GB/T 16886.17-2005Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances (English PDF)
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Issued by
General Administration of Quality Supervision, Inspection and Quarantine
Level / Type
National · Recommended
Issue date
November 4, 2005
Implementation date
April 1, 2006
Scope
GB/T 16886.17-2005 (Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances) is available as an English-translated PDF.
GB/T 16886.17-2005 is the Chinese standard "Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances". Its scope clause reads: This 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. Its clauses include terms and definitions.
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Document preview — GB/T 16886.17-2005
National Standard of the People's Republic of China
- ICS
- 11.100
- Classification
- C 30
Issued by: General Administration of Quality Supervision, Inspection and Quarantine
Contents
- Foreword3
- Introduction5
- 1 Scope6
- 2 Normative references6
- 3 Terms and definitions6
- 4 General principles for establishing allowable limits10
- 5 Establishment of tolerable intake (TI) for specific leachable substances12
- 6 Calculation of tolerable exposure (TE)22
- 7 Feasibility evaluation26
- 8 Benefit evaluation27
- 9 Allowable limits27
- 10 Reporting requirements28
- Annex D (informative) Risk analysis report36
- Bibliography37
1 Scope
This 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 references
The 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 definitions
For 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
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 29 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- GB/T 16886.1-2001Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 16886 · ISO 10993
Cited by
- GB/T 47144-2026Requirements for the development, validation and routine control of cleaning processes for medical devices
- YY/T 1815-2022Biological evaluation of medical devices-Application for the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
- YY/T 1823-2022Cardiovascular implants-Standard test method for nickel ion release of nickel-titanium alloy
- YY/T 1778.1-2021Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
- YY/T 0953-2020Medical carboxymethyl chitosan
- YY/T 0525-2009Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file
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Related Standards
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 16886.10-2024 — Biological evaluation of medical devices - Part 10: Tests for skin sensitization
GB/T 16886.11-2021 — Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
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