EN ISO 12052-2017 en Health informatics - Digital imaging and communication in medicine (DICOM) including workflow and data management.pdf

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1、Health informatics - Digital imaging and communication in medicine (DICOM) including workflow and data management (ISO 12052:2017)BS EN ISO 12052:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 12052 Septem

2、ber 2017 ICS 35.240.80 Supersedes EN ISO 12052:2011English Version Health informatics - Digital imaging and communication in medicine (DICOM) including workflow and data management (ISO 12052:2017) Informatique de sant - Imagerie numrique et communication en mdecine (DICOM) incluant le droulement de

3、s oprations et la gestion des donnes (ISO 12052:2017) Medizinische Informatik - Digitale Bildverarbeitung und Kommunikation in der Medizin (DICOM) inklusive Workflow und Datenmanagement (ISO 12052:2017) This European Standard was approved by CEN on 12 September 2017. CEN members are bound to comply

4、with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Ma

5、nagement Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same

6、status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, M

7、alta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brusse

8、ls 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 12052:2017 ENational forewordThis British Standard is the UK implementation of EN ISO 12052:2017. It is identical to ISO 12052:2017. It supersedes BS EN ISO 12052:2011, wh

9、ich is withdrawn.The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a co

10、ntract. Users are responsible for its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 96986 7ICS 35.240.80Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the a

11、uthority of the Standards Policy and Strategy Committee on 30 September 2017.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 12052:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 12052 September 2017 ICS 35.240.80 Supersedes EN ISO 12052:2011Eng

12、lish Version Health informatics - Digital imaging and communication in medicine (DICOM) including workflow and data management (ISO 12052:2017) Informatique de sant - Imagerie numrique et communication en mdecine (DICOM) incluant le droulement des oprations et la gestion des donnes (ISO 12052:2017)

13、Medizinische Informatik - Digitale Bildverarbeitung und Kommunikation in der Medizin (DICOM) inklusive Workflow und Datenmanagement (ISO 12052:2017) This European Standard was approved by CEN on 12 September 2017. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipul

14、ate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European St

15、andard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the n

16、ational standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,

17、Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and

18、 by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 12052:2017 EBS EN ISO 12052:2017EN ISO 12052:2017 (E) 3 European foreword This document (EN ISO 12052:2017) has been prepared by Technical Committee ISO/TC 215 “Health informatics” in collaboration with Technical Committee CE

19、N/TC 251 “Health informatics” the secretariat of which is held by NEN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2018, and conflicting national standards shall be withdrawn at the late

20、st by March 2018. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 12052:2011. According to the CEN-CENELEC Internal R

21、egulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland

22、, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 12052:2017 has been approved by CEN as EN ISO 12052:2017 without any modification.

23、ISO 12052:2017(E)Foreword iv0 Introduction .v1 Scope . 12 Normative references 13 Terms and definitions . 24 Abbreviated terms 35 Requirements 45.1 Provisions 45.2 Conformance . 46 Overview of the content of the DICOM standard . 46.1 Document structure 46.2 PS3.2: Conformance 56.3 PS3.3: Information

24、 object definitions . 76.4 PS3.4: Service class specifications . 86.5 PS3.5: Data structure and semantics . 86.6 PS3.6: Data dictionary 86.7 PS3.7: Message exchange . 96.8 PS3.8: Network communication support for message exchange 96.9 PS3.9: Retired (formerly point-to-point communication support for

25、 message exchange) 106.10 PS3.10: Media storage and file format . 106.11 PS3.11: Media storage application profiles . 116.12 PS3.12: Storage functions and media formats for data interchange .126.13 PS3.13: Retired (formerly print management point-to-point communication support) 126.14 PS3.14: Graysc

26、ale standard display function .136.15 PS3.15: Security and system management profiles .136.16 PS3.16: Content mapping resource 136.17 PS3.17: Explanatory information . 136.18 PS3.18: Web services 136.19 PS3.19: Application hosting 136.20 PS3.20: Imaging reports using HL7 clinical document architectu

27、re .147 Referencing the DICOM standard .15Bibliography .17 ISO 2017 All rights reserved iiiContents PageBS EN ISO 12052:2017ISO 12052:2017(E)Foreword iv0 Introduction .v1 Scope . 12 Normative references 13 Terms and definitions . 24 Abbreviated terms 35 Requirements 45.1 Provisions 45.2 Conformance

28、. 46 Overview of the content of the DICOM standard . 46.1 Document structure 46.2 PS3.2: Conformance 56.3 PS3.3: Information object definitions . 76.4 PS3.4: Service class specifications . 86.5 PS3.5: Data structure and semantics . 86.6 PS3.6: Data dictionary 86.7 PS3.7: Message exchange . 96.8 PS3.

29、8: Network communication support for message exchange 96.9 PS3.9: Retired (formerly point-to-point communication support for message exchange) 106.10 PS3.10: Media storage and file format . 106.11 PS3.11: Media storage application profiles . 116.12 PS3.12: Storage functions and media formats for dat

30、a interchange .126.13 PS3.13: Retired (formerly print management point-to-point communication support) 126.14 PS3.14: Grayscale standard display function .136.15 PS3.15: Security and system management profiles .136.16 PS3.16: Content mapping resource 136.17 PS3.17: Explanatory information . 136.18 P

31、S3.18: Web services 136.19 PS3.19: Application hosting 136.20 PS3.20: Imaging reports using HL7 clinical document architecture .147 Referencing the DICOM standard .15Bibliography .17 ISO 2017 All rights reserved iiiContents PageBS EN ISO 12052:2017ISO 12052:2017(E)ForewordISO (the International Orga

32、nization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been establis

33、hed has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization

34、.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with th

35、e editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any pa

36、tent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www .iso .org/ patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

37、For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: ww

38、w .iso .org/ iso/ foreword .html.This document was prepared by Technical Committee ISO/TC 215, Health informatics.This second edition cancels and replaces the first edition (ISO 12052:2006), of which it constitutes a minor revision.The changes made are as follows: Clause 1, 6.18, 6.19, 6.20 and Clau

39、se 7 have been revised; informative material has been added to the Introduction.iv ISO 2017 All rights reservedBS EN ISO 12052:2017ISO 12052:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of

40、 preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental

41、, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO

42、/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).Attention is drawn to the possibi

43、lity that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of p

44、atent declarations received (see www .iso .org/ patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to

45、 conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www .iso .org/ iso/ foreword .html.This document was prepared by Technical Committee ISO/TC 215, Health informatics.Thi

46、s second edition cancels and replaces the first edition (ISO 12052:2006), of which it constitutes a minor revision.The changes made are as follows: Clause 1, 6.18, 6.19, 6.20 and Clause 7 have been revised; informative material has been added to the Introduction.iv ISO 2017 All rights reserved ISO 1

47、2052:2017(E)0 IntroductionDigital Imaging and Communications in Medicine (DICOM) is the standard for the communication and management of medical imaging information and related data.0.1 HistoryWith the introduction of computed tomography (CT) followed by other digital diagnostic imaging modalities i

48、n the 1970s, and the increasing use of computers in clinical applications, the American College of Radiology (ACR) and the National Electrical Manufacturers Association (NEMA) recognized the emerging need for a standard method for transferring images and associated information between devices manufa

49、ctured by various vendors. These devices produce a variety of digital image formats.The American College of Radiology (ACR) and the National Electrical Manufacturers Association (NEMA) formed a joint committee in 1983 to develop a standard to: promote communication of digital image information, regardless of device manufacturer; facilitate the development and expansion of picture archiving and communication systems (PACS) that can also interface with other systems of hospital information; allow the creation of diagnostic information databas

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