NATO STANDARD

AMedP-1.13
ESSENTIAL PHYSICAL
REQUIREMENTS AND PERFORMANCE
CHARACTERISTICS OF FIELD TYPE
HIGH PRESSURE STEAM STERILIZERS
Edition A, Version 1
JANUARY 2015

NORTH ATLANTIC TREATY ORGANIZATION

ALLIED MEDICAL PUBLICATION

Published by the
NATO STANDARDIZATION OFFICE (NSO)
© NATO/OTAN
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 NORTH ATLANTIC TREATY ORGANIZATION (NATO)

NATO STANDARDIZATION OFFICE (NSO)

NATO LETTER OF PROMULGATION

8 January 2015

1. The enclosed Allied Medical Publication AMedP-1.13, Edition A, Version 1,

ESSENTIAL PHYSICAL REQUIREMENTS AND PERFORMANCE
CHARACTERISTICS OF FIELD TYPE HIGH PRESSURE STEAM STERILIZERS,
which has been approved by the nations in the Military Committee Medical
Standardization Board, is promulgated herewith. The agreement of nations to use
this publication is recorded in STANAG 2906.

2. AMedP-1.13, Edition A, Version 1, is effective upon receipt.

3. No part of this publication may be reproduced, stored in a retrieval system,

used commercially, adapted, or transmitted in any form or by any means, electronic,
mechanical, photo-copying, recording or otherwise, without the prior permission of
the publisher. With the exception of commercial sales, this does not apply to member
nations and Partnership for Peace countries, or NATO commands and bodies.

4. This publication shall be handled in accordance with C-M(2002)60.

Edvardas MAZEIKIS
Major General, LTUAF
Director, NATO Standardization Office
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RESERVED FOR NATIONAL LETTER OF PROMULGATION

I Edition A Version 1
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RECORD OF RESERVATIONS

CHAPTER RECORD OF RESERVATION BY NATIONS

General CAN, GBR

Note: The reservations listed on this page include only those that were recorded at time of
promulgation and may not be complete. Refer to the NATO Standardization Document
Database for the complete list of existing reservations.

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IV Edition A Version 1
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RECORD OF SPECIFIC RESERVATIONS

[nation] [detail of reservation]

CAN Canada current field sterilizers do not have the programmable
sterilization cycles that are mentioned in this document. Currently,
our OR techs monitor the cycles to get the same results. We can
certainly include having programmable sterilization cycles when we
replace our current fields sterilizers in the future.
GBR UK cannot implement in full as the STANAG is not detailed or
prescriptive enough. Type 1 steriliser that the STANAG refers to
(Para 1.2.1) are not capable of sterilizing wrapped or cannulated
instruments/sets/porous loads.

Note: The reservations listed on this page include only those that were recorded at time of
promulgation and may not be complete. Refer to the NATO Standardization Document
Database for the complete list of existing reservations.

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VI Edition A Version 1
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TABLE OF CONTENTS

CHAPTER 1 GENERAL ...................................................................................... 1-1

CHAPTER 2 VALIDATION .................................................................................. 2-1
CHAPTER 3 ROUTINE CONTROLS, PERFORMANCE CHARACTERISTICS .. 3-1
CHAPTER 4 PHYSICAL REQUIREMENTS ........................................................ 4-1

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CHAPTER 1 GENERAL

1.1. High pressure in this context refers to one bar gauge or higher pressure.

1.2. High pressure steam sterilizers will be classified primarily by function.

1.2.1. Type 1 – Small sterilizers. These are sterilizers unable to

accommodate a sterilization module designed by a rectangular
parallelepiped of dimensions 600 x 300 x 300 mm. The chamber
volume doesn’t exceed 60 litres. The design shall comply with the
standard EN 13060: 2010. Sterilizers shall contain an air release
assembly to expel air from the sterilizing chamber and prevent
stratification.

1.2.2. Type 2 – Large sterilizers. These are jacketed sterilizers able to

accommodate one or more sterilization modules. The design shall
comply with the standard EN 285: 2009. Provision is made for
reduced negative pressure (vacuum) to be produced in the chamber
to ensure exhausting of air prior to steam entry for sterilization. To
accelerate the drying process, vacuum shall also be drawn after
sterilization. To avoid contamination, the air drawn in after sterilization
shall pass an adequate sterile filter.

1.3. Each sterilizer within a classification will have standard performances and
broadly similar physical characteristics.

1.4. Sterilizers shall comply with demands of sterilization quality described in the
chapter 3 « Routine controls, performance characteristics » and ensure a
constant steam quality without causing emissions of noxious products for health
or environment.

