GB/T 32309-2015 English PDF

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GB/T 32309-2015: Hydrogen peroxide low temperature plasma sterilizer
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 32309-2015	399	Add to Cart	4 days	Hydrogen peroxide low temperature plasma sterilizer	Valid

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Basic data

Standard ID: GB/T 32309-2015 (GB/T32309-2015)
Description (Translated English): Hydrogen peroxide low temperature plasma sterilizer
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C47
Classification of International Standard: 11.080.10
Word Count Estimation: 19,132
Date of Issue: 2015-12-10
Date of Implementation: 2016-09-01
Quoted Standard: GB/T 191; GB/T 1616; GB 4793.1; GB/T 4982; GB/T 14710-2009; GB/T 18268.1; GB/T 18268.21; GB/T 18268.22; GB/T 18268.23; GB/T 18268.24; GB/T 18268.25; GB/T 18268.26; GB 19192-2003; GBZ 159-2004; WS/T 132-1999; YY 0466
Regulation (derived from): National Standard Announcement 2015 No.38
Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary: This standard specifies the terms and definitions, requirements, test methods, inspection rules and marks, packaging, instructions for use, transport and storage of hydrogen peroxide low-temperature plasma sterilizers (hereinafter referred to as sterilizers). This standard applies to only hydrogen peroxide as sterilization medium, can produce plasma low-temperature sterilizer. This standard does not specify safety requirements related to the use of the risk range and does not prescribe the requirements for confirmation and routine control of low temperature hydrogen peroxide plasma.

GB/T 32309-2015: Hydrogen peroxide low temperature plasma sterilizer

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Hydrogen peroxide low temperature plasma sterilizer ICS 11.080.10 C47 National Standards of People's Republic of China Hydrogen peroxide low temperature plasma sterilizer Issued on. 2015-12-10 2016-09-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released

Table of Contents

Introduction Ⅲ 1 Scope 1 2 Normative references 1 3 Terms and definitions 4 Category 2 5 Requirement 2 6 Test methods 7 7 Inspection rules 10 8 signs, packaging, manual, transportation and storage 11 Appendix A (informative) sterilizer sterilization requirements of article 13

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This standard was proposed by the China Food and Drug Administration. This standard by the National Standardization Technical Committee disinfection technology and equipment (SAC/TC200) centralized. This standard is drafted by. Shandong Xinhua Medical Instrument Co., Ltd., Guangzhou, the State Food and Drug Administration Medical Devices Quality The amount of supervision and inspection center. Participated in the drafting of this standard. Medical Devices Co., Ltd. Hangzhou Yi Road, Chengdu old Ken Technology Co., Ltd. The main drafters of this standard. Wang Junjie, Yang Lei, Wang Hongmin, the new Mr Wong, Chen Jia Ye, Huang Xiulian, Sun Jiansheng, Liu Yong. Hydrogen peroxide low temperature plasma sterilizer

1 Scope

This standard specifies the hydrogen peroxide low temperature plasma sterilizer (hereinafter referred to as sterilization) terms and definitions, requirements, test methods, inspection Inspection rules and signs, packaging, manual, transport and storage. This standard applies only to hydrogen peroxide sterilization media, capable of producing low-temperature plasma sterilizer. This standard does not specify the scope of the risks involved in the use of security requirements, low-temperature hydrogen peroxide plasma, validation and routine control unspecified Claim. Note. This standard refers to the low temperature sterilization, the sterilizing chamber temperature of not more than 60 ℃.

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. GB/T 191 Packaging - Pictorial signs GB/T 1616 Industrial hydrogen peroxide GB 4793.1 measurement, control and laboratory safety requirements for electrical equipment - Part 1. General requirements GB/T 4982 Vacuum technology - Quick release couplings - Dimensions - Part 1. Clamping Type GB/T 14710-2009 medical electrical environmental requirements and test methods EMC requirements for electrical equipment GB/T 18268 (all parts) measurement, control and laboratory use GB 19192-2003 contact lens care solution hygiene requirements GB Z159-2004 workplace air sampling regulate hazardous substances monitoring Spectrophotometric method WS/T 132-1999 Workplace air hydrogen peroxide Symbol YY0466 medical equipment used with medical device labels, labeling and information provided Disinfection Technical Specification (Version 2002) People's Republic of China Ministry of Health

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 Plasma plasma Positive and negative ions ionized by the reaction of the gas molecules, and other forms charged species coexist. Partially ionized plasma forms part, which contains positive and negative ions, free radicals, vacuum ultraviolet light, neutral atoms and molecules. Note. This standard plasma belongs to the category of low temperature plasma. 3.2 Ventilation aeration Part or parts of the sterilization process. Under certain conditions the air is injected into the sterilization chamber clean process. 3.3 Sterilization cycle sterilizationcycle Sterilized for the purpose of automatic program execution stage within the sterilizer. ......

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