EN ISO 10993-1:2025

SLOVENSKI STANDARD
oSIST prEN ISO 10993-1:2024
01-september-2024
Biološko ovrednotenje medicinskih pripomočkov - 1. del: Zahteve in splošna
načela za oceno biološke varnosti znotraj procesa obvladovanja tveganja (ISO/DIS
10993-1:2024)
Biological evaluation of medical devices - Part 1: Requirements and general principles
for the evaluation of biological safety within a risk management process (ISO/DIS 10993-
1:2024)
Biologische Beurteilung von Medizinprodukten - Teil 1: Anforderungen und allgemeine
Grundsätze für die Beurteilung der biologischen Sicherheit im Rahmen eines
Risikomanagementsystems (ISO/DIS 10993-1:2024)
Évaluation biologique des dispositifs médicaux - Partie 1: Exigences et principes
généraux pour l’évaluation de la sécurité biologique au sein d’un processus de gestion
des risques (ISO/DIS 10993-1:2024)
Ta slovenski standard je istoveten z: prEN ISO 10993-1
ICS:
11.100.20 Biološko ovrednotenje Biological evaluation of
medicinskih pripomočkov medical devices
oSIST prEN ISO 10993-1:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 10993-1:2024
oSIST prEN ISO 10993-1:2024
DRAFT
International
Standard
ISO/DIS 10993-1
ISO/TC 194
Biological evaluation of medical
Secretariat: DIN
devices —
Voting begins on:
Part 1: 2024-06-24
Requirements and general
Voting terminates on:
2024-09-16
principles for the evaluation of
biological safety within a risk
management process
ICS: 11.100; 11.100.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
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Reference number
ISO/DIS 10993-1:2024(en)
oSIST prEN ISO 10993-1:2024
DRAFT
ISO/DIS 10993-1:2024(en)
International
Standard
ISO/DIS 10993-1
ISO/TC 194
Biological evaluation of medical
Secretariat: DIN
devices —
Voting begins on:
Part 1:
Requirements and general
Voting terminates on:
principles for the evaluation of
biological safety within a risk
management process
ICS: 11.100; 11.100.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
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Published in Switzerland Reference number
ISO/DIS 10993-1:2024(en)
ii
oSIST prEN ISO 10993-1:2024
ISO/DIS 10993-1:2024(en)
Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 General principles . 7
4.1 Biological evaluation within an ISO 14971 risk management framework .7
4.2 Medical device life cycle .9
4.3 Animal welfare .10
5 Biological evaluation process .10
5.1 Overview .10
5.2 Biological evaluation plan .10
6 Biological risk analysis .12
6.1 General approach . 12
6.2 Identification of characteristics related to biological safety . 13
6.3 Identification of biological hazards, biologically hazardous situations, and potential
biological harms .14
6.4 Categorization of medical device and determination of scope of evaluation . 15
6.4.1 General . 15
6.4.2 Exposure duration categories . 15
6.4.3 Calculation of exposure duration for medical devices with daily contact with
tissues .16
6.4.4 Calculation of exposure duration for medical devices with intermittent contact
with tissues .16
6.4.5 Body contact and biological effects for consideration .16
6.5 Identified biological effects for evaluation . 20
6.5.1 Overall approach . 20
6.5.2 totoxicity .21
6.5.3 Sensitisation .21
6.5.4 Irritation .21
6.5.5 Systemic toxicity .21
6.5.6 Local effects after tissue contact . 22
6.5.7 Genotoxicity . 22
6.5.8 Carcinogenicity . 23
6.5.9 Haemocompatibility . 23
6.5.10 Other biological effects. 23
6.5.11 Other Factors to be considered .24
6.6 Gap analysis . 26
6.6.1 General . 26
6.6.2 Medical devices evaluated using previous versions of the standard .27
6.7 Biological equivalence .27
6.8 Testing . 29
6.8.1 General principles . 29
6.8.2 Biological, physical and chemical testing . 30
6.8.3 Degradation testing .31
6.8.4 Toxicokinetic studies .31
6.9 Biological risk estimation .31
7 Biological evaluation .32
8 Biological risk control .33
9 Biological evaluation report . .33
10 Production and post-production activities .33

