BSI-DSZ-CC-0596-V2-2018
for
ORGA 930 M online and Cherry ST-1530,
Version 4.7.0:1.0.0
from
Ingenico Healthcare GmbH
BSI - Bundesamt für Sicherheit in der Informationstechnik, Postfach 20 03 63, D-53133 Bonn
Phone +49 (0)228 99 9582-0, Fax +49 (0)228 9582-5477, Infoline +49 (0)228 99 9582-111
Certification Report V1.0 CC-Zert-327 V5.21
BSI-DSZ-CC-0596-V2-2018 (*)
eHealth: Smart Card Readers
ORGA 930 M online and Cherry ST-1530
Version 4.7.0:1.0.0
from Ingenico Healthcare GmbH
PP Conformance: Common Criteria Protection Profile Mobile Card
Terminal for the German Healthcare System
(MobCT), Version 1.4, BSI-CC-PP-0052-2015, 24
September 2014
Functionality: PP conformant
Common Criteria Part 2 extended Assurance:
Common Criteria Part 3 conformant
EAL 3 augmented by ADV_FSP.4, ADV_IMP.1,
ADV_TDS.3, ALC_TAT.1 und AVA_VAN.5
The IT Product identified in this certificate has been evaluated at an approved evaluation
facility using the Common Methodology for IT Security Evaluation (CEM), Version 3.1
extended by Scheme Interpretations for conformance to the Common Criteria for IT
Security Evaluation (CC), Version 3.1. CC and CEM are also published as ISO/IEC 15408
and ISO/IEC 18045.
(*) This certificate applies only to the specific version and release of the product in its
evaluated configuration and in conjunction with the complete Certification Report and
Notification. For details on the validity see Certification Report part A chapter 4
The evaluation has been conducted in accordance with the provisions of the certification
scheme of the German Federal Office for Information Security (BSI) and the conclusions
of the evaluation facility in the evaluation technical report are consistent with the
evidence adduced.
This certificate is not an endorsement of the IT Product by the Federal Office for
Information Security or any other organisation that recognises or gives effect to this
certificate, and no warranty of the IT Product by the Federal Office for Information
Security or any other organisation that recognises or gives effect to this certificate, is
either expressed or implied.
Bonn, 25 September 2018
For the Federal Office for Information Security
Bernd Kowalski L.S.
Head of Division
SOGIS
Recognition Agreement
for components up to
EAL 4
Common Criteria
Recognition Arrangement
recognition for components
up to EAL 2
Bundesamt für Sicherheit in der Informationstechnik
Godesberger Allee 185-189 - D-53175 Bonn - Postfach 20 03 63 - D-53133 Bonn
Phone +49 (0)228 99 9582-0 - Fax +49 (0)228 9582-5477 - Infoline +49 (0)228 99 9582-111
Certification Report BSI-DSZ-CC-0596-V2-2018
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BSI-DSZ-CC-0596-V2-2018 Certification Report
Contents
A. Certification.......................................................................................................................6
1. Preliminary Remarks.....................................................................................................6
2. Specifications of the Certification Procedure................................................................6
3. Recognition Agreements...............................................................................................7
4. Performance of Evaluation and Certification.................................................................8
5. Validity of the Certification Result..................................................................................8
6. Publication.....................................................................................................................9
B. Certification Results........................................................................................................10
1. Executive Summary.....................................................................................................11
2. Identification of the TOE..............................................................................................13
3. Security Policy.............................................................................................................15
4. Assumptions and Clarification of Scope......................................................................15
5. Architectural Information..............................................................................................15
6. Documentation............................................................................................................16
7. IT Product Testing........................................................................................................17
8. Evaluated Configuration..............................................................................................18
9. Results of the Evaluation.............................................................................................19
10. Obligations and Notes for the Usage of the TOE......................................................21
11. Security Target...........................................................................................................21
12. Definitions..................................................................................................................21
13. Bibliography...............................................................................................................23
C. Excerpts from the Criteria...............................................................................................25
D. Annexes..........................................................................................................................26
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Certification Report BSI-DSZ-CC-0596-V2-2018
A. Certification
1. Preliminary Remarks
Under the BSIG1 Act, the Federal Office for Information Security (BSI) has the task of
issuing certificates for information technology products.
Certification of a product is carried out on the instigation of the vendor or a distributor,
hereinafter called the sponsor.
A part of the procedure is the technical examination (evaluation) of the product according
to the security criteria published by the BSI or generally recognised security criteria.
The evaluation is normally carried out by an evaluation facility recognised by the BSI or by
BSI itself.
The result of the certification procedure is the present Certification Report. This report
contains among others the certificate (summarised assessment) and the detailed
Certification Results.
The Certification Results contain the technical description of the security functionality of
the certified product, the details of the evaluation (strength and weaknesses) and
instructions for the user.
2. Specifications of the Certification Procedure
The certification body conducts the procedure according to the criteria laid down in the
following:
● Act on the Federal Office for Information Security1
● BSI Certification and Approval Ordinance2
● BSI Schedule of Costs3
● Special decrees issued by the Bundesministerium des Innern (Federal Ministry of the
Interior)
● DIN EN ISO/IEC 17065 standard
● BSI certification: Scheme documentation describing the certification process (CC-
Produkte) [3]
● BSI certification: Scheme documentation on requirements for the Evaluation Facility, its
approval and licencing process (CC-Stellen) [3]
● Common Criteria for IT Security Evaluation (CC), Version 3.14
[1] also published as
ISO/IEC 15408.
