BSI-DSZ-CC-0519-V5-2024
for
Stationäres eHealth Kartenterminal ORGA 6141
online 3.9.0:2.0.0/ 3.9.0:1.2.0
from
Worldline 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 V5.47
BSI-DSZ-CC-0519-V5-2024 (*)
Stationäres eHealth-Kartenterminal
Stationäres eHealth Kartenterminal ORGA 6141 online
3.9.0:2.0.0/ 3.9.0:1.2.0
from Worldline Healthcare GmbH
PP Conformance: Common Criteria Protection Profile Electronic
Health Card Terminal (eHCT), BSI-CC-PP-0032-V3-
2023, 06.02.2023
Functionality: PP conformant
Common Criteria Part 2 conformant
Assurance: Common Criteria Part 3 conformant
EAL 3 augmented by ADV_FSP.4, ADV_IMP.1,
ADV_TDS.3, ALC_TAT.1, AVA_VAN.4
valid until: 23 September 2029
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 5.
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, 24 September 2024
For the Federal Office for Information Security
Sandro Amendola L.S.
Director-General
SOGIS
Recognition Agreement
for components up to
EAL 4
Common Criteria
Recognition Arrangement
recognition for components
up to EAL 2 and ALC_FLR
only
Bundesamt für Sicherheit in der Informationstechnik
Godesberger Allee 87 - 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-0519-V5-2024
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BSI-DSZ-CC-0519-V5-2024 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.............................................................................................12
3. Security Policy...........................................................................................................14
4. Assumptions and Clarification of Scope.....................................................................14
5. Architectural Information............................................................................................14
6. Documentation...........................................................................................................14
7. IT Product Testing......................................................................................................15
8. Evaluated Configuration.............................................................................................17
9. Results of the Evaluation...........................................................................................17
10. Obligations and Notes for the Usage of the TOE.....................................................20
11. Security Target.........................................................................................................20
12. Regulation specific aspects (eIDAS, QES)..............................................................20
13. Definitions................................................................................................................20
14. Bibliography.............................................................................................................22
C. Excerpts from the Criteria.............................................................................................24
D. Annexes........................................................................................................................25
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Certification Report BSI-DSZ-CC-0519-V5-2024
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
● BMI Regulations on Ex-parte Costs 3
● Special decrees issued by the Bundesministerium des Innern und für Heimat (Federal
Ministry of the Interior and Community)
● 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
BMI Regulations on Ex-parte Costs - Besondere Gebührenverordnung des BMI für individuell
zurechenbare öffentliche Leistungen in dessen Zuständigkeitsbereich (BMIBGebV), Abschnitt 7 (BSI-
Gesetz) - dated 2 September 2019, Bundesgesetzblatt I p. 1365
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BSI-DSZ-CC-0519-V5-2024 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.sogis.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.4 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: https://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 und für Heimat of 12 February 2007 in the
Bundesanzeiger dated 23 February 2007, p. 3730
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Certification Report BSI-DSZ-CC-0519-V5-2024
This certificate is recognized according to the rules of CCRA-2014, i. e. up to and including
CC part 3 EAL 2 and ALC_FLR 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 Stationäres eHealth Kartenterminal ORGA 6141 online, 3.9.0:2.0.0/
3.9.0:1.2.0 has undergone the certification procedure at BSI. This is a re-certification
based on BSI-DSZ-CC-0519-V4-2022. Specific results from the evaluation process BSI-
DSZ-CC-0519-V4-2022 were re-used.
The evaluation of the product Stationäres eHealth Kartenterminal ORGA 6141 online,
3.9.0:2.0.0/ 3.9.0:1.2.0 was conducted by TÜV Informationstechnik GmbH. The evaluation
was completed on 6 September 2024. TÜV Informationstechnik GmbH is an evaluation
facility (ITSEF)5
recognised by the certification body of BSI.
For this certification procedure the applicant is: Worldline Healthcare GmbH.
The product was developed by: Worldline 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 24
September 2024 is valid until 23 September 2029. Validity can be re-newed by re-
certification.