iii
oSIST prEN ISO 10993-1:2024
ISO/DIS 10993-1:2024(en)
Annex A (informative) Material selection and characterisation to support the biological
evaluation of a medical device .35
Annex B (informative) Rationale for key changes in the biological effects listed in Tables 1-4 .38
Annex C (informative) Possible approaches to biological risk estimation .40
Annex ZA (informative) Relationship between this European Standard the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be covered .42
Bibliography .45

iv
oSIST prEN ISO 10993-1:2024
ISO/DIS 10993-1:2024(en)
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.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity, or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 194, Biological and clinical evaluation of medical
devices, in collaboration with the European Committee for Standardization (CEN) Technical Committee
CEN/TC 206, Biocompatibility of medical and dental materials and devices, in accordance with the Agreement
on technical cooperation between ISO and CEN (Vienna Agreement).
This sixth edition cancels and replaces the fifth edition (ISO 10993-1:2018), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— The standard has been completely reorganised and the title was changed to align with the risk
management framework described in ISO 14971.
— Additional content has been added to provide more detailed guidance and clarification of calculation of
exposure duration.
— Additional content has been added to provide more detailed guidance on characterisation of the device
and identification of biological hazards.
— The identification of biological effects (previously referred to as biological endpoints) has been modified.
— The term “externally communicating” has been replaced in the normative text by language which reflects
the specific tissue contact of device components.
— The term “effects after implantation” has been changed to “local effects after tissue contact” as some
non-implanted devices also will need this type of assessment.
— Annex A has been revised to move much of the content to the normative text. The remaining text in
Annex A is now confined to provision of guidance on materials characterisation.
— New Annex B explains the rationale for the changes to biological effects listed in Table 1-Table 4.
— New Annex C provides guidance on possible approaches to biological risk estimation.

v
oSIST prEN ISO 10993-1:2024
ISO/DIS 10993-1:2024(en)
A list of all parts in the ISO 10993 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

vi
oSIST prEN ISO 10993-1:2024
ISO/DIS 10993-1:2024(en)
Introduction
The primary aim of this document is to provide guidance and requirements for the biological evaluation of
a finished medical device within a risk management process in order to protect humans from biological risks
arising from the use of medical devices. Biological evaluation compares the estimated biological risk against
given risk criteria to determine the acceptability of the biological risk as part of the overall risk management.
Biological evaluation is primarily concerned with medical device biological safety, through consideration
of risks associated with biological hazards. Nonetheless, some activities undertaken in the course of
biological evaluation in addition to assessments of long-term safety may also generate information on
device performance, for example use of functional implant models to assess long-term responses such as
tissue ingrowth. Biological evaluation, as described in this document, is synonymous with biocompatibility
evaluation.
Biological evaluation is conducted on the finished medical device as it is intended to be used. The principles
and methods described can also be useful in the evaluation of candidate materials or prototype devices
during a medical device development process, and data obtained from such evaluations can be of value in
assessment of the finished medical device.
Medical device design is wide-ranging, and, at one extreme, a medical device consists only of a single material,
which can exist in more than one physical form, while at the other extreme, is a complex article consisting of
numerous components made from multiple materials. Biological safety cannot be considered in isolation from
the overall medical device design and can require the balancing of conflicting requirements. For example, the
choice of the best material with respect to its biological safety can result in a less functional medical device.
The evaluation of biological safety is also conducted in the context of the specific intended use of a particular
medical device. Materials can be safe in one medical device and not in another. It is impossible to make
generalised conclusions about the safety of a particular material for all medical applications. Biological
responses that are regarded as adverse, caused by a material in one application, may not be regarded as
adverse in a different situation.
When biological testing is required to support an overall biological evaluation, such testing is based upon
in vitro, ex vivo, or in vivo models. The interpretation of the results of biological tests requires caution
because the inherent variability in biological responses between species and individuals means that the
biological response observed in animal or cell culture models can differ from those observed in clinical
use. Differences in response to the same material among individuals means that some individuals can
have adverse reactions, even to well-established materials. Thus, biological evaluation is an exercise in risk
management. When applied in the evaluation of candidate materials or prototype devices during a medical
device development process, it also allows the informed and timely consideration of risk control measures
like using alternative materials, manufacturing processes or designs.
The biological evaluation processes described in this document draw on all available sources of information
relevant to biological safety of the medical device, including post-market information. This allows a
comprehensive review of the medical device, identification of biological hazards and the biological harms which
can arise and estimation of the associated risks. This comprehensive approach allows the identification of
any gaps in the existing data set and the consequent need for conduct of supplementary assessments (e.g.,
chemical analysis and hazard identification, or biological testing to refine the biological risk estimates).
This document is supported by a wide range of test methods and other guidance published in other
documents in the ISO 10993 series as well as other standards. Users should also consider more specific
guidance contained in device specific standards where available. For some novel or unusual materials or
technologies, it can be difficult to use the established methods described in the ISO 10993 series. This
document allows for the use of alternate procedures where scientifically justified.
The welfare of animals is very important and the selection of test methods and evolution of testing within
the ISO 10993 framework is directed to continue to reduce, refine and, where possible, replace the use of
animals for biological testing.