1
Act on the Federal Office for Information Security (BSI-Gesetz - BSIG) of 14 August 2009,
Bundesgesetzblatt I p. 2821
2
Ordinance on the Procedure for Issuance of Security Certificates and approval by the Federal Office for
Information Security (BSI-Zertifizierungs- und -Anerkennungsverordnung - BSIZertV) of 17 December
2014, Bundesgesetzblatt 2014, part I, no. 61, p. 2231
3
Schedule of Cost for Official Procedures of the Bundesamt für Sicherheit in der Informationstechnik
(BSI-Kostenverordnung, BSI-KostV) of 03 March 2005, Bundesgesetzblatt I p. 519
6 / 27
BSI-DSZ-CC-0596-V2-2018 Certification Report
● Common Methodology for IT Security Evaluation (CEM), Version 3.1 [2] also published
as ISO/IEC 18045.
● BSI certification: Application Notes and Interpretation of the Scheme (AIS) [4]
3. Recognition Agreements
In order to avoid multiple certification of the same product in different countries a mutual
recognition of IT security certificates - as far as such certificates are based on ITSEC or
CC - under certain conditions was agreed.
3.1. European Recognition of CC – Certificates (SOGIS-MRA)
The SOGIS-Mutual Recognition Agreement (SOGIS-MRA) Version 3 became effective in
April 2010. It defines the recognition of certificates for IT-Products at a basic recognition
level and, in addition, at higher recognition levels for IT-Products related to certain SOGIS
Technical Domains only.
The basic recognition level includes Common Criteria (CC) Evaluation Assurance Levels
EAL 1 to EAL 4. For "Smartcards and similar devices" a SOGIS Technical Domain is in
place. For "HW Devices with Security Boxes" a SOGIS Technical Domains is in place, too.
In addition, certificates issued for Protection Profiles based on Common Criteria are part of
the recognition agreement.
The current list of signatory nations and approved certification schemes, details on
recognition, and the history of the agreement can be seen on the website at
https://www.sogisportal.eu.
The SOGIS-MRA logo printed on the certificate indicates that it is recognised under the
terms of this agreement by the related bodies of the signatory nations. A disclaimer
beneath the logo indicates the specific scope of recognition.
This certificate is recognized according to the rules of SOGIS-MRA, i.e. up to and including
CC part 3 EAL 4 components. The evaluation contained the component AVA_VAN.5 that is
not mutually recognised in accordance with the provisions of the SOGIS MRA. For mutual
recognition the EAL 4 components of these assurance families are relevant.
3.2. International Recognition of CC – Certificates (CCRA)
The international arrangement on the mutual recognition of certificates based on the CC
(Common Criteria Recognition Arrangement, CCRA-2014) has been ratified on 08
September 2014. It covers CC certificates based on collaborative Protection Profiles (cPP)
(exact use), CC certificates based on assurance components up to and including EAL 2 or
the assurance family Flaw Remediation (ALC_FLR) and CC certificates for Protection
Profiles and for collaborative Protection Profiles (cPP).
The current list of signatory nations and approved certification schemes can be seen on
the website: http://www.commoncriteriaportal.org.
The Common Criteria Recognition Arrangement logo printed on the certificate indicates
that this certification is recognised under the terms of this agreement by the related bodies
of the signatory nations. A disclaimer beneath the logo indicates the specific scope of
recognition.
4
Proclamation of the Bundesministerium des Innern of 12 February 2007 in the Bundesanzeiger dated
23 February 2007, p. 3730
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Certification Report BSI-DSZ-CC-0596-V2-2018
This certificate is recognized according to the rules of CCRA-2014, i. e. up to and including
CC part 3 EAL 2 components.
4. Performance of Evaluation and Certification
The certification body monitors each individual evaluation to ensure a uniform procedure, a
uniform interpretation of the criteria and uniform ratings.
The product ORGA 930 M online and Cherry ST-1530, Version 4.7.0:1.0.0 has undergone
the certification procedure at BSI.
The evaluation of the product ORGA 930 M online and Cherry ST-1530, Version
4.7.0:1.0.0 was conducted by TÜV Informationstechnik GmbH. The evaluation was
completed on 9 July 2018. TÜV Informationstechnik GmbH is an evaluation facility
(ITSEF)5
recognised by the certification body of BSI.
For this certification procedure the applicant is: Ingenico Healthcare GmbH.
The product was developed by: Ingenico Healthcare GmbH.
The certification is concluded with the comparability check and the production of this
Certification Report. This work was completed by the BSI.
5. Validity of the Certification Result
This Certification Report applies only to the version of the product as indicated. The
confirmed assurance package is valid on the condition that
● all stipulations regarding generation, configuration and operation, as given in the
following report, are observed,
● the product is operated in the environment described, as specified in the following report
and in the Security Target.
For the meaning of the assurance components and assurance levels please refer to CC
itself. Detailed references are listed in part C of this report.
The Certificate issued confirms the assurance of the product claimed in the Security Target
at the date of certification. As attack methods evolve over time, the resistance of the
certified version of the product against new attack methods needs to be re-assessed.
Therefore, the sponsor should apply for the certified product being monitored within the
assurance continuity program of the BSI Certification Scheme (e.g. by a re-assessment or
re-certification). Specifically, if results of the certification are used in subsequent evaluation
and certification procedures, in a system integration process or if a user's risk
management needs regularly updated results, it is recommended to perform a re-
assessment on a regular e.g. annual basis.
In order to avoid an indefinite usage of the certificate when evolved attack methods would
require a re-assessment of the products resistance to state of the art attack methods, the
maximum validity of the certificate has been limited. The certificate issued on
25 September 2018 is valid until 24 September 2023. Validity can be re-newed by re-
certification.
