FINAL
ISO
AMENDMENT
DRAFT
11737-1:2018
FDAM 1
ISO/TC 198
Sterilization of health care products —
Secretariat: ANSI
Microbiological methods —
Voting begins on:
2020-07-02
Part 1:
Voting terminates on:
Determination of a population of
2020-08-27
microorganisms on products
AMENDMENT 1
Stérilisation des produits de santé — Méthodes microbiologiques —
Partie 1: Détermination d'une population de microorganismes sur des
produits
AMENDEMENT 1
ISO/CEN PARALLEL PROCESSING
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO 11737-1:2018/FDAM 1:2020(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. ISO 2020
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ISO 11737-1:2018/FDAM 1:2020(E)
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© ISO 2020

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ii © ISO 2020 – All rights reserved
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ISO 11737-1:2018/FDAM 1:2020(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 www .iso .org/

iso/ foreword .html.

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

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.
© ISO 2020 – All rights reserved iii
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ISO 11737-1:2018/FDAM 1:2020(E)
Sterilization of health care products — Microbiological
methods —
Part 1:
Determination of a population of microorganisms on
products
AMENDMENT 1
Clause 4
Replace with the following:
4 General

4.1 The development, validation and routine control of a sterilization process is a critical element

in product realization of health care product. To ensure the consistent implementation of the

requirements specified in this document, the necessary processes need to be established, implemented

and maintained. Processes of particular importance in relation to the development, validation and

routine control of a sterilization process include but are not limited to:
— control of documentation, including records,
— assignment of management responsibility,

— provision of adequate resources, including competent human resources and infrastructure,

— control of product provided by external parties,
— identification and traceability of product throughout the process, and
— control of non-conforming product.

NOTE ISO 13485 covers all stages of the lifecycle of medical devices in the context of quality management

systems for regulatory purposes. National and/or regional regulatory requirements for the provision of health

care product can require the implementation of a full quality management system and the assessment of that

system by a recognized conformity assessment body.

4.2 A process shall be specified for the calibration of all equipment, including instrumentation for test

purposes, used in meeting the requirements of this document.
B.3.3.4

B.3.3.4 MPN methods are simple to perform, and the statistical basis for the method makes it

more appropriate for general assessment rather than accurate determinations. The MPN method for

[27]

10 samples of a single dilution is shown in Table 5 of the FDA BAM . This single dilution method

does not incorporate additional dilutions that could provide further information about the number of

microorganisms producing a positive sample. Alternatively, Formula (B.1) can be used for individual

samples or SIPs to determine a most probable number. Formula (B.1) is a simplified version of the

[42]
original formula from Cochran .
n 1
 
MPNs()dSor IP =ln (B.1)
 
sSIP
 
where
sd is for single dilution;
ln represents natural log;
n is the total number of samples tested;
s is the number of samples negative for growth.
Bibliography
Add the following:

Cochran W. Estimation of Bacterial Densities by Means of the Most Probable Number, Biometrics. 6:105-

116, 1950
2 © ISO 2020 – All rights reserved
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ISO 11737-1:2018/FDAM 1:2020(E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on active implantable
medical devices [OJ L 189] aimed to be covered

This European standard has been prepared under a Commission’s standardisation request M/023 to

provide one voluntary means of conforming to essential requirements of Council Directive 90/385/EEC

of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable

medical devices [OJ L 189].

Once this standard is cited in the Official Journal of the European Union under that Directive, 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.

NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk

management process needs to be in compliance with 90/385/EEC, as amended by 2007/47/EC. This means that

risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’,

according to the wording of the corresponding essential requirement.

NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential

requirements 1, 4, 5, 8, 9 and 10of the Directive.

NOTE 3 This Annex ZA is based on normative references according to the table of references in the European

foreword, replacing the references in the core text.

NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this

European Standard.
© ISO 2020 – All rights reserved 3
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ISO 11737-1:2018/FDAM 1:2020(E)
Table ZA.1 — Correspondence between this European Standard and Annex I
of Directive 90/385/EEC [OJ L 189]
Essential Requirements (ERs) Clauses of this EN Qualifying remarks/Notes
of Directive 90/385/EEC
7 4, 5, 6, 7, 8, 9 This standard addresses the deter-
mination of the population of micro-
organisms on or in a medical device
as part of the validation and routine
control of a sterilization process.
This relevant Essential Require-
ment is partly addressed in this
European Standard and only in
conjunction with the applicable
standard for validation and routine
control of the sterilization process
being employed. Design and pack-
aging for maintenance of sterility
during transportation and storage
are not covered. Aspects of manu-
facture other than those related to
sterilization are not covered.

WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European

Standard is maintained in the list published in the Official Journal of the European Union. Users

of this standard should consult frequently the latest list published in the Official Journal of the

European Union.

WARNING 2 — Other Union legislation may be applicable to the products falling within the scope

of this standard.
4 © ISO 2020 – All rights reserved
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ISO 11737-1:2018/FDAM 1:2020(E)
Annex ZB
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices [OJ L
169] aimed to be covered

This European Standard has been prepared under a Commission's standardization request M/023 to

provide one voluntary means of conforming to essential requirements of Council Directive 93/42/EEC

of 14 June 1993 concerning medical devices [OJ L 169].

Once this standard is cited in the Official Journal of the European Union under that Directive, compliance

with the normative clauses of this standard given in Table ZB.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.

NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk

management process needs to be in compliance with 93/42/EEC, as amended by 2007/47/EC. This means that

risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’,

according to the wording of the corresponding essential requirement.

NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential

requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.

NOTE 3 This Annex ZB is based on normative references according to the table of references in the European

foreword, replacing the references in the core text.

NOTE 4 When an Essential Requirement does not appear in Table ZB.1, it means that it is not addressed by this

European Standard.
© ISO 2020 – All rights reserved 5
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ISO 11737-1:2018/FDAM 1:2020(E)
Table ZB.1 — Correspondence between this European Standard and Annex I
of Directive 93/42/EEC [OJ L 169]
Essential Requirements (ERs) Clauses of this EN Qualifying remarks/Notes
of Directive 93/42/EEC
8.3 4, 5, 6, 7, 8, 9 This standard addresses the deter-
mination of the population of micro-
organisms on or in a medical device
as part of the validation and routine
control of a sterilization process.
This relevant Essential Require-
ment is partly addressed in this
European Standard and only in
conjunction with the applicable
standard for validation and routine
control of the sterilization process
being employed. Design and pack-
aging for maintenance of sterility
during transportation and storage
are not covered. Aspects of manu-
facture other than those related to
sterilization are not covered.
8.4 4, 5, 6, 7, 8, 9 This relevant Essential Require-
ment is only partly addressed in
this European Standard. Aspects
of manufacture other than those
related to determination of the
population of microorganisms are
not covered.

WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European

Standard is maintained
...

ISO 11737-1:2018/FDAmd 1