vii
oSIST prEN ISO 10993-1:2024
oSIST prEN ISO 10993-1:2024
DRAFT International Standard ISO/DIS 10993-1:2024(en)
Biological evaluation of medical devices —
Part 1:
Requirements and general principles for the evaluation of
biological safety within a risk management process
1 Scope
This document specifies requirements and general principles governing the biological evaluation of medical
devices within a risk management process per ISO 14971. This document applies to the evaluation of medical
devices that have direct contact or indirect contact with either:
— a patient's body during intended use or reasonably foreseeable misuse; or
— the body of other users who are not patients, if the medical device is intended for personal protection (e.g.,
medical gloves, masks).
Biological evaluation assesses the biological safety of the medical device by considering the biological risks
associated with:
— constituents of a medical device; and
— tissue-device interactions (including physical effects).
The biological evaluation specified by this document can address the biological safety of the medical device
throughout its life cycle from design and development through initial use of the finished medical device to final
decommissioning or withdrawal from use. The evaluation considers both the biological safety of the finished
device in first use, and the significance of any changes to the medical device which can occur throughout the
life cycle. However, the evaluation of risks related to environmental impacts of decommissioning of medical
devices are not within the scope of this document. This version of the standard does not mandate re-testing of
medical devices that are already on the market and have established and acceptable safety profiles (see 6.6.2).
This document can be useful to support clinical or usability evaluations of medical devices. For example, a
biological evaluation is a pre-requisite for conduct of a clinical trial. This means that principles outlined by
this standard can be applied to evaluation of prototype or development stage devices as well as to finished
medical devices.
Other parts of ISO 10993 cover specific aspects of biological evaluation such as chemical characterisation,
biological testing, sample preparations, animal welfare and toxicological risk assessment.
For some types of medical devices, specific requirements from other standards (outside the ISO 10993-series)
can be considered with justification for the approach taken in the event of differences between ISO 10993
requirements and those provided in other standards. For example, the ISO 18562 series of standards
provides specific requirements for biological evaluation of breathing gas pathway medical devices and
ISO 7405 provides specific requirements for biological evaluation of dental devices.
The evaluation of risks related to infectious agents (e.g., bacteria, moulds, yeasts, viruses, transmissible
spongiform encephalopathy (TSE) agents) is not within the scope of this document.
NOTE 1 The evaluation of bacterial endotoxins is addressed by ISO 11737-3.
NOTE 2 Evaluation of risks related to viruses, TSE agents and other pathogens is addressed by the ISO 22442 series,
which provide requirements for risk assessments for materials of animal origin.

oSIST prEN ISO 10993-1:2024
ISO/DIS 10993-1:2024(en)
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 10993-2, Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 10993-3, Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and
reproductive toxicity
ISO 10993-4, Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
ISO 10993-6, Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
ISO 10993-9, Biological evaluation of medical devices — Part 9: Framework for identification and quantification
of potential degradation products
ISO 10993-10, Biological evaluation of medical devices — Part 10: Tests for skin sensitization
ISO 10993-11, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
ISO 10993-12, Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
ISO 10993-13, Biological evaluation of medical devices — Part 13: Identification and quantification of
degradation products from polymeric medical devices
ISO 10993-14, Biological evaluation of medical devices — Part 14: Identification and quantification of
degradation products from ceramics
ISO 10993-15, Biological evaluation of medical devices — Part 15: Identification and quantification of
degradation products from metals and alloys
ISO 10993-16, Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation
products and leachables
ISO 10993-17, Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical
device constituents
ISO 10993-18, Biological evaluation of medical devices — Part 18: Chemical characterization of medical device
materials within a risk management process
ISO/TS 10993-19, Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and
topographical characterization of materials
ISO/TS 10993-20, Biological evaluation of medical devices — Part 20: Principles and methods for
immunotoxicology testing of medical devices
ISO 10993-23, Biological evaluation of medical devices — Part 23: Tests for irritation
ISO 14971:2019, Medical devices — Application of risk management to medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/

oSIST prEN ISO 10993-1:2024
ISO/DIS 10993-1:2024(en)
3.1
biocompatibility
ability of a medical device (3.25) or material (3.24) to perform with an appropriate host response in a specific
application
3.2
biological effect
observable or measurable change that occurs in a living organism as a result of exposure to the physical
characteristics, or a chemical constituent (3.13) of a medical device (3.25) as well as to a physical or
biological agent
3.3
biological equivalence
circumstance where the composition, physical characteristics and manufacturing process of a new medical
device (3.25) or material (3.24) can be shown to be similar to an existing comparator medical device (3.25) for
which there are existing data demonstrating biological safety (3.10) in a relevant type and duration of body
contact and that no new or increased biological risks (3.7) are identified for the new medical device (3.25)
3.4
biological evaluation
biocompatibility evaluation
process of comparing the biological risk (3.7) of a medical device (3.25) against defined criteria to determine
the acceptability of the biological risk (3.7)
[SOURCE: ISO 14971:2019, 3.14, modified – “biological” and “biocompatibility” were added before
“evaluation” in the terms; in the definition, “risk evaluation” removed prior to “process”, “biological risk”
replaced “estimated risk”, “defined criteria” replaced “given risk criteria”, and “biological risk” replaced “risk
evaluation”.]
3.5
biological harm
adverse biological effect (3.2) associated with a medical device (3.25) or material (3.24) interactions arising
from exposure to a biological hazard (3.6)
3.6
biological hazard
potential source of biological harm (3.5)
Note 1 to entry: Biological hazards relevant to the intended use (3.20) may arise from either exposure to a constituent
(3.13) of a medical device (3.25) or the physical characteristics (e.g. texture, stiffness, configuration) of the medical
device (3.25).
[SOURCE: ISO 14971:2019, 3.4, modified – “biological” has been added before “hazard” in the term and prior
to “harm” in the definition, and NOTE 1 to entry has been added.]
3.7
biological risk
combination of the probability of occurrence of biological harm (3.5) and the severity of that biological harm (3.5)
[SOURCE: ISO 14971:2019, 3.18, modified – “biological” has been added before “risk” in the term.]
3.8
biological risk analysis
systematic use of available information to identify biological hazards (3.6) and to estimate biological risks (3.7)
[SOURCE: ISO 14971:2019, 3.19, modified – “biological” has been added before “risk analysis” in the term.]

