GB/T 16886.1-2022_English: PDF (GB/T16886.1-2022)
Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
GB/T 16886.1-2022 | English | 590 |
Add to Cart
|
0--9 seconds. Auto-delivery
|
Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
| Valid |
GB/T 16886.1-2022
|
GB/T 16886.1-2011 | English | 125 |
Add to Cart
|
0--9 seconds. Auto-delivery
|
Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
| Obsolete |
GB/T 16886.1-2011
|
GB/T 16886.1-2001 | English | 639 |
Add to Cart
|
3 days [Need to translate]
|
Biological evaluation of medical devices -- Part 1: Evaluation and testing
| Obsolete |
GB/T 16886.1-2001
|
GB/T 16886.1-1997 | English | 599 |
Add to Cart
|
3 days [Need to translate]
|
Biological evaluation of medical devices--Part 1: Guidance on selection of tests
| Obsolete |
GB/T 16886.1-1997
|
Standard ID | GB/T 16886.1-2022 (GB/T16886.1-2022) | Description (Translated English) | Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process | Sector / Industry | National Standard (Recommended) | Classification of Chinese Standard | C30 | Classification of International Standard | 11.100.20 | Word Count Estimation | 39,381 | Date of Issue | 2022-04-15 | Date of Implementation | 2023-05-01 | Drafting Organization | Shandong Institute of Medical Device and Drug Packaging Inspection, State Drug Administration Medical Device Technology Review Center | Administrative Organization | National Technical Committee for Standardization of Biological Evaluation of Medical Devices (SAC/TC 248) | Proposing organization | State Drug Administration | Issuing agency(ies) | State Administration for Market Regulation, National Standardization Administration | Standard ID | GB/T 16886.1-2011 (GB/T16886.1-2011) | Description (Translated English) | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | Sector / Industry | National Standard (Recommended) | Classification of Chinese Standard | C30 | Classification of International Standard | 11.040.01 | Word Count Estimation | 27,272 | Date of Issue | 2011-06-16 | Date of Implementation | 2011-12-01 | Older Standard (superseded by this standard) | GB/T 16886.1-2001 | Quoted Standard | ISO 10993-2; ISO 10993-3; ISO 10993-4; ISO 10993-5; ISO 10993-6; ISO 10993-7; ISO 10993-9; ISO 10993-10; ISO 10993-11; ISO 10993-12; ISO 10993-13; ISO 10993-14; ISO 10993-15; ISO 10993-16; ISO 10993-17; ISO 10993-18-2005; ISO/TS 10993-19; ISO/TS 10993-20; ISO 14971 | Adopted Standard | ISO 10993-1-2009, IDT | Drafting Organization | Jinan, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center | Administrative Organization | Biological Evaluation of Medical Devices National Standardization Technical Committee | Regulation (derived from) | Announcement of Newly Approved National Standards No. 9 of 2011 | Proposing organization | State Food and Drug Administration | Issuing agency(ies) | Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China; Standardization Administration of China | Summary | This standard specifies: Medical Device Risk Management framework guiding biological evaluation of medical devices basic principles of human contact by equipment nature and timing of the general classification, all sources of relevant data evaluation, based on risk analysis based on the data available group identification of defects, biological safety of medical devices required for the analysis of other data set identification, medical assessment of biological safety. | Standard ID | GB/T 16886.1-2001 (GB/T16886.1-2001) | Description (Translated English) | Biological evaluation of medical devices--Part 1: Evaluation and testing | Sector / Industry | National Standard (Recommended) | Classification of Chinese Standard | C30 | Classification of International Standard | 11.040.01 | Word Count Estimation | 16,112 | Date of Issue | 2001/9/24 | Date of Implementation | 2002/2/1 | Older Standard (superseded by this standard) | GB/T 16886.1-1997 | Adopted Standard | ISO 10993-1-1997, IDT | Regulation (derived from) | Announcement of Newly Approved National Standards 2011 No. 9 | Proposing organization | State Drug Administration | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People Republic of China |
GB/T 16886.1-2022
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.100.20
CCS C 30
GB/T 16886.1-2022 / ISO 10993-1:2018
Replacing GB/T 16886.1-2011
Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management process
(ISO 10993-1:2018, IDT)
ISSUED ON: APRIL 15, 2022
IMPLEMENTED ON: MAY 01, 2023
Issued by: State Administration for Market Regulation;
Standardization Administration of the PRC.
