GB 4806.8-2022 PDF English
US$230.00 · In stock · Download in 9 secondsGB 4806.8-2022: National food safety standard - Food Contact Paper and Board Materials and Their Products Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid GB 4806.8: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| GB 4806.8-2022 | English | 230 |
Add to Cart
|
0-9 seconds. Auto-delivery
|
National food safety standard - Food Contact Paper and Board Materials and Their Products
| Valid |
| GB 4806.8-2016 | English | 75 |
Add to Cart
|
0-9 seconds. Auto-delivery
|
National food safety standard -- Food contact paper and board materials and their products
| Obsolete |
Excerpted PDFs (Download full copy in 9 seconds upon purchase)PDF Preview: GB 4806.8-2022
GB 4806.8-2022: National food safety standard - Food Contact Paper and Board Materials and Their Products
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GB4806.8-2022
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.100.20
CCS C 30
GB/T 16886.16-2021 / ISO 10993-16.2017
Replacing GB/T 16886.16-2013
Biological Evaluation of Medical Devices – Part 16.
Toxicokinetic Study Design for Degradation Products and
Leachables
(ISO 10993-16.2017, IDT)
Issued on. NOVEMBER 26, 2021
Implemented on. DECEMBER 01, 2022
Issued by. State Administration for Market Regulation;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword... 3
Introduction... 6
1 Scope... 9
2 Normative References... 9
3 Terms and Definitions... 9
4 Principles for Design of Toxicokinetic Studies... 11
5 Guidance on Test Methods... 12
5.1 General considerations... 12
5.2 Guidance on specific types of test... 14
5.2.1 General... 14
5.2.2 Absorption... 14
5.2.3 Distribution... 14
5.2.4 Metabolism and excretion... 15
Annex A (Normative) Circumstances in which Toxicokinetic Studies shall be
Considered... 17
Bibliography... 19
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 the Part 16 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 for Tests for Interactions with Blood;
--- Part 5.Tests for Cytotoxicity. in Vitro Methods;
--- 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 replaced GB/T 16886.16-2013 Biological Evaluation of Medical Devices - Part
16.Toxicokinetic Study Design for Degradation Products and Leachables. Compared with
GB/T 16886.16-2013, the major technical changes of this Document are as follows besides the
editorial modifications.
--- Modify the definition of term “Absorption” (see 3.1 of this Edition; 3.1 of 2013 Edition);
--- Modify "Principles for design of toxicokinetic studies" (see Clause 4 of this Edition;
Clause 4 of 2013 Edition);
--- Modify the "Guidance on test methods" (see Clause 5 of this Edition; Clause 5 of 2013
Edition);
--- Add information on toxicokinetic studies of nanomaterials (see A.4 of this Edition);
--- Modify the circumstances that shall be considered in toxicokinetic studies (see A.4 of
this Edition; A.4 of 2013 Edition).
This Document used translation method to equivalently adopt ISO 10993-16.2017 Biological
Evaluation of Medical Devices – Part 16.Toxicokinetic Study Design for Degradation Products
and Leachables.
The Chinese document that has a consistent correspondence with the international documents
normatively cited in this document is as follows.
--- GB/T 16886.1-2011 Biological Evaluation of Medical Devices - Part 1.Evaluation and
Testing within a Risk Management Process (ISO 10993-1.2009, IDT).
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 Quality Inspection Center for Medical
Device; and Shandong University.
Chief drafting staffs of this Document. Fan Chunguang, Liu Chenghu, Hou Li, Zhang Na, Liu
Xiangdong, and Dong Xiuli.
The historical editions replaced by this Document are as follows.
--- GB/T 16886.16-2003 was first-time published in 2003; first-time revised in 2013;
--- It is the second-time revised hereby.
1 Scope
This Document provides principles on designing and performing toxicokinetic studies relevant
to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies
in the biological evaluation of medical devices.
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
3 Terms and Definitions
For the purposes of this Document, the terms and definitions given in ISO 10993-1 and the
following apply.
Process by which a biomaterial is degraded in the physiological environment and the product(s)
eliminated and/or absorbed.
Time for the concentration of a specified substance to decrease to 50 % of its initial value in
the same body fluid or tissue.
4 Principles for Design of Toxicokinetic Studies
For analytical methods, other parts of ISO 10993 shall be used as relevant. The methods shall
be fully described in the study report (see 5.1.10). Quantitative analytical methods shall be
specific, sensitive and reproducible (see ISO 10993-18). Limit of detection/quantification shall
be defined and justified.
5 Guidance on Test Methods
Absorption depends on the route of administration, the physicochemical form of the test
substance and the vehicle. It can be estimated from blood, serum, excreta and tissue
concentrations.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
Tips & Frequently Asked QuestionsQuestion 1: How long will the true-PDF of English version of GB 4806.8-2022 be delivered?Answer: The full copy PDF of English version of GB 4806.8-2022 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice. Question 2: Can I share the purchased PDF of GB 4806.8-2022_English with my colleagues?Answer: Yes. The purchased PDF of GB 4806.8-2022_English will be deemed to be sold to your employer/organization who actually paid for it, including your colleagues and your employer's intranet. Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. www.ChineseStandard.us -- GB 4806.8-2022 -- Click this link and select your country/currency to pay, the exact amount in your currency will be printed on the invoice. Full PDF will also be downloaded/emailed in 9 seconds. Question 5: Should I purchase the latest version GB 4806.8-2022?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB 4806.8-2022 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically. How to buy and download a true PDF of English version of GB 4806.8-2022?A step-by-step guide to download PDF of GB 4806.8-2022_EnglishStep 1: Visit website https://www.ChineseStandard.net (Pay in USD), or https://www.ChineseStandard.us (Pay in any currencies such as Euro, KRW, JPY, AUD).
Step 2: Search keyword "GB 4806.8-2022".
Step 3: Click "Add to Cart". If multiple PDFs are required, repeat steps 2 and 3 to add up to 12 PDFs to cart.
Step 4: Select payment option (Via payment agents Stripe or PayPal).
Step 5: Customize Tax Invoice -- Fill up your email etc.
Step 6: Click "Checkout".
Step 7: Make payment by credit card, PayPal, Google Pay etc. After the payment is completed and in 9 seconds, you will receive 2 emails attached with the purchased PDFs and PDF-invoice, respectively.
Step 8: Optional -- Go to download PDF.
Step 9: Optional -- Click Open/Download PDF to download PDFs and invoice.
See screenshots for above steps: Steps 1~3 Steps 4~6 Step 7 Step 8 Step 9
|