oSIST prEN ISO 10993-1:2024
ISO/DIS 10993-1:2024(en)
3.9
biological risk assessment
overall process comprising a biological risk analysis (3.8) and a biological risk (3.7) evaluation
[SOURCE: ISO 14971:2019, 3.20, modified – “biological” has been added before the terms “risk analysis”, “risk
assessment” and “risk evaluation” in the term.]
3.10
biological safety
freedom from unacceptable biological risk (3.7) in the context of the intended use (3.20) or reasonably
foreseeable misuse (3.31)
[SOURCE: ISO 14971:2019, 3.26, modified – “biological” has been added before “safety” and “risk” in the term
and in the definition. Concept of “reasonably foreseeable misuse” added]
3.11
biologically hazardous situation
circumstances which result in exposure to one or more biological hazards (3.6)
[SOURCE: ISO 14971:2019, 3.5, modified – “biological” has been added before “hazardous situation” in the
term, “people, property or the environment is/are exposed” was replaced by “cause exposure”, and Note 1 to
entry was deleted.]
3.12
configuration
geometry
shape, size and relative arrangement of the parts of the medical device (3.25)
3.13
constituent
chemical that is present in or on the finished medical device (3.25) or its materials (3.24) of construction
Note 1 to entry: These can be intentionally or unintentionally added chemicals or compounds, such as: additives (e.g.
plasticizers, lubricants, stabilizers, anti-oxidants, colouring agents, fillers), manufacturing process residues (e.g.
monomers, catalysts, solvents, sterilant and cleaning agents), degradation products, reaction products, or impurities
or contaminants.
[SOURCE: ISO 10993-17:2023, 3.4, modified – Note 1 to entry has been modified to remove “constituents”, to
add “reaction products”, and to remove “(e.g. byproducts or side products)”].
3.14
contact day
any day in which a medical device (3.25) or component thereof comes into contact with tissues or circulating
blood, irrespective of the length of time of that contact within the day
3.15
direct contact
physical contact of a medical device (3.25) or component thereof, with tissues or circulating blood
3.16
extractable
constituent (3.13) that is released from a medical device (3.25) or material (3.24) when extracted using
laboratory extraction conditions and vehicles
[SOURCE: ISO 10993-18:2020, 3.16]
3.17
finished medical device
medical device (3.25) that is in the state in which it is intended to be used, following all manufacturing
processes such as packaging, storage and sterilization

oSIST prEN ISO 10993-1:2024
ISO/DIS 10993-1:2024(en)
3.18
implant
medical device (3.25) or component thereof, that is intended to be totally introduced into the human body
or to replace an epithelial surface or the surface of the eye, by means of surgical intervention and that is
intended to remain in place after the procedure
Note 1 to entry: The duration of implantation is dependent on the clinical need.
3.19
indirect contact
medical device (3.25) or component thereof, through which a fluid (liquid or gas) or semi-solid passes, prior
to the fluid or semi-solid coming into physical contact with tissue (in this case the medical device (3.25) or
component itself does not physically contact tissue)
3.20
intended use
intended purpose
use for which a product, process or service is intended according to the specifications, instructions and
information provided by the manufacturer (3.23)
Note 1 to entry: The intended medical indication, patient population, part of the body or type of tissue interacted with,
user (3.36) profile, use environment, and operating principle are typical elements of the intended use.
[SOURCE: ISO/IEC Guide 63:2019, 3.4]
3.21
leachable
substance that is released from a medical device (3.25) or material (3.24) during its clinical use
[SOURCE: ISO 10993-18:2020, 3.22; Note 1 to entry deleted]
3.22
life cycle
series of all phases in the life of a medical device (3.25), from the initial conception to final decommissioning
and disposal
Note 1 to entry: Phases within the life cycle can include “service life”, “use life”, lifetime or other terms as described in
different standards.
[SOURCE: ISO 14971:2019, 3.8; added Note 1 to entry]
3.23
manufacturer
natural or legal person with responsibility for the design or manufacture of a medical device (3.25) with
the intention of making the medical device (3.25) available for use, under their name, whether or not such a
medical device (3.25) is designed or manufactured by that person themselves or on their behalf by another
person(s)
[SOURCE: ISO 14971:2019, 3.9 – modified to change to “their name”, “person themselves” and “their behalf”;
deletion of all notes to entry]
3.24
material
synthetic or natural substance, including polymer, metal or alloy, ceramic, composite, tissue, used as a
medical device (3.25) or any part thereof
Note 1 to entry: These can include materials of construction, formulation additives or manufacturing aids.

