigierte fassung 2006-08-01)
This European Standard was approved by CEN on 12 May 2007.

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 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 Management Centre has the same status as the

official versions.

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

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,

Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels

© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11137-2:2007: E

worldwide for CEN national Members.
---------------------- Page: 2 ----------------------
EN ISO 11137-2:2007 (E)
Foreword

The text of ISO 11137-2:2006, corrected version 2006-08-01 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 EN ISO 11137-2:2007 by Technical

Committee CEN/TC 204 "Sterilization of medical devices", the secretariat of which is held by

BSI.

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 November 2007, and conflicting national

standards shall be withdrawn at the latest by May 2010.
This document supersedes EN ISO 11137-2:2006.

This document has been prepared under a mandate given to CEN by the European Commission

and the European Free Trade Association, and supports essential requirements of EU

Directive(s).

For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this

document.

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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,

Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United

Kingdom.
Endorsement notice

The text of ISO 11137-2:2006, corrected version 2006-08-01 has been approved by CEN as EN

ISO 11137-2:2007 without any modifications.
---------------------- Page: 3 ----------------------
EN ISO 11137-2:2007 (E)
ANNEX ZA
(informative)
Relationship between this International Standard and the Essential
Requirements of EU Directives 90/385/EEC of 20 June 1990 concerning
active implantable medical devices, 93/42/EEC of 14 June 1993 concerning
medical devices and 98/79/EC of 7 December 1988 concerning in vitro
diagnostic medical devices

This International Standard has been prepared under a mandate given to CEN by the European

Commission and the European Free Trade Association to provide one means of conforming to

Essential Requirements of the New Approach Directive, EU Directives 90/385/EEC of 20 June

1990 concerning active implantable medical devices, 93/42/EEC of 14 June 1993 concerning

medical devices and 98/79/EC of 7 December 1998 concerning in vitro diagnostic medical

devices.

Once this standard is cited in the Official Journal of the European Communities under that

Directive and has been implemented as a national standard in at least one Member State,

compliance with the normative clauses of this standard given in Table ZA.1 confers, within the

limits of the scope of this standard, a presumption of conformity with the corresponding Essential

Requirements of that Directive and associated EFTA regulations.

Table ZA.1 — Correspondence between this International Standard and Directive (EU

Directives 90/385/EEC of 20 June 1990 concerning active implantable medical devices,

93/42/EEC of 14 June 1993 concerning medical devices and 98/79/EC of 7 December 1988

concerning in vitro diagnostic medical devices)
Clause(s)/Sub-clause(s) Essential Essential Essential Qualifying
of this EN Requirements Requirements (ERs) Requirements (ERs) remarks/Notes
(ERs) of Directive of Directive of Directive
90/385/EEC 93/42/EEC 98/79/EC
4,5,6,7,8,9,10,11,12 B.2.3
7 8.3 In part
4,5,6,7,8,9,10,11,12
B.2.4
8.4

WARNING: Other requirements and other EU Directives may be applicable to the product(s)

falling within the scope of this standard.
---------------------- Page: 4 ----------------------
INTERNATIONAL ISO
STANDARD 11137-2
First edition
2006-04-15
Corrected version
2006-08-01
Sterilization of health care products —
Radiation —
Part 2:
Establishing the sterilization dose
Stérilisation des produits de santé — Irradiation —
Partie 2: Établissement de la dose stérilisante
Reference number
ISO 11137-2:2006(E)
ISO 2006
---------------------- Page: 5 ----------------------
ISO 11137-2:2006(E)
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ii © ISO 2006 – All rights reserved
---------------------- Page: 6 ----------------------
ISO 11137-2:2006(E)
Contents Page

Foreword............................................................................................................................................................. v

Introduction ....................................................................................................................................................... vi

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

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

3 Abbreviations, terms and definitions ..................................................................................................1

3.1 Abbreviations.........................................................................................................................................1

3.2 Terms ......................................................................................................................................................3

4 Definition and maintenance of product families for dose setting, dose substantiation and

sterilization dose auditing ....................................................................................................................4

4.1 General....................................................................................................................................................4

4.2 Defining product families......................................................................................................................4

