410.

07 Checklist for auditing sterilization

with moist heat according to ISO 17665‑1:2006

Ref: Device: Date:

Manufacturer:

Auditor: Signature
Name

1 Scope

This checklist is applicable for all sterilization processes for medical products carried out with moist
heat, such as processes with saturated steam venting systems, saturated steam active air removal,
active air removal systems, air-steam mixtures, water spray and water immersion, or other processes.
Compared with the previous versions, DIN 58946-6 and EN 554, the scope of ISO 17665-1 has been
extended and now also includes the requirements for the design of sterilization processes.
This checklist shall be used for assessment of operators of the corresponding sterilization facilities.
Where sterile products are to be included in the company’s product spectrum, a sterilization assess-
ment (including assessment of design and validation of sterilization processes) must be carried out
based on at least one product file of a sterile product. For sterile products of risk class III, the docu-
mentation of design and validation must be examined.
Where an assessment of sterilization procedures validation is necessary as a part of the QM assess-
ment for medical products, the “Checklist for auditing validation of sterilization with moist heat” should
be applied in case of moist heat used as the sterilizing agent.

2 Responsibilities and authority

Lead Auditor
The lead auditor is responsible for the examination and evaluation of the QM system in respect of the
customer’s system documentation, the related standards and the ruling according to ISO 13485
and/or the Council Directive 93/42/EWG.
He is responsible for the work of the audit team and for the observance of the DQS processes. In
case where the lead auditor is not a technical expert himself, he should accept the evaluation of the
sterilization validation by the technical expert without any protest.
Technical expert
The expert is responsible for the competent evaluation of the aspects of the QM system that are spe-
cific for a product or a procedure. The assessment of the design documentation, especially those
parts specifying the design and validation of sterilization procedures, is his essential task.

3 Approach to the evaluation

The goal of the assessment is to examine, whether the requirements of ISO 17665-1 are fulfilled, or
the satisfactory sterilization with moist heat is evidenced in any other way. Any alternatively allowed
procedure designated as such by the ISO 17665-1 shall be accepted.

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The present checklist must be used as an appliance for the assessment.

The assessment results must be formulated in the audit report, where a reference to this checklist can
be made.

4 Further applicable documents

Technical file review

Assessment guideline
ISO 17665-1 Edition November 2006 as DIN EN ISO 17665-1: Sterilization of health care products -
Moist heat - Part 1: Requirements for the design, validation and routine control of a sterilization proc-
ess for medical devices

5 Application of the assessment checklist

The checklist serves for the evaluation of audit results. Every audit requirement should be evaluated
separately.
The evaluation of the documentation and implementation of a standard’s requirement should be
documented in the column “Evaluation” in the following way:
1 = fulfilled
2 = partially fulfilled, still acceptable
3 = partially fulfilled, not acceptable
4 = not fulfilled
na = not applicable
The numbering of the questions corresponds to the numbers of the requirements as printed in ISO
17665-1.

6 Audit protocol

Please use the DQS form “Findings“ (“Feststellungen“). The findings must contain a reference to the
checklist questions. These can be entered in the column “Reference” (“Referenz”). Please use the
numbering system of the standard using at least two digits of the requirement’s number (e.g. 4.2 for
“Management Responsibility” associated with ISO 17665-1). Additional evidence, such as copies of
manufacturer’s documentation, should be ordered clearly (e.g. using the numbers).

7 Abbreviations

SAL Sterility assurance level

IQ Installation qualification
OQ Operation qualification
PQ Performance qualification

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Evalu-
No. Question

ation
4 Quality management systems

4.1 Documentation

4.1.1 Have procedures for the design, validation, routine control of the sterilization process (SP)
and product release from sterilization been specified?

4.1.2 Are all documents and records that are necessary according to ISO 17665-1 reviewed,
approved and controlled*) by the designated personnel (see 4.2.1)?

