GB/T 16886.9-2022 PDF in English
GB/T 16886.9-2022 (GB/T16886.9-2022, GBT 16886.9-2022, GBT16886.9-2022)
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Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products
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Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products
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Standards related to (historical): GB/T 16886.9-2022
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GB/T 16886.9-2022: PDF in English (GBT 16886.9-2022) GB/T 16886.9-2022
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.100.20
CCS C 30
GB/T 16886.9-2022 / ISO 10993-9:2019
Replacing GB/T 16886.9-2017
Biological Evaluation of Medical Devices – Part 9:
Framework for Identification and Quantification of
Potential Degradation Products
(ISO 10993-9:2019, IDT)
ISSUED ON: DECEMBER 30, 2022
IMPLEMENTED ON: JANUARY 01, 2024
Issued by: State Administration for Market Regulation;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 8
2 Normative References ... 8
3 Terms and Definitions ... 9
4 Principles for Design of Degradation Studies ... 10
4.1 General ... 10
4.2 Preliminary considerations ... 11
4.3 Study design ... 11
4.4 Characterization of degradation products from medical devices ... 12
5 Study Report ... 13
Annex A (Normative) Consideration of the Need for Degradation Studies ... 14
Annex B (Informative) Degradation Study Considerations ... 16
Bibliography ... 19
Biological Evaluation of Medical Devices – Part 9:
Framework for Identification and Quantification of
Potential Degradation Products
1 Scope
This Document provides general principles for the systematic evaluation of the potential and
observed degradation of medical devices through the design and performance of in vitro
degradation studies. Information obtained from these studies can be used in the biological
evaluation described in the GB/T (Z) 16886 series.
This document is applicable to both materials designed to degrade in the body as well as
materials that are not intended to degrade.
This document is not applicable to:
a) the evaluation of degradation which occurs by purely mechanical processes;
methodologies for the production of this type of degradation product are described in
specific product standards, where available;
NOTE: Purely mechanical degradation causes mostly particulate matter. Although this is excluded
from the scope of this document, such degradation products can evoke a biological response and
can undergo biological evaluation as described in other parts of GB/T (Z) 16886.
b) leachable components which are not degradation products;
c) medical devices or components that do not contact the patient's body directly or indirectly.
2 Normative References
The provisions in following documents become the essential provisions of this Document
through reference in this Document. For the dated documents, only the versions with the dates
indicated are applicable to this Document; for the undated documents, only the latest version
(including all the amendments) is applicable to this Document.
ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing
within a risk management process
NOTE: GB/T 16886.1-2022 Biological evaluation of medical devices - Part 1: Evaluation and
testing within a risk management process (ISO 10993-1:2018, IDT)
ISO 10993-2 Biological evaluation of medical devices – Part 2: Animal welfare
requirements
NOTE: GB/T 16886.2-2011 Biological evaluation of medical devices - Part 2: Animal welfare
requirements (ISO 10993-2:2006, IDT)
ISO 10993-13 Biological evaluation of medical devices – Part 13: Identification and
quantification of degradation products form polymeric medical devices
NOTE: GB/T 16886.13-2017 Biological evaluation of medical devices - Part 13: Identification and
quantification of degradation products from polymeric medical devices (ISO 10993-13:2010, IDT)
ISO 10993-14 Biological evaluation of medical devices – Part 14: Identification and
quantification of degradation products from ceramics
NOTE: GB/T 16886.14-2003 Biological evaluation of medical devices - Part 14: Identification and
quantification of degradation products from ceramics (ISO 10993-14:2001, IDT)
ISO 10993-15 Biological evaluation of medical devices – Part 15: Identification and
quantification of degradation products from metals and alloys
NOTE: GB/T 16886.15-2022 Biological evaluation of medical devices - Part 15: Identification and
quantification of degradation products from metals and alloys (ISO 10993-15: 2019, IDT)
3 Terms and Definitions
For the purposes of this document, the terms and definitions given in ISO 10993-1 and the
following apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
— ISO Online browsing platform: available at http://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
3.1 Degradation
Decomposition of a material.
3.2 Absorb
Action of a non-endogenous (foreign) material or substance passing through or being
apply the relevant materials-specific standards (e.g., crystallization of polymers).
Materials-specific or product-specific degradation standards that address identification and
quantification of degradation products should be considered in the design of degradation studies.
ISO 10993-13 (for polymers), ISO 10993-14 (for ceramics) or ISO 10993-15 (for metals and
alloys) shall apply if no suitable material-specific standard exists. Devices composed of two or
more material types should consider all relevant degradation standards.
ISO 10993-13, ISO 10993-14 and ISO 10993-15 consider only those degradation products
generated by a chemical alteration of the finished device. They are not applicable to degradation
of the device induced during its intended use by mechanical stress, wear or electromagnetic
radiation. For such degradation other methods should be considered.
4.2 Preliminary considerations
Careful consideration of the potential for intended or unintended degradation of a material is
essential to the evaluation of the biological safety of a device. Part of this consideration is an
assessment of the chemical characteristics and known degradation mechanisms, followed by an
assessment of the need for, and design of, experimental degradation studies.
It is neither necessary nor practical to conduct degradation studies for all medical devices. Refer
to Annex A to determine when degradation studies should be considered. The assessment of
the need for experimental degradation studies shall include a review of the literature and/or
documented clinical experience. Guidance on proper reviewing of the literature can be found
in ISO 10993-1. Such an assessment can potentially result in the conclusion that no further
testing is needed.
