1、BSI Standards PublicationHealth informatics Requirements for internationalmachine-readable coding ofmedicinal product package identifiersPD ISO/TS 16791:2014Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking
2、permitted without license from IHS-,-,-National forewordThis Published Document is the UK implementation of ISO/TS 16791:2014.The UK participation in its preparation was entrusted to TechnicalCommittee IST/35, Health informatics.A list of organizations represented on this committee can be obtained o
3、nrequest to its secretary.This publication does not purport to include all the necessary provisions ofa contract. Users are responsible for its correct application. The British Standards Institution 2014.Published by BSI Standards Limited 2014ISBN 978 0 580 75007 6ICS 35.240.80Compliance with a Brit
4、ish Standard cannot confer immunity fromlegal obligations.This Published Document was published under the authority of theStandards Policy and Strategy Committee on 30 April 2014.Amendments/corrigenda issued since publicationDate Text affectedPUBLISHED DOCUMENTPD ISO/TS 16791:2014Copyright British S
5、tandards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,- ISO 2014Health informatics Requirements for international machine-readable coding of medicinal product package identifiersInformatique d
6、e sant Exigences pour une identification internationale, lisible par capture automatique, des produits mdicinauxTECHNICAL SPECIFICATIONISO/TS16791First edition2014-04-01Reference numberISO/TS 16791:2014(E)PD ISO/TS 16791:2014Copyright British Standards Institution Provided by IHS under license with
7、BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-ISO/TS 16791:2014(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 utilize
8、d otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting 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 o
9、fficeCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgPublished in SwitzerlandPD ISO/TS 16791:2014Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or netwo
10、rking permitted without license from IHS-,-,-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 General . 64.2 Identification 64.3 Int
11、ernational 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 of care 125.5 Support of healthc
12、are 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 (Referencing ISO 11615 and ISO 11616) .17An
13、nex B (informative) Packaging hierarchy 18Annex C (informative) Relationship between MPID, PCID and GTIN 19Annex D (informative) Examples for Package Identifier 20Bibliography .22PD ISO/TS 16791:2014Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy No
14、t for ResaleNo reproduction or networking permitted without license from IHS-,-,-ISO/TS 16791:2014(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally
15、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, in liaison with ISO, also take part in the wo
16、rk. 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/IEC Directives, Part 1. In particular the diff
17、erent 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 possibility that some of the elements of this document ma
18、y 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 patent declarations received (see www.iso.org/paten
19、ts).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 meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principle
20、s in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 215, Health informatics.iv ISO 2014 All rights reservedPD ISO/TS 16791:2014Copyright British Standards Institution Provided by IHS under license
21、 with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-ISO/TS 16791:2014(E)IntroductionGlobally, healthcare regulators, medicinal product suppliers, and healthcare providers, among others, are facing increased pressure to ensure a more secure
22、 and safer supply chain 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 w
23、ill deliver outcomes to 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 Specificat
24、ion is to provide guidance 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 h
25、ealthcare supply chain. 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
26、wide spectrum of potential 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 organiz
27、ations (also called “issuing 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 sup
28、plies, apparels, medical 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
29、 of standards is used in 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
30、in this document is information given for the convenience of users and does not constitute an endorsement. ISO 2014 All rights reserved vPD ISO/TS 16791:2014Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking
31、permitted without license from IHS-,-,-Health informatics Requirements for international machine-readable coding of medicinal product package identifiers1 ScopeThis Technical Specification provides guidance on identification and labelling of medicinal products from the point of manufacture of packag
32、ed 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 interoperability requirements for other AIDC technologies e.g. Radio Frequency Identification (RFID).
33、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 applies. For undated references, the latest edition of the referenced document (including any amendm
34、ents) applies.ISO 11615, Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated medicinal product informationISO/IEC 15415, Information technology Automatic identification and data capture techniques Bar code symbo
35、l print quality test specification Two-dimensional symbolsISO/IEC 15416, Information technology Automatic identification and data capture techniques Bar code print quality test specification Linear symbolsISO 28219, Packaging Labelling and direct product marking with linear bar code and two-dimensio
36、nal symbolsISO 22742, Packaging Linear bar code and two-dimensional symbols for product packaging3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1 Terms3.1.1application identifierAIGS12)prefix that defines the meaning and purpose of the data elem
37、ent 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 information given for the convenience of users and does not constitute an endorsement.TECHNICAL SPECIFICATION ISO/TS
38、16791:2014(E) ISO 2014 All rights reserved 1PD ISO/TS 16791:2014Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-ISO/TS 16791:2014(E)3.1.2AIDC automatic identification
39、 and data capturemethods or technologies for automatically identifying 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
40、linear or 2-dimensional symbols and Radio Frequency Identification (RFID) 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.
41、1.4BAID_1unique identifier allocated to a specific batch of a medicinal 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)3.1.6batchl
42、otspecific manufacturing release of a medicinal product or item by the 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
43、 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-re
44、adable representation of data, showing data about the object to which it attachesNote 1 to entry: Originally bar codes represented data by varying the widths and spacings of parallel lines, and can be referred to as linear or one-dimensional (1D). Later they evolved into rectangles, dots, hexagons,
45、and other geometric patterns in two dimensions (2D). Although 2D systems use a variety of symbols, they are generally referred to as bar codes as well.3.1.9dispense medicationprepare and give out a medicinal product in accordance with a prescriptionNote 1 to entry: This includes asessing the pharmac
46、eutical appropriateness including decision support.2 ISO 2014 All rights reservedPD ISO/TS 16791:2014Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-ISO/TS 16791:2014
47、(E)3.1.10falsified medicinesfake medicines that pass themselves off as real, authorized medicinesSOURCE: European Medicines AgencyNote 1 to entry: It can be contaminated or contain the wrong or no active ingredient. They could have the right active ingredient but at the wrong dose.Note 2 to entry: W
48、HO is using the concept of “Spurious/falsely-labelled/falsified/counterfeit (SFFC) medicines”.3.1.11GTIN3)global trade item numbernumber that is used for the unique identification of trade items worldwideEXAMPLE 1 GS1 Identification Key which comprises a GS1 Company Prefix, an Item Reference and Check Digit.EXAMPLE 2 Used to identify trade items such as pharmaceuticals and medical devices.Note 1 to entry: See Annex C for the relationship between MPID, PCID, and GTIN.SOURCE: ISO/IEC 15420:2009, 3.7 modified, examples added; note 1 to entry added; dig