4.2 Management responsibility

4.2.1 Are responsibilities and authorities for all the requirements of ISO 17665-1 specified and
assigned*) to qualified persons?

4.2.2 Is there a contract agreement about the responsibilities and authorities, in case several
organizations (with separate quality management systems) are involved?

4.3 Product realization

4.3.1- Are procedures for purchasing, identification and traceability*) specified?

4.3.2

4.3.3 Is a system for calibration of all equipment and testing instruments specified**)?

4.4 Measurement, analysis and improvement — Control of nonconforming product

4.4 Are procedures for the control of nonconforming products, corrections, corrective actions
and preventive actions specified*)?

*) according to the applicable parts of ISO 13485

**) according to the applicable parts of ISO 13485 or ISO 10012

5 Sterilizing agent characterization

5.1 Sterilizing agent

5.1.1 Is moist heat defined as a sterilizing agent?

5.1.2 Are the acceptable impurities defined, so that they do not have impact on the safety of the
product?

5.2 Microbicidal effectiveness

5.2 Has the microbicidal effectiveness been determined and documented (in case of applica-
tion outside of widely accepted ranges)?

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5.3 Material effects

5.3 (Assessment according to the requirements of Sections 6 and 7)

5.4 Environmental considerations

5.4 Are there documented:

 evaluations of the possible environmental effects?
 specified actions for environmental protection?
 specified and implemented measures for control (if identified)?

6 Process and equipment characterization

6.1 Process

6.1.1 Does the specification of the sterilization process (SP) include:

a) a description of the work cycle?

b) the process parameters with its tolerances?

c) the product families which can be sterilized?

d) the requirements to preconditioning, if necessary for the effectiveness?

e) the position of the reference measurement point?

f) the lowest / highest pressure, which can occur in an empty chamber?

g) the pressure changing rate with its tolerance for every process step?

h) the highest allowed quantity of each impurity in a liquid / air / gas / steam, that are being
allowed into the chamber?

i) the process variables for verification of SP conduction?

j) the loading configuration?

k) all limitations of loading’s size and weight?

l) the periodical assessments of SP reproducibility*)?

m) the location for the biological indicators, if used*) (→8.5, 8.6!)?

n) the location for the chemical indicators, if used*) (→8.8!)?

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o) where the process effectiveness has been determined using microbiological methods:
the lowest lethality achieved by the SP cycle in the whole loading and the measures for
its estimation (in the loading, for which the SP has been designed)?

p) the treatment after a work cycle, if there is one provided in the SP?

*) incl. criteria for acceptance of the results

6.1.2 Does the specification of a SP with saturated steam additionally include:

a) exposure time, temperature measurement points, lowest / highest temperature that

may occur during the exposure time (measured in the empty chamber)?

b) the greatest allowed difference between the temperature measured at the reference
measurement point and the theoretical steam temperature value for the pressure
measured in the chamber?

c) if the steam diffusion is complicated through the materials of the given product family,
by the loading configuration or for other reasons:
a steam diffusion test as an evidence that the concentration of the diffused / residing
incondensable gases does not prevent the presence of the saturated steam on the
surfaces to be sterilized?

d) the greatest acceptable quantity of water that comes with the saturated steam, if it can
cause any adverse effect on product’s / packing system’s integrity?

e) the reference loadings for the confirmation (evaluation) of the process effectiveness for
the specified objects to be sterilized (product family, loading configuration, size /
weight)?

f) if a monitoring device is being used for the assessment of the process: the description
of the device, where it is to be placed and how the results should be evaluated?

g) the grade of dryness of the reference loading (estimated by weight or perceivable hu-
midity)?

6.1.3 Does the specification of the SP for contained product additionally include:

Note: a loading configuration that is most difficult to sterilize should be used as a

starting situation (worst case).

a) details about products and containers, or reference products, if applicable?

b) the feeding system and the loading’s size / position / arrangement in the chamber?

c) measurement points in an empty chamber and in the free space inside the chamber
around the loading, the temperature course in these points during the part of the work
cycle, for which a lethality is being demanded?