4.3 Designation of product to represent a product family for performance of a verification

dose experiment or sterilization dose audit .......................................................................................5

4.4 Maintaining product families ................................................................................................................6

4.5 Effect of failure of establishment of sterilization dose or of a sterilization dose audit on a

product family ........................................................................................................................................7

5 Selection and testing of product for establishing and verifying the sterilization dose .................7

5.1 Nature of product...................................................................................................................................7

5.2 Sample item portion (SIP) .....................................................................................................................8

5.3 Manner of sampling...............................................................................................................................8

5.4 Microbiological testing..........................................................................................................................9

5.5 Irradiation ...............................................................................................................................................9

6 Methods of dose establishment...........................................................................................................9

7 Method 1: dose setting using bioburden information .....................................................................10

7.1 Rationale...............................................................................................................................................10

7.2 Procedure for Method 1 for product with an average bioburden W 1,0 for multiple

production batches..............................................................................................................................11

7.3 Procedure for Method 1 for product with an average bioburden W 1,0 for a single

production batch..................................................................................................................................16

7.4 Procedure for Method 1 for product with an average bioburden in the range 0,1 to 0,9 for

multiple or single production batches...............................................................................................18

8 Method 2: Dose setting using fraction positive information from incremental dosing to

determine an extrapolation factor......................................................................................................18

8.1 Rationale...............................................................................................................................................18

8.2 Procedure for Method 2A....................................................................................................................19

8.3 Procedure for Method 2B....................................................................................................................22

9 Method VD — Substantiation of 25 kGy or 15 kGy as the sterilization dose...........................25

max

9.1 Rationale...............................................................................................................................................25

9.2 Procedure for Method VD for multiple production batches ...................................................26

max

9.3 Procedure for Method VD for a single production batch .......................................................29

max

9.4 Procedure for Method VD for multiple production batches ...................................................30

max

9.5 Procedure for Method VD for a single production batch .......................................................33

max

10 Auditing sterilization dose..................................................................................................................34

10.1 Purpose and frequency.......................................................................................................................34

© ISO 2006 – All rights reserved iii
---------------------- Page: 7 ----------------------
ISO 11137-2:2006(E)

10.2 Procedure for auditing a sterilization dose established using Method 1 or Method 2................ 35

10.3 Procedure for auditing a sterilization dose substantiated using VD ....................................... 37

max

11 Worked examples................................................................................................................................ 41

11.1 Worked examples for Method 1......................................................................................................... 41

11.2 Worked examples for Method 2......................................................................................................... 44

11.3 Worked examples for Method VD ................................................................................................ 53

max

11.4 Worked example of a sterilization dose audit for a dose established using Method 1, the

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

11.5 Worked example of a sterilization dose audit for a dose established using Method 2A, the

findings from which necessitated augmentation of the sterilization dose................................... 56

11.6 Worked example of a sterilization dose audit for a sterilization dose substantiated using

Method VD ................................................................................................................................... 58

max

Bibliography ..................................................................................................................................................... 59

iv © ISO 2006 – All rights reserved
---------------------- Page: 8 ----------------------
ISO 11137-2:2006(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.

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 11137-2 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.

This first edition, together with ISO 11137-1 and ISO 11137-3, cancels and replaces ISO 11137:1995.

ISO 11137 consists of the following parts, under the general title Sterilization of health care products —

Radiation:

⎯ Part 1: Requirements for development, validation and routine control of a sterilization process for medical

devices
⎯ Part 2: Establishing the sterilization dose
⎯ Part 3: Guidance on dosimetric aspects

This corrected version of ISO 11137-2:2006 incorporates changes in the following subclauses:

4.3.1.3, 5.1.1, 7.1, 7.2.3.2, 7.3.4.2, 7.4, 8.1, 8.2.3.1.1, 8.2.3.3.1, 8.2.6.3, 8.3.3.3.1, 8.3.6.3, 9.2.3.2,

9.2.4, 9.3.4.2, 9.3.5, 9.3.6.2, 9.4.1.2, 9.4.3.2, 9.4.5.2, 9.5.2.2, 9.5.4.2, 9.5.6.2, 10.2.5.2, 10.2.6.1,

10.3.3.2, 10.3.6.4.2, 11.3.
© ISO 2006 – All rights reserved v
---------------------- Page: 9 ----------------------
ISO 11137-2:2006(E)
Introduction

This part of ISO 11137 describes methods that may be used to establish the sterilization dose in accordance

with one of the two approaches specified in 8.2 of ISO 11137-1:2006. The methods used in these approaches

are:
a) dose setting to obtain a product-specific dose;
b) dose substantiation to verify a preselected dose of 25 kGy or 15 kGy.

