1、 Reference number ISO/TS 19218-1:2011(E) ISO 2011TECHNICAL SPECIFICATION ISO/TS 19218-1 First edition 2011-05-15 Medical devices Hierarchical coding structure for adverse events Part 1: Event-type codes Dispositifs mdicaux Structure de codage pour la cause et le type dvnement dfavorable Partie 1: Co
2、des de type dvnement ISO/TS 19218-1:2011(E) COPYRIGHT PROTECTED DOCUMENT ISO 2011 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission
3、 in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2011 All rights reservedIS
4、O/TS 19218-1:2011(E) ISO 2011 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Terms and definitions .1 3 Adverse-event-type code requirements2 4 Adverse-event-type codes2 Annex A (informative) Coding-system structure .12 Annex B (informative) Examples of event-type code se
5、lection .13 Bibliography15 ISO/TS 19218-1:2011(E) iv ISO 2011 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
6、 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 work. ISO collaborate
7、s closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards
8、. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. In other circumstances, particularly when there is an urgent market req
9、uirement for such documents, a technical committee may decide to publish other types of normative document: an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in an ISO working group and is accepted for publication if it is approved by more than 50 %
10、of the members of the parent committee casting a vote; an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting a vote. An ISO/PAS or ISO/TS is reviewe
11、d after three years in order to decide whether it will be confirmed for a further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an Inter
12、national Standard or be withdrawn. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO/TS 19218-1 was prepared by Technical Committee ISO/TC 210, Qua
13、lity management and corresponding general aspects for medical devices. This first edition of ISO/TS 19218-1, together with ISO/TS 19218-2, cancels and replaces ISO/TS 19218:2005, which has been technically revised. ISO/TS 19218 consists of the following parts, under the general title Medical devices
14、 Hierarchical coding structure for adverse events: Part 1: Event-type codes The following part is under preparation: Part 2: Evaluation codes ISO/TS 19218-1:2011(E) ISO 2011 All rights reserved vIntroduction The adverse-event coding system specified in this part of ISO/TS 19218 envisages that medica
15、l device adverse-event reporting will originate from one of two sources: either the user or the manufacturer of the device concerned. In this context, users can be health care providers, but can also be the general public. This part of ISO/TS 19218 provides a structure by which an adverse-event type
16、 can be used to collect medical device surveillance information in the post-market phase. It also enables this information to be easily exchanged on an international basis using the common codes. This part of ISO/TS 19218 can be used by the users, manufacturers and regulatory authorities in the foll
17、owing ways: users can report, to a manufacturer or a regulatory body, a code number to describe an adverse event that will be universally understood; manufacturers and regulatory authorities can easily recognize universally understood adverse-event types, which can be globally recognized by regulato
18、ry authorities; in addition, both users and manufacturers can apply these codes as part of a medical device surveillance or reporting system. TECHNICAL SPECIFICATION ISO/TS 19218-1:2011(E) ISO 2011 All rights reserved 1Medical devices Hierarchical coding structure for adverse events Part 1: Event-ty
19、pe codes 1 Scope This part of ISO/TS 19218 specifies requirements for a hierarchical coding structure for describing adverse events relating to medical devices. The codes are intended for use by medical device users, manufacturers, regulatory authorities, health care facilities and other organizatio
20、ns. The codes can be used for coding events that are not related to death or serious injury, or malfunctions that could lead to death or serious injury. This part of ISO/TS 19218 is not intended to be used to decide whether an incident is reportable or not. 2 Terms and definitions For the purposes o
21、f this document, the following terms and definitions apply. 2.1 adverse event event associated with a medical device that led to death or serious injury of a patient, user or other person, or that might lead to death or serious injury of a patient, user or other person if the event recurs NOTE 1 Thi
22、s definition is consistent with guidance in GHTF/SG2/N54/R8:2006 7 . NOTE 2 This definition includes malfunction or deterioration of a device which has not yet caused death or serious injury, but which could lead to death or serious injury. 2.2 serious injury serious deterioration in a state of heal
23、th that constitutes either a life-threatening illness or injury, or a permanent impairment of a body function or permanent damage to a body structure, or a condition necessitating medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body struct
24、ure NOTE 1 The term “permanent” means irreversible impairment or damage to a body structure or function, excluding minor impairment or damage. NOTE 2 This definition is consistent with guidance in GHTF/SG2/N21/R8:1999 5 . 2.3 intended use intended purpose objective intent of the manufacturer regardi
25、ng the use of a product, as reflected in the specifications, instructions or information provided by the manufacturer NOTE This definition is consistent with GHTF/SG1/N41/R9:2005 4 . ISO/TS 19218-1:2011(E) 2 ISO 2011 All rights reserved3 Adverse-event-type code requirements The adverse-event-type co
26、de characterizes the observed use/malfunction/failure of the medical device at the time the event occurred. The code shall be a four-digit numerical code selected from Table 1. NOTE 1 The single code that most closely describes the adverse event can be used. However, multiple codes can sometimes be
27、necessary to fully describe an adverse event. NOTE 2 The adverse-event-type code can be useful in describing the hazard presented by an adverse event. It can also be useful in “user reporting systems”. When combined with the adverse-event evaluation code (from ISO/TS 19218-2), the adverse event is b
28、etter characterized. NOTE 3 The adverse-event-type codes chosen to describe the adverse event at the time of the event reflect the most up-to-date assessment of the adverse event and can take into account any additional information learned between occurrence of the event and submission of the report