Table of Contents
Foreword ... 3
Introduction ... 6
1 Scope ... 10
2 Normative references ... 11
3 Terms and definitions ... 13
4 General principles applying to biological evaluation of medical devices ... 18
5 Categorization of medical devices ... 23
5.1 General ... 23
5.2 Categorization by nature of body contact ... 24
5.2.1 Non-contacting medical devices ... 24
5.2.2 Surface-contacting medical devices ... 24
5.2.3 Externally communicating medical devices ... 25
5.2.4 Implant medical devices ... 25
5.3 Categorization by duration of contact ... 26
5.3.1 Contact duration categories ... 26
5.3.2 Transitory-contacting medical devices ... 26
5.3.3 Medical devices with multiple contact duration categories ... 26
6 Biological evaluation process ... 27
6.1 Physical and chemical information for biological risk analysis ... 27
6.2 Gap analysis and selection of biological endpoints for assessment ... 28
6.3 Biological testing ... 29
6.3.1 General ... 29
6.3.2 Testing for evaluation ... 30
7 Interpretation of biological evaluation data and overall biological risk assessment 36
Annex A (Informative) Endpoints to be addressed in a biological risk assessment ... 38
Annex B (Informative) Guidance on the conduct of biological evaluation within a risk
management process ... 44
Annex C (Informative) Suggested procedure for literature review ... 62
Bibliography ... 65
Foreword
This document is drafted in accordance with GB/T 1.1-2020 "Directives for
standardization - Part 1: Rules for the structure and drafting of standardizing
documents".
The document is Part 1 of GB/T 16886 "Biological evaluation of medical devices".
GB/T 16886 has issued 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 leachables;
- Part 17: Establishment of allowable limits for leachable substances;
- Part 18: Chemical characterization of materials;
- Part 19: Physico-chemical, morphological and topographical characterization of
materials;
- Part 20: Principles and methods for immunotoxicology testing of medical devices.
This document replaces GB/T 16886.1-2011 "Biological evaluation of medical devices
- Part 1: Evaluation and testing within a risk management process". Compared with
GB/T 16886.1-2011, in addition to structural adjustment and editorial changes, the main
technical changes are as follows:
a) Add the scope of applicability and inapplicability for carrying out biological
hazard assessment (see Clause 1);
b) Add some terms and definitions used in GB/T 16886 (see Clause 3);
c) Add nanomaterial (see 3.15, 4.3, 6.1, 6.3.2, 6.3.2.13, 6.3.2.14, 6.3.2.15, B.3.1.2,
B.4.1.4) and absorbable material evaluation information (see B.4.3.3 and B.4.4.2);
d) Add biological evaluation procedures for medical devices [see 4.1 a)];
e) Add the content of the overall biological evaluation of medical devices [see 4.3
c)];
f) Add biological safety assessment requirements for "whole life-cycle of a medical
device" and "re-usable medical devices" (see 4.7 and 4.8);
g) Change the "Summary of the systematic approach to a biological evaluation of
medical devices as part of a risk management process" (see Figure 1; Figure 1 of
the 2011 edition);
h) Add requirements for biological risk assessment of commercially-marketed
medical devices when the edition of this document is updated (see 4.11);
i) Add the evaluation information of "Non-contacting medical devices" (see 5.2.1)
and the evaluation information of "Transitory-contacting medical devices" (see
5.3.2);
j) Change the description of medical devices that contact tissue, bone or pulp/dentin
systems [see 5.2.3 b); 5.2.2 b) of the 2011 edition];
k) Add "Gap analysis and selection of biological endpoints for assessment" (see 6.2);
l) Add procedures to be considered in selecting biological testing [see 5) in item b)
of 6.3.1];
m) Add requirements for acute systemic toxicity test or risk assessment (see 6.3.2.6);
n) Add the principle of using animal tests for biological endpoint studies (see 6.3.2.9);
o) Change the situation of considering biodegradation tests (see 6.3.2.13; 6.2.2.13 of
the 2011 edition);
Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management process
1 Scope
This document specifies:
- the general principles governing the biological evaluation of medical devices
within a risk management process;
- the general categorization of medical devices based on the nature and duration of
their contact with the body;
- the evaluation of existing relevant data from all sources;
- the identification of gaps in the available data set on the basis of a risk analysis;
- the identification of additional data sets necessary to analyse the biological safety
of the medical device;
- the assessment of the biological safety of the medical device.
This document applies to evaluation of materials and medical devices that are expected
to have direct or indirect contact with:
- the patient's body during intended use;
- the user’s body, if the medical device is intended for protection (e.g., surgical
gloves, masks and others).
This document is applicable to biological evaluation of all types of medical devices
including active, non-active, implantable and non-implantable medical devices.
