ISO/TS 19218-2:2012

TECHNICAL ISO/TS
SPECIFICATION 19218-2
First edition
2012-04-01
Medical devices — Hierarchical coding
structure for adverse events —
Part 2:
Evaluation codes
Dispositifs médicaux — Structure de codage pour la cause et le type
d’événement défavorable —
Partie 2: Codes d’évaluation
Reference number
ISO/TS 19218-2:2012(E)
©
ISO 2012

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ISO/TS 19218-2:2012(E)
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ISO/TS 19218-2:2012(E)
Contents Page
Foreword .iv
Introduction . v
1 Scope . 1
2 Terms 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
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ISO/TS 19218-2:2012(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 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 19218-2 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding
general aspects for medical devices.
This first edition 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: Evaluation codes
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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 which
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; however, 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 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.
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TECHNICAL SPECIFICATION ISO/TS 19218-2:2012(E)
Medical devices — Hierarchical coding 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 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.
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 has led to the death or serious injury of a patient, user or other
person, or that might lead to the death or serious injury of a patient, user or other person if it were to reoccur
[5]
NOTE 1 This definition is consistent with guidance in GHTF/SG2/N54/R8:2006 .
NOTE 2 It includes the malfunction or deterioration of a device which has not yet caused death or serious injury, 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 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 “Permanent” here means irreversible impairment or damage, excluding minor impairment or damage.
[5]
NOTE 2 This definition is consistent with guidance in GHTF/SG2/N54/R8:2006 .
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
[6]
NOTE This definition is consistent with GHTF/SG1/N41/R9:2005 .
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ISO/TS 19218-2:2012(E)
3 Adverse-event evaluation code requirements
The adverse-event evaluation code characterizes the latest conclusions of an analysis 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 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-event evaluation codes
Table 1 specifies adverse-event evaluation codes.
Table 1 — Adverse-event evaluation codes
Level 1 Level 2
Code Term Definition Code Term Definition
25000 Biological Event relating to, caused 25001 Abnormal or Abnormal or unexpected
by or affecting life or living unexpected physiological response such
organisms physiological as hypersensitivity
response
25002 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 of biological
material(s) in a device
resulting in a reaction
other than immediate
hypersensitivity
25004 Contamination by Presence of extraneous
foreign material material that renders a
device impure or potentially
harmful
NOTE Excludes
contamination during production
(see level 2 code 26503).
25005 Genotoxic Device’s ability to cause
problem damage to genetic material,
e.g. leading malignant
tumours [see ISO 10993 (all
parts)]
25006 Hematologic Device affects or impacts the
problem blood or its components [see
ISO 10993 (all parts)]
25007 Endotoxin Undesirable presence
contamination of toxins associated with
certain bacteria (e.g. gram
negative bacteria)
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ISO/TS 19218-2:2012(E)
Table 1 (continued)
Level 1 Level 2
Code Term Definition Code Term Definition
25008 Microbiological Undesirable presence of
contamination microorganisms or microbes
such as bacteria and fungi
(yeasts and moulds)
25009 Material or Undesirable presence of
material leachate pyrogens or fever-producing
pyrogenic problem organisms resulting from
materials that permeate
through the device
25100 Counterfeiting Event associated with the 25101 Counterfeit Imitation of a genuine
reproduction of a genuine medical device with the
medical device or the intent to deceive
forging of labelling or
product information with
the intent to deceptively
misrepresent the genuine
medical product
25102 Forged product Product labelling or other
information information that is not
provided or authorized by
the company responsible for
labelling the device
25300 Design Event associated with the 25301 Design deficiency Failure of the device to
failure of a medical device achieve its intended function
to achieve its intended due to inadequate design,
function due to inadequate including inappropriate risk
design or development assessment
process
25302 Development Failure of the device to
process deficiency achieve its intended function
due to an inadequate
development process
25303 Packaging Inadequate or inappropriate
packaging
25304 Safety measures Inadequate or missing safety
measures
25305 Usability Deficient or inadequate
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 25501 Electrical Electrical or electronic
an electrically powered component component defect (e.g.
device where an electrical resistor failure, capacitor
malfunction results in failure, transformer failure,
a device failure (e.g. microprocessor failure)
electrical circuitry, contact resulting in a device failure
or component failed), even
NOTE Excludes insulation
if the failure is intermittent
breakdown (see level 2
code 25506).
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ISO/TS 19218-2:2012(E)
Table 1 (continued)
Level 1 Level 2
Code Term Definition Code Term Definition
25502 Electrical circuitry Malfunction of an electrical
circuit resulting from events
such as fluid penetration or
overheating
25503 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 Device problem related to
system the electrical energy storage
system (e.g. rechargeable
battery, charging system
or capacitor) and including
problems such as premature
power source depletion and
battery explosions
25505 Improper Device problem related
construction to improper wire routing,
breakage due to unexpected
movement and other
construction deficiencies
25506 Insulation Device that has inadequate
or incorrect insulation
material, resulting in
exposure to hazardous
voltage
25507 Power source — Failure of the mains power,
loss of power causing a device to cease to
operate
25600 Electromagnetic Event associated with the 25601 Electromagnetic Medical device performance
interference malfunction of an active, immunity degradation resulting from an
electrically powered electromagnetic disturbance
medical device, caused
by electromagnetic
disturbance, including
radio-frequency
interference (RFI)
25602 Electromagnetic Medical devices that
emissions unintentionally emit
electromagnetic
disturbances that affect radio
services, other equipment
or the performance of other
medical devices or medical
systems
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ISO/TS 19218-2:2012(E)
Table 1 (continued)
Level 1 Level 2
Code Term Definition Code Term Definition
26000 Human factors Event associated with the 26001 Abnormal use Act or omission of an act by
application of knowledge the user or operator of the
about human capabilities medical device as a result of
(physical, sensory, conduct that is beyond any
emotional, and intellectual) reasonable means of risk
and limitations to the control by the manufacturer,
design and development e.g. deliberate violation of
of tools, devices, systems, instructions, procedures
environments, and or use prior to completing
organizations installation, causing a device
failure
NOTE Consistent with
AAMI HE75.
NOTE Consistent with
IEC 62366:2007, 3.1.
26002 Expiration date Use of the medical device
beyond the expiration date,
resulting in a device failure
26003 End of life Device failure resulting from
use beyond the intended
useful life of the product
26004 Inappropriate Use of a device in an
environment environment that results in
a failure or malfunction
26005 Incorrect Calibration performed
calibration 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 Device that malfunctions
problem because incorrectly installed,
set-up or configured
26007 Maintenance Failure or malfunction of
a device resulting from
inadequate routine or
periodic maintenance
26008 Non-hygienic Device fa
...