5
Information Technology Security Evaluation Facility
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BSI-DSZ-CC-0519-V5-2024 Certification Report
The owner of the certificate is obliged:
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 Stationäres eHealth Kartenterminal ORGA 6141 online, 3.9.0:2.0.0/
3.9.0:1.2.0 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
Worldline Healthcare GmbH
Konrad-Zuse-Ring 1
24220 Flintbek
Deutschland
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Certification Report BSI-DSZ-CC-0519-V5-2024
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-0519-V5-2024 Certification Report
1. Executive Summary
The Target of Evaluation (TOE) is a smart card terminal ORGA 6141 online Version
3.9.0:1.2.0 / 3.9.0:2.0.0 which fulfills the requirements to be used with the German
electronic Health Card (eHC) and the German Health Professional Card (HPC) based on
the regulations of the German healthcare system.
It has a card terminal with two ID1 Slots (HPC and eGK) and two SMC Slots (SM-KT
(supporting SMC-B and SMC-KT cards), a 20 key keypad, USB and LAN interfaces for the
use in the German healthcare system with KVK, HPC and eGK generation 1+ and
generation 2. Connection to a connector/SAC is possible via LAN and TCP/IP-protocol.
In its core functionality the TOE is not different from any other smart card terminal which
provides an interface to one or more smart cards including a mean to securely enter a PIN.
The Security Target [6] is the basis for this certification. It is based on the certified
Protection Profile Common Criteria Protection Profile Electronic Health Card Terminal
(eHCT), BSI-CC-PP-0032-V3-2023, 06.02.2023 [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, AVA_VAN.4.
The TOE Security Functional Requirements (SFR) relevant for the TOE are outlined in the
Security Target [6], chapter 6.1. They are all selected from Common Criteria Part 2. Thus
the TOE is CC Part 2 conformant.
The TOE Security Functional Requirements are implemented by the following TOE
Security Functionality:
TOE Security
Functionality
Addressed issue
SF_1 Trusted Communication Channels
All communication channel used by the eHealth/SAC applications to the connector/SAC
and remote users are trusted communication channel.
SF_2 Identification & Authentication
The TOE provides several authentication mechanisms for administrator and other users.
SF_3 Network Connections
The TOE accepts different subsets of SICCT commands depending on the pairing and
valid certificates.
SF_4 Secure Update
The TOE only allows firmware updates after verification of the integrity and authenticity of
that firmware.
SF_5 Secure PIN-entry
No subject shall read out the PIN or management credentials. All PINS are stored in
volatile memory only.
SF_6 Secure Data Deletion
All PINs, cryptographic keys and all information that is by a card in slot of the TOE or by
the connector/SAC will be overwritten with 0x00 as they are no longer used.
SF_7 Secure Management-Functions
The TOE is aware of three roles: administrator, reset administrator and user. The secure
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TOE Security
Functionality
Addressed issue
management functions are only available to the TOE administrator after successful
identification and authentication.
SF_8 Self-Test
The TOE can perform self-test on power-on and after activation by an authorized user.
SF_9 Secure Fail-State
The TOE will be put in a secure state in the case of: an alarm condition indicates possible
tampering, or self-test detects an error, or failure during firmware update.
SF_10 Physical Protection of the TOE
The TOE is protected against unnoticed tampering by security seals. The TOE has an
alarm function constantly checking for opening the TOE housing and a drill and probing
protection foil.
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 3.1.
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 3.3, 3.4 and 3.5.
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.
2. Identification of the TOE
The Target of Evaluation (TOE) is called:
Stationäres eHealth Kartenterminal ORGA 6141 online, 3.9.0:2.0.0/ 3.9.0:1.2.0
The following table outlines the TOE deliverables:
No Type Identifier Release Form of Delivery
1 HW TOE hardware part Version: 1.2.0
HC 03000000010301
HC 03000000020301
Version: 2.0.0
HC 03000000020302
HC 04000000020302
HC 05000000020302
HC 06000000020302
TOE hardware part.
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BSI-DSZ-CC-0519-V5-2024 Certification Report
No Type Identifier Release Form of Delivery
2 FW Firmware Image 3.9.0:1.2.0 (Release Date
15.07.2024)
3.9.0:2.0.0 (Release Date
15.07.2024)
Initially included in the TOE
3 DOC User guide (Bedienungsanleitung
Stationäres eHealth-Kartenterminal
ORGA 6141 online Hardware-
Version 1.2.0 und 2.0.0 (ORGA
Neo) mit Firmware-Version 3.9.0)
With the hash value (SHA256):
C2B443991D1F615B38AC401D7C
3BBC92E59C8EF47A27880F073C
85276EA17C30
24.5.1 Provided by the developer
on their homepage.