oSIST prEN ISO 10993-1:2024
ISO/DIS 10993-1:2024(en)
3.25
medical device
instrument, apparatus, implement, machine, appliance, implant (3.18), reagent for in vitro use, software,
material (3.24) or other similar or related article, intended by the manufacturer (3.23) to be used, alone or in
combination, for human beings, for one or more of the specific medical purpose(s) of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
— investigation, replacement, modification, or support of the anatomy or of a physiological process,
— supporting or sustaining life,
— control of conception,
— disinfection of a medical device (3.25),
— providing information by means of in vitro examination of specimens derived from the human body
and which does not achieve its primary intended action by pharmacological, immunological or metabolic
means, in or on the human body, but which may be assisted in its intended function by such means.
Note 1 to entry: Note to entry: Products which can be considered to be medical device in some jurisdictions but not in
others include:
— disinfection substances;
— aids for persons with disabilities;
— devices (3.25) incorporating animal or human tissues;
— devices (3.25) for in vitro fertilization or assisted reproduction technologies.
[SOURCE: ISO/IEC Guide 63:2019, 3.7]
3.26
medical device family
group of medical devices (3.25) manufactured by or for the same organization and having the same basic
design, materials (3.24), manufacturing process and performance characteristics related to safety, intended
use (3.20) and function
[SOURCE: ISO 13485:2016, 3.12, modified to add “materials and manufacturing process”]
3.27
nanomaterial
material (3.24) with any external dimension in the nanoscale or having internal structure or surface
structure in the nanoscale, where nanoscale is in the range of approximately 1 nm to 100 nm
[SOURCE: ISO/TR 10993-22:2017, 3.7, modified — Notes to entry have been deleted and nanoscale definition
included in nanomaterial definition.]
3.28
non-contacting
indicates that a medical device (3.25) or component thereof, has neither direct contact (3.14) nor indirect
contact (3.19) with tissues including blood
3.29
novel material
material (3.24) that has not previously been used in any medical device (3.25)

oSIST prEN ISO 10993-1:2024
ISO/DIS 10993-1:2024(en)
3.30
physical and chemical information
knowledge regarding a finished medical device (3.25) or material (3.24) including the identity of the supplier
and geometric, chemical and physical properties
3.31
reasonably foreseeable misuse
use of a medical device (3.25) in a way not intended by the manufacturer (3.23), but which can result from
readily predictable human behaviour
Note 1 to entry: Readily predictable human behaviour includes the behaviour of all types of users (3.36), e.g. lay and
professional users (3.36).
Note 2 to entry: Reasonably foreseeable misuse can be intentional or unintentional.
[SOURCE: ISO/14971:2019, 3.15 modified to change “product” to “medical device”]
3.32
risk estimation
process used to assign values to the probability of occurrence of harm and the severity of that harm
[SOURCE: ISO 14971:2019, 3.22]
3.33
Risk management
systematic application of management policies, procedures and practices to the tasks of analysing,
evaluating, controlling and monitoring biological risk (3.7)
[SOURCE: ISO/IEC Guide 63:2019, 3.15 – modified to add “biological” before “risk”]
3.34
total exposure period
the number of days a medical device (3.25) is considered to be in contact with tissues
Note 1 to entry: according to the nature of device use, this may be calculated either as:
— calendar days between first and last use of a medical device or of a replacement of the same medical device (3.25)
on a single patient or as
— the number of contact days occurring between first and last use of a medical device (3.25)
[SOURCE: ISO/DIS 18562-1:2022, 3.38 - modified to add ‘contact’ to days and remove note 1 and 2 and
“accessory” to entry]
3.35
toxicity
capability of a constituent (3.13) to cause a biological harm (3.5) under specified conditions of exposure or dose
3.36
user
person who comes into contact (including indirect contact (3.19) with a medical device (3.25) during its use,
including patients or persons who are required to operate or handle the device during its use
4 General principles
4.1 Biological evaluation within an ISO 14971 risk management framework
The biological (biocompatibility) evaluation of a medical device is conducted within a risk management process
in accordance with ISO 14971 (see Figure 1), which involves identification of biological hazards, estimation
of the associated biological risks, and determination of their acceptability (see 5.2).

oSIST prEN ISO 10993-1:2024
ISO/DIS 10993-1:2024(en)
The biological evaluation shall be planned (see 5.2), conducted and reported by knowledgeable and
experienced professionals, appropriately qualified by education, training, skills and experience, capable
of making informed decisions based upon scientific data and a knowledge of relevant medical devices.
Qualification of evaluators shall be documented (see Clause 9).
In understanding the relationship between ISO 14971 and ISO 10993 series, it is useful to apply the risk
management terminology of ISO 14971 as follows:
— Biological hazards can arise
...