1、 ISO 2012 Medical devices Hierarchical coding structure for adverse events Part 2: Evaluation codes Dispositifs mdicaux Structure de codage pour la cause et le type dvnement dfavorable Partie 2: Codes dvaluation TECHNICAL SPECIFICATION ISO/TS 19218-2 First edition 2012-04-01 Reference number ISO/TS
2、19218-2:2012(E) ISO/TS 19218-2:2012(E) ii ISO 2012 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2012 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 mi
3、crofilm, without permission 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 ISO/TS
4、 19218-2:2012(E) ISO 2012 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope 1 2 T erms and definitions . 1 3 Adverse-event evaluation code requirements . 2 4 Adverse-event evaluation codes . 2 Annex A (informative) Coding system structure 12 Bibliography .13 ISO/TS 19218-2:201
5、2(E) Foreword 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 ISO technical committees. Each member body interested in a subject for whic
6、h 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 collaborates closely with the International Electrotechnical Commission (IEC) on all ma
7、tters 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. Draft International Standards adopted by the technical committees are circ
8、ulated 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 requirement for such documents, a technical committee may decide to publish oth
9、er types of 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 % of the members of the parent committee casting a vote; an ISO Technical Specification
10、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 whether it will be confirmed for a further thre
11、e 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. Attention is drawn to the possibility that some of
12、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 19218-2 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices. This first edit
13、ion of ISO/TS 19218-2, together with ISO/TS 19218-1, cancels and replaces ISO/TS 19218:2005, which has been technically revised. ISO 19218 consists of the following parts, under the general title Medical devices Hierarchical coding structure for adverse events: Part 1: Event-type codes Part 2: Evalu
14、ation codes iv ISO 2012 All rights reserved ISO/TS 19218-2:2012(E) Introduction It is envisaged that the adverse-event evaluation codes specified in this part of ISO 19218 will originate primarily from the manufacturer of the device concerned. This Technical Specification provides a structure by whi
15、ch adverse-event evaluations can be used to collect medical device surveillance information in the post-market phase. It will also enable this information to be easily exchanged on an international basis using the common codes. It can be used by healthcare providers and other users of the devices; h
16、owever, a number of the evaluation codes characterize the results of analyses or investigations conducted by the manufacturer or regulatory authorities, who can use it to recognize the results of analyses or investigations of adverse events by means of globally recognized evaluation codes, and apply
17、 these codes as part of a medical device surveillance or reporting system. Annex A shows how adverse-event codes can be used in conjunction with other data elements in order to facilitate global data exchange between regulatory bodies. ISO 2012 All rights reserved v Medical devices Hierarchical codi
18、ng structure for adverse events Part 2: Evaluation codes 1 Scope 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 m
19、edical 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
20、 to be used to decide whether or not an incident is reportable. 2 T erms and definitio ns For the purposes of this document, the following terms and definitions apply. 2.1 adverse event event associated with a medical device that has led to the death or serious injury of a patient, user or other per
21、son, or that might lead to the death or serious injury of a patient, user or other person if it were to reoccur NOTE 1 This definition is consistent with guidance in GHTF/SG2/N54/R8:2006 5 . NOTE 2 It includes the malfunction or deterioration of a device which has not yet caused death or serious inj
22、ury, but which could lead to death or serious injury. NOTE 3 This definition is not intended to be used in determining if an event is reportable to a regulatory authority. 2.2 serious injury serious deterioration in state of health that constitutes either a life threatening illness or injury, or a p
23、ermanent 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 structure NOTE 1 “Permanent” here means irreversible impairment or damage, ex
24、cluding minor impairment or damage. NOTE 2 This definition is consistent with guidance in GHTF/SG2/N54/R8:2006 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 ma
25、nufacturer NOTE This definition is consistent with GHTF/SG1/N41/R9:2005 6 . TECHNICAL SPECIFICATION ISO/TS 19218-2:2012(E) ISO 2012 All rights reserved 1 ISO/TS 19218-2:2012(E) 3 Adverse-event evaluation code requirements The adverse-event evaluation code characterizes the latest conclusions of an a
26、nalysis or investigation of the adverse event. The code shall be a five-digit numerical code selected from Table 1. NOTE 1 Multiple codes can be necessary to fully describe the results of the evaluation of an adverse event. NOTE 2 The adverse-event evaluation code can be useful for manufacturers and
27、 regulatory authorities when following up on reported adverse events. When combined with the adverse-event-type code, the characteristics of the adverse event are succinctly communicated. NOTE 3 The latest conclusions characterize the event at any stage of an analysis or investigation. 4 Adverse-eve
28、nt evaluation codes Table 1 specifies adverse-event evaluation codes. Table 1 Adverse-event evaluation codes Level 1 Level 2 Code Term Definit ion Code Term Definit ion 25000 Biological Event relating to, caused by or affecting life or living organisms 25001 Abnormal or unexpected physiological resp
29、onse Abnormal or unexpected physiological response such as hypersensitivity25002 Biocompatibility Device causes cellular or tissue responses that elicit an undesirable local or systemic effect in the recipient or beneficiary of that therapy see ISO 10993 (all parts)25003 Biological material Presence