DOC Brief instruction (Kurzanleitung
Stationäres eHealth-Kartenterminal
ORGA 6141 online Hardware-
Version 1.2.0 und 2.0.0 (ORGA
Neo) mit Firmware-Version 3.9.0).
24.6.2 Delivered with the delivery
package of the TOE.
DOC Endnutzer-Checkliste „Sichere
Lieferkette“
With the hash value (SHA256):
65FFFF99A99B641502D859FC4E
A980AA1158250EA08FF1020FD6
55ABFFBECF53.
22.9.1 Provided by the developer
on their homepage.
Table 2: Deliverables of the TOE
The TOE is delivered to the end user in such a way as defined by the secure delivery
chain [13].
According to [13] the TOE will be firstly delivered from developer Worldline Healthcare
GmbH to the company CGM (CompuGroup Medical Deutschland AG). From this point the
secure delivery chain is identical to the certified secure delivery chain (Cert.-ID.: BSI-DSZ-
CC-0950).
The transport to the user is also defined in the concept of the secure delivery chain (BSI-
DSZ-CC-0950). The service technician or the end user installs the product ORGA 6141
online 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 is not manipulated or replaced and therefore the integrity and authenticity of the
TOE is guaranteed.
The TOE can be identified within the management menu as following:
Services → Status → TOE identification:
• Firmware Version: 3.9.0
• Hardware-Version: 1.2.0 or 2.0.0
• Produktversion: 3.9.0:1.2.0 or 3.9.0:2.0.0
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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,
• Protection of the TSF,
• TOE Access and
• Trusted Path/Channels.
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.ENV: It is assumed that the TOE is used in a controlled environment,
• OE.ADMIN: The administrator of the TOE and the medical supplier shall be non-
hostile, well trained and have to know the existing guidance documentation of the
TOE,
• OE.SM: The TOE will use a secure module (SM-KT) that represents the
cryptographic identity of the TOE in form of an X.509 certificate,
• OE.PUSH_SERVER: The TOE administrator is responsible for the correct operation
of the Push Server, and
• OE.ID000_CARDS: All smartcards of form factor ID000 shall be properly sealed
after they are brought into the TOE Details can be found in the Security Target [6],
chapter 4.2.
5. Architectural Information
A high level description of the IT product and its major components can be found in the
Security Target [6], chapter 1.3.1 and 1.3.2.
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-0519-V5-2024 Certification Report
7. IT Product Testing
7.1. Developer Testing Approach
The Security Target [6] has identified one firmware version and two hardware versions of
the TOE under evaluation. The developer used three TOE test configurations for his
testing approach.
The test setup comprises a laptop, a Connector, a TOE and three virtual card kits. Further
hardware is used to create a LAN, to connect all used components.
• Coverage and depth tests are done together.
• Tests considering the different roles that can access the TOE.
• Tests covering all TSF subsystems in the TOE design.
• Developer provided mappings to the tested TSFI(s), SFR(s), subsystem(s), and use
cases.
• Different testing approaches are used:
◦ Code analysis,
◦ Test suite (automatic and manual test).
• The test descriptions comprise (inter alia):
◦ Pre conditions: Preparative steps,
◦ Test steps: Core test steps,
◦ Post conditions: Clearance steps to tidy up before the next test.
Verdict for this activity
The developer’s testing efforts have been proven sufficient to demonstrate that the TSFIs
and subsystems perform as expected.
All test cases in each test scenario were run successfully on the TOE and they all
PASSED according to their expected result.
7.2. Evaluator tests
For the Re-evaluation a subset of tests was repeated.
The evaluation body used the same test configurations and test environment as the
developer during functional testing.
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 test results.
Verdict for the independent testing:
No deviations were found between the expected and the actual test results.
7.3. Penetration Testing
The configuration defined in the ST was tested. Furthermore, different TOE variants were
used during penetration testing to verify different mechanisms.
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Certification Report BSI-DSZ-CC-0519-V5-2024
The overall test result is that no deviations were found between the expected and the
actual test results; moreover, no attack scenario with the attack potential Moderate was
actually successful.