The basis of the dose setting methods described in this part of ISO 11137 (Methods 1 and 2) owe much to the

[17] [18]

ideas first propounded by Tallentire (Tallentire, 1973 ; Tallentire, Dwyer and Ley, 1971 ; Tallentire and

[19] [8]

Khan, 1978 ). Subsequently, standardized protocols were developed (Davis et al., 1981 ; Davis,

[9]

Strawderman and Whitby, 1984 ) which formed the basis of the dose setting methods detailed in the AAMI

[4], [6]
Recommended Practice for Sterilization by Gamma Radiation (AAMI 1984, 1991 ).

Methods 1 and 2 and the associated sterilization dose audit procedures use data derived from the inactivation

of the microbial population in its natural state on product. The methods are based on a probability model for

the inactivation of microbial populations. The probability model, as applied to bioburden made up of a mixture

of various microbial species, assumes that each such species has its own unique D value. In the model, the

probability that an item will possess a surviving microorganism after exposure to a given dose of radiation is

defined in terms of the initial number of microorganisms on the item prior to irradiation and the D values of

the microorganisms. The methods involve performance of tests of sterility on product items that have received

doses of radiation lower than the sterilization dose. The outcome of these tests is used to predict the dose

needed to achieve a predetermined sterility assurance level, SAL.

Methods 1 and 2 may also be used to substantiate 25 kGy if, on performing a dose setting exercise, the

derived sterilization dose for an SAL of 10 is u 25 kGy. The basis of the method devised specifically for

[14]

substantiation of 25 kGy, Method VD , was put forward by Kowalski and Tallentire (1999) . Subsequent

max

evaluations involving computational techniques demonstrated that the underlying principles were soundly

[13]

based (Kowalski, Aoshuang and Tallentire, 2000) and field trials confirmed that Method VD is effective

max

in substantiating 25 kGy for a wide variety of medical devices manufactured and assembled in different ways

[16]
(Kowalski et al., 2002) .

A standardized procedure for the use of VD for substantiation of a sterilization dose of 25 kGy has been

max

published in the AAMI Technical Information Report Sterilization of health care products — Radiation

[5]

sterilization — Substantiation of 25 kGy as a sterilization dose — Method VD (AAMI TIR27:2001) , a text

max

on which the method described herein is largely based. Method VD is founded on dose setting Method 1

max

and, as such, it possesses the high level of conservativeness characteristic of Method 1. In a similar manner

to the dose setting methods, it involves performance of tests of sterility on product items that have received a

dose of radiation lower than the sterilization dose. The outcomes of these tests are used to substantiate that

25 kGy achieves an SAL of 10 .

To link the use of VD for the substantiation of a particular preselected sterilization dose, the numerical

max

value of the latter, expressed in kGy, is included as a superscript to the VD symbol. Thus, for

max
substantiation of a sterilization dose of 25 kGy the method is designated VD .
max
15 25

Method VD is based on the same principles as Method VD described above. The test procedure is

max max
25 15

the same as Method VD , but VD is limited to product with average bioburden u 1,5. The outcomes

max max

of these tests are used to substantiate that 15 kGy achieves a sterility assurance level of 10 .

This part of ISO 11137 also describes methods that may be used to carry out sterilization dose audits in

accordance with ISO 11137-1:2006, Clause 12. Following establishment of the sterilization dose, sterilization

dose audits are performed routinely to confirm that the sterilization dose continues to achieve the desired SAL.

vi © ISO 2006 – All rights reserved
---------------------- Page: 10 ----------------------
INTERNATIONAL STANDARD ISO 11137-2:2006(E)
Sterilization of health care products — Radiation —
Part 2:
Establishing the sterilization dose
1 Scope

This part of ISO 11137 specifies methods of determining the minimum dose needed to achieve a specified

requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to

achieve a sterility assurance level, SAL, of 10 . This part of ISO 11137 also specifies methods of dose

auditing in order to demonstrate the continued effectiveness of the sterilization dose.

