GB/T 16886.7-2015 PDF English
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Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
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GB/T 16886.7-2015: Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
---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/GBT16886.7-2015
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.100
C 30
GB/T 16886.7-2015 / ISO 10993-7.2008
Replacing GB/T 16886.7-2001
Biological evaluation of medical devices -
Part 7.Ethylene oxide sterilization residuals
(ISO 10993-7.2008, IDT)
Issued on. DECEMBER 10.2015
Implemented on. JANUARY 01, 2017
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... 6
1 Scope... 7
2 Normative references... 7
3 Terms and definitions... 8
4 Requirements... 8
5 Product release... 20
Annex A (normative) Evaluation of gas chromatograms... 23
Annex B (informative) Gas chromatographic determination for EO and ECH 27
Annex C (informative) Flowchart and guidance for the application of this Part of
ISO 10993 series of standards to the determination of EO and ECH residuals
in medical devices... 32
Annex D (informative) Factors influencing product residual... 41
Annex E (informative) Extraction conditions for determination of residual EO43
Annex F (informative) Rationale for the provisions of this Part of ISO 10993 45
Annex G (informative) Establishment of allowable limits for EO... 51
Annex H (informative) Establishment of allowable limits for ECH... 75
Annex I (informative) Establishment of allowable limits for EG... 86
Annex J (informative) Preparation of EO and ECH standards... 92
Annex K (informative) Ethylene oxide residue measuring methods... 97
Bibliography... 107
Foreword
GB/T 16886 “Biological evaluation of medical devices” consists of 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 of tests for interactions with blood;
-- Part 5.Tests for in vitro cytotoxicity;
-- Part 6.Tests for local effects after implantation;
-- Part 7.Ethylene oxide sterilization residuals;
-- Part 8.Selection and limitation of reference materials for biological tests;
-- Part 9.Framework for identification and quantification of potential
degradation products;
-- Part 10.Tests for irritation and 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 Part is Part 7 of GB/T 16886.
This Part was drafted in accordance with the rules given in GB/T 1.1-2009.
This Part replaces GB/T 16886.7-2001 “Biological evaluation of medical
devices - Part 7.Ethylene oxide sterilization residuals”. Compared with GB/T
16886.7-2001, the main changes are as follows.
-- modified the introduction;
-- modified 4.1 General;
-- modified 4.3 Allowable limits. adding the overview; modifying the amounts
of allowable limit for ethylene oxide (EO) and 2-chloroethanol (ECH);
adding the tolerable contact limits for surface contact devices and implants;
modifying the average daily exposure dose for special devices EO and
ECH;
-- modified 4.4.3 Product sampling;
-- modified 4.4.6 Product extraction;
-- modified Annex A Evaluation of gas chromatograms;
-- modified Annex B Gas chromatographic determination for EO and ECH.
integrating EO and ECH standard preparation, instrumentation, reagents
and product leaching into Annex J and Annex K; adding the determination
of precision, linearity, method detection limit and limit of quantitation;
deleting Gas chromatographic conditions recommended by Table B.2;
-- added Flowchart and guidance for the application of this Part of GB/T
16886 series of standards to the determination of EO and ECH residuals
in medical devices;
-- modified previous Annex A (present Annex E) Extraction conditions for
determination of residual EO;
-- modified description of previous Annex E (present Annex F). modifying the
name as “Rationale for the provisions of this Part of GB/T 16886”;
integrating the determination of EO and ECH allowable limits into Annex
G and Annex H respectively; completing and improving;
-- added Annex G Establishment of allowable limits for EO;
-- added Annex H Establishment of allowable limits for ECH;
-- added Annex I Establishment of allowable limits for EG;
-- added Annex J Preparation of EO and ECH standards;
-- added Annex K Ethylene oxide residue measuring methods.
This Part uses translation method to identically adopt ISO 10993-7.2008
“Biological evaluation of medical devices - Part 7.Ethylene oxide sterilization
residuals”.
The Chinese documents which have consistency with the international
normative references in this Part are as follows.
GB/T 16886.1-2001, Biological evaluation of medical devices - Part 1.
Evaluation and testing (ISO 10993-1.1997, IDT)
GB/T 16886.3-2008, Biological evaluation of medical devices - Part 3.Tests
for genotoxicity carcinogenicity and reproductive toxicity (ISO 10993-
3.2003, IDT)
GB/T 16886.10-2005, Biological evaluation of medical devices - Part 10.
Tests for irritation and delayed-type hypersensitivity (ISO 10993-10.2002,
IDT)
GB/T 16886.12-2005, Biological evaluation of medical devices - Part 12.
Sample preparation and reference materials (ISO 10993-12.2002, IDT)
GB/T 16886.17-2005, Biological evaluation of medical devices - Part 17.
Establishment of allowable limits for leachable substances (ISO 10993-
17.2002, IDT)
This Part was proposed by China Food and Drug Administration.
This Part shall be under the jurisdiction of National Technical Committee on
Medical Device Biology Evaluation of Standardization Administration of China
(SAC/TC 248).
The drafting organization of this Part. China Food and Drug Administration
Jinan Medical Device Quality Supervision and Inspection Center.
Main drafters of this Part. Luo Hongyu, Shi Yanping, Pan Huaxian, Sun
Guangyu, Liu Lili, Shen Yong, Xu Kai.
Versions of standard substituted by this Part is.
-- GB/T 16886.7-2001.
1 Scope
This Part of GB/T 16886 specifies allowable limits for residual ethylene oxide
(EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical
devices, procedures for the measurement of EO and ECH, and methods for
determining compliance so that devices may be released.
2 Normative references
The following referenced documents are indispensable for the application of
this document. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any
amendments) applies.
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 defined in ISO
10993-1 and ISO 10993-17 as well as the followings apply.
extraction until the amount of EO or ECH in a subsequent extraction is less than
10 % of that detected in the first extraction, or until there is no analytically
significant increase in the cumulative residue levels detected
4 Requirements
In establishing the maximum daily doses of EO and ECH that a medical device
is allowed to deliver to patients, devices shall be categorized according to the
duration of contact.
Devices shall be placed into one of three exposure categories in accordance
with ISO 10993-1, 5.3.
5 Product release
Dissipation curves are used to estimate the post-sterilization time required for
products, or families of similar products, to reach residue limits, principally for
EO, in compliance with 4.3.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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