The owner of the certificate is obliged:
5
Information Technology Security Evaluation Facility
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BSI-DSZ-CC-0596-V2-2018 Certification Report
1. when advertising the certificate or the fact of the product's certification, to refer to
the Certification Report as well as to provide the Certification Report, the Security
Target and user guidance documentation mentioned herein to any customer of the
product for the application and usage of the certified product,
2. to inform the Certification Body at BSI immediately about vulnerabilities of the
product that have been identified by the developer or any third party after issuance
of the certificate,
3. to inform the Certification Body at BSI immediately in the case that security relevant
changes in the evaluated life cycle, e.g. related to development and production sites
or processes, occur, or the confidentiality of documentation and information related
to the Target of Evaluation (TOE) or resulting from the evaluation and certification
procedure where the certification of the product has assumed this confidentiality
being maintained, is not given any longer. In particular, prior to the dissemination of
confidential documentation and information related to the TOE or resulting from the
evaluation and certification procedure that do not belong to the deliverables
according to the Certification Report part B, or for those where no dissemination
rules have been agreed on, to third parties, the Certification Body at BSI has to be
informed.
In case of changes to the certified version of the product, the validity can be extended to
the new versions and releases, provided the sponsor applies for assurance continuity (i.e.
re-certification or maintenance) of the modified product, in accordance with the procedural
requirements, and the evaluation does not reveal any security deficiencies.
6. Publication
The product ORGA 930 M online and Cherry ST-1530, Version 4.7.0:1.0.0 has been
included in the BSI list of certified products, which is published regularly (see also Internet:
https://www.bsi.bund.de and [5]). Further information can be obtained from BSI-Infoline
+49 228 9582-111.
Further copies of this Certification Report can be requested from the developer6
of the
product. The Certification Report may also be obtained in electronic form at the internet
address stated above.
6
Ingenico Healthcare GmbH
Konrad-Zuse-Ring 1
24220 Flintbek
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Certification Report BSI-DSZ-CC-0596-V2-2018
B. Certification Results
The following results represent a summary of
● the Security Target of the sponsor for the Target of Evaluation,
● the relevant evaluation results from the evaluation facility, and
● complementary notes and stipulations of the certification body.
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BSI-DSZ-CC-0596-V2-2018 Certification Report
1. Executive Summary
Target of Evaluations (TOE) are the mobile card terminal variants “ORGA 930 M online”,
the most widely identical “Cherry ST-1530” and the firmware updates for “ORGA 930 M”
and “Cherry ST-1530 Update” in Version 4.7.0:1.0.0 by Ingenico Healthcare GmbH. In
total, the TOE encompasses four product variants7
which were evaluated.
The TOE is a smart card terminal used for the German healthcare system as a Mobile
Card Terminal (MobCT). It is used by medical suppliers during visits to read out insurance
data from a German electronic Health Card (eHC) of a health insured person.
The Security Target [6] is the basis for this certification. It is based on the certified
Protection Profile Common Criteria Protection Profile Mobile Card Terminal for the German
Healthcare System (MobCT), Version 1.4, BSI-CC-PP-0052-2015, 24 September 2014 [8].
The TOE Security Assurance Requirements (SAR) are based entirely on the assurance
components defined in Part 3 of the Common Criteria (see part C or [1], Part 3 for details).
The TOE meets the assurance requirements of the Evaluation Assurance Level EAL 3
augmented by ADV_FSP.4, ADV_IMP.1, ADV_TDS.3, ALC_TAT.1 und AVA_VAN.5.
The TOE Security Functional Requirements (SFR) relevant for the TOE are outlined in the
Security Target [6], chapter 6.1. They are selected from Common Criteria Part 2 and some
of them are newly defined. Thus the TOE is CC Part 2 extended.
The TOE Security Functional Requirements are implemented by the following TOE
Security Functionality:
TOE Security Functionality Addressed issue
SF_1 - Secure Identification &
Authentication
The TOE provides several authentication mechanisms for the
roles administrator, medical supplier and developer and
associates users with roles. Each user has to be successfully
identified and authenticated before being allowed to perform any
TSF-mediated action.
SF_2 - Secure Residual The TOE terminates an authenticated session and thereby
delete all unencrypted sensitive information from the memory:
On dropping of the authenticated state, power loss and
deallocation of the resource from temporary data in the
persistent storage of the TOE and in the volatile memory of the
TOE.
SF_3 - Secure Self-Tests The TOE performs self-tests at initial start-up and they can be
started manually via the management functions. The self-tests
check the TOE's functionality by evaluating the integrity of the
stored data. This includes the integrity of the firmware in
processor flash (loader and application) and integrity of TSF
SFLASH-Page with configuration data.
SF_4 - Secure Data Protection The TOE encrypts health insurance data stored in the persistent
storage of the TOE with the cryptographic algorithm AES-GCM
and cryptographic key size of 256 bits and with a symmetric
cryptographic key. The generation of the symmetric
cryptographic key is initiated and performed by the authorised
card of the user.
SF_5 - Secure Management The TOE grants access to the management functions i.e.
installing firmware, import of cross CVCs, management of time
7
For a detailed description of all four product variants see Chapter B.8.
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Certification Report BSI-DSZ-CC-0596-V2-2018
TOE Security Functionality Addressed issue
settings, resetting to factory defaults, management of the
administrator login credentials, and printer control, to the
administrator who has to authenticate himself by PIN-entry or for
the latter to perform a successful Challenge & Response
operation with the TOE.
SF_6 - Secure Card_Communication When an authorised card is put into one of the TOE's slots, the
TOE will read out the card’s X.509 certificate and check whether
the card claims to be an authorised card, whether the X.509
certificate of this authorised card is mathematically correct, and
whether the current date given by the TOE falls within the validity
period of the certificate before permitting any other interaction
with a card.
The Card holder PIN entered via the PIN pad is only sent to the
card slot where the authorised card is plugged in. No PIN is sent
to the card slot where the eHC is plugged in.
SF_7 - Secure DMS_Communication The TOE enables the medical supplier to transfer data records
from the persistent storage to the DMS only. The transmission
takes place via error detection code (EDC). After the data record
has been transferred to the DMS successfully it is deleted from
the device.
