GB/T 18279.2-2015 PDF in English
GB/T 18279.2-2015 (GB/T18279.2-2015, GBT 18279.2-2015, GBT18279.2-2015)
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Sterilization of health care products -- Part 2: Guidance on the application of GB 18279.1
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Standards related to: GB/T 18279.2-2015
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GB/T 18279.2-2015: PDF in English (GBT 18279.2-2015) GB/T 18279.2-2015
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080.01
C 47
GB/T 18279.2-2015 / ISO/TS 11135-2:2008
Partially replacing GB 18279-2000
Sterilization of health care products - Part 2: Guidance on
the application of GB 18279.1
(ISO/TS 11135-2:2008, Sterilization of health care products - Part 2: Guidance on the
application of ISO 11135-1, IDT)
ISSUED ON: DECEMBER 10, 2015
IMPLEMENTED ON: JULY 01, 2017
Issued by: General Administration of Quality Supervision, Inspection and
Quarantine of the People's Republic of China;
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 ... 7
4 Quality management systems ... 8
5 Sterilizing agent characterization ... 9
6 Process and equipment characterization ... 9
7 Product definition ... 11
8 Process definition ... 17
9 Validation ... 21
10 Routine monitoring and control ... 31
11 Product release from sterilization ... 34
12 Maintaining process effectiveness ... 35
Annex A (informative) Guidance on GB 18279.1-2015 Annex A Determination of
process lethality - Biological indicator/bioburden approach ... 40
Annex B (informative) Guidance on GB 18279.1-2015 Annex B Conservative
determination of lethal rate of the sterilization process - Overkill approach ... 51
Bibliography ... 54
Foreword
GB 18279 "Sterilization of health care products" consists of the following parts:
- Part 1: Requirements for development, validation and routine control of a
sterilization process for medical devices;
- Part 2: Guidance on the application of GB 18279.1.
This Part is Part 2 of GB 18279.
This Part was drafted in accordance with the rules given in GB/T 1.1-2009.
This Part together with GB 18279.1 replaces GB 18279-2000 "Medical devices.
Validation and routine control of ethylene oxide sterilization".
This Part identically uses ISO/TS 11135-2:2008 "Sterilization of health care products -
Part 2: Guidance on the application of ISO 11135-1".
The Chinese documents which have consistency with the international normative
reference in this Part are as follows:
- GB 18282.1-2015, Sterilization of health care products - Chemical indicator - Part
1: General requirements (ISO 11140-1:2005, IDT);
- GB/T 19973.1-2015, Sterilization of medical devices - Microbiological methods -
Part 1: Determination of a population of microorganisms on products (ISO 11737-
1:2006, IDT);
- YY/T 0287-2003, Medical devices. Quality management systems. Requirements
for regulatory purposes (ISO 13485:2003, IDT);
- YY/T 0802-2010, Sterilization of medical devices. Information to be provided by
the manufacturer for the processing of resterilizable medical devices (ISO
17664:2004, IDT).
This Part made the following editorial changes:
- Some editorial modifications have been made in accordance with the requirements
of GB/T 1.1;
- The foreword of ISO/TS 11135-2:2008 is deleted;
- Some international standards appearing in the introduction and references are
replaced by corresponding Chinese standards.
Sterilization of health care products - Part 2: Guidance on
the application of GB 18279.1
1 Scope
This Part of GB 18279 provides guidance for the requirements in GB 18279.1-2015. It
does not repeat the requirements and is not intended to be used in isolation.
The exclusions in GB 18279.1 apply also to this Part.
For ease of reference, the clause numbering in this Part corresponds to that in GB
18279.1-2015. Further guidance for the requirements given in GB 18279.1-2015 is also
included in Annex C of GB 18279.1 and should be used in conjunction with this Part.
This Part is intended for people who have a basic knowledge of the principles of EO
sterilization but may need help in determining how to best meet the requirements
contained in GB 18279.1-2015. This document is not intended for people lacking a
basic knowledge of the principles of EO sterilization.
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.
GB 18279.1-2015, Sterilization of health care products - Ethylene oxide - Part 1:
Requirements for development, validation and routine control of a sterilization
process for medical devices (ISO 11135-1:2007, IDT)
GB 18281.2-2015, Sterilization of health care products - Biological indicators - Part
2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-
2:2006, IDT)
ISO 11140-1:2005, Sterilization of health care products - Chemical indicators - Part
1: General requirements
ISO 11737-1, Sterilization of medical devices - Microbiological methods - Part 1:
Determination of a population of microorganisms on products
ISO 13485:2003, Medical devices - Quality management systems - Requirements for
regulatory purposes
ISO 17664, Sterilization of medical devices - Information to be provided by the
manufacturer for the processing of resterilizable medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 dunnage
material used to mimic all or part of a sterilization load
3.2 health care facility
set of physical infrastructure elements intended to support the delivery of specific
health-related services
3.3 processing group
collection of products or product families that can be sterilized in the same EO
sterilization process
NOTE: All products within the group have been determined to present an equal or lesser challenge
to the sterilization process than the challenge device for that group.
3.4 EO product family
collection of products that are determined to be similar or equivalent for validation
purposes
3.5 re-usable medical device
medical device designated or intended by the manufacturer as suitable for reprocessing
and re-use
NOTE: This is not a medical device that is designated or intended by the manufacturer for single
use only.
3.6 single use medical device
medical device that is designated or intended by the manufacturer for one-time use only
3.7 sterilization specialist
person with knowledge of the sterilization technology being utilized and its effects upon
materials and microorganisms
NOTE: This level of knowledge has been obtained by both practical and theoretical means and the
person does not require guidance on the basic principles of the technology involved.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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