ISO/TS 19218-1:2011

TECHNICAL ISO/TS
SPECIFICATION 19218-1
First edition
2011-05-15

Medical devices — Hierarchical coding
structure for adverse events —
Part 1:
Event-type codes
Dispositifs médicaux — Structure de codage pour la cause et le type
d'événement défavorable —
Partie 1: Codes de type d'événement




Reference number
ISO/TS 19218-1:2011(E)
©
ISO 2011

---------------------- Page: 1 ----------------------
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 in writing from either ISO at the address below or
ISO's 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 copyright@iso.org
Web www.iso.org
Published in Switzerland

ii © ISO 2011 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/TS 19218-1:2011(E)
Contents Page
Foreword .iv
Introduction.v
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 .12
Annex B (informative) Examples of event-type code selection .13
Bibliography.15

© ISO 2011 – All rights reserved iii

---------------------- Page: 3 ----------------------
ISO/TS 19218-1:2011(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 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 collaborates 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. 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 requirement 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 % 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 reviewed 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
International 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, Quality 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 — Hierarchical coding
structure for adverse events:
⎯ Part 1: Event-type codes
The following part is under preparation:
⎯ Part 2: Evaluation codes

iv © ISO 2011 – All rights reserved

---------------------- Page: 4 ----------------------
ISO/TS 19218-1:2011(E)
Introduction
The adverse-event coding system specified in this part of ISO/TS 19218 envisages that medical 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 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 following
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 regulatory authorities;
⎯ in addition, both users and manufacturers can apply these codes as part of a medical device surveillance
or reporting system.

© ISO 2011 – All rights reserved v

---------------------- Page: 5 ----------------------
TECHNICAL SPECIFICATION ISO/TS 19218-1:2011(E)

Medical 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, 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 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 death or serious injury of a patient, user or other person if the event recurs
[7]
NOTE 1 This definition is consistent with guidance in GHTF/SG2/N54/R8:2006 .
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 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 prevent 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.
[5]
NOTE 2 This definition is consistent with guidance in GHTF/SG2/N21/R8:1999 .
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
[4]
NOTE This definition is consistent with GHTF/SG1/N41/R9:2005 .
© ISO 2011 – All rights reserved 1

---------------------- Page: 6 ----------------------
ISO/TS 19218-1:2011(E)
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.
NOTE 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 “user 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 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 Level 2
Level 1 term Level 1 definition Level 2 term Level 2 definition
code code
1000 Activation, Issue associated with any 1001 Difficult to Position Issue associated with users
Positioning or deviations from device- experiencing difficulty or
Separation documented performance uneasiness to deploy a
specifications relating to the device, device component,
sequence of events for or both, to a specified
activation or positioning of location.
the device or one of its
components into a specific
body location.
NOTE 1 “Deployment” is
synonymous with “activation”.
  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 separate as intended.
  1004 Premature Issue associated with an
Activation 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 system.

2 © ISO 2011 – All rights reserved

---------------------- Page: 7 ----------------------
ISO/TS 19218-1:2011(E)
Table 1 (continued)
Level 1 Level 2
Level 1 term Level 1 definition Level 2 term Level 2 definition
code code
1100 Computer Issue associated with 1101 Hardware Issue Issue associated with
Hardware hardware that affects device hardware that affects device
performance or performance.
communication with another
device.
  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
system.
1200 Computer Software Issue associated with 1201 Application Issue associated with the
written programs, codes or Program Issue requirement for software to
software system that affects fulfil its function within an
device performance or intended use or application.
communication with another
device.
  1202 Programming Issue associated with the
Issue 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 Issue associated with 1301 Connection Issue Issue associated with
Fitting linking of device, device linking of a device, device
components, or the component, or the
functional units set up to functional units set up to
provide means for a transfer provide means for a transfer
of liquid, gas, electricity or of liquid, gas, electricity or
data. 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 Issue associated with the
Disconnect 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.

© ISO 2011 – All rights reserved 3

---------------------- Page: 8 ----------------------
ISO/TS 19218-1:2011(E)
Table 1 (continued)
Level 1 Level 2
Level 1 term Level 1 definition Level 2 term Level 2 definition
code code
  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
information do not match or
fit.
  1305 Loose or Issue associated with the
Intermittent connection of a device or
Connection 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 Electrical/ Issue associated with a 1401 Arcing Issue associated with
Electronic failure of the electrical or electrical current flowing
electronic circuitry or through a gap between two
components of the device. conductive surfaces,
typically resulting in a visible
flash 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 associated with
Issue device features that are
designed to respond to a
physical stimulus
(temperature, illumination,
motion, cardiac rhythms)
that do not transmit a
resulting signal for
interpretation or
measurement.
  1404 Power Source Issue associated with the
Issue internal power of the device
(e.g. battery, transformer,
fuel cell or other power
sources).
  1405 Spark Issue associated with the
discharge of electricity
between two bodies
previously electrically
charged (e.g. electrostatic
discharge).

4 © ISO 2011 – All rights reserved

---------------------- Page: 9 ----------------------
ISO/TS 19218-1:2011(E)
Table 1 (continued)
Level 1 Level 2
Level 1 term Level 1 definition Level 2 term Level 2 definition
code code
1500 External Conditions Issue associated with the 1501 Environmental Issue associated with fine
surrounding conditions in Particulates solids or liquid particles,
which the device is being such as dust, smoke, fumes
used or stored, such as or mist suspended in the
temperature, noise, lighting, immediate atmosphere in
ventilation or power supply. 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 Loss of Power Issue associated with the
failure of primary power
provided by the facility (e.g.
electrical, gas, fluid
pressure).
1600 Implantable Device The migration, malfunction 1601 Migration of Device Issue associated with an
Failure or failure of an implanted or Device undesired movement of a
device (active or non- Component device, device component,

active). or both, related to its
movement away from or
dislodging from a source.
  1602 Osseo- Issue associated with
disintegration Issue interconnection between
bone and an implanted
device.
1700 Incompatibility Issue associated with the 1701 Component or Issue associated with the
device not being compatible Accessory incompatibility of any
with another device Incompatibility device, device component,
component, patient or or both, while being
substance (medication, operated in the same use
body fluid, etc.) that it environment, thereby
contains or transports. leading to a dysfunction
between the device and its
components.
  1702 Device-Device Issue associated with the
Incompatibility incompatibility of two or
more devices while being
operated in the same use
environment, thereby
leading to a dysfunction of
more than one device.
  1703 Patient-Device Issue associated with the
Incompatibility interaction between the
patient's physiology or
anatomy and the device that
affects the patient or device
(e.g. biocompatibility or
immunological issues).

© ISO 2011 – All rights reserved 5

---------------------- Page: 10 ----------------------
ISO/TS 19218-1:2011(E)
Table 1 (continued)
Level 1 Level 2
Level 1 term Level 1 definition Level 2 term Level 2 definition
code code
1800 Infusion/Flow Issue associated with the 1801 Deflation Issue Issue associated with the
device failing to deliver inability of a device, device
liquids or gases as intended component, or both, to
(e.g. delivering drugs at release its contents.
incorrect rate, issues with
drawing fluid from a system,
etc.).
  1802 Improper Flow or Issue associated with the
Infusion unsubstantiated regulation
and delivery of therapy
(e.g. air, gas, drugs or fluids
into a device or a patient
under positive pressure that
is being generated by a
pump).
  1803 Inflation Issue Issue associated with the
inability of a device, device
component, or both, to
expand or enlarge with the
intended inflation agent
(e.g. saline or air).
  1804 No Flow Issue arising from the
device failing to deliver
...