Guidance on the biological evaluation of leachable including degradation products is given in
ISO 10993-1, ISO 10993-16 and ISO 10993-17. See ISO 10993-18 for guidance on the
chemical characterization of materials and their leachable used in medical devices. See ISO/TS
10993-19 for guidance on the physic-chemical, morphological and topographical
characterization of materials. Consideration of these standards prior to conducting degradation
studies can prove helpful in distinguishing degradation products from other leachable.
NOTE: Despite the difference between degradation products and other leachable, it can be possible to
combine a study on degradation products with a study on other leachable components. Distinguishing
between degradation products and other types of leachable might not be necessary for further biological
evaluation studies. However, when a reduction of the level of leachable components is deemed necessary
as a risk control measure, this information is important. Additionally, some degradation products cannot
leach from the device but can still impact the properties of the device.
4.3 Study design
A degradation study plan complete with the purpose of the study shall be designed and
documented to address the issues identified in 4.1. The approved study plan shall define the
analytical methods by which the following characteristics of degradation products are to be
investigated:
a) chemical properties;
b) physicochemical properties;
c) physical morphology (as applicable).
The approved study plan shall also describe the methods used to generate degradation products.
The methods for generating degradation products should be optimized and scientifically
justified. The degradation products should be identified and quantified using methods described
in ISO 10993-18.
The approved study plan for multi-component devices shall take into account each individual
component/material and shall consider synergistic effects on the degradation of the different
components as well as the possibility of secondary reactions between/among the degradation
products.
NOTE: Degradation can in most cases be modelled by in vitro tests. During degradation pH needs to be
controlled to a clinically relevant range, especially if pH can affect degradation product composition.
The user needs to be aware that both the degradation rate and amount of generated by-products can be
affected if pH is different from that expected for the service environment.
4.4 Characterization of degradation products from medical devices
The degradation products produced in the study can be particulate or soluble compounds or
ions. Appropriate analytical methods to characterize these products shall be used and reported
in the study report. These methods shall be adequately qualified for their intended purpose. If
particles are generated, they shall be characterized with regard to size, shape, surface area and
other relevant characteristics.
Because the physical and chemical properties of particulate materials can change at the
nanoscale (approximately 1 nm to 100 nm), this can affect their toxicological properties. For
those medical devices composed of or containing nanoscale materials, the user is referred to
ISO/TR 10993-22 for a thorough consideration of the impact on the risk assessment of
nanoscale products.
If biological evaluation of the degradation products is required, then care shall be taken in the
design of the degradation study in order to ensure that it does not interfere with the biological
assay.
Considerations for the degradation study are provided in Annex B. The protocol shall include
a) identification and characterization of device and/or material and intended use,
b) identification and characterization of possible mechanism of degradation,
Annex A
(Normative)
Consideration of the Need for Degradation Studies
Degradation studies shall be considered if:
a) the device is designed to be absorbed by the body or
b) the device is intended to be implanted for longer than thirty days or
c) an informed consideration of the material(s) system indicates that toxic degradation
products could be released during body contact.
However, degradation studies might not be needed if sufficient material formulation, and
manufacturing process information are available and degradation data relevant to degradation
products in the intended use already exist.
NOTE: Relevant degradation data can include information on degradation mechanism, degradation rate,
identification and quantity of degradation products, and particle shape/size and distribution.
The need for in vivo studies shall be considered in light of results from in vitro studies.
Where appropriate, in vitro experiments shall be considered for investigating theoretically
possible degradation processes. In vivo studies shall take into consideration ISO 10993-2. In
vivo and in vitro studies shall also be considered for determining the probability of occurrence
of degradation and the identification of probable degradation products and the degradation rate.
The flowchart in Figure A.1 illustrates the logic applicable to these considerations. For
polymers that are intended to hydrolytically degrade, e.g., polylactide, the user is referred to
ISO 13781.
Annex B
(Informative)
Degradation Study Considerations
B.1 General
This annex contains aspects that need to be considered in the evaluation of possible degradation.
Appropriate practical studies should be considered in the case where essential information is
missing on the degradation of devices or materials and the biological effects of potential
degradation products.
B.2 Description of medical device and/or material
The following should be considered when describing the device or material under study:
a) name of medical device and/or material;
b) function of medical device;
c) intended use;
d) intended biological environment;
e) composition of the material;
f) conditioning of the material (e.g., processing, sterilization);
g) surface condition;
h) dimensions;
i) construction of device or material under study (e.g., single component, single component
to be used with others and the nature of their interaction, or multicomponent device —
assessment carried out for each component material);
j) contact duration;
k) shelf life;
NOTE: For some products storage can impact degradation, and therefore degradation studies to
support labelled shelf life can be important.
l) other relevant characterizations.
B.3 Assessment of potential and known degradation products
B.3.1 General
Degradation of material can occur within the bulk, or majority, of the material. Degradation
can also occur at the surface of the material. Both bulk and surface degradation can occur at the
same time and can influence one another.
B.3.2 Bulk material changes
Intended or unintended changes in the bulk material can lead to particulate degradation products
and can influence the stability of the surface. For example, bulk material changes can occur as
follows:
— during fabrication;
— during sterilization;
— during storage and due to instability;
— during implantation and while implanted;
— during changes in the physical state (swelling, phase transitions, etc.);
— by intended in vivo degradation.
B.3.3 Release of substances from the surface
Release of substances from the surface can be induced by processes such as the following:
— chemical reactions (e.g., depolymerization);
— leaching;
— diffusion;
— peeling, scaling off.
B.3.4 Multicomponent device or device used with other components
In addition to the considerations for single-component systems, items such as the following
need to be addressed:
— breakdown of structures;
— delamination;
— migration of substances from one component to another;
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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