29、. 4 Adverse-event-type codes Table 1 specifies adverse-event-type codes. Table 1 Adverse-event-type codes Level 1 code Level 1 term Level 1 definition Level 2 code Level 2 term Level 2 definition 1000 Activation, Positioning or Separation Issue associated with any deviations from device- documented
30、performance specifications relating to the sequence of events for activation or positioning of the device or one of its components into a specific body location. NOTE 1 “Deployment” is synonymous with “activation”. 1001 Difficult to Position Issue associated with users experiencing difficulty or une
31、asiness to deploy a device, device component, or both, to a specified location. 1002 Failure to Activate Issue associated with the inability of a device or device component to be activated. 1003 Failure to Separate Issue associated with the failure of the device or one of its components to detach or
32、 separate as intended. 1004 Premature Activation Issue associated with an early and unexpected activation of the device, device component, or both, from the system. 1005 Delayed Activation Issue associated with a delayed and unexpected activation of the device, device component, or both, from the sy
33、stem. ISO/TS 19218-1:2011(E) ISO 2011 All rights reserved 3Table 1 (continued) Level 1 code Level 1 term Level 1 definition Level 2 code Level 2 term Level 2 definition 1100 Computer Hardware Issue associated with hardware that affects device performance or communication with another device. 1101 Ha
34、rdware Issue Issue associated with hardware that affects device performance. 1102 Network Issue Issue associated with the deviations from documented system specifications that affect overall system performance or the performance of an individual device or collection of devices connected to that syst
35、em. 1200 Computer Software Issue associated with written programs, codes or software system that affects device performance or communication with another device. 1201 Application Program Issue Issue associated with the requirement for software to fulfil its function within an intended use or applica
36、tion. 1202 Programming Issue Issue associated with the written program code or application software used to satisfy a stated need or objective for functioning of the device, including incorrect software programming, dose, parameter and power calculations. 1300 Connection or Fitting Issue associated
37、with linking of device, device components, or the functional units set up to provide means for a transfer of liquid, gas, electricity or data. 1301 Connection Issue Issue associated with linking of a device, device component, or the functional units set up to provide means for a transfer of liquid,
38、gas, electricity or data. 1302 Disconnection Issue associated with a linked device, device component, or both, having a sufficient open space (disconnection) to prevent gas, liquid or electrical current flowing between connectors. 1303 Failure to Disconnect Issue associated with the linking of a dev
39、ice, device component, or both, whereby termination of the transfer of liquid, gas, electricity or information cannot be accomplished, or linking components do not come apart, or disconnect, when expected. ISO/TS 19218-1:2011(E) 4 ISO 2011 All rights reservedTable 1 (continued) Level 1 code Level 1
40、term Level 1 definition Level 2 code Level 2 term Level 2 definition 1304 Fitting Problem Issue associated with the connection of a device, device component, or both, whereby channels, switching systems and other functional units set up to provide means for a transfer of liquid, gas, electricity or
41、information do not match or fit. 1305 Loose or Intermittent Connection Issue associated with the connection of a device or device component being loose or intermittent. 1306 Misconnection Issue associated with the improper connection of a device, device component or a connection not in accordance wi
42、th device specifications. 1400 Electrical/ Electronic Issue associated with a failure of the electrical or electronic circuitry or components of the device. 1401 Arcing Issue associated with electrical current flowing through a gap between two conductive surfaces, typically resulting in a visible fl
43、ash of light. 1402 Circuit Failure Issue associated with a failure of the internal network paths or electrical circuitry (i.e. electrical components, circuit boards, wiring). 1403 Device Sensing Issue Issue associated with device features that are designed to respond to a physical stimulus (temperat
44、ure, illumination, motion, cardiac rhythms) that do not transmit a resulting signal for interpretation or measurement. 1404 Power Source Issue Issue associated with the internal power of the device (e.g. battery, transformer, fuel cell or other power sources). 1405 Spark Issue associated with the di
45、scharge of electricity between two bodies previously electrically charged (e.g. electrostatic discharge). ISO/TS 19218-1:2011(E) ISO 2011 All rights reserved 5Table 1 (continued) Level 1 code Level 1 term Level 1 definition Level 2 code Level 2 term Level 2 definition 1500 External Conditions Issue
46、associated with the surrounding conditions in which the device is being used or stored, such as temperature, noise, lighting, ventilation or power supply. 1501 Environmental Particulates Issue associated with fine solids or liquid particles, such as dust, smoke, fumes or mist suspended in the immedi
47、ate atmosphere in which the device is being used. 1502 Fumes or Vapours Issue associated with the visibility, odour or toxicity of an ambient vapour or gas which affects the operation of the device. 1503 Inadequate Storage Issue associated with inadequate or inappropriate storage of the device. 1504
48、 Loss of Power Issue associated with the failure of primary power provided by the facility (e.g. electrical, gas, fluid pressure). 1600 Implantable Device Failure The migration, malfunction or failure of an implanted device (active or non- active). 1601 Migration of Device or Device Component Issue
49、associated with an undesired movement of a device, device component, or both, related to its movement away from or dislodging from a source. 1602 Osseo- disintegration Issue Issue associated with interconnection between bone and an implanted device. 1700 Incompatibility Issue associated with the device not being compatible with another device component, patient or substance (medication, body fluid, etc.) that it contains or transports. 1701 Component or Accessory Incompatibility Issue associated with the inc