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d) the highest / lowest temperature and temperature changing rates during the part of the
work cycle, for which a lethality is being demanded?

e) the method that is being used to define, at which point the highest / lowest tempera-
ture can be measured?

6.2 Equipment

6.2.1 Does the specification for the equipment for carrying out SP include:

a) the designation of the equipment and accessories?

b) the materials of the equipment and accessories for accommodation and transfer into
the chamber of steam / gases / liquids (observe the impurities! →6.1.1 h)?

c) for each measurement chain for the control / indication / recording of the SP:
1) description of the measurement chain?
2) the properties of the sensor and its location point?
3) the method for verification that the measurement chain calibration is traceable to
a national calibration standard?

d) the maximum rate of change in pressure?

e) the errors that can be recognized by the equipment and warning indicators?

f) the safety features, including those for the protection of personnel and environment?

g) the declaration of conformity with the local / regional / national emission regulations?

h) where vacuum is being used: the leakage test, incl. acceptance criteria?

i) the device for the detection of the allowed / residing incondensable gases, if used?

6.2.2 Does the specification for the operation of equipment and accessories include:

a) the work cycle(s) for automatic control, incl. the possibilities of changing the pro-
grams?

b) a step-by-step user manual?

c) a method for detection of defects leading to inattainability of procedure parameters,

and the measures to be taken in such cases?

d) instructions for calibration and maintenance?

e) possibilities to determine incorrect measuring results (in the controls, display / indica-
tion, records)?

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f) a possibility to receive technical support?

6.2.3 Does the specification of the installation site for the equipment include:

a) the architectural, spatial and environmental conditions?

b) instructions for assembly?

c) possibilities of supply with operating resources necessary for the proper operation:
1) possibilities for separation / barriers?
2) the minimal / maximal pressure?
3) the highest temperature?
4) the minimal flow rate?
5) the filtration?
6) the lowest / highest voltage,
die largest electrical connection cable?
7) the highest concentrations of non-condensable gases and water (in liquid
state) in the saturated steam?
8) the greatest quantities of each impurity?

d) the loadable structures carrying heavy parts of the equipment?

e) the materials of the transfer line for steam / gas / air / water into room where the steri-
lizer is installed?

f) the documentation of observance of local / regional / national emission regulations?

Is it being observed that:

6.2.4  the transport system does not prevent the even distribution of sterilizing conditions and
does not lead to any damage?

6.2.5  an inefficient SP does not appear as efficient?

6.2.6  there are documented procedure instructions by equipment’s manufacturer for soft-
ware validation (application, changes, application in the production which could affect
the conformity of the equipment with its specification)?

7 Product definition

7.1 Is the product specified?

7.2 Is the packing system specified and does it conform with ISO 11607-1 and ISO 11607-2?

7.3-7.4 Are the product families and the criteria for classification into a product family specified?

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7.5 Is the process challenge device (PCD) defined, where used?

Regarding the process variables (e.g. T, p, dp/dt, dT/dt), is it being observed that:

7.6  the limiting values are specified for all materials (or material combinations)?

 the adverse effects of product’s exposure to the sterilizing agent has been detected for
each process parameter combination?

7.7  the range limits for the humidity in the product / packing system is specified prior to
sterilization (where relevant for the effectiveness of the SP)?

7.8  for the contained products: the stability and efficacy are not affected by the sterilization
temperature and exposure time?

7.9  every change incl. the maximally maintainable range limit is specified (where relevant
for the product integrity)?

7.10 Is there a specified system that assures products’ (packing system’s) state prior to sterili-
zation, incl.:

a) cleaning and disinfection (if reprocessed), reusable packing systems (where used)?

b) packing system’s integrity prior to and after the SP?

c) environmental controls in the areas relevant for product’s bioburden?

d) where the process parameters are referred to bioburden: a bioburden estimation ac-
cording to ISO 11737-1?

8 Process definition

8.1 Is the sterilization process (SP) defined including the process parameters and their limit-
ing values (6.1)?

8.2 Is the reproducibility being confirmed by measuring the physical process parameters
where the sterilization process is being worked out?

Is it being observed that:

8.3  the product is not being exposed to the process parameters outside their limiting val-
ues or to impurities relevant to its integrity (→7.6, 7.9)?

8.4  for SP with saturated steam: the concentration of residing non-condensable gases
does not prevent contact of the sterilizing agent with the product (→6.1.2 c, 6.2.1 i)?

8.5-8.7 For biological indicators, is it being observed that:

 they correspond to the requirements of ISO 11138-1 and ISO 11138-3?

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 the testing germ, population, resistance, application method are specified*)?

 the type of the SP to be applied is taken into account*)?

 the expected or the determined bioburden is taken into account*)?

 for the contained products: the influence of the product (packing system) on the lethal-
ity of the testing germ is known?

*) where biological indicators are applied with the method according to 8.11 a)

8.8 For chemical indicators, is it being observed that:

 they are conform with the applicable parts of ISO 11140 (incl. the following parts)?

 they do not lead to any adverse effect on the product during / after the SP by a reac-
tion / impurity / transfer?

8.9 Are the validity of PCD as a testing device, the test methods and the acceptance criteria
for their results determined and documented?

8.10 Is the sterilization process (SP) determined using one of the following bases:
 data from product / packaging material manufacturer and from the manufacturer of the
sterilizer (→ISO 17664)?
 similarity with a product, that has already been classified into a product family?
 design of a work cycle that will deliver the specified SAL?

8.11 Has the SAL to be achieved, been defined using one of the following methods:
a) determination based on the knowledge about the bioburden of the product?
b) determination by the overkill-method (germ killing above the common extent)?
c) definition by evidencing exposure of all product parts to the process parameters, that
have been selected according to an official national or regional pharmacopoeia?
d) estimation as equivalent with the requirement of c) or exceeding it (the product is then
classified into a product family, for which there already is a specified SP; the compen-
sation time does not exceed the greatest value of this family’s products)?

8.12 For the microbiological design of the SP:

 is the bioburden estimated acc. to ISO 11737-1?

 are sterility assessments carried out acc. to ISO 11737-2?

 is the product used for the design of the SP representative of the routinely manufac-
tured products?

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 are reproducible cycles with less effective process parameters (than those of the SP)
possible, so that the volume of the surviving population allows for interpolation with
regard to the total result?

8.13 Is the treatment after exposure to the SP specified (if necessary)?

9 Validation
9.1 General

9.1.1 Is there a documented procedural approach for every validation phase?

9.1.2 Is it being verified that every object of the equipment used during the validation is conform
with its specification?

9.1.3 Is there a corresponding record for every change to product, equipment, SP made during
the validation, and is the specification being adapted in such cases (→Section 12)?

9.1.4 Does the measurement chain of every used testing instrument include:

 a calibration that is traceable to a national standard?

 a valid maintenance certificate?

 a calibration state (verified according to the technical requirements and the applicable
management requirements)?

 calibration verification for the range of values used for the control of SP and for
evaluation of the test results obtained using the measurement chain?

9.1.5 Is the correlation between the measured values of the instruments located at/on the steri-
lizer and those gained with independent testing instruments located at/on approximately
the same points verified?

9.1.6 If applicable, are the error recognition systems verified?

9.1.7 (No requirement)

9.1.8 Is the adequacy of the intended periodical assessments [→6.1.1 l) and 10.3] verified?

9.2 Installation qualification (IQ)

9.2.1- Does the IQ verify that:

9.2.3

 the equipment and the documentation corresponds to 6.2.1-6.2.3?

 the supply with operation resources corresponds to 6.2.3?