SF_8 - Secure Firmware-Update On firmware update the TOE can be securely updated with new
firmware. The secure update guarantees that only authentic
firmware electronically signed by the manufacturer will be
accepted by the TOE and installed on the TOE. For signature
verification purposes the TOE firmware contains the public
cryptographic key and the TOE performs a signature verification
for firmware updates with cryptographic algorithms SHA and
RSA and cryptographic key sizes of SHA-512 and RSA-4096.
Additional Security Measures
SM_1 - Security Seals The TOE's integrity is protected against unauthorised and
unnoticed attempts to tamper with the TOE by security seals.
Table 1: TOE Security Functionalities
For more details please refer to the Security Target [6], chapter 7.
The assets to be protected by the TOE are defined in the Security Target [6], chapter 1.4.7.
Based on these assets the TOE Security Problem is defined in terms of Assumptions,
Threats and Organisational Security Policies. This is outlined in the Security Target [6],
chapter 3.
This certification covers the configurations of the TOE as outlined in chapter 8.
The vulnerability assessment results as stated within this certificate do not include a rating
for those cryptographic algorithms and their implementation suitable for encryption and
decryption (see BSIG Section 9, Para. 4, Clause 2).
The certification results only apply to the version of the product indicated in the certificate
and on the condition that all the stipulations are kept as detailed in this Certification
Report. This certificate is not an endorsement of the IT product by the Federal Office for
Information Security (BSI) or any other organisation that recognises or gives effect to this
certificate, and no warranty of the IT product by BSI or any other organisation that
recognises or gives effect to this certificate, is either expressed or implied.
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BSI-DSZ-CC-0596-V2-2018 Certification Report
2. Identification of the TOE
The Target of Evaluation (TOE) is called:
ORGA 930 M online and Cherry ST-1530, Version 4.7.0:1.0.0
The following table outlines the TOE deliverables8
:
No Type Identifier Release Form of Delivery
Ingenico TOE: ORGA 930 M online
1a HW+FW ORGA 930 M online HW and Firmware Image
SHA-256:
16348be6d3fb122a525d548cbe886190828741f1
d7abf2a6bcb709e91a92ffc8
4.7.0:1.0.0 TOE delivered according
to Secure delivery chain
[16]
Firmware Image is initially
included in the TOE
1b FW Firmware Image ORGA 930 M
SHA-256:
68d63c2df9bdf2f0c008c76c56a66156d0a521c35
f5819e78e65fea05c6df2c0
4.7.0:1.0.0 Provided by the developer
on its homepage
2 DOC Bedienungsanleitung Mobiles eHealth
Kartenterminal ORGA 930 M online mit
Firmware-Version 4.7.0 [10]
SHA-256:
35dc7f0a8f55db76f982f3dd78bc49f22fd21191be
c3bec82748d5876f8fcb8c
8.6.1 Provided by the developer
on its homepage
3 DOC Kurzanleitung Mobiles eHealth Kartenterminal
ORGA 930 M online mit Firmware-Version 4.7.0
[11]
SHA-256:
f1c261380f4f6b998d6cd7450a12626ed61436f5d
69abfcec983118977c127c9
8.5.1 Delivered within the
delivery package of the
TOE
4 DOC Installationsanleitung: Firmware-Upgrade des
mobilen Gesundheitskartenlesegerätes ORGA
930 M mit Firmware V3.20 [12]
SHA-256:
d0c98e422d66a16264930580e3ec99e113e6eef
ab5b47f71f63b9a2f0d8636ee
8.4.1 Delivered within the
delivery package of the
TOE
Note: Only for TOE
variant ORGA 930 M
5 DOC Endnutzer-Checkliste „Sichere Lieferkette“ [16]
SHA-256:
894340793632b65682744dd4cfdd63e06d4f03b5
6f3434d48cc520ec53a77fb1
8.6.1 Provided by the developer
on its homepage
Cherry TOE: Cherry ST-1530
1a HW+FW Cherry ST-1530 HW and Firmware Image
SHA-256:
247a126c770930a4101c2822aa740800248c1ab
780c025cb92cd5fa923c6810a
4.7.0:1.0.0 TOE delivered according
to Secure delivery chain
[16]
Firmware Image is initially
included in the TOE
8
For a detailed description of all four product variants "ORGA 930 M online", "Cherry ST-1530", "ORGA
930 M" and "Cherry ST-1530 Update" relevant for this evaluation see Chapter B.8.
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Certification Report BSI-DSZ-CC-0596-V2-2018
No Type Identifier Release Form of Delivery
1b FW Firmware Image Cherry ST-1530 Update
SHA-256:
84160170f7a9c10f81562946583d17cbfef64d76e
e3b2620ba0dccc2ac081c44
4.7.0:1.0.0 Provided by the developer
on their homepage
2 DOC Informationen vor Inbetriebnahme:
Bedienungsanleitung für Benutzer -
Bedienungsanleitung für Administrator - ST-1530
Mobiles Terminal eHealth Kartenterminal mit
Firmware-Version V4.7.0 [13]
SHA-256:
b79c5a4e418531a7a1f836b5103f5a35ffec6be10
1c4d25655c141c7cef3881a
8.6.2 Provided by the developer
on its homepage
3 DOC Kurzanleitung vor Inbetriebnahme - ST-1530
Mobiles Terminal eHealth Kartenterminal mit
Firmware-Version V4.7.0 [14]
SHA-256:
7fb808701066977d909b91f4de2750f5293a6c03
e95c8dd0e9ee09a9768f3844
8.5.1 Delivered within the
delivery package of the
TOE
4 DOC Installationsanleitung: Firmware-Upgrade des
mobilen Gesundheitskartenlesegerätes ST-1530
mit Firmware V3.20 [15]
SHA-256:
2132c9f2f578a92940e29997e35ac8f84228f8c5c
050bf43411385ec7ca91228
8.5.1 Delivered within the
delivery package of the
TOE
Note: Only for TOE
variant Cherry ST-1530
Update
5 DOC Endnutzer-Checkliste „Sichere Lieferkette“ [16]
SHA-256:
894340793632b65682744dd4cfdd63e06d4f03b5
6f3434d48cc520ec53a77fb1
8.6.1 Provided by the developer
on its homepage
Table 2: Deliverables of the TOE
The TOE variants “ORGA 930 M online” and “Cherry ST-1530” are delivered to the end
user in such a way as defined by the delivery chain [16].
