CEN/TS 18170:2025
(Main)Functional requirements for the electronic archiving services
Functional requirements for the electronic archiving services
This NWI Will be a TS and will specify additional requirements for qualified or not qualified trust services implementing electronic archiving service with specific regard to :
• Functional requirements to use for receipt, storage, retrieval and deletion to ensure that the electronic data and electronic documents (electronically-born documents and paper documents that have been scanned and digitized) are preserved in such a way that they are accessible and durably safeguarded against loss and unauthorized alteration or disposal, except for authorized changes concerning their electronic format.
• Procedures and technologies ensuring the accuracy of the origin, the durability and legibility, integrity of the electronic data and electronic documents beyond the technological validity period and at least throughout the legal or contractual preservation period, while maintaining their integrity and their origin.
• Procedures and technologies to use to allow authorised relying parties to receive a report in an automated manner that confirms that an electronic data and electronic documents retrieved from a qualified electronic archive enjoys the presumption of integrity of the data and electronic documents from the beginning of the preservation period to the moment of retrieval.
• Procedures and technologies to prevent unauthorized access and improper use of the confidential and restricted data and electronic documents.
• Interactions between electronic archiving trust services and other trust services.
• Procedures and technologies to reach and obtain a green sustainability approach when possible.
Richtlinien und funktionale Anforderungen an den elektronischen Archivierungsdienst
Exigences fonctionnelles pour les services d'archivage électronique
La CEI 60601-2-25:2011 s'applique à la sécurité de base et aux performances essentielles des électrocardiographes, destinés de par leur nature ou comme partie intégrante d'un système électro-médical, à la production de rapports d'électrocardiographie à des fins de diagnostic. Les appareils destinés à être utilisés dans des conditions environnementales extrêmes ou non maîtrisées à l'extérieur d'un hôpital ou du cabinet d'un médecin, telles que dans des ambulances et dans un aéronef, doivent satisfaire à la présente norme particulière. Des normes supplémentaires peuvent s'appliquer pour ces environnements d'utilisation. Ne relèvent pas du domaine d'application de la présente norme particulière:
a) la partie des appareils électro-médicaux qui fournit des boucles vecto-cardiographiques;
b) les appareils électro-médicaux de surveillance électrocardiographique ambulatoire couverts par la CEI 60601-2-47, lorsqu'ils ne sont pas destinés à obtenir des rapports d'électrocardiographie à des fins de diagnostic;
c) les moniteurs cardiaques couverts par la CEI 60601-2-27 lorsqu'ils ne sont pas destinés à obtenir des rapports d'électrocardiographie à des fins de diagnostic.
Cette deuxième édition annule et remplace la première édition de la CEI 60601-2-25, parue en 1993, et la première édition de la CEI 60601-2-51, parue en 2003. La mise à jour des normes particulières afin de faire référence à la troisième édition de la norme générale a permis de fusionner les premières éditions de la CEI 60601-2-25 et de la CEI 60601-2-51 en une seule norme. Une remise en forme et des modifications techniques ont été effectuées. Cette deuxième édition de la CEI 60601-2-25 constitue une révision technique de ces deux normes.
Funkcionalne zahteve za storitve elektronskega arhiviranja
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2025
Funkcionalne zahteve za storitve elektronskega arhiviranja
Functional requirements for the electronic archiving services
Richtlinien und funktionale Anforderungen an den elektronischen Archivierungsdienst
Exigences fonctionnelles pour les services d'archivage électronique
Ta slovenski standard je istoveten z: CEN/TS 18170:2025
ICS:
01.140.20 Informacijske vede Information sciences
35.240.30 Uporabniške rešitve IT v IT applications in information,
informatiki, dokumentiranju in documentation and
založništvu publishing
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
CEN/TS 18170
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
May 2025
TECHNISCHE SPEZIFIKATION
ICS 01.140.20; 35.240.30; 37.080
English Version
Functional requirements for the electronic archiving
services
Exigences fonctionnelles pour les services d'archivage Richtlinien und funktionale Anforderungen an den
électronique elektronischen Archivierungsdienst
This Technical Specification (CEN/TS) was approved by CEN on 13 May 2025 for provisional application.
The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.
CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TS 18170:2025 E
worldwide for CEN national Members.
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
3.1 Terms related to electronic trust service. 6
3.2 Terms related to digital objects . 8
3.3 3.3 Terms related to electronic archiving . 9
4 Symbols and abbreviated terms . 10
5 Position statement . 10
6 Policies and practices . 11
6.1 Policy and practice statement . 11
6.2 Terms and conditions . 12
6.3 Information security policy . 12
6.4 Agreements . 12
6.4.1 General. 12
6.4.2 Service agreement . 12
6.4.3 Submission agreement . 14
7 Trust Service Provider management and operation . 15
7.1 General. 15
7.2 Internal organization . 15
7.3 Human resources. . 15
7.4 Asset management . 15
7.5 Access control. 15
7.6 Cryptographic controls and monitoring . 16
7.7 Physical and environmental . 16
7.8 Operation . 16
7.9 Network . 16
7.10 Vulnerabilities and incident management . 16
7.11 Collection of evidence . 16
7.12 Business continuity management . 16
7.13 EATSP termination and termination plans . 16
7.14 Compliance . 16
7.15 Supply Chain . 17
8 Information packages — Information Package Format . 17
9 Submission Information Package . 17
9.1 General. 17
9.2 Submission Information Package Format . 17
9.3 Components of the SIP . 17
9.4 Other metadata in the SIP . 17
9.5 Content Data Object Formats . 18
9.6 Transfer submission . 18
9.7 Receive submission . 18
9.8 Audit submission . 18
9.8.1 General. 18
9.8.2 Scope of verification defined in the “submission agreement” . 18
10 Archival Information Package . 19
10.1 General . 19
10.2 AIP Generation . 20
10.2.1 General . 20
10.2.2 Archival Information Package Format . 20
10.2.3 Components of the AIP . 20
10.2.4 Transformation of SIPs into AIPs . 20
10.2.5 Transformation of Content Data Objects into other formats . 20
10.2.6 Map and list of archiving formats for Content Data Objects . 21
10.3 Storage infrastructure and localization . 21
10.4 Storage security - AIP Integrity . 21
10.5 Media migration and format conversion during preservation period. 21
10.5.1 Storage media migration . 21
10.5.2 Format conversion . 21
10.6 Deletion . 22
11 Dissemination Information Package . 22
12 Transfer process . 23
12.1 General . 23
12.2 Transfer Requirements . 23
12.2.1 General . 23
12.2.2 Identification of transfer Requirements . 23
12.2.3 Design of the transfer Interface . 23
12.2.4 Documentation of transfer process . 24
12.3 Responsibilities . 24
13 Traceability of operations . 25
13.1 Traceability of operations . 25
13.2 Criticality of events . 25
13.3 Common features of critical and non critical events . 25
13.3.1 Reliable time of events . 25
13.3.2 Traceability of initiator . 25
13.3.3 separation of traced events . 25
13.4 Non-critical events . 25
13.5 Critical events . 26
13.6 Integrity protection of critical events and digital objects . 27
13.6.1 General . 27
13.6.2 Protection using digital signature techniques .
...
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