BSI-DSZ-CC-0519-V4-2022
for
ORGA 6141 online V3.8.2:1.2.0
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 V5.41
BSI-DSZ-CC-0519-V4-2022 (*)
Stationäres eHealth-Kartenterminal
ORGA 6141 online
V3.8.2:1.2.0
from Worldline Healthcare GmbH
PP Conformance: Common Criteria Protection Profile Electronic
Health Card Terminal (eHCT) Version 3.7, BSI-CC-
PP-0032-V2-2015-MA-01, 22 May 2017
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
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, 25 July 2022
For the Federal Office for Information Security
Sandro Amendola 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 and ALC_FLR
only
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-0519-V4-2022
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BSI-DSZ-CC-0519-V4-2022 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............................................................................................................13
4. Assumptions and Clarification of Scope.....................................................................13
5. Architectural Information.............................................................................................14
6. Documentation...........................................................................................................14
7. IT Product Testing.......................................................................................................14
8. Evaluated Configuration.............................................................................................16
9. Results of the Evaluation............................................................................................17
10. Obligations and Notes for the Usage of the TOE.....................................................19
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-V4-2022
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]
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-V4-2022 Certification Report
● Common Criteria for IT Security Evaluation (CC), Version 3.14
[1] also published as
ISO/IEC 15408
● 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 under SOGIS-MRA for all assurance components selected.
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-V4-2022
This certificate is recognized according to the rules of CCRA-2014, i. e. up to and including
CC part 3 EAL 2+ 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 ORGA 6141 online, V3.8.2:1.2.0 has undergone the certification procedure at
BSI. This is a re-certification based on BSI-DSZ-CC-0519-V3-2021. Specific results from
the evaluation process BSI-DSZ-CC-0519-V3-2021 were re-used.
The evaluation of the product ORGA 6141 online, V3.8.2:1.2.0 was conducted by TÜV
Informationstechnik GmbH. The evaluation was completed on 21 July 2022. 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 25 July 2022
is valid until 24 July 2027. Validity can be re-newed by re-certification.
5
Information Technology Security Evaluation Facility
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BSI-DSZ-CC-0519-V4-2022 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 ORGA 6141 online, V3.8.2:1.2.0 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-V4-2022
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-V4-2022 Certification Report
1. Executive Summary
The Target of Evaluation (TOE) is the smart card terminal ORGA 6141 online Version
3.8.0:1.2.0 which fulfils 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) Version 3.7, BSI-CC-PP-0032-V2-2015-MA-01, 22. Mai 2017 [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 and 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 channels used by the eHealth/SAC applications to
the connector/SAC and remote users are trusted communication
channels.
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 a slot
of the TOE or by the connector/SAC will be overwritten with 0x00 when
they are no longer used.
SF_7: Secure Management-
Functions
The TOE is aware of three roles: administrator, reset administrator and
user. The secure 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:
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Certification Report BSI-DSZ-CC-0519-V4-2022
TOE Security Functionality Addressed issue
• 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.
SM_1: Sealing The TOE is protected against unnoticed manipulations 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 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:
ORGA 6141 online, V3.8.2:1.2.0
The following table outlines the TOE deliverables:
No Type Identifier Release Form of Delivery
1 HW TOE hardware part HC 03000000010301
or
HC 03000000020301
TOE hardware part.
2 FW Firmware Image 3.8.2:1.2.0 Initially included in the
TOE.
3 DOC User guide (Bedienungsanleitung
Stationäres eHealth Kartenterminal ORGA
6141 online mit Firmware-Version 3.8.2)
With the hash value (SHA256):
40b23541707636398671cf25eba36e5742c
30bfd888f0f28ec3f5de84a938a78
22.5.3 Provided by the
developer on their
homepage.
4 DOC Brief instruction (Kurzanleitung Stationäres
eHealth Kartenterminal ORGA 6141 online
mit Firmware-Version 3.8.2)
22.6.1 Delivered with the
delivery package of the
TOE.
