GB/T 16886.12-2023 PDF English
Search result: GB/T 16886.12-2023_English: PDF (GB/T16886.12-2023)
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Name of Chinese Standard | Status |
| GB/T 16886.12-2023 | English | 320 |
Add to Cart
|
0-9 seconds. Auto-delivery.
|
Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials
| Valid |
| GB/T 16886.12-2017 | English | 145 |
Add to Cart
|
0-9 seconds. Auto-delivery.
|
Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials
| Obsolete |
| GB/T 16886.12-2005 | English | 220 |
Add to Cart
|
0-9 seconds. Auto-delivery.
|
Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials
| Obsolete |
| GB/T 16886.12-2000 | English | 519 |
Add to Cart
|
3 days
|
Biological evaluation of medical devices--Part 12: Sample preparation and reference materials
| Obsolete |
BUY with any currencies (Euro, JPY, GBP, KRW etc.): GB/T 16886.12-2023 Related standards: GB/T 16886.12-2023
PDF Preview: GB/T 16886.12-2023
PDF Preview: GB/T 16886.12-2017
PDF Preview: GB/T 16886.12-2005
GB/T 16886.12-2023: PDF in English (GBT 16886.12-2023) GB/T 16886.12-2023
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.100.20
CCS C 30
GB/T 16886.12-2023 / ISO 10993-12:2021
Replacing GB/T 16886.12-2017
Biological Evaluation of Medical Devices – Part 12: Sample
Preparation and Reference Materials
(ISO 10993-12:2021, IDT)
ISSUED ON: NOVEMBER 27, 2023
IMPLEMENTED ON: DECEMBER 1, 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 ... 8
4 General Requirements ... 11
5 Reference Materials (RMs) ... 12
5.1 General ... 12
5.2 Certification of RMs for biological safety testing ... 12
6 Use of RMs as Experimental Controls ... 13
7 Test Sample Selection ... 13
8 Test Sample and RM Preparation ... 14
9 Selection of Representative Portions from a Medical Device ... 14
10 Preparation of Extracts of Samples ... 15
10.1 General ... 15
10.2 Containers for extraction ... 15
10.3 Extraction conditions and methods ... 15
10.4 Extraction conditions for materials that polymerize in situ ... 20
11 Records ... 20
Annex A (Informative) Experimental Controls ... 22
Annex B (Informative) General Principles on, and Practices of, Test Sample Preparation
and Sample Selection ... 23
Annex C (Informative) Principles of Test Sample Extraction ... 25
Annex D (informative) Exhaustive Extraction of Polymeric Materials for Biological
Evaluation ... 28
Bibliography ... 31
Foreword
This Document was drafted as per the rules specified in GB/T 1.1-2020 Directives for
Standardization – Part 1: Rules for the Structure and Drafting of Standardizing Documents.
This Document is Part 12 of GB/T (Z) 16886 Biological Evaluation of Medical Devices. GB/T
(Z) 16886 consists of the following parts:
--- Part 1: Evaluation and testing within a risk management process;
--- Part 2: Animal welfare requirements;
--- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity;
--- Part 4: Selection of tests for interactions with blood;
--- Part 5: Tests for in vitro cytotoxicity;
--- Part 6: Tests for local effects after implantation;
--- Part 7: Ethylene oxide sterilization residuals;
--- Part 9: Framework for identification and quantification of potential degradation products;
--- Part 10: Tests for irritation and skin sensitization;
--- Part 11: Tests for systemic toxicity;
--- Part 12: Sample preparation and reference materials;
--- Part 13: Identification and quantification of degradation products from polymeric
medical devices;
--- Part 14: Identification and quantification of degradation products from ceramics;
--- Part 15: Identification and quantification of degradation products from metals and alloys;
--- Part 16: Toxicokinetic study design for degradation products and leachable;
--- Part 17: Establishment of allowable limits for leachable substances;
--- Part 18: Chemical characterization of medical device materials within a risk management
process;
--- Part 19: Physio-chemical, morphological and topographical characterization of materials;
--- Part 20: Principles and methods for immunotoxicology testing of medical devices;
--- Part 22: Nanomaterials guide;
--- Part 23: Tests for irritation.
This Document replaced GB/T 16886.12-2017 Biological Evaluation of Medical Devices - Part
12: Sample Preparation and Reference Materials. Compared with GB/T 16886.12-2017, the
major technical changes of this Documents are as follows besides the structural adjustments
and editorial modifications:
a) Change the "Scope" to cover only the extraction of biological evaluation tests (see Clause
1 of this Edition; Clause 1 of the 2017 Edition);
b) Delete the terms and definitions of "accelerated extraction" and "simulated use
extraction" (see 3.1 and 3.14 of the 2017 Edition); and change the definitions of "strict
extraction", "extreme extraction", "extractables" and "leachable" (see 3.3, 3.4, 3.7 and
3.9 of this Edition; 3.4, 3.5, 3.8 and 3.10 of the 2017 Edition);
c) Change the list items of extraction conditions (see 10.3.1 of this Edition; 10.3.1 of the
2017 Edition).
This Document equivalently adopts ISO 10993-12:2021 Biological Evaluation of Medical
Devices – Part 12: Sample Preparation and Reference Materials.