● The first option is the secure delivery of the TOE from the developer Ingenico to the
companies CGM (CompuGroup Medical Deutschland AG) or T-Systems. From this
point, the secure delivery chain is identical to the certified secure delivery chain from the
certification BSI-DSZ-CC-0950-V2-2018 (CGM) resp. BSI-DSZ-CC-0928-2018 (T-
Systems).
● The direct transport to the end user via the parcel service TNT is the second allowed
secure delivery chain. The service technician or the end user installs the product Mobile
Card Terminal within the premises of the end user.
The guidance defines all steps the end user has to perform to check if the secure delivery
chain was correctly used and to check that the TOE was not manipulated or replaced and
therefore the integrity and authenticity of the TOE is guaranteed.
The TOE can be identified within the management menu \Service\Status\. There, the
product version 4.7.0:1.0.0 is displayed.
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BSI-DSZ-CC-0596-V2-2018 Certification Report
3. Security Policy
The Security Policy is expressed by the set of Security Functional Requirements and
implemented by the TOE. It covers the following issues:
● Cryptographic Support
● User Data Protection
● Identification and Authentication
● Security Management
● TOE Access
● Protection of the TSF
4. Assumptions and Clarification of Scope
The Assumptions defined in the Security Target and some aspects of Threats and
Organisational Security Policies are not covered by the TOE itself. These aspects lead to
specific security objectives to be fulfilled by the TOE-Environment. The following topics are
of relevance:
● OE.MEDIC: The medical supplier shall be non hostile, always act with care, and read
the existing guidance documentation of the TOE.
● OE.ADMIN: The administrator shall be non hostile, always act with care, knows the
existing guidance documentation of the TOE and adhere to the rules of the TOEs
environment.
● OE.Developer: The developer is assumed to be non hostile, always act with care and
knows the existing guidance documentation of the TOE.
● OE.CARDS: The authorised cards and the eHC are smart cards that comply with the
specification of the gematik.
● OE.DMS: The TOE shall only be connected to a Data Management System for a
practice or hospital that is trusted by the medical supplier.
● OE.PHYSICAL: The secure TOE environment shall protect the TOE against physical
manipulation.
● OE.ENVIRONMENT: While the TOE is in use by either the medical supplier or the
administrator, they shall always keep the TOE under their control. This applies to its
authenticated as well as its unauthenticated state.
Details can be found in the Security Target [6], chapter 4.2.
5. Architectural Information
The following figure is an overview of the TOE architecture:
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Certification Report BSI-DSZ-CC-0596-V2-2018
Figure 1: TOE Architecture
The figure presents the main building blocks of the TOE and their relation to the
environment. The TSF is broken down into the following five subsystems:
● Loader: The subsystem "Loader" contains the bootloader of the TOE, which executes
the start-up process.
● Application: The subsystem "Application" involves the applications of the device.
● Loader Driver: The subsystem "Loader Driver" includes the drivers of the hardware from
the TOE for the interaction with subsystem “Loader”.
● Application Driver: The subsystem "Application Driver" includes the drivers of the
hardware from the TOE for the interaction with subsystem “Application”.
● Hardware: The hardware contains all electronic and mechanical components of the main
processor and the connected peripherals.
6. Documentation
The evaluated documentation as outlined in table 2 is being provided with the product to
the customer. This documentation contains the required information for secure usage of
the TOE in accordance with the Security Target.
Additional obligations and notes for secure usage of the TOE as outlined in chapter 10 of
this report have to be followed.
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BSI-DSZ-CC-0596-V2-2018 Certification Report
7. IT Product Testing
7.1. Developer's Test
Test Configurations
The ST [6] has identified four configurations of the TOE, which are most widely identical,
see B.8. Therefore, not all four configurations had to be tested with the same rigour.
The test setup comprises a laptop with the test suite Qumate, a TOE, two virtual card kits
and real smart cards (eHC, HPC, SMC-B). The virtual card kits are used to simulate
special situations, for example, a smart card with wrong/invalid certificate.
Testing Approach
● Coverage and depth tests are performed together
● Tests considering the different roles that can access the TOE are performed
● Tests covering all TSF subsystems in the TOE design are performed
● Different testing approaches were used, i.e. code analysis and test suites (automatic
and manual test)
Verdict for the Activity
The developer’s testing efforts have been proven sufficient to demonstrate that the TSFIs
and subsystems perform as expected.
7.2. Independent Evaluator Tests
Test Configurations
The evaluation body used the same test configurations and test environment as the
developer during functional testing.
Testing Approach
The evaluation body chose to broadly cover the existing interfaces without specific
restrictions. All interfaces were considered during testing.
The evaluation body chose to inspect all developer tests. In the end, eight developer tests
were not repeated due to their duration and additional hardware requirements.
The evaluator conducted additional independent testing covering the stationary mode and
guidance testing.
Verdict for the Activity
No deviations were found between the expected and the actual test results.
7.3. Penetration Testing
Test Configurations
The configuration defined in the ST was tested. Furthermore, different TOE variants were
used during penetration testing to verify different mechanisms.
The TOE was delivered by the developer in different configurations: A final operational and
a special AVA variant. The AVA configuration provided debugging outputs, which allowed
the evaluator to have a look at the running system.