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CHAPTER 2 VALIDATION

2.1. A validation of each sterilizer shall be carried out in accordance with the
normative references before its first use. Each verification will be recorded to
make up the validation file, used as reference for future cycles.

2.2. This validation file must contain at least:

2.2.1. Sterilizer designation.
2.2.2. Test procedures: functioning, default conditions, maintenance.
2.2.3. Installation conditions.
2.2.4. Sterilization processes (description, parameters, tolerances…).
2.2.5. Operational qualification conditions if necessary.
2.2.6. Results of operational qualification if necessary.

2.3. If a type 2 sterilizer is moved to another site, an operational qualification or

requalification shall be performed before using the sterilizer. These operations
must comply with the methods described in the standard EN ISO 17665-1:
2006.

2.4. Every operation performed on the system in order to control its performances
and every preventive or corrective action shall be recorded in the sterilizer file.

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CHAPTER 3 ROUTINE CONTROLS, PERFORMANCE CHARACTERISTICS

3.1. High pressure steam sterilizers must be subject to routine controls to

demonstrate that their performances meet the national and international
requirements and that they correspond to the tolerance range specified during
the validation of the applied process.

3.2. Before starting to use the sterilizer and at least once a day, the steam
penetration test shall be achieved.
For the type 1 sterilizers, the method to follow is described in the standard
EN 13060: 2010. The test pack to be used is described in the standard EN 867-
5: 2001, and an indicator in accordance with the standard ISO 11140-3: 2009 is
placed in the centre of the pack test.
For the type 2 sterilizers, the method to follow and the standard test pack are
described in the standard EN 285: 2009. The indicator to be used must be in
accordance with the standard ISO 11140-3: 2009 and be placed in the centre of
the pack test.
As alternative to the Bowie-Dick test, it is possible to realize the steam
penetration test with systems conforming to the standard ISO 11140-4: 2007.

3.3. During each operational cycle, a process indicator of type 1 in accordance with
the standard ISO 11140-1: 2009 shall be used.

3.4. During each operational cycle, a sterilization process control shall be realized
according to the procedure defined during the validation. The use of emulating
indicators of type 6 in accordance with the standard ISO 11140-1: 2009 is
advisable.

3.5. After each operational cycle, a visual inspection must be performed to check
the load dryness and its packaging.

3.6. After each operational cycle, the process variables of temperature, time and
pressure, recorded by the sterilizer during the cycle must be compared with the
specified limits defined during the validation and be archived.

3.7. The sterilized load shall only be accepted after examination of all the controls
results. Acceptance criterias are defined in the standard ISO 17665-2: 2009.

3.8. In addition, if the sterilization process makes use of a vacuum, air leakage test
can be carried out at specified intervals. The recommended interval for this test
is once a week.

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CHAPTER 4 PHYSICAL REQUIREMENTS

4.1. The sterilizer shall be light in weight, and ideally, should not weigh more then
200 kg when packed for a type 1 sterilizer.

4.2. The design of the sterilizer should limit risks of deterioration or separation of
internal components during transportation (for example in tactical vehicles over
rough terrain). From this perspective, the frame of the device could be
strengthened to avoid kink or sagging for example.

4.3. It shall be so constructed that the sterilization process under any circumstances
takes place within a temperature range of 134°C to 138° for instruments and
non-rubber items and 120°C to 125°C for the rubber items.

4.4. The sterilizer shall allow programming of several sterilization cycles depending
the kind of items to sterilize. At least one cycle to inactivate causative agents of
spongiform encephalopathies (prion) must be programmed.

4.5. A range of essential spares should be provided with the sterilizer. Spare
heating elements (electrical) and door sealing gaskets should be included in
these spares. The sterilizer should encase all equipment and spares necessary
for operation when possible.

4.6. Servicing data and operating instructions shall be provided for each sterilizer,
English versions should also be provided when possible. Basic operating
instructions must be displayed on a panel fixed to the control panel of the
sterilizer or be located where they are easily visible to the operator when he is
in position to operate the controls. Operating symbols should be used.

4.7. Energy source. Alternative energy source should be provided whenever this will
not significantly increase the cost or complexity, or be in conflict with the
nationally and internationally recognized standards. Alternative includes
electricity or external steam sources.

4.8. Identification marking. The sterilizer shall have a nameplate attached, marked
with the following information:
4.8.1. Manufacturer’s name.
4.8.2. Model number.
4.8.3. Serial number.
4.8.4. Year of manufacture.

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4.9. Instrumentation. The sterilizer shall include instrumentation as defined in the

appropriate standard depending its type. This instrumentation shall ensure that
the sterilization conditions are satisfied at any point of the sterilization chamber.
Sterilization cycle variables shall be printed at the end of cycle to be archived.

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