ISO/HL7 27953-2:2011
Current
Current
The latest, up-to-date edition.
Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance — Part 2: Human pharmaceutical reporting requirements for ICSR
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Language(s)
French, English
Published date
21-11-2011
Important note : Users cannot be edited or removed once added to your Multi user PDF.
ISO 27593-2:2011 seeks to create a standardized framework for international regulatory reporting and information sharing by providing a common set of data elements and a messaging format for transmission of ICSRs for adverse drug reactions (ADR), adverse events (AE), infections, and incidents that can occur upon the administration of one or more human pharmaceutical products to a patient, regardless of source and destination.
| DevelopmentNote |
Supersedes ISO/DIS 27953-2. (11/2011) Available in CD-ROM format (contains program files). (12/2013)
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| DocumentType |
Standard
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| Pages |
0
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| PublisherName |
International Organization for Standardization
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| Status |
Current
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| Standards | Relationship |
| NF EN ISO 27953-2 : 2013 | Identical |
| NBN EN ISO 27953-2 : 2012 | Identical |
| NEN EN ISO 27953-2 : 2011 | Identical |
| NS EN ISO 27953-2 : 2011 | Identical |
| PN EN ISO 27953-2 : 2012 | Identical |
| UNI EN ISO 27953-2 : 2012 | Identical |
| BS EN ISO 27953-2:2011 | Identical |
| EN ISO 27953-2:2011 | Identical |
| DIN EN ISO 11240:2013-03 | Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement (ISO 11240:2012) |
| PD CEN ISO/TS 16791:2015 | Health informatics. Requirements for international machine-readable coding of medicinal product package identifiers |
| I.S. EN ISO 11238:2012 | HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED INFORMATION ON SUBSTANCES (ISO 11238:2012) |
| S.R. CEN ISO/TS 19256:2017 | HEALTH INFORMATICS - REQUIREMENTS FOR MEDICINAL PRODUCT DICTIONARY SYSTEMS FOR HEALTH CARE (ISO/TS 19256:2016) |
| S.R. CEN ISO/TS 16791:2015 | HEALTH INFORMATICS - REQUIREMENTS FOR INTERNATIONAL MACHINE-READABLE CODING OF MEDICINAL PRODUCT PACKAGE IDENTIFIERS (ISO/TS 16791:2014) |
| BS PD ISO/TS 16791 : 2014 | HEALTH INFORMATICS - REQUIREMENTS FOR INTERNATIONAL MACHINE-READABLE CODING OF MEDICINAL PRODUCT PACKAGE IDENTIFIERS |
| PD CEN ISO/TS 20443:2018 | Health informatics. Identification of medicinal products. Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information |
| CEN ISO/TS 20443:2018 | Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/TS 20443:2017) |
| UNE-EN ISO 11238:2013 | Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances (ISO 11238:2012) |
| UNE-EN ISO 11615:2013 | Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2012) |
| UNI EN ISO 11238 : 2012 | HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED INFORMATION ON SUBSTANCES |
| I.S. EN ISO 11616:2017 | HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED PHARMACEUTICAL PRODUCT INFORMATION (ISO 11616:2017) |
| CEN ISO/TS 20451:2018 | Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information (ISO/TS 20451:2017) |
| ISO 11240:2012 | Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of units of measurement |
| S.R. CEN ISO/TS 20451:2018 | HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - IMPLEMENTATION GUIDELINES FOR ISO 11616 DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED PHARMACEUTICAL PRODUCT INFORMATION (ISO/TS 20451:2017) |
| UNE-EN ISO 11240:2013 | Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement (ISO 11240:2012) |
| ISO 11615:2017 | Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information |
| PD CEN ISO/TS 19256:2017 | Health informatics. Requirements for medicinal product dictionary systems for health care |
| ISO/TS 20451:2017 | Health informatics — Identification of medicinal products — Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information |
| EN ISO 11238:2012 | Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances (ISO 11238:2012) |
| BS EN ISO 11238:2012 | Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of regulated information on substances |
| EN ISO 11615:2017 | Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2017) |
| CEN ISO/TS 16791:2015 | Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers (ISO/TS 16791:2014) |
| BS EN ISO 11240:2012 | Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of units of measurement |
| 16/30344636 DC : 0 | BS EN ISO 11615 - HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED MEDICINAL PRODUCT INFORMATION |
| BS EN ISO 11616:2017 | Health informatics. Identification of medicinal products. Data elements and structures for unique identification and exchange of regulated pharmaceutical product information |
| EN ISO 11616:2017 | Health informatics - Identification of medicinal products - Data elements and structures for the Unique Identification and Exchange of regulated Pharmaceutical Product Information (ISO 11616:2017) |
| ISO/TS 19256:2016 | Health informatics — Requirements for medicinal product dictionary systems for health care |
| EN ISO 11240:2012 | Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement (ISO 11240:2012) |
| S.R. CEN ISO/TS 20443:2018 | HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - IMPLEMENTATION GUIDELINES FOR ISO 11615 DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED MEDICINAL PRODUCT INFORMATION (ISO/TS 20443:2017) |
| BS EN ISO 11615:2017 | Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of regulated medicinal product information |
| ISO 11238:2012 | Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated information on substances |
| DIN EN ISO 11238:2013-03 | HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED INFORMATION ON SUBSTANCES (ISO 11238:2012) |
| I.S. EN ISO 11615:2017 | HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED MEDICINAL PRODUCT INFORMATION (ISO 11615:2017) |
| UNI EN ISO 11240 : 2012 | HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF UNITS OF MEASUREMENT |
| ISO 11616:2017 | Health informatics — Identification of medicinal products — Data elements and structures for unique identification and exchange of regulated pharmaceutical product information |
| I.S. EN ISO 11240:2012 | HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF UNITS OF MEASUREMENT (ISO 11240:2012) |
| ISO/TS 20443:2017 | Health informatics — Identification of medicinal products — Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information |
| CEN ISO/TS 19256:2017 | Health informatics - Requirements for medicinal product dictionary systems for health care (ISO/TS 19256:2016) |
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