ISO/TS 19218-2:2012
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Medical devices Hierarchical coding structure for adverse events Part 2: Evaluation codes
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23-09-2021
English
20-03-2012
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ISO/TS 19218-2:2012 specifies requirements for a hierarchical coding structure for characterizing the results of the analysis or evaluation of adverse events relating to medical devices. The codes are intended primarily for use by medical device manufacturers and regulatory authorities. They can also be used for coding the results of the analysis or evaluation of events other than those related to death or serious injury, as well as malfunctions that could lead to death or serious injury.
ISO/TS 19218-2:2012 is not intended to be used to decide whether or not an incident is reportable.
| DevelopmentNote |
Together with ISO TS 19218-1, Supersedes ISO TS 19218. (03/2012)
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| DocumentType |
Technical Specification
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| Pages |
13
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| ProductNote |
THIS STANDARD ALSO REFERS TO GHTF/SG2/N54/R8:2006,GHTF/SG1/N41/R9:2005,GHTF/SG2/N31/R8:2003,GHTF/SG2/N21/R8:1999
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| PublisherName |
International Organization for Standardization
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| Status |
Withdrawn
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| Supersedes |
| Standards | Relationship |
| PD ISO/TS 19218-2:2012 | Identical |
| AAMI ISO TIR 19218-2 : 2012 | Identical |
| NEN NPR ISO/TS 19218-2 : 2012 | Identical |
| ISO/TS 19218-1:2011 | Medical devices Hierarchical coding structure for adverse events Part 1: Event-type codes |
| IEC TR 80001-2-1:2012 | Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples |
| PD IEC/TR 80001-2-1:2012 | Application of risk management for IT-networks incorporating medical devices Step-by-step risk management of medical IT-networks. Practical applications and examples |
| ANSI/AAMI/IEC TIR80001-2-1:2012 | APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-1: STEP BY STEP RISK MANAGEMENT OF MEDICAL IT-NETWORKS - PRACTICAL APPLICATIONS AND EXAMPLES |
| AAMI ISO TIR 19218-1 : 2011 | MEDICAL DEVICES - HIERARCHAL CODING STRUCTURE FOR ADVERSE EVENTS - PART 1: EVENT-TYPE CODES |
| ISO/TS 19218-1:2011 | Medical devices Hierarchical coding structure for adverse events Part 1: Event-type codes |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| ISO 15225:2016 | Medical devices Quality management Medical device nomenclature data structure |
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