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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

Similar standards

Editions of YY/T 0158

EditionTitleRevisionStatus
YY/T 0158-2013Gasket ring on pressure steam sterilizercurrent editionCurrent
YY/T 0158-2005Gasket ring on pressure steam sterilizerprevious editionSuperseded

This page sells the current edition, YY/T 0158-2013. Earlier editions are listed for reference only.

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