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 the installation corresponds to 6.2.3?

 the equipment and the systems for operational safety according to their specifica-
tions?

 the work cycles progress according to their description (6.1.1 a)?

 there no leakage of/in the supplied operational resources and in the equipment?

9.3 Operation qualification (OQ)

9.3.1- Does the OQ verify that:

9.3.2

 the installed equipment is conducting the specified SP (Section 8)?

 there is data determined to each requirement of 6.1?

 there is a documented justification for the number and position of the temperature
sensors capable of submitting evidence for the temperature distribution inside the
chamber (empty, with test load) according to the requirements?

9.4 Performance qualification (PQ)

9.4.1- Is there a documented justification for the quantity and position of temperature sensors
9.4.2
that allow evidencing of the fulfilled requirements in the sterilizer loading?

Are all of the following aspects being observed / fulfilled during the PQ:

9.4.3 a) documented confirmation of the successful IQ and OQ?

b) Test load consisting of the routinely sterilized products in the configuration which is
most difficult for sterilization?

c) packing system identical with that used routinely?

d) preconditioning according to the specification (6.1.1 d)?

e) the loading configuration according to its specification (worst case!) (6.1.1 j)?

f) size and weight of the loading according to the specification (6.1.1 k)?

9.4.4 a) application of the SP defined according to Section 8 and the limiting values corre-
sponding to those defined for the SP (7.6)?

b) the data according to 6.1.3 is available (for contained products)?

c) the course of the exposure effect on/in the whole product is being registered
[reference measurement point, biological and chemical indicators, 6.1.1 e), m), n)]?

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d) the exposure time, min/max temperatures in the loading, position of the measurement
points according to specification (6.1.2)?

e) the temperature profiles during the plateau time: measured at the reference meas-
urement point and in/on the loading, estimated from the pressure (6.1.2 a)?

f) the reaction of the chemical indicators (8.8)?

g) the reaction of the PCD?

h) the packing system’s integrity?

9.4.5 If the sterilization process is based on the bioburden or has been verified microbiologi-
cally: are biological indicators being used at the specified points (8.5, 8.6, 6.1.1 m) and
being exposed to the SP under one of the following conditions:
 exposure with a lower process efficiency as standard and extrapolation of the results?
 exposure to a complete treatment at the process parameters at their lowest tolerance
values, in order to confirm the germ killing effectiveness?
 germ killing procedure above the common extent (overkill)?

9.4.6 Are the reproducibility and the correspondence of the SP with its specification being evi-
denced by a series of at least three consecutive treatments with the SP?

9.4.7 In case the sterilization process does not correspond with its specification, are a corre-
sponding assessment and corrective action being taken?

9.5 Review and approval of validation

9.5.1 Is there a documented review that the information gained by the IQ, OQ and PQ corre-
sponds with the criteria for its acceptance (4.2.1)?

9.5.2 Is there a documented confirmation of the SP specification (incl. the process parameters
with their tolerances) using the criteria in respect to a designated sterilizer loading, ad-
dressing at least the following aspects:

a) the product families that can be treated?

b) the loading configurations?

c) the size and weight of the sterilizer loading?

d) the measures for preconditioning of each product?

e) a description of the packing system and the packing methods?

f) where applicable, the distribution of the products inside a packing?

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g) the periodical assessments (10.3)?

h) the PCD and the product families, for which it is relevant?

i) where applicable, the bioburden?

10 Routine monitoring and control

10.1 Are the procedures for the routine monitoring and control being carried out with every
work cycle?

10.2 Is the evidence of the successful maintenance and of the reassessment (if applicable)
being verified?

10.3 Are there periodical tests for verification of the operational readiness, where applicable, in
which at least the following aspects are being checked:

a) air leakage in the sterilization chamber?

b) quality of the saturated steam (or another heat transferring medium) — e.g. test of
non-condensable gases, contained humidity, impurities, etc.?

c) automated control — e.g. verification of workflows?

d) steam penetration?

e) the reproducibility of the sterilization process?

