GB/T 16886.17-2005 PDF in English
GB/T 16886.17-2005 (GB/T16886.17-2005, GBT 16886.17-2005, GBT16886.17-2005)
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Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances
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Standards related to (historical): GB/T 16886.17-2005
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GB/T 16886.17-2005: PDF in English (GBT 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.
Table of Contents
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
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
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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