GB/T 18279.2-2015 in English

《GB/T 18279.2-2015医疗保健产品的灭菌 环氧乙烷 第2部分：GB 18279.1应用指南》由TC200（全国消毒技术与设备标准化技术委员会）归口，主管部门为国家药品监督管理局。
GB18279的本部分为实施GB18279.1―2015的要求提供指南。本部分不再重述这些要求,也不属于独立应用的准则。
GB18279.1中不适用的条款,本部分也同样不适用。
为方便参照,本部分的条款编号与GB18279.1―2015的编号对应。GB18279.1―2015附录C 已包含了GB18279.1要求的详细指南,宜结合本部分一起应用。
本部分主要适用于已经掌握环氧乙烷灭菌的基本原理,但在更好满足GB18279.1―2015的要求方面需要帮助的人员使用。本部分不适用于缺乏环氧乙烷灭菌基本知识的人员。

GB/T 18279.2-2015 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 is also included in Annex C of GB 18279.1-2015 and should be used in conjunction with this part.

This guidance document 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 part 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 terms and definitions in this document 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 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

4 Quality management systems

4.1 Documentation

4.1.1 No guidance offered.

4.1.2 No guidance offered.

4.2 Management responsibility

4.2.1 Each organization should establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities.

4.2.2 No guidance offered.

4.3 Product realization

4.3.1 Purchasing procedures in a health care facility should ensure that re-usable medical devices are supplied with validated instructions for cleaning, disinfection, sterilization and aeration as specified in ISO 17664.

4.3.2 For those facilities that do not fully comply with ISO 13485, such as health care facilities, procedures for identification of product and maintenance of traceability, should include the labelling of each item or package prior to sterilization with a lot control identifier that includes the following information:

a) the sterilizer ID or code;

b) the date of sterilization;

c) the cycle number (i.e. the cycle run of the day or sterilizer).

It is recommended that the identity of the person who assembled the pack also be included on the identifier, to allow for further investigation if a problem should arise.

Lot identification information enables personnel to retrieve items in the event of a recall and to trace problems to their source.

4.3.3 No guidance offered.

4.4 Measurement, analysis and improvement - Control of non-conforming product

No guidance offered.

5 Sterilizing agent characterization

5.1 Sterilizing agent

EO is a highly penetrative gas that will permeate most packaging materials and polymeric materials. Widely recognized compositions include 100 % EO and blends with carbon dioxide or nitrogen. The storage conditions for EO should be in accordance with the EO manufacturer’s recommendations and all applicable regulations.

5.2 Microbicidal effectiveness

No guidance offered.

5.3 Materials effects

No guidance offered.

5.4 Environmental considerations

5.4.1 EO is toxic, flammable and explosive; therefore, extreme caution should be used during its storage, handling and use.

5.4.2 Effluent gas should be discharged through an EO-gas treatment system, such as a catalytic oxidiser, wet acid scrubber or thermal oxidiser.

When choosing a diluent, its ozone depleting potential should be taken into consideration.

6 Process and equipment characterization

Foreword I
Introduction III
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management systems
5 Sterilizing agent characterization
6 Process and equipment characterization
7 Product definition
8 Process definition
9 Validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
Annex A (Informative) Guidance on GB 18279.1-2015 Annex A Determination of process lethality - Biological indicator/bioburden approach
Annex B (Informative) Guidance on GB 18279.1-2015 Annex B Conservative determination of lethal rate of the sterilization process - Overkill approach
Bibliography