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YY/T 0158-2013: Gasket ring on pressure steam sterilizer
Status: Obsolete YY/T 0158: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0158-2013 | English | 279 |
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3 days [Need to translate]
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Gasket ring on pressure steam sterilizer
| Obsolete |
YY/T 0158-2013
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| YY/T 0158-2005 | English | 239 |
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2 days [Need to translate]
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Spring type gasket on pressure steam sterilizer
| Obsolete |
YY/T 0158-2005
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| YY/T 0158-1994 | English | 239 |
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2 days [Need to translate]
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(Pressure steam sterilization equipment gasket)
| Obsolete |
YY/T 0158-1994
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PDF similar to YY/T 0158-2013
Standard similar to YY/T 0158-2013 YY/T 0802.1 YY/T 1268 YY 1277 YY/T 0802.2 Basic data | Standard ID | YY/T 0158-2013 (YY/T0158-2013) | | Description (Translated English) | Gasket ring on pressure steam sterilizer | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C47 | | Classification of International Standard | 11.080.99 | | Word Count Estimation | 7,712 | | Older Standard (superseded by this standard) | YY/T 0158-2005 | | Quoted Standard | GB/T 528; GB/T 531.1; GB/T 2828.1; GB/T 2829; GB/T 3512; GB/T 9969; HG/T 2198 | | Regulation (derived from) | State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies: pressure steam sterilization equipment gasket classification, requirements, test methods, inspection rules, marking and instruction manual and packaging, transportation and storage. This standard applies to: the design pressure of | YY/T 0158-2013: Gasket ring on pressure steam 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.
Gasket ring on pressure steam sterilizer
ICS 11.080.99
C47
People's Republic of China pharmaceutical industry standards
Replacing YY/T 0158-2005
Pressure steam sterilization equipment gasket
Issued on. 2013-10-21
2014-10-01 implementation
China Food and Drug Administration released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
Instead of the standard YY/T 0158-2005 "pressure steam sterilization equipment gasket."
This standard compared with YY/T 0158-2005, the main changes are as follows.
--- The standard name was changed to "pressure steam sterilization equipment gasket";
--- Original standard Chapter 1 "Scope" was amended;
--- Increasing the silicone gasket in the original standard 3.1 "classification";
--- Original standard Chapters 4 and 5 was amended.
This standard was proposed by the China Food and Drug Administration.
This standard by the National Standardization Technical Committee disinfection technology and equipment.
This standard was drafted. State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Shanghai Hua nuclear medical instrument line
Co., Ltd, Zhangjiagang Hualing Medical Equipment Manufacturing Co., Ltd.
The main drafters of this standard. Xu Honglei, Zhenghong Qin, Huang new Zhoujian Fang.
This standard by the National Standardization Technical Committee disinfection technology and equipment responsible for the interpretation.
This standard replaces the standards previously issued as follows.
--- YY/T 0158-1994; YY/T 0158-2005.
Pressure steam sterilization equipment gasket
1 Scope
This standard specifies pressure steam sterilization equipment Gasket classification, requirements, test methods, inspection rules, marking and instruction manual
And packaging, transportation and storage.
This standard applies to the design pressure is less than 0.4MPa, the design temperature in the range of 115 ℃ ~ 150 ℃ pressure steam sterilization equipment
Gasket (hereinafter referred to as "gasket").
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 528 Determination of vulcanized rubber or thermoplastic rubber tensile stress-strain properties
GB/T 531.1 vulcanized rubber or thermoplastic rubber hardness test pushed Part 1. Shore hardness method (Shore hardness)
GB/T 2828.1 Sampling procedures for inspection - Part 1. by acceptance quality limit (AQL) retrieval batch inspection sampling plan
GB/T 2829 periodic inspection Sampling procedures and tables (suitable for process stability test)
GB/T 3512 vulcanized rubber or thermoplastic rubber hot air and heat accelerated aging test
GB/T 9969 General Instructions industrial products
General requirements for HG/T 2198 vulcanized rubber physical test method
Category 3
Press gasket seal and compress the seal can be divided into two types of self-sealing.
Note. The gasket may be formed of rubber, silicone and other materials made of.
4 Requirements
4.1 Appearance
Gasket surface should be smooth and clean, there should be no obvious scars, cracks, bubbles, burrs and no visible impurities.
4.2 Tensile strength
Tensile strength of the sealing gasket should be not less than 5MPa.
4.3 Elongation at break
Gasket elongation at break of not less than 150%.
4.4 Tearing permanent deformation
Gasket tearing permanent deformation should not exceed 30%.
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