Please note some contents of this Document may involve patents. The issuing agency of this
Document shall not assume the responsibility to identify these patents.
This Document was proposed by National Medical Products Administration.
This Document shall be under the jurisdiction of National Technical Committee on Biological
Evaluation on Medical Device of Standardization Administration of China (SAC/TC 248).
Drafting organizations of this Document: Shandong Medical Device and Drug Packaging
Inspection Institute; and Sichuan University.
Chief drafting staffs of this Document: Liang Jie, Sun Xiaoxia, Sun Lingxiao, Yuan Tun, and
Qu Qiujin.
The historical editions replaced by this Standard are as follows:
--- GB/T 16886.12-2000 was first-time published in 2000; first-time revised in 2005; and
second-time revised in 2017.
--- It is third-time revised hereby.
Biological Evaluation of Medical Devices – Part 12: Sample
Preparation and Reference Materials
1 Scope
This Document specifies requirements and gives guidance on the procedures in the preparation
of samples and the selection of reference materials for medical device testing primarily in
biological test systems primarily in accordance with one or more parts of the ISO 10993 series.
Specifically, this document addresses the following:
— test sample selection;
— selection of representative portions from a medical device;
— test sample preparation;
— experimental controls;
— selection of, and requirements for, reference materials;
— preparation of extracts.
This Document is not applicable to live cells but can be relevant to the material or medical
device components of combination products containing live cells.
Extractions for chemical characterization are covered in ISO 10993-18. Clauses 7, 8, 9, 10 [with
the exception of 10.3.5 and 10.3.11 b)], and 11 can apply to extractions for chemical
characterization. Information given in C.1 ~ C.4 of Annex C can also be relevant.
2 Normative References
There are no normative references in this Document.
3 Terms and Definitions
For the purposes of this Document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following
not alter the phase equilibrium of the material. Phase alteration can affect the amount and type
of extractables.
For example, two possibilities exist when elevated temperatures are used:
— the energy of the increased temperature can cause either increased cross-linking or
polymerization of the polymer, or both, and, therefore, decrease the amount of free
monomer that is available to migrate from the polymer;
— the increased temperature can cause degradation products to form that are not typically
found in the finished medical device under conditions of use.
10.3.2 For materials that are intended to dissolve or absorb under conditions of use, the selection
of extraction conditions described in 10.3 might need to consider the thermal properties (e.g.,
glass transition temperature, namely, Tg of polymers) of device materials of construction and
the relevant clinical use conditions. For these materials, the extracts prepared based on 10.3
may have changes either in osmolarities or in the pH that may not be appropriate for the test
system to be dosed. Any adjustment applied to the extracts prior to biocompatibility testing
should be justified.
NOTE: For more information on sample preparation for testing of absorbable medical devices, see ISO
10993-3, ISO 10993-6, ISO 10993-13, ISO 10993-14, ISO 10993-15, ISO 10993-18 and ISO/TS 37137-
1.
Perform extraction using the appropriate extraction vehicle and the conditions of time and
temperature to simulate exaggerated exposure wherever possible. Complete dissolution using
the extraction vehicles and conditions recommended by this document can be appropriate, if
justified; however, caution should be taken since complete device dissolution can create
challenges for subsequent biological testing (e.g., difficulty in dosing animals with neat test
extract if viscosity is increased, difficulty in interpreting in vitro cell-based test failure data in
case of increased osmolality or pH change). For chemical characterization and hazard
assessment of potential intermediate degradants that cannot otherwise be evaluated under these
testing conditions, see ISO 10993-17 and ISO 10993-18.
10.3.3 The standard surface area can be used to determine the volume of extraction vehicle
needed. This area includes the combined area of all tissue contacting surfaces of the sample and
ignores the contribution of indeterminate surface irregularities. When the surface area cannot
be determined due to configuration of the sample, a mass/volume of extracting fluid shall be
used. See Table 1.
Other surface-area-to-volume extraction ratios, for example, those related to evaluation of
porous materials can be used if they simulate the conditions during clinical use or result in a
measure of the hazard potential (ISO/TS 10993-19 describes the tests for the morphological
characterization of porous materials.)
Materials may be cut into small pieces before the extraction to enhance submersion in the
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
|