BS ISO 20301-2014 Health informatics Health cards General characteristics《健康信息学 健康卡 一般特性》.pdf

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1、BSI Standards PublicationBS ISO 20301:2014Health informatics Healthcards General characteristicsBS ISO 20301:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 20301:2014. Itsupersedes BS ISO 20301:2006 which is withdrawn.The UK participation in its preparati

2、on was entrusted to TechnicalCommittee IST/35, Health informatics.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication.

3、 The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 79521 3ICS 35.240.80Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 3

4、1 January 2014.Amendments issued since publicationDate Text affectedBS ISO 20301:2014 ISO 2014Health informatics Health cards General characteristicsInformatique de sant Cartes de sant Caractristiques gnralesINTERNATIONAL STANDARDISO20301Second edition2014-01-15Reference numberISO 20301:2014(E)BS IS

5、O 20301:2014ISO 20301:2014(E)ii ISO 2014 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2014All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or post

6、ing on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrighti

7、so.orgWeb www.iso.orgPublished in SwitzerlandBS ISO 20301:2014ISO 20301:2014(E) ISO 2014 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 24 Abbreviated terms 35 Physical characteristics . 36 Visually readable data 36.1 Purpose

8、s of visually readable data 36.2 Items of visually readable data . 36.3 Field identifier of visually readable data 57 Recording technique. 57.1 Recording technique for visually readable data . 57.2 Magnetic stripes . 57.3 Integrated circuits with contacts . 57.4 Contactless integrated circuits 57.5

9、Optical memory 57.6 Other recording technique 68 Test method . 6Annex A (informative) Examples of field identifiers written in Latin-1 code 7Annex B (informative) Examples of healthcare card layout . 8Bibliography .12BS ISO 20301:2014ISO 20301:2014(E)ForewordISO (the International Organization for S

10、tandardization) 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 established has the ri

11、ght 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.The procedure

12、s 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 the editorial ru

13、les 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 patent rights ident

14、ified 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.For an explanation o

15、n the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is I

16、SO/TC 215, Health informatics.This second edition cancels and replaces the first edition (ISO 20301:2006), of which it constitutes a minor revision.iv ISO 2014 All rights reservedBS ISO 20301:2014ISO 20301:2014(E)IntroductionThe purpose of using machine-readable cards in the field of healthcare is t

17、o improve the quality of health service and the efficient use of healthcare resources in the field. The primary consideration in creating this International Standard has been to improve patient service and patient safety, as well as improve the practical use of healthcare cards in clinical fields.St

18、andardizing the clinical practice of medicine and defining a standardized healthcare delivery service structure are not included in this International Standard.In years past, healthcare cards have been used to exchange healthcare data by placing necessary and appropriate information on the surface o

19、f the cards in order to implement the health service of each country. However, as people now move more frequently across borders, healthcare cards issued in one country or area are increasingly being used in another, and with this consideration in mind, this International Standard has been designed

20、to apply to healthcare cards that will be used internationally.It would be pertinent for ISO/TC 215 and ISO/IEC JTC1/SC 17 to discuss the standardization of the characteristics and operation of other cards, which are not covered by this International Standard.This International Standard is designed

21、to accept relevant technologies and recording techniques for cards.The data elements and data structures in healthcare cards are under consideration within ISO/TC 215. ISO 2014 All rights reserved vBS ISO 20301:2014BS ISO 20301:2014Health informatics Health cards General characteristics1 ScopeThis I

22、nternational Standard describes general characteristics of machine-readable cards used in the field of healthcare.This International Standard is designed to confirm the identities of both the healthcare application provider and the healthcare cardholder in order that information can be exchanged by

23、using cards issued for healthcare service.This International Standard focuses on the machine-readable cards of ID-1 type defined in ISO/IEC 7810 that are issued for healthcare services provided in a service area that crosses the national borders of two or more countries/areas.This International Stan

24、dard applies directly or refers to existing ISO standards for the physical characteristics and recording techniques. Security issues follow the requirements of each healthcare card system.In addition, this International Standard regulates the visual information written on the card.2 Normative refere

25、ncesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO

26、21549-1:2013, Health informatics Patient healthcard data Part 1: General structureISO 21549-2:2004, Health informatics Patient healthcard data Part 2: Common objectsISO/IEC 7810, Identification cards Physical characteristicsISO/IEC 7811 (all parts), Identification cards Recording techniqueISO/IEC 78

27、12-1, Identification cards Identification of issuers Part 1: Numbering systemISO/IEC 7816 (all parts), Identification cards Integrated circuit cardsISO/IEC 10373 (all parts), Identification cards Test methodsISO/IEC 10536 (all parts), Identification cards Contactless integrated circuit(s) cards Clos

28、e-coupled cardsISO/IEC 11693 (all parts), Identification cards Optical memory cardsISO/IEC 14443 (all parts), Identification cards Contactless integrated circuit cards Proximity cardsISO/IEC 15420 (all parts), Information technology Automatic identification and data capture techniques EAN/UPC bar co

29、de symbology specificationISO/IEC 15438 (all parts), Information technology Automatic identification and data capture techniques PDF417 bar code symbology specificationISO/IEC 15693 (all parts), Identification cards Contactless integrated circuit cards Vicinity cardsINTERNATIONAL STANDARD ISO 20301:

30、2014(E) ISO 2014 All rights reserved 1BS ISO 20301:2014ISO 20301:2014(E)ISO/IEC 24789 (all parts), Identification cards Card service life3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1applicationprovided for specific services in healthcare fiel

31、ds, which could be carried out by using a separate set of information stored in the healthcare data cardEXAMPLE An application for making appointments for medical treatment, an application for providing access to medical records, and an application for certifying health funding status are all exampl

32、es of healthcare applications.3.2card issuerentity that records the information to activate the card, register, and distribute to the healthcare cardholderEXAMPLE A hospital could be an issuer of cards for handling appointments for medical treatment or for accessing medical records. A health funding

33、 agency could be an issuer of cards for health funding.3.3field identifiercharacter strings, numeric characters, and/or icons placed near the visually readable data that help to identify the data3.4front side of the cardback side of the cardfront/back side of the card is defined in standards related

34、 to the applied recording techniques and card technologies, e.g. ISO/IEC 7811 for cards with embossing and/or magnetic stripes, ISO/IEC 7816 for integrated circuit cards, and ISO/IEC 11693 (all parts) for optical memory cards3.5healthcare application providerentity that provides healthcare services

35、to the healthcare cardholder and in the course of doing so, makes use of the card and records the health care application information onto the cardsEXAMPLE A hospital could be a healthcare application provider by handling appointments for medical treatment or by providing access control to medical r

36、ecords. A health funding agency could be a healthcare application provider by issuing cards for health funding. A health funding agency could also be a healthcare application provider by certifying the health funding status of the healthcare cardholder.Note 1 to entry: If the card contains an applic

37、ation for medical appointments, a hospital could be an application provider as it provides appointment services to the patients, while it could also be a user of the card if the card contains an application for health funding services, as the hospital could get reimbursed from the health funding age

38、ncy.3.6healthcare data cardcard conformant to ISO/IEC 7816 (all parts) intended for use within the healthcare domainSOURCE: ISO 21549-1:2013, definition 3.23.7healthcare cardholderindividual transporting a healthcare data card, which contains a record with the individual identified as the major reco

39、rd personSOURCE: ISO 21549-2:2004, definition 3.82 ISO 2014 All rights reservedBS ISO 20301:2014ISO 20301:2014(E)3.8itemsingle distinct part of the visually readable data3.9recording techniquetechnique to put visually readable data onto the card surface or to write data in non-volatile memories3.10s

40、ervice areacountries/areas where the healthcare data card is intended to be used and where the healthcare service obtained by using the card is provided3.11visually readable datadata that are placed on the surface of the healthcare data card to be read visually by users4 Abbreviated termsPAN Primary

41、 Account NumberIIN Issuer Identification Number5 Physical characteristicsThe physical characteristics follow the specifications defined by ISO/IEC 7810 and the specifications defined by the International Standards for the recording techniques. For example, ISO/IEC 7811 for cards using embossing and/

42、or magnetic stripes, ISO/IEC 7816 for cards using IC with contacts, and ISO/IEC 11693 (all parts) for optical memory cards.The physical characteristics of a healthcare card shall be in compliance with the relevant standards of the applied recording techniques and card technologies, for example, ISO/

43、IEC 7811 for cards with embossing and/or magnetic stripes, ISO/IEC 7816 for integrated circuit cards, ISO/IEC 14443, ISO 10536, and ISO 15693 for contactless integrated circuit cards, and ISO/IEC 11693 (all parts) for optical memory cards.6 Visually readable data6.1 Purposes of visually readable dat

44、aThe items defined by this International Standard are designed for either of the following two purposes.Purpose 1: Identification of the application provider and healthcare cardholder.Purpose 2: Provision of information for contacting the card issuer and the healthcare cardholder within the service

45、area.The visually readable data may not be meant to replace or may not be the same as the data stored within the card by means of magnetic, optical memory, electronic, or other machine-readable technologies. Also, other visually readable information or items can appear on the card.6.2 Items of visua

46、lly readable data6.2.1 Application provider identifierThe application provider identifier shall follow the regulations below for purpose 1 defined in 6.1. ISO 2014 All rights reserved 3BS ISO 20301:2014ISO 20301:2014(E)The written or drawn information to identify the application provider shall appea

47、r on the card.The identifier shall be written or drawn in one or more languages that could be understood within the service area.This item shall be written or drawn on the same side as the healthcare cardholder identifier.The application provider identifier can follow: the PAN defined in ISO/IEC 781

48、2-1 when the application provider identifier is combined with the cardholder identifier defined in 6.2.2; ISO 20302.6.2.2 Healthcare cardholder identifierThe healthcare cardholder identifier shall appear on the card, and follow the regulations below for purpose 1 defined in 6.1.The name or the infor

49、mation of the healthcare cardholder defined by the healthcare application provider shall appear on the card.The healthcare cardholder identifier shall be written or drawn in one or more languages that could be understood within the service area.This item shall be written or drawn on the same side as the application provider identifier.The healthcare cardholder identifier can follow the PAN for the cardholder identifier defined in ISO/IEC 7812-1 when it is combined with the application provide