Testing Approach
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The evaluation body conducted penetration testing based on functional areas of concern
derived from the SFRs and architectural mechanisms of the TOE. The areas were
prioritized with regards to various factors, e.g. attack surface, estimated flaw likelihood,
developer testing coverage, detectability of flaws during developer testing.
The penetration testing activities were performed as tests and as analytical tasks.
Whenever an analysis was estimated to yield better results, the evaluator chose the
analytical approach.
Attack Scenarios
The evaluation body considered security analysis and penetration testing in the following
areas:
● Handling of HPC / eHC / KVK smart cards,
● Update,
● Authentication,
● Secure encryption / decryption,
● Leakage.
Tested Security Functionality
The evaluator ensured that all areas listed above were tested. The penetration testing was
then conducted based on priorities as described above. Therefore, a complete coverage of
security functional testing based on functional areas of concern was performed.
Verdict for the Activity
The overall test result is that no deviations were found between the expected and the
actual test results. No attack scenario with the attack potential High was actually
successful in the TOE’s operational environment provided that all measures required by
the developer are applied.
8. Evaluated Configuration
The evaluation covers four variants of the TOE as defined in the ST [6]. The hardware of
all product variants is identical except for the branding. The text Cherry ST-1530 is printed
on the case of the product variants "Cherry ST-1530" and "Cherry ST-1530 Update"
instead of ORGA 930 M for the product variants "ORGA 930 M online" and "ORGA 930 M".
The differences in the configuration of the product variants are listed in Chapter 1.2 of the
ST [6].
"ORGA 930 M online" and "Cherry ST-1530" are new devices, which already contain the
current TOE firmware on delivery. The delivery of hard- and firmware is part of the
evaluation.
The firmware versions "ORGA 930 M" and "Cherry ST-1530 Update" which can be
downloaded from the developer's website provide existing, already delivered devices with
an firmware update. The delivery of the hardware was not part of the evaluation process.
The four variants are:
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● ORGA 930 M online (#1 in table 2), mobile card terminal, graphical display, 2 full size
slots (eHC / KVK and HPC / SMC-B). This involves the delivery of new ORGA 930 M
online devices.
• TOE Version: 4.7.0:1.0.0/930MONLINE
• The TOE version includes the following versions:
Version Hardware: 1.0.0
Manufacturing code: HC 00 04 00 00
Version Loader: 7.4.0
Version Application: 4.7.0
Version Configuration: 1.0.0/930MONLINE
● Cherry ST-1530 (#7 in table 2), this product is identical to the product ORGA 930 M
online except for the branding which is Cherry ST-1530 instead of ORGA 930 M and the
configurations (see ST [6], Chapter 1.4). This involves the delivery of new Cherry ST-
1530 devices.
• TOE Version: 4.7.0:1.0.0/ST1530
• Version Configuration: 1.0.0/ST1530
● ORGA 930 M (#2 in table 2), this product is identical to ORGA 930 M online except for
ALC_DEL and the configurations (see ST [6], Chapter 1.4) after updating the application
and the loader to the same version of ORGA 930 M online. This is just the delivery of
updates to existing ORGA 930 M eGK devices.
• TOE Version: 4.7.0:1.0.0/930M
• Version Configuration: 1.0.0/930M
● Cherry ST-1530 Update (#8 in table 2), this product is identical to Cherry ST-1530
except for ALC_DEL and the configurations (see ST [6], Chapter 1.4) after updating the
application and the loader to the same version of ORGA 930 M online. This is just a
delivery of updates to existing Cherry ST-1530 devices.
• TOE Version: 4.7.0:1.0.0/ST1530UPDATE
• Version Configuration: 1.0.0/ST1530UPDATE
9. Results of the Evaluation
9.1. CC specific results
The Evaluation Technical Report (ETR) [7] was provided by the ITSEF according to the
Common Criteria [1], the Methodology [2], the requirements of the Scheme [3] and all
interpretations and guidelines of the Scheme (AIS) [4] as relevant for the TOE.
The Evaluation Methodology CEM [2] was used.
As a result of the evaluation the verdict PASS is confirmed for the TOE variants “ORGA
930 M online” and “Cherry ST-1530” for the following assurance components:
All components of the EAL 3 package including the class ASE as defined in the CC (see
also part C of this report)
● The components ADV_FSP.4, ADV_IMP.1, ADV_TDS.3, ALC_TAT.1 und AVA_VAN.5
augmented for this TOE evaluation.
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The evaluation has confirmed:
● PP Conformance: Common Criteria Protection Profile Mobile Card Terminal for the
German Healthcare System (MobCT), Version 1.4, BSI-CC-PP-
0052-2015, 24 September 2014 [8]
● for the Functionality: PP conformant
Common Criteria Part 2 extended
● for the Assurance: Common Criteria Part 3 conformant
EAL 3 augmented by ADV_FSP.4, ADV_IMP.1, ADV_TDS.3,
ALC_TAT.1 und AVA_VAN.5
The results of the evaluation are only applicable to the two above-mentioned TOE variants
as defined in chapter 2 and the configuration as outlined in chapter 8 above.
The hardware delivery for the TOE variants “ORGA 930 M” and “Cherry ST-1530 Update”
was not evaluated so that the assurance component ALC_DEL.1 cannot be claimed. The
evaluation has confirmed for the assurance of the TOE variants “ORGA 930 M” and
“Cherry ST-1530 Update”: Common Criteria Part 3 conformant, ADV_ARC.1, ADV_FSP.4,
ADV_IMP.1, ADV_TDS.3, AGD_OPE.1, AGD_PRE.1, ALC_CMC.3, ALC_CMS.3,
ALC_DVS.1, ALC_LCD.1, ALC_TAT.1, ASE_CCL.1, ASE_ECD.1, ASE_INT.1, ASE_OBJ.2,
ASE_REQ.2, ASE_SPD.1, ASE_TSS.1, ATE_COV.2, ATE_DPT.1, ATE_FUN.1, ATE_IND.2
und AVA_VAN.5. Their functionality is PP conformant, Common Criteria Part 2 extended,
and their behaviour is identical with the TOE variants “ORGA 930 M online” resp. “Cherry
ST-1530” after the firmware update.
