1、ANSI/AAMI/ ISO TIR 19218-1:2011 Fax: +1-703-525-1067. Printed in the United States of America ISBN 157020424-1 AAMI Technical Information Report A technical information report (TIR) is a publication of the Association for the Advancement of Medical Instrumentation (AAMI) Standards Board that address
2、es a particular aspect of medical technology. Although the material presented in a TIR may need further evaluation by experts, releasing the information is valuable because the industry and the professions have an immediate need for it. A TIR differs markedly from a standard or recommended practice,
3、 and readers should understand the differences between these documents. Standards and recommended practices are subject to a formal process of committee approval, public review, and resolution of all comments. This process of consensus is supervised by the AAMI Standards Board and, in the case of Am
4、erican National Standards, by the American National Standards Institute. A TIR is not subject to the same formal approval process as a standard. However, a TIR is approved for distribution by a technical committee and the AAMI Standards Board. Another difference is that, although both standards and
5、TIRs are periodically reviewed, a standard must be acted onreaffirmed, revised, or withdrawnand the action formally approved usually every five years but at least every 10 years. For a TIR, AAMI consults with a technical committee about five years after the publication date (and periodically thereaf
6、ter) for guidance on whether the document is still usefulthat is, to check that the information is relevant or of historical value. If the information is not useful, the TIR is removed from circulation. A TIR may be developed because it is more responsive to underlying safety or performance issues t
7、han a standard or recommended practice, or because achieving consensus is extremely difficult or unlikely. Unlike a standard, a TIR permits the inclusion of differing viewpoints on technical issues. CAUTION NOTICE: This AAMI TIR may be revised or withdrawn at any time. Because it addresses a rapidly
8、 evolving field or technology, readers are cautioned to ensure that they have also considered information that may be more recent than this document. All standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI are voluntary, and their
9、 application is solely within the discretion and professional judgment of the user of the document. Occasionally, voluntary technical documents are adopted by government regulatory agencies or procurement authorities, in which case the adopting agency is responsible for enforcement of its rules and
10、regulations. Comments on this technical information report are invited and should be sent to AAMI, Attn: Standards Department, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. ANSI Technical Report This AAMI TIR has been registered by the American National Standards Institute as an ANSI T
11、echnical Report. Publication of this ANSI Technical Report has been approved by the accredited standards developer (AAMI). This document is registered as a Technical Report series of publications according to the Procedures for the Registration of Technical Reports with ANSI. This document is not an
12、 American National Standard and the material contained herein is not normative in nature. Comments on the content of this document should be sent to AAMI, Attn: Standards Department, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Contents Page Glossary of equivalent standards . v Commit
13、tee representation vii Background of AAMI adoption of ISO/TS 19218-1:2011 viii Foreword . ix Introduction . x 1 Scope. 1 2 Terms and definitions 1 3 Adverse-event-type code requirements 2 4 Adverse-event-type codes 2 Annex A (informative) Coding-system structure 14 Annex B (informative) Examples of
14、event-type code selection 15 Bibliography 17 2011 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR19218-1:2011 v Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. For ea
15、ch International Standard that has been adopted by AAMI (and ANSI), the table below gives the corresponding U.S. designation and level of equivalency to the International Standard. NOTE: Documents are sorted by international designation. The code in the US column, “(R)20xx” indicates the year the do
16、cument was officially reaffirmed by AAMI. E.g., ANSI/AAMI/ISO 10993-4:2002/(R)2009 indicates that 10993-4, originally approved and published in 2002, was reaffirmed without change in 2009. Other normatively referenced International Standards may be under consideration for U.S. adoption by AAMI; ther
17、efore, this list should not be considered exhaustive. International designation U.S. designation Equivalency IEC 60601-1:2005 Technical Corrigendum 1 and 2 ANSI/AAMI ES60601-1:2005 and ANSI/AAMI ES60601-1:2005/A2:2010 ANSI/AAMI ES60601-1:2005/C1:2009 (amdt) Major technical variations C1 Identical to
18、 Corrigendum 1 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 reviewed after three years in order to decide w
19、hether 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 International Standard or be withdrawn. Atten
20、tion 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, Quality management and corresponding genera
21、l 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 Hierarchical coding structure for adver
22、se events: Part 1: Event-type codes The following part is under preparation: Part 2: Evaluation codes x 2011 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR19218-1:2011 Introduction The adverse-event coding system specified in this part of ISO/TS 19218 envisages that med
23、ical 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 t
24、ype 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 f
25、ollowing 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 regul
26、atory authorities; in addition, both users and manufacturers can apply these codes as part of a medical device surveillance or reporting system. 2011 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR19218-1:2011 1 AAMI Technical Information Report ANSI/AAMI/ISO TIR19218-1:
27、2011Medical devices Hierarchical coding structure for adverse events Part 1: Event-type 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
28、, manufacturers, regulatory authorities, health care facilities and other organizations. 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
29、 whether an incident is reportable or not. 2 Terms and definitions For the purposes of 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 deat
30、h or serious injury of a patient, user or other person if the event recurs NOTE 1 This definition is consistent with guidance in GHTF/SG2/N54/R8:20067. 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 d
31、eath or serious injury. 2.2 serious injury serious deterioration in a state of health 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 p
32、revent permanent impairment of a body function or permanent damage to a body structure 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
33、5. 2.3 intended use intended purpose objective intent of the manufacturer regarding 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/R9:20054. 2 2011 Association for the Advancement
34、 of Medical Instrumentation ANSI/AAMI/ISO TIR19218-1:2011 3 Adverse-event-type code requirements The adverse-event-type code 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. N
35、OTE 1 The single code that most closely describes the adverse event can be used. However, multiple codes can sometimes be 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 “u
36、ser reporting systems”. When combined with the adverse-event evaluation code (from ISO/TS 19218-2), the adverse event is better 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
37、 and can take into account any additional information learned between occurrence of the event and submission of the report. 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 L
38、evel 2 definition 1000 Activation, Positioning or Separation Issue associated with any deviations from device-documented 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 “Deploymen
39、t” is synonymous with “activation”. 1001 Difficult to Position Issue associated with users experiencing difficulty or uneasiness 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
40、activated. 1003 Failure to Separate Issue associated with the failure of the device or one of its components to detach or 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 A
41、ctivation Issue associated with a delayed and unexpected activation of the device, device component, or both, from the system. 2011 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR19218-1:2011 3 Table 1 (continued) Level 1 code Level 1 term Level 1 definition Level 2 code
42、 Level 2 term Level 2 definition 1100 Computer Hardware Issue associated with hardware that affects device performance or communication with another device. 1101 Hardware Issue Issue associated with hardware that affects device performance. 1102 Network Issue Issue associated with the deviations fro
43、m documented system specifications that affect overall system performance or the performance of an individual device or collection of devices connected to that system. 1200 Computer Software Issue associated with written programs, codes or software system that affects device performance or communica
44、tion with another device. 1201 Application Program Issue Issue associated with the requirement for software to fulfill its function within an intended use or application. 1202 Programming Issue Issue associated with the written program code or application software used to satisfy a stated need or ob
45、jective for functioning of the device, including incorrect software programming, dose, parameter and power calculations. 1300 Connection or Fitting Issue associated with linking of device, device components, or the functional units set up to provide means for a transfer of liquid, gas, electricity o
46、r 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, gas, electricity or data. 1302 Disconnection Issue associated with a linked device, device component, or both, having a sufficient open
47、 space (disconnection) to prevent gas, liquid or electrical current flowing between connectors. 4 2011 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR19218-1:2011 Table 1 (continued) Level 1 code Level 1 term Level 1 definition Level 2 code Level 2 term Level 2 definitio
48、n 1303 Failure to Disconnect Issue associated with the linking of a device, 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. 1304 Fitting Problem Is
49、sue 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 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 with device specifications. 1400 Electr
