EN ISO TS 16791-2015 en Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers《健康信息学 药用产品包装标识国际机读编码要求》.pdf

1、BSI Standards PublicationPD CEN ISO/TS 16791:2015Health informatics Requirements for internationalmachine-readable coding ofmedicinal product package identifiersPD ISO/TS 16791:2014PD CEN ISO/TS 16791:2015 PUBLISHED DOCUMENTNational forewordThis Published Document is the UK implementation of CEN ISO

2、/TS 16791:2015. It is identical to ISO/TS 16791:2014. It supersedesPD ISO/TS 16791:2014 which is withdrawn. The UK participation in its preparation was entrusted to TechnicalCommittee IST/35, Health informatics.A list of organizations represented on this committee can be obtainedon request to its se

3、cretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 89778 8ICS 35.240.80Compliance with a British Standard canno

4、t confer immunity from legal obligations.This British Standard was published under the authority of the StandardsPolicy and Strategy Committee on 30 April 2014.Amendments/corrigenda issued since publicationDate Text affected30 September 2015 This corrigendum renumbers PD ISO/TS 16791:2014as PD CEN I

5、SO/TS 16791:2015.TECHNICAL SPECIFICATION SPCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN ISO/TS 16791 September 2015 ICS 35.240.80 English Version Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers (ISO/TS 16791:2014) Informatique

6、 de sant - Exigences pour une identification internationale, lisible par capture automatique, des produits mdicinaux (ISO/TS 16791:2014) Medizinische Informatik - Anforderungen fr maschinenlesbare internationale Kodierungen fr Verpackungen von Arzneimitteln (ISO/TS 16791:2014)This Technical Specific

7、ation (CEN/TS) was approved by CEN on 31 August 2015 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

8、 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)

9、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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary

10、, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC

11、 Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. CEN ISO/TS 16791:2015 EPD CEN ISO/TS 16791:2015CEN ISO/TS 16791:2015 (E) 3 European foreword This document (CEN ISO/TS 16791:20

12、15) has been prepared by Technical Committee ISO/TC 215 “Health informatics” in collaboration with Technical Committee CEN/TC 251 “Health informatics” the secretariat of which is held by NEN. Attention is drawn to the possibility that some of the elements of this document may be the subject of paten

13、t rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria,

14、 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey

15、and the United Kingdom. Endorsement notice The text of ISO/TS 16791:2014 has been approved by CEN as CEN ISO/TS 16791:2015 without any modification. CEN ISO/TS 16791:2015 (E) 3 European foreword This document (CEN ISO/TS 16791:2015) has been prepared by Technical C m ittee ISO/TC 215 “Health informa

16、tics” in collaboration with Technical Committee CEN/TC 251 “Health informatics” the secretariat of which is held by NEN. Attention is drawn to the possibility that some of the elements of this document may be the subject f patent rights. CEN and/or CENELEC shall not be held responsible for identifyi

17、ng any or all such patent rights. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugo

18、slav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, S itzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO/TS 16791:2014

19、 has been approved by CEN as CEN ISO/TS 16791:2015 without any modification. ISO/TS 16791:2014(E) ISO 2014 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 13.1 Terms . 13.2 Abbreviations . 54 Procedural background. 64.1 Genera

20、l . 64.2 Identification 64.3 International machine readable coding 64.4 Medicinal product 74.5 Labelling . 74.6 Package identifier . 84.7 Serialization . 85 Usage requirements 95.1 General . 95.2 Traceability 95.3 Measures to combat falsification of medicines 105.4 Improving patient safety at point

21、of care 125.5 Support of healthcare systems . 125.6 Procurement and stock management 145.7 Overview of the normative options 156 Economic aspects 156.1 General 156.2 Manufacturer perspective 166.3 Healthcare provider perspective 16Annex A (informative) Relationship between PhPID and MPID (Referencin

22、g ISO 11615 and ISO 11616) .17Annex B (informative) Packaging hierarchy 18Annex C (informative) Relationship between MPID, PCID and GTIN 19Annex D (informative) Examples for Package Identifier 20Bibliography .22PD CEN ISO/TS 16791:2015ISO/TS 16791:2014(E)ForewordISO (the International Organization f

23、or 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 established has th

24、e 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.The proce

25、dures 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 editoria

26、l 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 patent rights i

27、dentified 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 explanati

28、on on 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

29、is ISO/TC 215, Health informatics.iv ISO 2014 All rights reservedPD CEN ISO/TS 16791:2015ISO/TS 16791:2014(E)IntroductionGlobally, healthcare regulators, medicinal product suppliers, and healthcare providers, among others, are facing increased pressure to ensure a more secure and safer supply chain

30、for medicinal products. The primary objective is to ensure optimal patient safety outcomes. International organizations such as the World Health Organization (WHO) and the Council of Europe, along with many other healthcare organizations are also seeking robust systems that will deliver outcomes to

31、enhance overall supply chain integrity, to prevent product falsification and to improve patient safety, especially at the point of care.Machine readable coding is a technology capable of achieving these stated outcomes. Therefore, the core purpose of this Technical Specification is to provide guidan

32、ce for machine-readable coding based on globally harmonized and interoperable standards for wide scale international implementation.This Technical Specification outlines the requirements to implement international machine-readable coding on medicinal product packages in the healthcare supply chain.

