GB/Z 16886.22-2022Biological evaluation of medical devices - Part 22: Guidance on nanomaterials (English PDF)

foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules for Standardization Documents"

drafting.

This document is part 22 of GB/T (Z) 16886 "Biological Evaluation of Medical Devices". GB/T (Z) 16886 has issued the following

part.

--- Part 1.Evaluation and testing in the risk management process;

--- Part 2.Animal welfare requirements;

--- Part 3.Genotoxicity, carcinogenicity and reproductive toxicity tests;

--- Part 4.Selection of blood interaction tests;

--- Part 5.In vitro cytotoxicity test;

--- Part 6.Local reaction test after implantation;

--- Part 7.Ethylene oxide sterilization residues;

--- Part 9.Qualitative and quantitative framework for potential degradation products;

--- Part 10.Irritation and skin sensitization test;

--- Part 11.Systemic toxicity test;

--- Part 12.Sample preparation and reference materials;

--- Part 13.Qualification and quantification of degradation products of polymer medical devices;

--- Part 14.Qualitative and quantitative of ceramic degradation products;

--- Part 15.Qualitative and quantitative analysis of metal and alloy degradation products;

--- Part 16.Toxicokinetic study design of degradation products and leachable substances;

--- Part 17.Establishment of allowable leachable limits;

--- Part 18.Chemical characterization of medical device materials in the risk management process;

--- Part 19.Characterization of physical chemistry, morphology and surface properties of materials;

--- Part 20.Principles and methods of medical device immunotoxicology testing;

--- Part 22.Nanomaterials Guidelines.

This document is equivalent to ISO /T R10993-22.2017 "Biological Evaluation of Medical Devices Part 22.Guidelines for Nanomaterials", document

The type is adjusted from the ISO technical report to my country's national standardization guiding technical document.

Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying patents.

Introduction

This document is intended to provide guidance for the biological evaluation of medical devices that contain, result from, or consist of nanomaterials. How many nanomaterial terms

kind of definition. This document will use the ISO definition. When a material has external and internal dimensions on the nanometer scale, that is, when its dimensions or

When the structure composition is between 1nm and 100nm, it is considered as a nanomaterial (ISO /T S80004-1.2015). For regulatory purposes,

It is advisable to check the applicable regulatory definitions for a particular country. Other features (such as nano-specific properties) can also be included in such

in the definition of.

Morphological structures formed on the surface of medical devices may also have nanoscale dimensions. Therefore, the impact of this structure on the biological response of the device

Possible impacts also need to be considered.

Nano-objects with a length ranging from 1 nm to 100 nm may be produced during the life cycle of a medical device.

Evaluation of adverse effects that may be caused by nano-objects produced by medical devices in any link of preparation, use, wear or degradation. This applies to

Medical devices manufactured using nanomaterials, and medical devices not manufactured using nanomaterials, but which may generate nanoscale abrasive or degrading particles

medical equipment. For the biological evaluation of medical devices, knowledge of the potential generation and/or release of nanoobjects from such materials is essential.

need.

The procedures described in GB/T (Z) 16886 for the biological evaluation of medical devices can be used for those medical devices containing nano-objects,

But these nanoobjects will not be released from the device, because they are an integral part of the device. However, when nanoobjects may be released

When, it is also necessary to conduct a safety evaluation of the released nano-objects. In addition to the evaluation of medical devices, it is also possible to evaluate the composition or composition of nanomaterials

be evaluated individually.

This document provides trained professionals with a general approach to the biological evaluation of nanomaterials in the context of medical device evaluation,

It also discusses how to use other parts of GB/T (Z) 16886 when evaluating nanomaterials. Various tests described in GB/T (Z) 16886

Certain methods may not always be applicable to the testing of nanomaterials. Nanomaterials themselves can exist in the form of powders or colloidal dispersions, but

It can also be present in medical devices as nanostructured materials or materials and/or medical device surface structures when combined with a matrix. usually,

The nanomaterial itself needs to be evaluated, not the leach solution typically used when testing biological materials or medical devices.

price. Nanomaterials present particular challenges when performing test systems and interpretation of test results commonly used in medical device evaluation.

Nanotechnology, the development of nanomaterials, and the evaluation of the potential toxicity of such materials are emerging fields, and this document represents only the

time knowledge. Although appropriate tools and methods for evaluating nanomaterials are still being developed, consideration is given to risk/benefit analyses, providing relevant

Characterization of nanomaterials and data on biological effects to address safety issues in their application in the field of medical devices.

This document addresses how medical devices containing, produced, or composed of nanomaterials are

Guidance is provided for biological evaluation of machinery.

GB/T (Z) 16886 "Biological Evaluation of Medical Devices" is proposed to be composed of 21 parts.

--- Part 1.Evaluation and testing in the risk management process. The purpose is to protect human beings from potential

In the biological risk, and describe the biological evaluation of the medical device in the risk management process, as the overall evaluation of the medical device and

An integral part of the development process.

--- Part 2.Animal welfare requirements. The purpose is to maximize the use of scientifically sound non-animal tests to ensure that they are used to evaluate medical

Animal tests on the biological performance of materials used in devices comply with recognized ethical and scientific principles.

--- Part 3.Genotoxicity, carcinogenicity and reproductive toxicity tests. The purpose is to determine the potential genotoxicity, carcinogenicity

or reproductive toxicity medical devices to provide evaluation guidelines and methods.