Penetration testing approach:
The evaluation body conducted penetration testing based on functional areas of concern
(according to CEM §1651) derived from SFRs and architectural mechanisms. The areas
were prioritized with regard to various factors, e. g. attack surface, estimated flaw
likelihood, developer testing coverage, detectability of flaws during developer testing.
Medium and high areas were guaranteed to be penetration tested, with a stronger
emphasis on high priorities. Low priorities were also considered during penetration, but
could be less emphasized, if developer tests were found to be sufficient. The penetration
testing activities were performed as tests and as analytical tasks. Whenever an analysis
was estimated to yield better results, the evaluators chose the analytical approach.
Analytical activities were especially applied in the areas Update, Random Number
Generation and Hardening Mechanisms. Combined approaches were also applied.
TOE test configurations:
The TOE was delivered by the developer in different configurations: This includes a final
operational and a special ATE variant and a special AVA variant. The ATE configuration is
only used for self-protection tests. It allows the evaluator to safely trigger various tamper
protection circuits, that otherwise would destroy the TOE. The AVA configuration is
equipped with a serial connection. This allows the evaluator to have a look at the running
system and, for example, review the list of running processes. Both variants are using
modified hardware and software. The software is modified using compile time switched.
Beside that the source code for all three versions is the same.
Attack scenarios having been tested:
The evaluation body considered penetration testing in the following areas (according to
CEM §1651):
• TLS Connections,
• Update,
• Hardening Mechanisms,
• Self-Protection,
• Remote Management,
• Network Services.
Tested security functionality:
The evaluator ensured that all areas listed above are tested. Actually, the evaluation body
used a more detailed list during the analysis and testing. The penetration testing was then
conducted based on priorities as described above. Therefore, a complete coverage of
security functional testing based on technical areas of concern is performed.
Verdict for the sub-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 Moderate was actually
successful in the TOE’s operational environment provided that all measures required by
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BSI-DSZ-CC-0519-V5-2024 Certification Report
the developer are applied. All test cases in each test scenario were run successfully on the
TOE and they all PASSED according to their expected result.
8. Evaluated Configuration
This certification covers the following configurations of the TOE:
• TOE software version 3.9.0
• TOE hardware version 1.2.0 / 2.0.0
There is only one evaluated configuration of the TOE.
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 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, AVA_VAN.4
augmented for this TOE evaluation.
As the evaluation work performed for this certification procedure was carried out as a re-
evaluation based on the certificate BSI-DSZ-CC-0519-V4-2022, re-use of specific
evaluation tasks was possible. The focus of this re-evaluation was on
• Update of open-source components,
• Bug fixing for the TOE,
• Product expansion,
◦ Remote Management Interface as second administration interface,
◦ SMC-B PIN entry via the Remote Management Interface,
◦ VPN authentication method PSK and EAP-TLS.
The evaluation has confirmed:
● PP Conformance:Common Criteria Protection Profile Electronic Health Card Terminal
(eHCT), BSI-CC-PP-0032-V3-2023, 06.02.2023 [8]
● for the Functionality: PP conformant
Common Criteria Part 2 conformant
● for the Assurance: Common Criteria Part 3 conformant
EAL 3 augmented by ADV_FSP.4, ADV_IMP.1, ADV_TDS.3,
ALC_TAT.1, AVA_VAN.4
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The results of the evaluation are only applicable to the TOE as defined in chapter 2 and
the configuration as outlined in chapter 8 above.
9.2. Results of cryptographic assessment
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
Comments
TLS key
establishment
Diffie-Hellman as part of
TLS cipher suites
TLS_DHE_RSA_WITH_
AES_128_CBC_SHA,
TLS_DHE_RSA
_WITH_AES_256_CBC
_SHA
[RFC5246] 2048 [RFC3526], DH
group = 14, DH
min exponent
length = 384 bits,
Forward secrecy
= yes
FCS_CKM.1.1/
Connector
TLS key
establishment
Elliptic Curve Diffie-
Hellman as part of TLS
cipher suites
TLS_ECDHE_ECDSA_
WITH_AES_128_GCM_
SHA256,
TLS_ECDHE_ECDSA_
WITH_AES_256_GCM_
SHA384,
Additional for
webserver:
TLS_ECDHE_ECDSA_
WITH_AES_128_CBC_
SHA256,
TLS_ECDHE_ECDSA_
WITH_AES_256_CBC_
SHA384,
TLS_ECDHE_ECDSA_
WITH_AES_128_CCM,
TLS_ECDHE_ECDSA_
WITH_AES_256_CCM
[RFC5246],
[RFC5289],
[RFC4492],
[RFC7251]
256,
384,
512
According to
[gemSpec_Krypt,
A_17124 and
5.8]
brainpoolP256r1
and
brainpoolP384r1
elliptic curves
must be
supported, cf.
