Valid

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

Preview PDF

This is a limited preview

Buy now to download the full PDF (98 pages)

Need quotation for your management?

Get a formal quotation for GB/Z 16886.22-2022 in 30 minutes.

Issued by

State Administration for Market Regulation, China National Standardization Administration

Level / Type

National · Recommended

Issue date

December 30, 2022

Implementation date

January 1, 2024

Scope

GB/Z 16886.22-2022 (Biological evaluation of medical devices - Part 22: Guidance on nanomaterials) is available as an English-translated PDF.

GB/Z 16886.22-2022 is the Chinese standard "Biological evaluation of medical devices - Part 22: Guidance on nanomaterials".

Its scope clause reads: 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.

Found what you need?

Document preview — GB/Z 16886.22-2022

National Standard of the People's Republic of China

ICS: 11.100.20
Classification: C 30

Issued by: State Administration for Market Regulation, China National Standardization Administration

Preface
Introduction
1 Scope
2 Normative references
3 Terms and Definitions
4 General principles
4.1 General
4.2 Biological evaluation of nanomaterials
4.3 Classification of nanomaterials
4.4 Equivalence of nanomaterials
5 Characterization of Nanomaterials
5.1 General
5.2 Characterization parameters and methods
5.3 Use of reference material
6 Sample preparation
6.1 General
6.2 Special Considerations for Nanostructured Materials
6.3 Special considerations for nanoobjects
6.4 Characterization, storage and stability of reserve nanomaterials
6.5 Description of the chemical composition of stock solutions and dosing dispersions
6.6 Characterization of stored dispersions
6.7 Characterization of dosing solutions prepared from storage dispersions
6.8 Dose measurement
6.9 Additional matters
6.9.1 Endotoxins
6.9.2 Sterilization
7 Release of Nanoobjects from Medical Devices
7.1 General
7.2 Degradation products
7.3 Nanoobjects Released by Abrasion
7.4 In situ processing
8 Toxicokinetics
8.1 General
8.2 Influencing factors of toxicokinetics
8.2.1 Physical and chemical properties
8.2.2 Biomolecular adsorption
8.2.3 Routes of exposure
8.2.4 Dose
8.2.5 Species and sex
8.2.6 Measurement techniques
9 Toxicological evaluation
9.1 General
9.2 In vitro cytotoxicity test
9.2.1 General
9.2.2 Consideration of nanomaterials on test interference
9.2.3 Considerations for relevant doses and dose metrics
9.2.4 Considerations of Nanobody Dynamics
9.3 Genotoxicity, carcinogenicity and reproductive toxicity
9.3.1 General
9.3.2 In vitro genotoxicity test
9.3.3 In vivo genotoxicity test
9.3.4 Carcinogenicity
9.3.5 Reproductive toxicity
9.4 Immunotoxicity, sensitization and irritation
9.4.1 General
9.4.2 Immunotoxicity
9.4.3 Sensitization
9.4.4 Stimuli
9.5 Blood compatibility
9.5.1 General
9.5.2 Activation of the complement system
9.5.3 Specific considerations for blood compatibility testing
9.6 Systemic toxicity
9.7 Pyrogenicity
9.8 Implantation
10 Characterization and description of test results
11 Risk assessment
11.1 General
11.2 Exposure assessment
11.3 Biological hazard identification
11.4 Risk Estimation
11.5 Risk assessment
12 Biological Evaluation Report

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)

GB/T 16886.23 | GB/T 16886.19 | GB/T 16886.20 | GB/T 16886.2 | GB/T 16886.17 | GB/T 16886.18 | […]

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 98 pages — is available in the English PDF.

Referenced standards

Normative references

GB/T 39261-2020Nanotechnologies. Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment

ISO 10993

How to Download GB/Z 16886.22-2022

1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.