33、It assists all stakeholders implement, use, and optimize Automatic Identification and Data Capture Identification (AIDC) technologies in their respective enterprises with a particular attention to Health Informatics. In that respect, it complements ISO 11615.As AIDC offers a wide spectrum of potenti

34、al solutions, particularly for data carriers such as barcodes, it has highlighted the importance of properly defining data structures to prevent ambiguity when information is encoded and captured.Furthermore, the semantics of data carried can be defined by a number of organizations (also called “iss

35、uing agencies”), some with commercial activities, some with a national emphasis, and others with a standard development organizations objective. This particular specification focuses on the GS1 System of Standards1).The majority of supplies (such as processed food, office supplies, apparels, medical

36、 devices and equipment, medicinal products, etc.) in healthcare around the world use the GS1 System of Standards for AIDC as it is multi-sectorial and a globally implemented system of standards. Interoperability along the supply chain is easier to achieve once a single system of standards is used in

37、 any market, including healthcare.This Technical Specification is intended to guide healthcare packaging designers, regulatory affairs specialists, logistics operators, and others to implement AIDC solutions for healthcare.1) GS1 is a registered trademark. Any trademark used in this document is info

38、rmation given for the convenience of users and does not constitute an endorsement. ISO 2014 All rights reserved vPD CEN ISO/TS 16791:2015Health informatics Requirements for international machine-readable coding of medicinal product package identifiers1 ScopeThis Technical Specification provides guid

39、ance on identification and labelling of medicinal products from the point of manufacture of packaged medicinal product to the point of dispensing the product.This Technical Specification outlines best practice for AIDC barcoding solutions for applications. Users can, however, consider the coding int

40、eroperability requirements for other AIDC technologies e.g. Radio Frequency Identification (RFID).2 Normative referencesThe 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 ap

41、plies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 11615, Health informatics I dentification of medicinal products D ata elements and structures for the unique identification and exchange of regulated medicinal product informationISO/I

42、EC 15415, Information technology A utomatic identification and data capture techniques B ar code symbol print quality test specification Tw o-dimensional symbolsISO/IEC 15416, Information technology A utomatic identification and data capture techniques B ar code print quality test specification Li n

43、ear symbolsISO 28219, Packaging Labelling and direct product marking with linear bar code and two-dimensional symbolsISO 22742, Packaging Li near bar code and two-dimensional symbols for product packaging3 Terms and definitionsFor the purposes of this document, the following terms and definitions ap

44、ply.3.1 Terms3.1.1application identifierAIGS12)prefix that defines the meaning and purpose of the data element that follows, as defined in ISO/IEC 15418 and GS1 General SpecificationsSOURCE: ISO 19762-1:2008, 01.01.942) GS1 is a registered trademark. Any trademark used in this document is informatio

45、n given for the convenience of users and does not constitute an endorsement.TECHNICAL SPECIFICATION ISO/TS 16791:2014(E) ISO 2014 All rights reserved 1PD CEN ISO/TS 16791:2015ISO/TS 16791:2014(E)3.1.2AIDC automatic identification and data capturemethods or technologies for automatically identifying

46、objects, collecting data about them, and entering that data directly into computer systems, eliminating manual entryNote 1 to entry: The methods or technologies typically considered as part of AIDC include bar codes which can be linear or 2-dimensional symbols and Radio Frequency Identification (RFI

47、D) tags/chips.3.1.3authenticationcomparing the attributes of the object itself to what is known about objects of that originNote 1 to entry: Attributes include unique identifier besides overt, covert, and/or forensic solutions.3.1.4BAID_1unique identifier allocated to a specific batch of a medicinal

48、 product which appears on the outer packaging of the medicinal product3.1.5BAID_2unique identifier allocated to a specific batch of a medicinal product which appears on the immediate packaging (not the outer packaging)3.1.6batchlotspecific manufacturing release of a medicinal product or item by the

49、manufacturerSOURCE: ISO 11615:2012, 3.1.7 modified, “lot” was added as a preferred term.3.1.7batch numberlot numberidentifier assigned to a specific batch of a medicinal product or item resulting from a manufacturing process at a specific point of timeNote 1 to entry: Batch number permits its manufacturing history to be traced.Note 2 to entry: Batch number is made of series of ASCII characters.SOURCE: ISO 11615:2012, 3.1.8 modified, “lot number” was added as a preferred term; notes were added.3.1.8bar codeoptical machine-readable