9.2. Results of cryptographic assessment
The strength of the cryptographic algorithms was not rated in the course of this certification
procedure (see BSIG Section 9, Para. 4, Clause 2). But cryptographic functionalities with a
security level of lower than 100 bits can no longer be regarded as secure without
considering the application context. Therefore, for these functionalities it shall be checked
whether the related crypto operations are appropriate for the intended system. Some
further hints and guidelines can be derived from the 'Technische Richtlinie BSI TR-02102'
(https://www.bsi.bund.de).
The following table gives an overview of the cryptographic functionalities inside the TOE to
enforce the security policy and outlines its rating from cryptographic point of view. Any
Cryptographic Functionality that is marked in column 'Security Level above 100 Bits' of the
following table with 'no' achieves a security level of lower than 100 Bits (in general context)
only.
Purpose Cryptographic
Mechanism
Standard of
Implementation
Key Size
in Bits
Security Level
above 100 Bits
Cryptographic operation for
signature verification of
firmware updates
RSASSA-PKCS1-v1_5 with
RSA-4096 and SHA-512
PKCS#1 (RSA),
FIPS 180-4 (SHA)
4096 Yes
Challenge&Response
mechanism [17]
SHA-1 FIPS 180-4 (SHA) 160 No
Integrity of the TSF SHA-512 FIPS 180-4 (SHA) 512 Yes
Table 3: TOE cryptographic functionality
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The following table gives an overview of the cryptographic functionalities inside the TOE to
enforce the security policy and outlines the standard of application where its specific
appropriateness is stated.
Purpose Cryptographic
Mechanism
Standard of Implementation Key Size in
Bits
Standard of
Application
Encryption /
decryption of health
insurance data
AES-256 in
GCM mode
FIPS-197 (AES),
NIST SP 800-38D (AES-GCM)
256 with a tag-
length of 256
gemSpec_Krypt
[18]
Table 4: TOE cryptographic functionality
The strength of the these cryptographic algorithms was not rated in the course of this
certification procedure (see BSIG Section 9, Para. 4, Clause 2).
10. Obligations and Notes for the Usage of the TOE
The documents as outlined in table 2 contain necessary information about the usage of the
TOE and all security hints therein have to be considered. In addition all aspects of
Assumptions, Threats and OSPs as outlined in the Security Target not covered by the TOE
itself need to be fulfilled by the operational environment of the TOE.
The customer or user of the product shall consider the results of the certification within his
system risk management process. In order for the evolution of attack methods and
techniques to be covered, he should define the period of time until a re-assessment of the
TOE is required and thus requested from the sponsor of the certificate.
The limited validity for the usage of cryptographic algorithms as outlined in chapter 9 has
to be considered by the user and his system risk management process, too.
If available, certified updates of the TOE should be used. If non-certified updates or
patches are available the user of the TOE should request the sponsor to provide a re-
certification. In the meantime a risk management process of the system using the TOE
should investigate and decide on the usage of not yet certified updates and patches or
take additional measures in order to maintain system security.
In addition, the following aspects need to be fulfilled when using the TOE:
For the certified use as a mobile card terminal, the stationary mode “stationäre Betriebsart”
is not allowed. As described in the installation manuals [12] and [15], the administrator is
however required to temporarily change the mode to “stationäre Betriebsart” for the
duration of an update of the TOE to a newer certified version.
11. Security Target
For the purpose of publishing, the Security Target [6] of the Target of Evaluation (TOE) is
provided within a separate document as Annex A of this report.
12. Definitions
12.1. Acronyms
AES Advanced Encryption Standard
AIS Application Notes and Interpretations of the Scheme
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BSI Bundesamt für Sicherheit in der Informationstechnik / Federal Office for
Information Security, Bonn, Germany
BSIG BSI-Gesetz / Act on the Federal Office for Information Security
C2C Card-to-Card-Authentication
CCRA Common Criteria Recognition Arrangement
CC Common Criteria for IT Security Evaluation
CEM Common Methodology for Information Technology Security Evaluation
cPP Collaborative Protection Profile
DMS Data Management System
EAL Evaluation Assurance Level
eHC Electronic Health Card
eHCT Electronic Health Card Terminal
ETR Evaluation Technical Report
gematik Gesellschaft für Telematikanwendungen der Gesundheitskarte mbH
HPC Health Professional Card
IT Information Technology
ITSEF Information Technology Security Evaluation Facility
KVK Krankenversichertenkarte
MobCT Mobile Health Card Terminal
PP Protection Profile
SAR Security Assurance Requirement
SFP Security Function Policy
SFR Security Functional Requirement
SMC Secure Module Card
ST Security Target
TOE Target of Evaluation
TSF TOE Security Functionality
12.2. Glossary
Augmentation - The addition of one or more requirement(s) to a package.
Collaborative Protection Profile - A Protection Profile collaboratively developed by an
International Technical Community endorsed by the Management Committee.
Extension - The addition to an ST or PP of functional requirements not contained in CC
part 2 and/or assurance requirements not contained in CC part 3.
Formal - Expressed in a restricted syntax language with defined semantics based on well-
established mathematical concepts.
Informal - Expressed in natural language.
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Object - A passive entity in the TOE, that contains or receives information, and upon which
subjects perform operations.
Package - named set of either security functional or security assurance requirements
Protection Profile - A formal document defined in CC, expressing an implementation
independent set of security requirements for a category of IT Products that meet specific
consumer needs.
Security Target - An implementation-dependent statement of security needs for a specific
identified TOE.
Semiformal - Expressed in a restricted syntax language with defined semantics.
