|
US$399.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email.
GB/T 32309-2015: Hydrogen peroxide low temperature plasma sterilizer
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 32309-2015 | English | 399 |
Add to Cart
|
4 days [Need to translate]
|
Hydrogen peroxide low temperature plasma sterilizer
| Valid |
GB/T 32309-2015
|
PDF similar to GB/T 32309-2015
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.
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 32309-2015_English be delivered?Answer: Upon your order, we will start to translate GB/T 32309-2015_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time. Question 2: Can I share the purchased PDF of GB/T 32309-2015_English with my colleagues?Answer: Yes. The purchased PDF of GB/T 32309-2015_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet. Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.
|