This document also gives guidelines for the assessment of biological hazards arising
from:
- risks, such as changes to the medical device over time, as a part of the overall
biological safety assessment;
- breakage of a medical device or medical device component which exposes body
tissue to new or novel materials.
Other parts of GB/T 16886 cover specific aspects of biological assessments and related
tests. Device-specific or product standards address mechanical testing.
This document excludes hazards related to bacteria, fungi, yeasts, viruses, transmissible
spongiform encephalopathy (TSE) agents and other pathogens.
2 Normative references
The contents of the following documents, through normative references in this text,
constitute indispensable provisions of this document. Among them, for dated references,
only the edition corresponding to that date applies to this document. For undated
references, the latest edition (including all amendments) applies to this document.
GB/T 16886.2-2011 Biological evaluation of medical devices - Part 2: Animal
welfare requirements (ISO 10993-2:2006, IDT)
GB/T 16886.11-2021 Biological evaluation of medical devices - Part 11: Tests for
systemic toxicity (ISO 10993-11:2017, IDT)
YY/T 0316-2016 Medical devices - Application of risk management to medical
devices (ISO 14971:2007, IDT)
ISO 10993-2 Biological evaluation of medical devices - Part 2: Animal welfare
requirements
ISO 10993-3 Biological evaluation of medical devices - Part 3: Tests for genotoxicity,
carcinogenicity and reproductive toxicity
Note: GB/T 16886.3-2019 Biological evaluation of medical devices - Part 3: Tests for
genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014, IDT)
ISO 10993-4 Biological evaluation of medical devices - Part 4: Selection of tests for
interactions with blood
Note: GB/T 16886.4-2022 Biological evaluation of medical devices - Part 4: Selection of tests
for interactions with blood (ISO 10993-4:2017, IDT)
ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro
cytotoxicity
Note: GB/T 16886.5-2017 Biological evaluation of medical devices - Part 5: Tests for in vitro
cytotoxicity (ISO 10993-5:2009, IDT)
ISO 10993-6 Biological evaluation of medical devices - Part 6: Tests for local effects
after implantation
Note: GB/T 16886.6-2022 Biological evaluation of medical devices - Part 6: Tests for local
effects after implantation (ISO 10993-6:2016, IDT)
ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide
......
GB/T 16886.1-2011
ICS 11.040.01
C 30
NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC
OF CHINA
GB/T 16886.1-2011 / ISO 10993-1. 2009
Replacing GB/T 16886.1-2001
Biological evaluation of medical devices --
Part 1. Evaluation and testing within a risk
management process
(ISO 10993-1. 2009, IDT)
ISSUED ON. JUNE 16, 2011
IMPLEMENTED ON. NOVEMBER 01, 2011
Issued by.
General Administration of Quality Supervision, Inspection and
Quarantine of the People’s Republic of China;
Standardization Administration of the People’s Republic of China
Table of Contents
Foreword ... 3
Introduction ... 7
1 Scope ... 9
2 Normative references... 9
3 Terms and definitions ... 11
4 General principles applying to biological evaluation of medical devices ... 13
5 Classification of medical devices ... 16
6 Biological evaluation process ... 19
7 Interpretation of biological evaluation data and overall biological safety
assessment ... 27
Annex A (Informative) Biological evaluation trial... 29
Annex B (Informative) Guidance of risk management process ... 30
Annex C (Informative) Suggested procedure for document review ... 34
Bibliography ... 37
Translation References and Original Chinese Standard ... 38
Foreword
GB/T 16886 Biological evaluation of medical devices consists of 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 trial for interactions with blood;
— Part 5. Test 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 delayed-type hypersensitivity;
— 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 leachables;
— Part 17. Establishment of allowable limits for leachable substances;
This Part is Part 1 of GB/T 16886.
There are other standards for biological trial in other aspects.
This Part is drafted according to the rules specified in GB/T 1.1-2009.
This Part replaces GB/T16886.1-2001 Biological Evaluation of Medical Devices -- Part 1.
Evaluation and Test. Compared with GB/T 16886.1-2001, the main contents modified are
as follows.