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BSI-DSZ-CC-0519-V4-2022 Certification Report
No Type Identifier Release Form of Delivery
5 DOC Endnutzer-Ckeckliste „Sichere Lieferkette“ 20.7.1 Provided by the develo-
per 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:
• Softwareversion 3.8.2, Hardware-Version 1.2.0
• Produktversion 3.8.2:1.2.0
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,
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• OE.CONNECTOR: The connector in the environment has to be trustworthy and
provides the possibility to establish a Trusted Channel with the TOE including a
means for mutual authentication
• 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 internal network of the medical supplier is equipped with a
so called Push Server for automatic firmware updates 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 + 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.
7. IT Product Testing
7.1. Developer's Test according to ATE_FUN
TOE test configurations:
The Security Target [6] has identified solely one configuration of the TOE under evaluation.
Nevertheless, the developer used three TOE test configurations for his testing approach:
• C1: TOE without any modification. The setup comprises the TOE connected to a
computer via LAN.
• C2: TOE with debug capabilities. The TOE offers serial access to the system.
Similar to C1 this TOE is also connected to a computer via LAN.
• C3: TOE modified for hardware tamper protection tests. This TOE uses the same
firmware source code as C1 but has some debugging options enabled that allow
triggering the tamper protection without erasing the master key.
TOE test environment:
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.
Testing approach:
Coverage and depth tests are done together.
• The tests considered the different roles that can access the TOE.
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BSI-DSZ-CC-0519-V4-2022 Certification Report
• The tests covered all TSF subsystems in the TOE design.
• The developer provided mappings to the tested TSFI(s), SFR(s), subsystem(s), and
use cases.
• Different testing approaches were used:
◦ Code analysis, and
◦ 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 the 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.
TOE test configurations:
The evaluation body used the same test configurations and test environment as the
developer during functional testing.
TSFI selection criteria:
The evaluation body chose to broadly cover the existing interfaces without specific
restrictions.
TSFI tested:
All interfaces were considered during testing.
Developer tests performed:
The evaluation body chose to inspect all developer test results.
Verdict for the sub-activity:
No deviations were found between the expected and the actual test results.
7.3. Penetration Testing according to AVA_VAN
Overview:
The configuration defined in the ST was tested. Furthermore, different TOE variants were
used during penetration testing to verify different mechanisms. 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:
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Certification Report BSI-DSZ-CC-0519-V4-2022
The evaluation body conducted penetration testing based on functional areas of concern
(according to CEM §1605) 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 §1605):
• TLS Connections,
• Update,
• Hardening Mechanisms,
• Self-Protection, and
• 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
the developer are applied.
8. Evaluated Configuration
This certification covers the following configurations of the TOE:
• TOE software version: 3.8.2
• TOE hardware version: 1.2.0
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BSI-DSZ-CC-0519-V4-2022 Certification Report
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-V3-2021, re-use of specific
evaluation tasks was possible. The focus of this re-evaluation was on:
• The TOE and the related developer evidence were updated to Version 3.8.2:1.2.0,
• The Linux kernel, openssl and other components were updated,
• Necessary changes were made to stabilise the unit's behaviour regarding ESD
events.
The evaluation has confirmed:
● PP Conformance: Common Criteria Protection Profile Electronic Health Card
Terminal (eHCT) Version 3.7, BSI-CC-PP-0032-V2-2015-MA-01, 22 May 2017 [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
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
[RFC5246] 2048 [RFC3526], DH group
= 14, DH min
exponent length = 384
FCS_CKM.1.1/
Connector
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Purpose Cryptographic
Mechanism
Standard of
Implementation
Key Size
in Bits
Standard of
Application
Comments
TLS_DHE_RSA_WI
TH_AES_128_CBC
_SHA,
TLS_DHE_RSA
_WITH_AES_256_
CBC_SHA
bits, Forward secrecy
= yes
TLS key
establishment
Elliptic Curve Diffie-
Hellman as part of
TLS cipher suites
TLS_ECDHE_ECD
SA_WITH_AES_12
8_GCM_SHA256,
TLS_ECDHE_ECD
SA_WITH_AES_25
6_GCM_SHA384
[RFC5246],
[RFC5289],
[RFC4492]
256,
384
According to
[gemSpec_Krypt,
A_17124 and 5.8]
brainpoolP256r1 and
brainpoolP384r1
elliptic curves must be
supported, cf.
