EN ISO TS 19844-2015 en Health informatics - Identification of medicinal products - Implementation guidelines for data elements and structures for the unique identification and exc.pdf

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1、BSI Standards PublicationHealth informatics Identification of medicinal products Implementationguidelines for data elements and structures for the unique identification and exchange of regulated information on substancesPD CEN ISO/TS 19844:2015National forewordThis Published Document is the UK imple

2、mentation of CEN ISO/TS19844:2015.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 onrequest to its secretary.This publication does not purport to include all the necessary pro

3、visions ofa contract. Users are responsible for its correct application. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 87004 0ICS 35.240.80Compliance with a British Standard cannot confer immunity fromlegal obligations.This Published Document was publis

4、hed under the authority of theStandards Policy and Strategy Committee on 31 January 2016.Amendments/corrigenda issued since publicationDate Text affectedPUBLISHED DOCUMENTPD CEN ISO/TS 19844:2015TECHNICAL SPECIFICATION SPCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN ISO/TS 19844 December 2015 IC

5、S 35.240.80 English Version Health informatics - Identification of medicinal products - Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances (ISO/TS 19844:2015)Informatique de sant - Identification des mdicaments

6、 - Lignes directrices pour la mise en oeuvre des lments de donnes et structures pour lidentification unique et lchange dinformations rglementes sur les substances (ISO/TS 19844:2015) Medizinische Informatik - Identifikation von Arzneimitteln - Anwendungsleitfaden fr die Struktur und kontrollierten V

7、okabularien zur Identifikation und Beschreibung von Substanzen und Inhaltsstoffen (ISO/TS 19844:2015) This Technical Specification (CEN/TS) was approved by CEN on 4 April 2016 for provisional application. The period of validity of this CEN/TS is limited initially to three years. After two years the

8、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 l

9、evel 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,

10、 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 and Unite

11、d Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC 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

12、ISO/TS 19844:2015 EPD CEN ISO/TS 19844:2015CEN ISO/TS 19844:2015 (E) 2 Contents Page European foreword . 3 PD CEN ISO/TS 19844:2015CEN ISO/TS 19844:2015 (E) 3 European foreword This document (CEN ISO/TS 19844:2015) has been prepared by Technical Committee ISO/TC 215 “Health informatics“ in collabora

13、tion 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 patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all suc

14、h 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 Yugoslav Republic of

15、Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO/TS 19844:2015 has been approve

16、d by CEN as CEN ISO/TS 19844:2015 without any modification. PD CEN ISO/TS 19844:2015ISO/TS 19844:2015 ISO 2015 All rights reserved iii Contents PageForeword . viii Introduction ix 1 Scope . 1 2 Normative references . 2 3 General background and history 2 4 Substance (Mandatory) 3 4.1 Introduction . 3

17、 4.2 Defining Substances 5 4.3 Substance Types (Mandatory). 7 4.4 Substance ID (Mandatory) . 10 4.5 Substance Names (Mandatory) 11 4.5.1 Substance Name . 12 4.5.2 Substance Name Type 12 4.5.3 Language 13 4.5.4 Official Name (repeat as necessary) . 13 4.6 Reference Sources (Mandatory) 15 4.6.1 Public

18、 Domain 16 4.6.2 Reference Source Type 16 4.6.3 Reference Source Class . 16 4.6.4 Reference Source ID . 17 4.6.5 Reference Source Citation 17 4.6.6 Reference Source Document (new class to be included in the second edition of ISO 11238) 17 4.6.7 Reference Source Document Type (new class to be include

19、d in the second edition of ISO 11238) . 18 4.6.8 Reference Source Document Classification (new class to be included in the second edition of ISO 11238) . 18 4.6.9 Reference Source URL (new class to be included in the second edition of ISO 11238) 18 4.7 Substance Code (Conditional) 18 4.7.1 Code 19 4

20、.7.2 Code System 19 4.7.3 Code System ID . 20 4.7.4 Code System Status . 20 4.7.5 Code System Status Change Date . 20 4.7.6 Comment 20 4.7.7 Reference Source . 21 4.7.8 Substance Classification (repeat as necessary) . 21 4.7.9 Target 23 4.7.10 Gene 25 4.7.11 Gene Elements 26 4.7.12 Substance Relatio

21、nship . 27 4.8 Structure (repeat as necessary) (Conditional) 29 4.8.1 Structural Representation Type 34 4.8.2 Structural Representation . 35 4.8.3 Structural Representation Attachment 35 4.8.4 Stereochemistry 35 4.8.5 Optical Activity . 36 4.8.6 Molecular Formula . 36 4.8.7 Molecular Formula by Moie

22、ties (new class to be included in the second edition of ISO 11238) 37 4.8.8 Isotope (repeat as necessary) 37 PD CEN ISO/TS 19844:2015ISO/TS 19844:2015 iv ISO 2015 All rights reserved 4.9 Amount (Conditional) . 38 4.9.1 Average . 38 4.9.2 Low Limit 38 4.9.3 High Limit 39 4.9.4 Unit . 39 4.9.5 Non-num