--- Part 4.Test selection for interaction with blood. The purpose is to provide a general basis for the evaluation of the interaction between medical devices and blood

Require.

--- Part 5.In vitro cytotoxicity test. The purpose is to provide a test method for evaluating the cytotoxicity of medical devices in vitro.

--- Part 6.Local reaction test after implantation. The purpose is to provide a basis for evaluating local reactions after implantation of biomaterials used in medical devices.

experiment method.

--- Part 7.Ethylene oxide sterilization residues. The purpose is to apply EO and

The allowable limit of 2-chloroethanol (ECH) residues, EO and ECH residues provide testing steps and determine whether the device can

The factory provides detection methods.

--- Part 9.Qualitative and quantitative framework for potential degradation products. The purpose is to systematically review the potential and observed

Biodegradation and the design and conduct of biodegradation studies provide basic principles.

--- Part 10.Irritation and skin sensitization tests. The purpose is to provide protection for potential irritation and skin sensitization of medical devices and their constituent materials.

for evaluation steps.

--- Part 11.Systemic toxicity test. The purpose is to provide tests for the evaluation of medical device materials causing potential adverse systemic reactions

Step by step guide.

--- Part 12.Sample preparation and reference materials. The purpose is to provide a basis for sample preparation methods and reference materials in the biological evaluation of medical devices.

material selection guide.

--- Part 13.Qualitative and quantitative analysis of degradation products of polymeric medical devices. The purpose is to provide finished polymer medical devices for clinical use

Provide general requirements for qualitative and quantitative experimental design of degradation products in mechanical simulation environment.

--- Part 14.Qualitative and quantitative ceramic degradation products. The purpose is to provide a solution for the quantification of degradation products obtained from ceramic materials.

supply method.

--- Part 15.Qualitative and quantitative analysis of degradation products of metals and alloys. The purpose is to provide metallic medical devices or relevant clinically applicable

General requirements for qualitative and quantitative test design should be provided for degradation products of material samples.

--- Part 16.Toxicokinetic study design of degradation products and leachable substances. The purpose is to provide design and

Principles for conducting toxicokinetic studies.

--- Part 17.Establishment of allowable leachable limits. The purpose is to provide a basis for the establishment of allowable limits for leachable substances in medical devices

method.

--- Part 18.Chemical characterization of medical device materials in the risk management process. The purpose is for the qualitative and quantitative analysis of medical device components

(where necessary) to provide a framework for identifying biological hazards and estimating and controlling biological risks in material components.

--- Part 19.Physicochemical, morphological and surface characterization of materials. The purpose is to identify and evaluate the final medical device material

Physical properties such as various parameters and test methods for physicochemical, morphological and surface properties (PMT).

--- Part 20.Principles and methods of medical device immunotoxicology testing. The purpose is to provide information on the potential immunotoxicity of medical devices

A review of immunotoxicology and guidance on methods for examining the immunotoxicity of different types of medical devices.

--- Part 22.Nanomaterials Guidelines. The purpose is to provide a basis for the biological evaluation of medical devices containing, producing or consisting of nanomaterials.

for guidance.

--- Part 23.Stimulation test. The purpose is to provide a procedure for evaluating the irritation potential of medical devices and their constituent materials.

Biological Evaluation of Medical Devices

Part 22.Guidelines for Nanomaterials

1 Scope

This document provides considerations for the biological evaluation of medical devices consisting of or containing nanomaterials, as well as

Nanomaterials are not used in the production of devices (or components), but they degrade, wear out, or undergo mechanical processing (such as in-situ grinding of medical devices,

guidance on the evaluation of nano-objects produced by polishing, etc.

This document applies to the following.

---Characterization of nanomaterials;

---Sample preparation for nanomaterial testing;

--- release of nano-objects in medical devices;

--- Toxicokinetics of nano-objects;

---Biological evaluation of nanomaterials;

--- the description of the result;

---Risk assessment of nanomaterials in medical device evaluation;

---biological evaluation report;

--- Nanostructures on the surface of medical devices that are expected to be produced during design, manufacturing and processing.

This document does not apply to the following.

---Natural and biological nanomaterials that have not been designed, manufactured or processed to be used in medical devices;

---Nanostructures inside bulk materials;

---Unexpected nanostructures on the surface of medical devices produced during design, manufacture and processing.

NOTE. Examples of unintended nanostructures on medical device surfaces are extrusion scribing and machining/tooling markings.

This document aims to provide a general framework and focus on the importance of evaluating medical

important aspects to consider when considering the safety of medical devices. In addition, this document points out that the measured

Several common unanticipated difficulties and obstacles found when experimenting with nanomaterials. As a national standardization guiding technical document, this document represents

Presents current technical knowledge related to nanomaterials, does not list or provide detailed experimental protocols. This document can be used as a focus on including

basis for future papers on detailed protocols for material testing.

2 Normative references

The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references

For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to

this document.

Note. GB/T (Z) 16886 Biological evaluation of medical devices (all parts) [ISO 10993 (all parts)]

ISO /T R13014 Guidelines for Characterization of Physicochemical Properties of Nanotechnology Nanomaterials Before Toxicological Evaluation (Nanotechnologies-Guid-

ment)

Note. GB/T 39261-2020 Guidelines for Characterization of Physicochemical Properties of Nanotechnology Nanomaterials Before Toxicological Evaluation (ISO /T R13014.2012, IDT)