[RFC5639] and
[RFC7027]
Additional for
webserver:
brainpoolP512r1
and
secp256r1,
secp384r1,
secp512r1,
[SECG-SEC2]]
[RFC8422]
FCS_CKM.1.1/
Connector
FCS_CKM.1.1/
Management
TLS Peer
Authentication
RSA-2048 as part of
TLS cipher suites
TLS_DHE_RSA_WITH_
AES_128_CBC_SHA,
TLS_DHE_RSA_WITH_
AES_256_CBC_SHA
[RFC5246] 2048 Limited support
for TLS v1.2,
according to
[gemSpec_Krypt]
FCS_CKM.1.1/
Connector
TLS Peer
Authentication
ECDSA as part of the
TLS cipher suites
[RFC5246],
[RFC5289],
256 [gemSpec_Krypt,
A_17090]
FCS_CKM.1.1/
Connector
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BSI-DSZ-CC-0519-V5-2024 Certification Report
Purpose Cryptographic
Mechanism
Standard of
Implementation
Key Size
in Bits
Standard of
Application
Comments
TLS_ECDHE_ECDSA_
WITH_AES_128_GCM_
SHA256,
TLS_ECDHE_ECDSA_
WITH_AES_256_GCM_
SHA384
[RFC4492]
TLS payload
encryption
AES-128
(TLS_DHE_RSA_WITH
_AES_128_CBC_SHA),
AES-256
(TLS_DHE_RSA_WITH
_AES_256_CBC_SHA)
in CBC mode
[RFC5246] 128,
256
Limited support
for TLS v1.2,
according to
[gemSpecKrypt]
FCS_CKM.1.1/
Connector
TLS payload
encryption
and message
authentication
AES-128,
(TLS_ECDHE_ECDSA_
WITH_AES_128_GCM_
SHA256),
AES-256
(TLS_ECDHE_ECDSA_
WITH_AES_256_GCM_
SHA384)
in GCM mode
[RFC5246],
[RFC5289]
128,
256
[gemSpec_Krypt] FCS_CKM.1.1/
Connector
TLS Message
Authentication
HMAC-SHA as part of
TLS cipher suites
TLS_DHE_RSA_WITH_
AES_128_CBC_SHA,
TLS_DHE_RSA_WITH_
AES_256_CBC_SHA
[RFC5246] 160 Limited support
for TLS v1.2,
according to
[gemSpec_Krypt]
FCS_CKM.1.1/
Connector
TLS Signature
Verification
SHA-256 with RSA [PKCS#1] 2048 [FIPS180-4] FCS_CKM.1.1/
Connector
TLS Signature
Verification
SHA-256 with ECDSA [RFC5246],
[RFC5289],
[RFC4492]
256 [gemSpec_Krypt,
A_17090]
FCS_CKM.1.1/
Connector
TSF Signature
Verification
RSASSA-PKCS1-V1_5
with SHA-256
[PKCS#1] 2048 [FIPS180-4] FCS_COP.1.1/
SIG
TSF Signature
Verification
RSASSA-PKCS1-V1_5
with SHA-256
[PKCS#1] 4096 [FIPS180-4] FCS_COP.1/
SIG_TSP
TSF Signature
Verification
RSASSA-PKCS1-V1_5
with SHA-256
[PKCS#1] 4096 [FIPS180-4] FCS_COP.1/
SIG_FW
Table 3: TOE cryptographic functionality
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Certification Report BSI-DSZ-CC-0519-V5-2024
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).
According to the application standards in the table above, especially the standards issued
by gematik, the algorithms are suitable for the intended purposes listed above. An explicit
validity period is not given.
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.
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. Regulation specific aspects (eIDAS, QES)
None.