23、eric Value . 39 4.10 Source Material (Conditional) 39 4.10.1 Source Material Class. 40 4.10.2 Source Material Type . 41 4.10.3 Source Material state . 41 4.10.4 Organism ID 41 4.10.5 Organism Name . 41 4.10.6 Development Stage . 42 4.10.7 Part Description (repeat as necessary) 42 4.10.8 Fraction (re

24、peat as necessary) 42 4.10.9 Organism 43 4.11 Modification (repeat as necessary) (Conditional) 49 4.11.1 Modification Type . 50 4.11.2 Residue Modified 51 4.11.3 Residue Site . 51 4.11.4 Structural Modification . 51 4.12 Property (Conditional) . 55 4.12.1 Property Type 56 4.12.2 Property Name . 56 4

25、.12.3 Property Parameters (new class to be included in the second edition of ISO 11238) 56 4.12.4 Substance Name . 57 4.12.5 Substance ID 57 4.12.6 Amount type 57 4.13 Version (repeat as necessary) (Mandatory) . 57 4.13.1 Version Number 57 4.13.2 Effective date 58 4.13.3 Change Made . 58 5 Substance

26、 definitions 58 5.1 Chemical Substance 58 5.1.1 Structure 59 5.1.2 Stoichiometric 59 5.1.3 Stoichiometric Chemicals. 59 5.1.4 Comment 62 5.1.5 Non- Stoichiometric Chemicals 62 5.2 Proteins/ Peptides 64 5.2.1 Microheterogeneity 65 5.2.2 Sequence Type . 66 5.2.3 Number of subunits 66 5.2.4 Disulfide L

27、inkage 66 5.2.5 Comment 67 5.2.6 Protein Subunit (repeat as necessary) 67 5.2.7 Molecular Weight (repeat as necessary) 69 5.2.8 Glycosylation 69 5.2.9 Structure 71 5.2.10 Modification 71 5.2.11 Property . 71 5.2.12 Molecular Weight 71 5.3 Nucleic Acids . 72 5.3.1 Structure 73 5.3.2 Sequence Type . 7

28、3 5.3.3 Number of Subunits 73 5.3.4 Area of hybridisation . 74 PD CEN ISO/TS 19844:2015ISO/TS 19844:2015 ISO 2015 All rights reserved v 5.3.5 Comment 74 5.3.6 Nucleic Acid Subunit (repeat as necessary) 74 5.3.7 Modification 77 5.3.8 Property 77 5.3.9 Molecular Weight 77 5.4 Polymers To be addressed

29、in more detail in the next edition of this Technical Specification 78 5.4.1 Substance Name . 79 5.4.2 Structure . 79 5.4.3 Polymer Class . 79 5.4.4 Polymer Geometry 80 5.4.5 Copolymer Sequence type 80 5.4.6 Comment 80 5.4.7 Monomer Description (repeat as necessary) . 80 5.4.8 Structural Repeat (repe

30、at as necessary) 81 5.4.9 Molecular Weight (repeat as necessary) 83 5.4.10 Property (repeat as necessary) . 83 5.4.11 Reference Source (repeat as necessary) 83 5.5 Structurally-Diverse Substances . 83 5.5.1 herbals and Substances Used in the Preparation of Plant-Based Allergenic Extracts 84 5.5.2 Va

31、ccines Annex addressing this will be included in the next edition of this Technical Specification 93 5.5.3 Purified Blood Products and Polyclonal Antibodies Annex addressing this will be included in the next edition of this Technical Specification 93 5.5.4 Cells and Tissues Annex addressing this wil

32、l be included in the next edition of this Technical Specification . 93 5.5.5 Minerals Annex addressing this will be included in the next edition of this Technical Specification 93 5.6 Mixture Substance (repeat as necessary) 94 5.6.1 Mixture Type . 94 5.6.2 Mixture Constituent (repeat as necessary) .

33、 94 6 specified substance (Optional) 95 6.1 specified substance Group 1 (repeat as necessary) . 96 6.1.1 specified substance Group 1 ID 97 6.1.2 specified substance Group1 Name 97 6.1.3 Substance Name (repeat as necessary). 97 6.1.4 Substance Code 97 6.1.5 Version (repeat as necessary) 97 6.1.6 Refe

34、rence Sources . 97 6.1.7 Property (repeat as necessary) . 97 6.1.8 Fraction (new class to be included in the second edition of ISO 11238) 98 6.1.9 Modification 98 6.1.10 Reference Information (repeat as necessary) 98 6.1.11 Constituent (repeat as necessary) 98 6.1.12 Physical Form (repeat as necessa

35、ry) . 99 6.2 specified substance Group 1 intended for herbal Substance and herbal Preparation . 100 6.2.1 specified substance Group 1 ID 101 6.2.2 specified substance Group1 Name 101 6.2.3 Reference Sources . 101 6.2.4 Fraction (new class to be included in the second edition of ISO 11238) 101 6.2.5

36、Modification (new classes to be included in the second edition of ISO 11238) . 102 6.2.6 Constituent (repeat as necessary) 102 6.2.7 Physical Form (repeat as necessary) . 103 6.3 specified substance Group 2 (repeat as necessary) . 104 6.3.1 specified substance Group2 ID . 107 6.3.2 specified substan