10.4 Is the conduction of the SP being verified by:

 chemical (8.8) or biological (8.5, 8.6) systems reaction, where used?

 confirmation of the routine control data with the validation data within the specified
tolerances?

10.5 Do the data of the SP with saturated steam include:

a) the sterilization temperature, the pressure inside the chamber, the theoretical steam
temperature during the plateau time?

b) the length of the plateau time?

c) the chamber temperature and pressure for every step of the work cycle?

d) the results gained with a PCD?

e) the temperature/pressure values in the system for SP monitoring, where used?

10.6 Do the data of the SP with saturated steam include:

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a) the temperatures measured in the reference systems (if used as a part of the process
controls)?

b) the profiles of the chamber temperature and pressure for: heating up, exposure and
cooling down?

c) the temperature profile for heating up, exposure and cooling down measured in the
product at the reference measurement point and points of chemical / biological indica-
tors [6.1.1 c), m), n)] (where used as a part of process controls)?

d) the plateau time / exposure time?

e) the values of the process parameters for the homogeneity of the media used for heat-
ing up?

f) the results of the evaluation of loading confirming its dryness and integrity of the pack-
ing system?

11 Product release from sterilization

11.1 Are there specified procedural approaches for the assessment of records?

Are there specified procedural approaches for the release of products from sterilization?
Do they contain the requirements for definition of the SP as conforming to its specification
(9.5.2, 10.3, 10.5, 10.6)?

Are the nonconforming products defined as such and handled acc. to 4.4?

11.2 Is there a specified system for the clear differentiation between treated and untreated ob-
jects?

12 Maintaining process effectiveness

12.1 Evidence of continual effectiveness

12.1.1 Is the product to be sterilized identical with its definition (Section 7), loading configuration
(6.1.1 j) and the criteria for size and weight (6.1.1 k)?

12.1.2 Is the successful completion of the periodical evaluations, calibrations, bringing into op-
eration and reassessments being verified?

12.1.3 Are the environmental conditions being evaluated periodically?

12.1.4 Are the hygiene requirement specified and observed?

12.1.5 Is there a periodical inspection for air leakage (where vacuum is being used)?

12.1.6 Is there test of steam penetration taking place daily before usage of the equipment (where
steam is being used)?

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12.1.7 Does the product correspond to the requirement for maximal bioburden (where applica-
ble)?

12.2 Recalibration

12.2 Are the accuracy and reliability of each measurement chain for control, indication and
registering of the sterilizing process verified periodically (4.3.3)?

12.3 Maintenance of equipment

12.3.1- Is the maintenance of the equipment assured according to ISO 13485?

12.3.3

Is the preventive maintenance planned and conducted acc. to the requirements?

12.4 Reassessment
(in defined periods or after a change)

12.4.1- Are there specified work instructions for reassessment?

12.4.2

Are the corrections which make a reassessment necessary defined?

Is the scope of the reassessment justified?

12.4.2- Are there documented methods / specified criteria for the evaluation of acceptability of the
12.4.3
reassessment’s result data?

12.5 Evaluation of changes

(to SP / product / requirements)

12.5 Is every change being evaluated in respect to its consequences for the SP effectiveness?
The following aspects must be taken into account, if applicable:
a) substitution of a part (where it makes a change of a process parameter possible)
b) substitution of a part (where it makes a leakage possible)
c) change of homogeneity in the sterilization chamber
d) new or changed software or hardware
e) change to a process parameter
f) change in supply of operational resources,
consequences of maintenance in supply of operational resources
g) change to the packing / packing method
h) change to the loading configuration
i) change of the materials, material source, product design

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Are the results of the evaluation of a change documented, including the justification for the
made decisions and the scope of the changes to the SP / product / requirements for reas-
sessment (if applicable)?

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