13. Definitions
13.1. Acronyms
AES Advanced Encryption Standard
AIS Application Notes and Interpretations of the Scheme
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
CCRA Common Criteria Recognition Arrangement
CC Common Criteria for IT Security Evaluation
CEM Common Methodology for Information Technology Security Evaluation
cPP Collaborative Protection Profile
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BSI-DSZ-CC-0519-V5-2024 Certification Report
EAL Evaluation Assurance Level
ECDSA Elliptic Curve Digital Signature Algorithm (DSA)
eGK elektronische Gesundheitskarte
eHC Electronic Health Card
ETR Evaluation Technical Report
HPC Health Professional Card
IT Information Technology
ITSEF Information Technology Security Evaluation Facility
KVK Krankenversichertenkarte
PIN Personal Identification Number
PP Protection Profile
RSA Asymmetrical Cryptographie (Rivest, Shamir und Adleman)
SAC Signature Application Component
SAR Security Assurance Requirement
SFP Security Function Policy
SFR Security Functional Requirement
SMC Security Module Card
SM-KT Security Module Kartenterminal
ST Security Target
TOE Target of Evaluation
TSF TOE Security Functionality
TSP Trust-Service Provider that issues connector/SAC certificates
13.2. 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.
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.
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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.
14. Bibliography
[1] Common Criteria for Information Technology Security Evaluation, Version 3.1,
Part 1: Introduction and general model, Revision 5, April 2017
Part 2: Security functional components, Revision 5, April 2017
Part 3: Security assurance components, Revision 5, April 2017
https://www.commoncriteriaportal.org
[2] Common Methodology for Information Technology Security Evaluation (CEM),
Evaluation Methodology, Version 3.1, Rev. 5, April 2017,
https://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 TOE7
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 for the Evaluation of the Product ORGA 6141 online BSI-DSZ-CC-
0519-V5-2024, Version 4.1.22, 20.06.2024, Worldline Healthcare GmbH
[7] Evaluation Technical Report (ETR Summary), Version 2, 2024-08-30, TÜV
Informationstechnik GmbH (confidential document)
[8] Common Criteria Protection Profile Electronic Health Card Terminal (eHCT), BSI-
CC-PP-0032-V3-2023, 06.02.2023
[9] Configuration list SW, VSVN List, Version 3.9.0, 2024-07-15, Worldline Healthcare
GmbH (confidential document)
[10] Configuration list HW, Datensatz PDXpert, Version 3.9.0, 2024-07-09, Worldline
Healthcare GmbH (confidential document)
[11] Bedienungsanleitung Stationäres eHealth Kartenterminal ORGA 6141 online
Hardware-Version 1.2.0 und 2.0.0 (ORGA Neo) mit Firmware-Version 3.9.0, Version
24.5.1, 2024-06-05, Worldline Healthcare GmbH
7
specifically
• AIS 1, Version 14, Durchführung der Ortsbesichtigung in der Entwicklungsumgebung des Herstellers
• AIS 32, Version 7, CC-Interpretationen im deutschen Zertifizierungsschema
• AIS 38, Version 2, Reuse of evaluation results
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BSI-DSZ-CC-0519-V5-2024 Certification Report
[12] Kurzanleitung Stationäres eHealth-Kartenterminal ORGA 6141 online Hardware-
Version 1.2.0 und 2.0.0 (ORGA Neo) mit Firmware-Version 3.9.0, Version 24.6.2,
2024-06-21, Worldline Healthcare GmbH
[13] Endnutzer-Checkliste „Sichere Lieferkette“, Version 22.9.1, 2022-10-07, Worldline
Healthcare GmbH
[14] Sichere Lieferkette - Lieferung an Endnutzer/LEI, Version 10, 2022-11-28, Worldline
Healthcare GmbH
[15] Sichere Lieferkette - für den Versand über Konnektorlieferketten, Version 5, 2022-
11-14, Worldline Healthcare GmbH
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Certification Report BSI-DSZ-CC-0519-V5-2024
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 10.5
• 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 12
• On the detailed definitions of the assurance components for the TOE evaluation
refer to CC Part 3 chapters 13 to 17
• 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 https://www.commoncriteriaportal.org/cc/
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BSI-DSZ-CC-0519-V5-2024 Certification Report
D. Annexes
List of annexes of this certification report
Annex A: Security Target provided within a separate document.
Note: End of report
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