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Pass box sterilized with vaporous hydrogen peroxide
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Basic data
| Standard ID | JB/T 20176-2017 (JB/T20176-2017) |
| Description (Translated English) | Pass box sterilized with vaporous hydrogen peroxide |
| Sector / Industry | Mechanical & Machinery Industry Standard (Recommended) |
| Classification of Chinese Standard | C92 |
| Word Count Estimation | 11,111 |
| Date of Issue | 2017-01-09 |
| Date of Implementation | 2017-07-01 |
| Regulation (derived from) | Ministry of Industry and Information Technology Announcement No.2 of 2017 |
| Issuing agency(ies) | Ministry of Industry and Information Technology |
| Summary | This standard specifies the marking, requirements, test methods, inspection rules, signs, instructions for use, packaging, transportation and storage of vaporized hydrogen peroxide sterilization transfer chamber. |
JB/T 20176-2017: Pass box sterilized with vaporous hydrogen peroxide
---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.
(Vaporized hydrogen peroxide sterilization delivery compartment)
ICS 11.120.30
C92
Record number. 57134-2017
People's Republic of China pharmaceutical machinery industry standards
Vaporized hydrogen peroxide sterilization transfer chamber
2017-01-09 Published
2017-07-01 implementation
Ministry of Industry and Information Technology of the People's Republic of China
Foreword
This standard is in accordance with GB/T 1.1-2009 "Standardization Guide Part 1. Standard structure and preparation" and GB/T.20001.10-2014
"Standard writing rules Part 10. Product standards" given the rules.
This standard proposed by the China Pharmaceutical Equipment Industry Association.
This standard by the National Pharmaceutical Equipment Standardization Technical Committee (SAC/TC356) centralized.
This standard was drafted by. Shanghai East Futong Technology Co., Ltd.
Participated in the drafting of this standard. Zhejiang Tailin Biotechnology Co., Ltd., Wenzhou City, Quality and Technical Supervision Inspection and Waugh, Wenzhou Veken Health
Experimental Equipment Co., Ltd.
The main drafters of this standard. Zheng Xiaodong, Zheng Jinwang, Cheng Jinsheng, Wu Wenlei, Xu Wenchao, Jin Chunfeng, summer letter group, Zhan Xin, Chen Chao.
Vaporized hydrogen peroxide sterilization transfer chamber
1 Scope
This standard specifies the vaporizer hydrogen peroxide sterilization transfer chamber marking, requirements, test methods, inspection rules, signs, instructions, packaging,
Transport and storage.
This standard applies to vaporization of hydrogen peroxide on the surface of the sterile material delivery chamber (hereinafter referred to as "transfer chamber").
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 Packaging - Pictorial signs
Mechanical and Electrical Safety Machinery - Electrical Equipment Part 1. General Specifications
Transport packaging and receiving goods mark standards
GB/T 9969 Industrial Products Manual General
The Generation of GB/T 10111 Random Number and Its Application in Product Quality Sampling Inspection
GB/T 13306 signs
GB/T 13384 mechanical and electrical product packaging General technical conditions
GB/T 13554 high efficiency air filter
Sterile biological indicators for health care products - Part 1. General principles
GB/T.19972 health care products sterilization biological indicators selection, use and test results to determine the guidelines
Cleanrooms and related controlled environments Part 7. Isolators
Classification of sealed closures and methods of inspection
GBZ 2.1 Occupational exposure limits for hazardous agents in the workplace Part 1. Chemical hazardous agents
Determination of oxides in the air at workplaces GBZ/T 160.32-2004
Pharmaceutical machinery product model compilation method
People's Republic of China Pharmacopoeia (2015 edition) four
3 mark
3.1 model preparation
Delivery module model according to the provisions of YY/T 0216-1995 prepared.
Function code. Delivery module
Type code. Vaporization
Specification code. Chamber nominal volume, L
3.2 Marking examples
Example .NQ600. Represents a vaporized hydrogen peroxide sterilization delivery chamber of nominal volume 600L.
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