Subject - An active entity in the TOE that performs operations on objects.
Target of Evaluation - An IT Product and its associated administrator and user guidance
documentation that is the subject of an Evaluation.
TOE Security Functionality - Combined functionality of all hardware, software, and
firmware of a TOE that must be relied upon for the correct enforcement of the SFRs.
13. Bibliography
[1] Common Criteria for Information Technology Security Evaluation, Version 3.1,
Part 1: Introduction and general model, Revision 4, September 2012
Part 2: Security functional components, Revision 4, September 2012
Part 3: Security assurance components, Revision 4, September 2012
http://www.commoncriteriaportal.org
[2] Common Methodology for Information Technology Security Evaluation (CEM),
Evaluation Methodology, Version 3.1, Rev. 4, September 2012,
http://www.commoncriteriaportal.org
[3] BSI certification: Scheme documentation describing the certification process (CC-
Produkte) and Scheme documentation on requirements for the Evaluation Facility,
approval and licencing (CC-Stellen), https://www.bsi.bund.de/zertifizierung
[4] Application Notes and Interpretations of the Scheme (AIS) as relevant for the TOE9
https://www.bsi.bund.de/AIS
[5] German IT Security Certificates (BSI 7148), periodically updated list published also
on the BSI Website, https://www.bsi.bund.de/zertifizierungsreporte
[6] Security Target BSI-DSZ-CC-0596-V2-2018, Version 3.30, 2018-05-04, Common
Criteria Security Target for the Evaluation of the Product ORGA 900 of Ingenico
Healthcare GmbH according to the Common Criteria 3.1 Level EAL3+, Ingenico
Healthcare GmbH
[7] Evaluation Technical Report, Version 3, 2018-06-28, Evaluation Technical Report
Summary, TÜV Informationstechnik GmbH, (confidential document)
9
specifically
• AIS 32, Version 7, CC-Interpretationen im deutschen Zertifizierungsschema
• AIS 34, Version 3, Evaluation Methodology for CC Assurance Classes for EAL 5+ (CCv2.3 &
CCv3.1) and EAL 6 (CCv3.1)
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[8] Common Criteria Protection Profile Mobile Card Terminal for the German Healthcare
System (MobCT), Version 1.4, BSI-CC-PP-0052-2015, 24 September 2014
[9] Configuration list for the TOE, 2018-06-22, Konfigurationsliste (confidential
document)
[10] Guidance documentation for the TOE, Version 8.6.1, Bedienungsanleitung Mobiles
eHealth Kartenterminal ORGA 930 M online mit Firmware-Version 4.7.0
[11] Guidance documentation for the TOE, Version 8.5.1, Kurzanleitung Mobiles eHealth
Kartenterminal ORGA 930 M online mit Firmware-Version 4.7.0
[12] Guidance documentation for the TOE, Version 8.4.1, Installationsanleitung:
Firmware-Upgrade des mobilen Gesundheitskartenlesegerätes ORGA 930 M mit
Firmware V3.20
[13] Guidance documentation for the TOE, Version 8.6.2, Informationen vor
Inbetriebnahme: Bedienungsanleitung für Benutzer - Bedienungsanleitung für
Administrator - ST-1530 Mobiles Terminal eHealth Kartenterminal mit Firmware-
Version V4.7.0
[14] Guidance documentation for the TOE, Version 8.5.1, Kurzanleitung vor
Inbetriebnahme - ST-1530 Mobiles Terminal eHealth Kartenterminal mit Firmware-
Version V4.7.0
[15] Guidance documentation for the TOE, Version 8.5.1, Installationsanleitung:
Firmware-Upgrade des mobilen Gesundheitskartenlesegerätes ST-1530 mit
Firmware V3.20
[16] Guidance documentation for the TOE, Version 8.6.1, Endnutzer-Checkliste "Sichere
Lieferkette"
[17] Guidance documentation for the TOE, Version 0.5, Verfahren zum Ruecksetzen des
Admin PINs im ORGA900 und ORGA 6000
[18] Gematik crypto specification "Einführung der Gesundheitskarte - Verwendung
kryptographischer Algorithmen in der Telematikinfrastruktur", gemSpec_Krypt,
Version 2.4.0, gematik
[19] Referenced crypto standards:
FIPS PUB 180-4 Secure Hash Signature Standard (SHS), NIST, March 2012
FIPS 197 - Federal Information Processing Standards Publication 197: ADVANCED
ENCRYPTION STANDARD (AES), NIST, November 2001
PKCS #1 v2.2: RSA Cryptography Standard, October 2012
NIST SP 800-38D Recommendation for Block Cipher Modes of Operation:
Galois/Counter Mode (GCM) and GMAC, November 2007
[20] Ingenico: “Sichere Lieferkette - für den Palettenversand von Großmengen”, Version
21, 05.04.2018
[21] Ingenico: “Sichere Lieferkette - Lieferung an Endnutzer/LEI”, Version 6, 15.05.2018
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C. Excerpts from the Criteria
For the meaning of the assurance components and levels the following references to the
Common Criteria can be followed:
• On conformance claim definitions and descriptions refer to CC part 1 chapter 10.4
• On the concept of assurance classes, families and components refer to CC Part 3
chapter 7.1
• On the concept and definition of pre-defined assurance packages (EAL) refer to CC
Part 3 chapters 7.2 and 8
• On the assurance class ASE for Security Target evaluation refer to CC Part 3
chapter 11
• On the detailled definitions of the assurance components for the TOE evaluation
refer to CC Part 3 chapters 12 to 16
• The table in CC part 3 , Annex E summarizes the relationship between the
evaluation assurance levels (EAL) and the assurance classes, families and
components.
The CC are published at http://www.commoncriteriaportal.org/cc/
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D. Annexes
List of annexes of this certification report
Annex A: Security Target provided within a separate document.
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Note: End of report
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