30、 of biological material(s) in a device resulting in a reaction other than immediate hypersensitivity25004 Contamination by foreign material Presence of extraneous material that renders a device impure or potentially harmful NOTE Excludes contamination during production (see level 2 code 26503).25005
31、 Genotoxic problem Devices ability to cause damage to genetic material, e.g. leading malignant tumours see ISO 10993 (all parts)25006 Hematologic problem Device affects or impacts the blood or its components see ISO 10993 (all parts)25007 Endotoxin contamination Undesirable presence of toxins associ
32、ated with certain bacteria (e.g. gram negative bacteria) 2 ISO 2012 All rights reserved ISO/TS 19218-2:2012(E) Level 1 Level 2 Code Term Definit ion Code Term Definit ion25008 Microbiological contamination Undesirable presence of microorganisms or microbes such as bacteria and fungi (yeasts and moul
33、ds)25009 Material or material leachate pyrogenic problem Undesirable presence of pyrogens or fever-producing organisms resulting from materials that permeate through the device 25100 Counterfeiting Event associated with the reproduction of a genuine medical device or the forging of labelling or prod
34、uct information with the intent to deceptively misrepresent the genuine medical product 25101 Counterfeit Imitation of a genuine medical device with the intent to deceive25102 Forged product information Product labelling or other information that is not provided or authorized by the company responsi
35、ble for labelling the device 25300 Design Event associated with the failure of a medical device to achieve its intended function due to inadequate design or development process 25301 Design deficiency Failure of the device to achieve its intended function due to inadequate design, including inapprop
36、riate risk assessment25302 Development process deficiency Failure of the device to achieve its intended function due to an inadequate development process25303 Packaging Inadequate or inappropriate packaging25304 Safety measures Inadequate or missing safety measures25305 Usability Deficient or inadeq
37、uate characteristic of the user interface that establishes effectiveness, efficiency, ease of user learning and user satisfaction NOTE Consistent with IEC 62366:2007, 3.17. 25500 Electrical Event associated with an electrically powered device where an electrical malfunction results in a device failu
38、re (e.g. electrical circuitry, contact or component failed), even if the failure is intermittent 25501 Electrical component Electrical or electronic component defect (e.g. resistor failure, capacitor failure, transformer failure, microprocessor failure) resulting in a device failure NOTE Excludes in
39、sulation breakdown (see level 2 code 25506). Table 1 (continued) ISO 2012 All rights reserved 3 ISO/TS 19218-2:2012(E) Level 1 Level 2 Code Term Definit ion Code Term Definit ion25502 Electrical circuitry Malfunction of an electrical circuit resulting from events such as fluid penetration or overhea
40、ting25503 Electrical contact Electrical issue resulting in the malfunction of the device (e.g. make or break a contact, corrosion, high-resistance, thermal shock, or unintentional movement)25504 Energy storage system Device problem related to the electrical energy storage system (e.g. rechargeable b
41、attery, charging system or capacitor) and including problems such as premature power source depletion and battery explosions25505 Improper construction Device problem related to improper wire routing, breakage due to unexpected movement and other construction deficiencies25506 Insulation Device that
42、 has inadequate or incorrect insulation material, resulting in exposure to hazardous voltage25507 Power source loss of power Failure of the mains power, causing a device to cease to operate 25600 Electromagnetic interference Event associated with the malfunction of an active, electrically powered me
43、dical device, caused by electromagnetic disturbance, including radio-frequency interference (RFI) 25601 Electromagnetic immunity Medical device performance degradation resulting from an electromagnetic disturbance25602 Electromagnetic emissions Medical devices that unintentionally emit electromagnet
44、ic disturbances that affect radio services, other equipment or the performance of other medical devices or medical systems Table 1 (continued) 4 ISO 2012 All rights reserved ISO/TS 19218-2:2012(E) Level 1 Level 2 Code Term Definit ion Code Term Definit ion 26000 Human factors Event associated with t
45、he application of knowledge about human capabilities (physical, sensory, emotional, and intellectual) and limitations to the design and development of tools, devices, systems, environments, and organizations NOTE Consistent with AAMI HE75. 26001 Abnormal use Act or omission of an act by the user or
46、operator of the medical device as a result of conduct that is beyond any reasonable means of risk control by the manufacturer, e.g. deliberate violation of instructions, procedures or use prior to completing installation, causing a device failure NOTE Consistent with IEC 62366:2007, 3.1.26002 Expira
47、tion date Use of the medical device beyond the expiration date, resulting in a device failure26003 End of life Device failure resulting from use beyond the intended useful life of the product26004 Inappropriate environment Use of a device in an environment that results in a failure or malfunction260
48、05 Incorrect calibration Calibration performed incorrectly or not performed at all, resulting in inaccurate results provided by medical devices involved in measurements (e.g. temperature, weight, pH, IVD test results)26006 Installation problem Device that malfunctions because incorrectly installed,
49、set-up or configured26007 Maintenance Failure or malfunction of a device resulting from inadequate routine or periodic maintenance26008 Non-hygienic condition Device failure resulting from inadequate hygienic status of the user or locality of the user26009 Patient anatomy/ physiology Device failure resulting from use inadequate or inappropriate for the anatomy/physiology of the patient involved26010 Patient condition Failure or poor performance of a device resulting from the patient condition (possib
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