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BSI PD ISO/TS 19218-2:2012

Medical devices. Hierarchical coding structure for adverse events -- Evaluation codes

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BSI PD ISO/TS 19218-2:2012

Medical devices. Hierarchical coding structure for adverse events -- Evaluation codes

PUBLISH DATE 2012

PAGES 22

Document Information

This part of ISO 19218 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.

This part of ISO 19218 is not intended to be used to decide whether or not an incident is reportable.


SDO	BSI: British Standards Institution
Document Number	ISO/TS 19218-2
Publication Date	May 31, 2012
Language	en - English
Page Count	22
Revision Level
Supercedes
Committee	CH/210/3

Publish Date	Document Id	Type	View
May 31, 2012	PD ISO/TS 19218-2:2012	Revision

SDO	Document	Title
BSI	BSI DD ISO/TS 19218-1	Medical devices. Hierarchical coding structure for adverse events -- Event-type codes
ISO	ISO 19218-1	Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes
BSI	BSI DD ISO/TS 19218	Medical devices. Coding structure for adverse event type and cause
BSI	BSI BS EN ISO 15225	Medical devices. Quality management. Medical device nomenclature data structure
BSI	BSI BS EN ISO 10993-17	Biological evaluation of medical devices -- Toxicological risk assessment of medical device constituents
BSI	BSI BS EN ISO 17664-2	Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices -- Non-critical medical devices
ISO	ISO 10993-18	Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process
ISO	ISO 17664-2	Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices
BSI	BSI BS EN ISO 17664-1	Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices -- Critical and semi-critical medical devices
CSA	CSA ISO 17664-2	Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices (Adopted ISO 17664-2:2021, first edition, 2021-02)
AAMI	ANSI/AAMI/ISO 17664-2	Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 2: Non-critical medical devices
BSI	BSI BS EN 556-2	Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE' -- Requirements for aseptically processed medical devices
BSI	BSI BS EN 556-1	Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE' -- Requirements for terminally sterilized medical devices
ISO	ISO 10993-17	Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents
AAMI	ANSI/AAMI/ISO 17664-1	Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 1: Critical and semi-critical medical devices
CSA	CSA ISO 17664-1	Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices (Adopted ISO 17664-1:2021, first edition, 2021-07)
ISO	ISO 17664-1	Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices
CSA	CSA ISO/IEC 29170-2/A1	Amendment 1:2020 to CAN/CSA-ISO/IEC 29170-2:16, Information technology — Advanced image coding and evaluation — Part 2: Evaluation procedure for nearly lossless coding - Amendment 1: Evaluation procedure parameters for nearly lossless coding of high dynamic range media and image sequences (Adopted amendment 1:2020 to ISO/IEC 29170-2:2015)
BSI	BSI DD ISO/TS 10993-20	Biological evaluation of medical devices -- Principles and methods for immunotoxicology testing of medical devices
BSI	BSI PD CEN/TR 17223	Guidance on the relationship between EN ISO 13485:2016 (Medical devices. Quality management systems. Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
BSI	BSI BS EN ISO 10993-13	Biological evaluation of medical devices -- Identification and quantification of degradation products from polymeric medical devices
NAVY	NAVSEAINST-4790.1	Expanded Ship Work Breakdown Structure (ESWBS) Hierarchical Structure Codes (HSC) for Ships, Ship Systems, and Surface Combatant Systems
AAMI	ANSI/AAMI/ISO 10993-1	Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
BSI	BSI BS EN ISO 11073-20701	Health informatics. Device interoperability -- Point-of-care medical device communication. Service oriented medical device exchange architecture and protocol binding
ISO	ISO/TS 10993-20	Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices