GB/T 16886.17-2025 (GB/T 16886.17-2005) PDF EnglishUS$150.00 · In stock · Download in 9 seconds
GB/T 16886.17-2005: Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid GB/T 16886.17: Historical versions
Similar standardsGB/T 16886.17-2005: Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances---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/GBT16886.17-2005 GB NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.100 C 30 GB/T 16886.17-2005 / ISO 10993-17.2002 Biological evaluation of medical devices - Part 17. Establishment of allowable limits for leachable substances (ISO 10993-17.2002, IDT) Issued on: NOVEMBER 04, 2005 Implemented on: APRIL 01, 2006 Issued by. General Administration of Quality Supervision, Inspection and Quarantine; Standardization Administration of the People's Republic of China. Table of ContentsForeword ... 3 Introduction ... 5 1 Scope ... 6 2 Normative references ... 6 3 Terms and definitions ... 6 4 General principles for establishing allowable limits ... 10 5 Establishment of tolerable intake (TI) for specific leachable substances ... 12 6 Calculation of tolerable exposure (TE) ... 22 7 Feasibility evaluation ... 26 8 Benefit evaluation ... 27 9 Allowable limits ... 27 10 Reporting requirements ... 28 Annex A (informative) Some typical assumptions for biological parameters .. 29 Annex B (informative) Risk assessment for mixtures of leachable substances ... 32 Annex C (informative) Conversion of allowable limits for systemic exposure and for body surface contact to maximum dose to patient from a medical device 33 Annex D (informative) Risk analysis report ... 36 Bibliography ... 37ForewordThis Part of GB/T 16886 identically uses ISO 10993-17.2002 “Biological evaluation of medical devices - Part 17. Establishment of allowable limits for leachable substances”. GB/T 16886 “Biological evaluation of medical devices” consists of the following parts. - Part 1. Evaluation and testing; - 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 cytotoxicity. in vitro methods; - Part 6. Tests for local effects after implantation; - Part 7. Ethylene oxide sterilization residuals; - Part 8. Guide to selection and quantification of reference materials for biological testing; - Part 9. Physico-chemical, morphological and topographical characterization of materials; - 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; Biological evaluation of medical devices - Part 17. Establishment of allowable limits for leachable substances1 ScopeThis Part of GB/T 16886 specifies a method for the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified. This Part is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices). Exposure to a particular chemical substance may arise from sources other than the device, such as food, water or air. This Part does not address the potential for exposure from such sources.2 Normative referencesThe following standards contain the provisions which, through reference in this Part of GB/T 16886, constitute the provisions of this Part. For dated references, subsequent amendments (excluding corrections) or revisions do not apply to this Part. However, the parties who enter into agreement based on this Part are encouraged to investigate whether the latest versions of these documents are applicable. For undated reference documents, the latest versions apply to this Part. GB/T 16886.1, Biological evaluation of medical devices - Part 1. Evaluation and testing (GB/T 16886.1-2001, idt ISO 10993-7.1997)3 Terms and definitionsFor the purposes of this Part of GB/T 16886, the terms and definitions given in GB/T 16886.1 and the following apply. 3.1 allowable limit; AL ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. |
