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GB 18281.5-2015: Sterilization of health care products -- Biological indicator -- Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
GB 18281.5-2015
Sterilization of health care products - Biological indicator - Part 5. Biological indicators for low-temperature steam and formaldehyde sterilization processes
ICS 11.080.01
C47
National Standards of People's Republic of China
Sterilization of health care products - Biological indicators
Part 5. Low temperature steam formaldehyde sterilization biological indicators
Sterilizationofhealthcareproducts-Biologicalindicator-Part 5. Biological
(ISO 11138-5.2006, IDT)
Issued on. 2015-12-10
2017-01-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Table of Contents
Introduction Ⅲ
Introduction Ⅳ
1 Scope 1
2 Normative references 1
3 Terms and definitions
4 1 General requirements
1 5 test bacteria
6 1 bacterial suspension
7 carrier and the inner packaging 2
8 carrier contamination and biological indicators 2
9 Number of microbial resistance and 2
Methods Appendix A (normative) Determination of low temperature steam formaldehyde sterilization process Resistance 3
Annex B (informative) low temperature steam formaldehyde principle with liquid biological indicators Test Method 4
Reference 5
Foreword
All technical content in this Part of GB 18281 is mandatory.
GB 18281 "Sterilization of health care products - Biological indicators" is divided into five parts.
--- Part 1. General;
--- Part 2. Biological indicators for ethylene oxide sterilization thereof;
--- Part 3. Biological indicators for moist heat sterilization;
--- Part 4. Biological indicators for dry heat sterilization thereof;
--- Part 5. low temperature steam formaldehyde sterilization biological indicators.
This section is part of the 5 GB 18281.
This section drafted in accordance with GB/T 1.1-2009 given rules.
This section uses the translation method identical with ISO 11138-5.2006 "Sterilization of health care products Biological indicators - Part 5. Low
Temperature steam formaldehyde sterilization biological indicators. "
Consistency correspondence between this part of international documents and normative references of our files are as follows.
--- GB 18281.1-2015 Sterilization of health care products - Biological indicators - Part 1. General (ISO 11138-1.2006,
IDT).
This part made the following editorial changes.
--- According to GB/T 1.1 requirements of a number of editorial changes;
--- Delete international standards foreword.
Please note that some of the content of this document may involve patents. Issuer of this document does not assume responsibility for the identification of these patents.
This part is proposed by the China Food and Drug Administration.
This part of the National Standardization Technical Committee disinfection technology and equipment (SAC/TC200) centralized.
This section drafted by. State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, located in Hangzhou Tailin Biotechnology
Preparation Co., Ltd. Shandong Xinhua Medical Instrument Co., Ltd.
The main drafters of this section. Xu Honglei, summer letter group, the new Mr Wong, Zhu Xiaoming.
introduction
GB 18281 specifies the biological indicator for monitoring sterilization cycle in the production, labeling, test methods and general performance requirements
Further comprising a carrier intended to be used to verify and monitor the bacterial suspension sterilization process. GB 18281 This section gives specific for low temperature steam
Biological indicator of claim formaldehyde vapor sterilization process.
GB 18281 standard series provided the general requirements and test methods required. Currently this series is advanced by professional standards
Manufacturers, users and regulatory authorities involved in standards development. The intention is not only not promote the use is not recommended in biological terms
Indicators, but to provide general requirements now known that the production of biological indicators.
Standard provides the general requirements for the verification and monitoring of low temperature steam formaldehyde sterilization processes (see ISO 14937).
Note. The standard has been published in some countries or regions may cover the requirements for sterilization or biological indicators.
The results of biological indicator selection, use and interpretation of visible ISO 14161.
Sterilization of health care products - Biological indicators
Part 5. Low temperature steam formaldehyde sterilization biological indicators
1 Scope
GB 18281 of the provisions of this part of the test microorganisms, bacterial suspension, the carrier contamination, biological indicator and low temperature steam formaldehyde sterilization
General requirements for sterilization agent to assess the treatment effect of biological indicator test method.
Note 1. The requirements for low temperature steam formaldehyde sterilization process control and confirmation, see ISO 14937.
Note 2. For the safety requirements in the workplace, see national or regional regulations.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
ISO 11138-1.2006 Sterilization of health care products - Biological indicators - Part 1. General (Sterilizationofhealthcare
products-Biologicalindicators-Part 1. Genralrequirements)
3 Terms and Definitions
As defined in ISO 11138-1 and the following terms and definitions apply to this document.
3.1
Low temperature steam formaldehyde sterilization low-temperaturesteamandformaldehydesterilization
By the power exhaust, so that pre-packaged goods in the vacuum state is exposed to steam at temperatures below 100 ℃, the injection of formaldehyde gas,
Such sterilizing agents in the maintenance time remains steady process.
4 General requirements
ISO 11138-1 requirements apply to this section.
5 test bacteria
5.1 Test bacteria should be Bacillus stearothermophilus or other has been found to comply with the requirements of this strain of microorganism equivalent performance.
Note 1. Bacillus stearothermophilus have been reclassified to Bacillus stearothermophilus.
Note 2. The currently considered applicable to Bacillus stearothermophilus, as NCIB8224, DSM6790, ATCC10149 and ATCC12980.
5.2 If the use of a test bacteria Bacillus stearothermophilus ground outside, then this strain of bacteria resistance test suitability should be determined.
6 bacterial suspension
ISO 11138-1 requirements apply to this section.
7 carrier and the inner packaging
7.1 low temperature steam formaldehyde sterilization agent biological indicator carriers and inner packing material should conform to ISO 11138-1.2006 5.2
And ISO 11138-1.2006 requirements in Appendix B of.
Note. Due to the cellulose surface chemical formaldehyde adsorption filter paper type is not suitable as a carrier.
7.2 should comply with the determined exposure conditions.
a) Minimum temperature exposure. not less than 5 ℃ (above the manufacturer claims the highest temperature);
b) maximum exposure temperature. According to the manufacturer's maximum claims; If the manufacturer is not declared, should not be less than the maximum exposure temperature
100 ℃;
c) Exposure time. not less than 60min.
Note. These conditions have become a caution, with practical limits on bacteria in the range of application of low temperature ...