GB/T 16886.9-2022 English PDF (GBT16886.9-2022)

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GB/T 16886.9-2022: Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products
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 produc...