This part of ISO 11137 defines product families for dose establishment and dose auditing.

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 the

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 the

population of microorganisms on product

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

in the validation of a sterilization process

ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes

3 Abbreviations, terms and definitions

For purposes of this document, the terms and definitions given in ISO 11137-1 and the following apply.

3.1 Abbreviations
3.1.1
dose to adjust the median ffp dose downwards, to the FFP dose
3.1.2
CD*

number of positive tests of sterility obtained from tests performed individually on 100 product items irradiated

in a Method 2 verification dose experiment
© ISO 2006 – All rights reserved 1
---------------------- Page: 11 ----------------------
ISO 11137-2:2006(E)
3.1.3
d *

dose derived from an incremental dose experiment performed on product items drawn from a given production

batch
3.1.4
initial estimate of the dose to provide an SAL of 10 for the test items

NOTE Generally, it is the median of the 3 d * values derived for a given product.

3.1.5
D**

final estimate of the dose to provide an SAL of 10 for the test items, which is used in the calculation of the

sterilization dose
3.1.6
DD*
dose delivered in a Method 2 verification dose experiment
3.1.7
estimate of D value of microorganisms present on product after exposure to DD*
3.1.8
D value
D value

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

conditions
[ISO/TS 11139:2006]

NOTE For the purposes of this document, D applies to the radiation dose only and not to time.

3.1.9
first fraction positive dose
ffp

lowest dose of an incremental dose series, applied to product items drawn from a given production batch, at

which at least one of the associated 20 tests of sterility is negative
3.1.10
First Fraction Positive dose
FFP

dose at which 19 positives out of the 20 tests of sterility are expected to occur, calculated by subtracting A

from the median of 3 ffp doses
3.1.11
First No Positive dose
FNP

estimate of the dose to provide an SAL of 10 for the test items, which is used in the calculation of DS

3.1.12
max

maximal verification dose for a given bioburden, consistent with the attainment of an SAL of 10 at a

specified sterilization dose of 15 kGy
3.1.13
max

maximal verification dose for a given bioburden, consistent with the attainment of an SAL of 10 at a

specified sterilization dose of 25 kGy
2 © ISO 2006 – All rights reserved
---------------------- Page: 12 ----------------------
ISO 11137-2:2006(E)
3.2 Terms
3.2.1
batch

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

produced during a defined cycle of manufacture
[ISO/TS 11139:2006]
3.2.2
bioburden

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

[ISO/TS 11139:2006]
3.2.3
false positive

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

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

or portions thereof, and the test medium
3.2.4
fraction positive

quotient in which the number of positive tests of sterility is given by the numerator and the number of tests

performed is given by the denominator
3.2.5
incremental dose

dose within a series of doses applied to a number of product, or portions thereof, and used in a dose setting

method to obtain or confirm the sterilization dose
3.2.6
negative test of sterility

test result for which there is no detectable microbial growth from product, or portion thereof, subjected to a test

of sterility
3.2.7
packaging system
combination of the sterile barrier system and protective packaging
[ISO/TS 11139:2006]
3.2.8
positive test of sterility

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

sterility
3.2.9
sample item portion
SIP
defined portion of a health care product that is tested
3.2.10
sterile barrier system

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

point of use
© ISO 2006 – All rights reserved 3
---------------------- Page: 13 ----------------------
ISO 11137-2:2006(E)
3.2.11
sterility assurance level
SAL

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

[ISO/TS 11139:2006]
–6 –3

NOTE The term sterility assurance level 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 .
3.2.12
sterilization dose audit

exercise undertaken to confirm the appropriateness of an established sterilization dose

3.2.13
verification dose

dose of radiation predicted to give a predetermined SAL W 10 used in establishing the sterilization dose

4 Definition and maintenance of product families for dose setting, dose
substantiation and sterilization dose auditing
...

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