YY/T 0158-2013Gasket ring on pressure steam sterilizer (English PDF)
压力蒸汽灭菌设备用密封垫圈
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
October 21, 2013
Implementation date
October 1, 2014
Scope
YY/T 0158-2013 is the English-translated version of 压力蒸汽灭菌设备用密封垫圈.
YY/T 0158-2013 is the Chinese pharmaceutical industry standard for the gasket ring of a pressure steam sterilizer, the seal of the chamber door.
It specifies the classification, the requirements, the test methods, the inspection rules, the marking and instruction manual and the rules for packaging, transport and storage, covering the dimensions and the hardness of the rubber, the tensile properties before and after ageing in steam, the compression set, the sealing performance and the service life. Issued on 21 October 2013, it has applied since 1 October 2014.
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Document preview — YY/T 0158-2013
National Standard of the People's Republic of China
- ICS
- 11.080.99
- Classification
- C 47
- Replacing
- YY/T 0158-2005
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 4 Requirements
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.
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 °C ~ 150 °C 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.
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%.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 528Rubber, vulcanized or thermoplastic -- Determination of tensile stress-strain properties
- GB/T 531.1Rubber, vulcanized or thermoplastic -- Determination of indentation hardness -- Part 1: Durometer method (Shore hardness)
- GB/T 2828.1Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
- GB/T 2829Sampling procedures and tables for periodic inspection by attributes
- GB/T 3512Rubber, vulcanized or thermoplastic - Accelerated ageing and heat resistance tests in hot air
- GB/T 9969General principles for preparation of instructions for use of industrial products
Similar standards
Editions of YY/T 0158
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY/T 0158-2013 | Gasket ring on pressure steam sterilizer | current edition | Current |
| YY/T 0158-2005 | Gasket ring on pressure steam sterilizer | previous edition | Superseded |
This page sells the current edition, YY/T 0158-2013. Earlier editions are listed for reference only.
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Related Standards
GB/T 2828.1-2012 — Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
GB/T 2829-2025 — Sampling procedures and tables for periodic inspection by attributes
GB/T 3512-2014 — Rubber, vulcanized or thermoplastic -- Accelerated ageing and heat resistance tests -- Air-oven method
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