— Modified the name of the Standard;
cytotoxicity (ISO 10993-5. 1999, IDT)
GB/T 16886.6-1997 Biological evaluation of medical devices -- Part 6. Tests for local
effects after implantation (ISO 10993-6. 1994, IDT)
GB/T 16886.7-2001Biological evaluation of medical devices -- Part 7. Ethylene oxide
sterilization residuals (ISO 10993-7. 2995, IDT)
GB/T 16886.9-2001 Biological evaluation of medical devices -- Part 9. Framework for
identification and quantification of potential degradation products (ISO 10993-9. 1999,
IDT)
GB/T 16886.10-2005 Biological evaluation of medical devices -- Part 10. Tests for irritation
and delayed-type hypersensitivity (ISO 10993-10. 2002, IDT)
GB/T 16886.11-1997Biological evaluation of medical devices -- Part 11. Tests for systemic
toxicity (ISO 10993-11. 1993, IDT)
GB/T 16886.12-2005 Biological evaluation of medical devices -- Part 12. Sample
preparation and reference materials (ISO 10993-12. 2002, IDT)
GB/T 16886.13-2001Biogical evaluation of medical devices -- Part 13. Identification and
quantification of degradation products from polymeric medical devices (ISO 10993-12.
1998, IDT)
GB/T 16886.14-2003Biological evaluation of medical devices -- Part 14. Identification and
quantification of degradation products from ceramics (ISO 10993-14. 2001, IDT)
GB/T 16886.15-2003 Biological evaluation of medical devices -- Part 15. Identification and
quantification of degradation products from metals and alloys (ISO 10993-15. 2000, IDT)
GB/T 16886.16-2003Biological evaluation of medical devices -- Part 16. Toxicokinetic
study design for degradation products and leachables (ISO 10993-15. 2000, IDT)
GB/T 16886.17-2005Biological evaluation of medical devices -- Part 17. Establishment of
allowable limits for leachable substances (ISO 10993-17. 2002, IDT)
YY/T 0316-2008 Medical devices -- Application of risk management to medical devices
(ISO 14971. 2007, IDT)
This Part is proposed by SFDA (State Food and Drug Administration)
This Part is under the jurisdiction of National Technical Committee (SAC/TC 248) on
Biological Evaluation on Medical Device of Standardization Administration of China.
The responsible drafting organization is Jinan Medical Device Quality Supervision
Inspection Centre of SFDA.
The chief drafting staffs of this Part include Wu Ping, You Shaohua and Liu Chenghu.
This Part replaces the following historical editions.
— GB/T 16886.1-2001; GB/T 16886.1-1997.
Introduction
The primary aim of this Part of GB/T 16886 / ISO 10993 is to protect humans from
potential biological risks arising from the use of medical devices. This Part is compiled
from numerous International and National Standards and Guidelines concerning the
biological evaluation of medical devices. It is intended to be a guiding document for the
biological evaluation of medical devices for risk management process (as part of overall
evaluation and development process for various medical devices). This approach
combines the review and evaluation of existing data from all sources with, where
necessary, the selection and application of additional trial, so that to perform holistic
biological evaluation to the usage safety of various medical devices. It must be
appreciated that the term “medical device” has wide-ranging meaning, it may be
consisted of a single material which may be existed in more than one physical form, it may
also be consisted of complex instruments which are consisted of multiple components or
apparatus components made of multiple materials.
GB/T 16886 / ISO 10993 addresses the determination of the effects of medical devices on
tissues, under general condition, it does not involve device of special application. Thus, for
a complete biological safety evaluation, it classifies medical devices according to the
nature and duration of their anticipated contact with human tissues when in use. It
indicates, in matrices, the biological data sets that need to be considered by various
medical devices.
The range of biological hazards is wide and complex. When considering the mutual
interaction between tissue and composing material, it cannot be isolated from the overall
device design. Thus, in designing a device, choosing the best material with respect to its
tissue interaction may not necessarily result good performance of device, the interaction
between tissue and material is only one of the characteristics to be considered in making
that choice. When implementing device’s function, biological evaluation must involve the
mutual interaction between the material prediction and tissue.
Tissue interactions refer to the adverse reaction caused by a material under the specific
application, it might not occur un other applications. Biological trial is usually based upon
in-vitro and semi-vivo trial methods and animal models, it cannot unequivocally conclude
that the same reaction will also occur in human body. Therefore, it can only be shown in
the form of caution to judge the predicted effect when the device is used in human body. In
addition, different individuals may respond differently to the same material, it indicates that
some patients can have adverse reactions even to well-established materials.
The role of this Part is to provide framework for planning biological evaluation of medical
device. Along with the scientific knowledge advancement and understanding of the basic
mechanisms of tissue responses, under the conditions that it is possible to obtain the
same relevant information as in-vivo model, it shall preferably adopt chemical analysis trial
and in-vitro model, so as the quantity of tested animals is minimized.
GB/T 16886 / ISO 10993 do not intent to rigidly specify a set of test methods, including
pass/fail criteria. As this might result in 2 possibilities. One of the possibilities is that
development and application of new medical device may be unnecessarily restrained,
another possibility is that a false sense of security may be generated by using the medical
device. Under the ...
......
|