[RFC5639] and
[RFC7027]
FCS_CKM.1.1/
Connector
TLS Peer
Authenticatio
n
RSA-2048 as part
of TLS cipher suites
TLS_DHE_RSA_WI
TH_AES_128_CBC
_SHA,
TLS_DHE_RSA_WI
TH_AES_256_CBC
_SHA
[RFC5246] 2048 Limited support for
TLS v1.2, according
to [gemSpec_Krypt]
FCS_CKM.1.1/
Connector
TLS Peer
Authenticatio
n
ECDSA as part of
the TLS cipher
suites
TLS_ECDHE_ECD
SA_WITH_AES_12
8_GCM_SHA256,
TLS_ECDHE_ECD
SA_WITH_AES_25
6_GCM_SHA384
[RFC5246],
[RFC5289],
[RFC4492]
256 [gemSpec_Krypt,
A_17090]
FCS_CKM.1.1/
Connector
TLS payload
encryption
AES-128
(TLS_DHE_RSA_W
ITH_AES_128_CB
C_SHA),
AES-256
(TLS_DHE_RSA_W
ITH_AES_256_CB
C_SHA)
in CBC mode
[RFC5246] 128, 256 Limited support for
TLS v1.2, according
to [gemSpecKrypt]
FCS_CKM.1.1/
Connector
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Purpose Cryptographic
Mechanism
Standard of
Implementation
Key Size
in Bits
Standard of
Application
Comments
TLS payload
encryption
and message
authentication
AES-128,
(TLS_ECDHE_ECD
SA_WITH_AES_12
8_GCM_SHA256),
AES-256
(TLS_ECDHE_ECD
SA_WITH_AES_25
6_GCM_SHA384)
in GCM mode
[RFC5246],
[RFC5289]
128, 256 [gemSpec_Krypt] FCS_CKM.1.1/
Connector
TLS Message
Authenticatio
n
HMAC-SHA as part
of TLS cipher suites
TLS_DHE_RSA_WI
TH_AES_128_CBC
_SHA,
TLS_DHE_RSA_WI
TH_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
Table 3: 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).
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.
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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
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
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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.
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.
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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 BSI-DSZ-CC-0519-V4-2022, Version 4.1.13, 2022-06-01, Security
Target for the Evaluation of the Product ORGA 6141 online of Worldline Healthcare
GmbH according to the Common Criteria 3.1 Level EAL3+, Wordline Healthcare
GmbH
[7] Evaluation Technical Report, Version 1, 2022-07-20, TÜV Informationstechnik
GmbH, (confidential document)
[8] Common Criteria Protection Profile Electronic Health Card Terminal (eHCT) Version
3.7, BSI-CC-PP-0032-V2-2015-MA-01, 22 May 2017
[9] Configuration list HW for the TOE, Version 3.8.2, 2022-07-12, Datensatz PDXpert
ORGA_6141_online_V_3.8.2_Freigegeben_2022_07_12.pdx, Worldline Healthcare
GmbH (confidential document)
[10] Configuration list SW for the TOE, Version 3.8.2, 2022-05-17, SVN Log Dateien:
SVN_log_ORGA_6141_online.zip, Worldline Healthcare GmbH (confidential
document)
[11] Guidance documentation for the TOE Bedienungsanleitung Stationäres eHealth
Kartenterminal ORGA 6141 online mit Firmware-Version 3.8.2, Version 22.5.3,
2022-05-31, Worldline Healthcare GmbH
[12] Guidance documentation for the TOE Kurzanleitung Stationäres eHealth
Kartenterminal ORGA 6141 online mit Firmware-Version 3.8.x, Version 22.6.1,
2022-06-02, Worldline Healthcare GmbH
[13] Guidance documentation for the TOE Endnutzer-Checkliste „Sichere Lieferkette“
Version 20.7.1, 2020-07-24, Wordline Healthcare GmbH
[14] Sichere Lieferkette - Lieferung an Endnutzer/LEI, Version 7, 2021-08-09, Wordline
Healthcare GmbH
7
specifically
• AIS 32, Version 7, CC-Interpretationen im deutschen Zertifizierungsschema
• AIS 38, Version 2, Reuse of evaluation results
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[15] Sichere Lieferkette - für den Palettenversand von Großmengen, Version 22, 2018-
12-13, Worldline Healthcare GmbH
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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 10.5
• 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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D. Annexes
List of annexes of this certification report
Annex A: Security Target provided within a separate document.
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