37、ce Group2 Name 107 6.3.3 Parent Substance ID . 107 6.3.4 Manufacturing 107 PD CEN ISO/TS 19844:2015ISO/TS 19844:2015 vi ISO 2015 All rights reserved 6.4 specified substance Group 2 for herbal preparations . 111 6.4.1 specified substance Group2 ID 111 6.4.2 specified substance Group2 Name 111 6.4.3 P

38、arent Substance ID . 111 6.4.4 Manufacturing 112 6.4.5 Version (repeat as necessary) 113 6.5 specified substance Group 3 (repeat as necessary) . 113 6.5.1 specified substance Group3 ID 114 6.5.2 specified substance Group3 Name 114 6.5.3 Parent Substance ID . 114 6.5.4 Grade . 115 6.5.5 Reference Sou

39、rce (repeat as necessary) 115 6.5.6 Version (repeat as necessary) 115 6.5.7 Reference Source (repeat as necessary) 116 6.5.8 Version (repeat as necessary) 116 Annex A (normative) Choosing a Substance ID 117 A.1 Requesting a Substance ID and providing information 117 Annex B (normative) Chemical Subs

40、tance . 119 B.0 Introduction 119 B.0.1 Proposal for the update of the ISO 11238 Substance standard . 120 B.0.2 Outline of Annex B 122 B.1 Scope 123 B.2 Terms and definitions . 123 B.3 Chemical Substance subtypes and Mixture Substance 132 B.3.1 Substance type, Chemical substance 132 B.3.2 Solid state

41、 forms of the Substance 132 B.3.3 Need to substantiate the chemical structure, molecular formula and molecular weight . 135 B.3.4 Polymorphism 136 B.3.5 Non-Stoichiometric chemical substances 137 B.3.6 Mixture substance 138 B.3.7 Multi substance material . 139 B.4 Discussion of the key elements of a

42、 chemical substance . 142 B.4.1 Identity of material 142 B.4.2 Nomenclature . 142 B.4.3 Molecular formula 142 B.4.4 Molecular weight . 143 B.4.5 Substance Structure . 143 B.4.6 Geometric Isomerism 146 B.4.7 Stereo-descriptors in systematic nomenclature: Substance with one centre of Asymmetry . 147 B

43、.4.8 Substance with two centres of Asymmetry, Epimers, Diastereomers . 148 B.4.9 Anomers . 148 B.4.10 Substance with more than two centres of Asymmetry (Mixture of stereoisomers) 151 B.4.11 Conclusion for the Key elements . 152 B.4.12 Decision tree for a new Substance ID 152 B.5 Discussing other ele

44、ments of importance regarding the characteristics of a substance . 153 B.5.1 Introduction 153 B.5.2 Naming Vegetable Oils 153 B.5.3 Castor Oil and related products . 169 B.5.4 Properties to be captured, related to liquids (Gas), Nitrous oxide 172 B.6 Examples 177 B.6.1 Example 1: Amlodipine besilate

45、 178 B.6.2 Example 2: Ponatinib hydrochloride . 185 B.6.3 Example 3: Benzathine Benzylpenicillin tetrahydrate, sterilised. . 201 B.6.4 specified substance Group 2 information level . 206 B.6.5 specified substance Group 3 information level . 207 B.7 Radiopharmaceutical substance . 207 B.7.1 Introduct

46、ion 207 PD CEN ISO/TS 19844:2015ISO/TS 19844:2015 ISO 2015 All rights reserved vii B.7.2 Example: Florbetapir 18F 208 B.7.3 Identity of material, combining the elements for Florbetapir 18F, Substance and specified substance information level. 209 B.7.4 specified substance Group 2 information level .

47、 214 Annex C (normative) Protein Substance . 215 C.1 Scope 215 C.2 Introduction 215 C.3 Peptide Substances . 216 C.3.1 Example IIIa: Protein Substance: Vasopressin . 216 C.3.2 Example IIIb: Desmopressin . 219 C.3.3 Example IIIc: Desmopressin Acetate 223 C.3.4 Example IIId: Calcitonin Salmon 227 C.3.

48、5 Example IIIe: Human Insulin 233 C.4 Element Group Protein, specified substance Group 1 . 235 C.4.1 Example IVa: Insulin Human Zinc Suspension (Amorphous), taken from EP/USP Monographs for Zinc Suspensions 235 C.4.2 Example IVb: Insulin Human Zinc Suspension (Crystalline), taken from EP/USP Monogra

49、phs for Zinc Suspensions 236 C.4.3 Example IVc: Insulin Human Zinc Suspension taken from EP/USP Monographs for Zinc Suspensions, including discussion for specified substance Group 3 information 237 C.5 Element Group Protein, specified substance Group 2 . 240 C.5.1 Example Va: Synthetic Calcitonin Salmon-Manufacturer Company Acme . 240 C.5.2 specified substance Group 2 information level . 240 C.5.3 Example Vb: Recombinant Calcitonin Salmon- Company Acme . 241 C.6 Element Group Protein, specified substance Group 3 . 241 C.6.1 Examp