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GB/T 16886.17-2025 English PDF

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Q: Should I purchase the latest version GB/T 16886.17-2025?

Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB/T 16886.17-2025 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.

GB/T 16886.17: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 16886.17-2025	RFQ	ASK	3 days	Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents	Valid
GB/T 16886.17-2005	150	Add to Cart	Auto, < 3 mins	Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances	Valid

Basic data

Standard ID: GB/T 16886.17-2025 (GB/T16886.17-2025)
Description (Translated English): Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents
Sector / Industry: National Standard (Recommended)
Date of Implementation: 2026-09-01
Older Standard (superseded by this standard): GB/T 16886.17-2005

GB/T 16886.17-2005 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.

Foreword ... 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 ... 37

Foreword

This 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 substances

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.

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)

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 ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of GB/T 16886.17-2025_English be delivered?

Answer: Upon your order, we will start to translate GB/T 16886.17-2025_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of GB/T 16886.17-2025_English with my colleagues?

Answer: Yes. The purchased PDF of GB/T 16886.17-2025_English will be deemed to be sold to your employer/organization who actually pays 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+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.

Question 5: Should I purchase the latest version GB/T 16886.17-2025?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB/T 16886.17-2025 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.