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GB/T 30690-2026Monitoring requirements and evaluation of sterilization effect of small pressure steam sterilizer (English PDF)

小型压力蒸汽灭菌器灭菌效果监测方法和评价要求

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

July 30, 2026

Implementation date

February 1, 2027

Scope

GB/T 30690-2026 is the English-translated version of 小型压力蒸汽灭菌器灭菌效果监测方法和评价要求.

GB/T 30690-2026 is the Chinese standard "Monitoring requirements and evaluation of sterilization effect of small pressure steam sterilizer".

Its scope clause reads: This document specifies the classification and uses, validation methods, and evaluation criteria for small-scale pressure steam sterilizers (hereinafter referred to as "small-scale sterilizers").

Requirements, daily monitoring methods, and evaluation criteria. This document applies to sterilizers with a sterilization chamber volume not exceeding 60 L. Its clauses include terms and definitions.

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Document preview — GB/T 30690-2026

National Standard of the People's Republic of China

ICS
11.080
Classification
C 59
Replacing
GB/T 30690-2014

Issued by: State Administration for Market Regulation; Standardization Administration of the PRC

Contents

  • Preface
  • 1.Scope
  • 2 Normative References
  • 3.Terms and Definitions
  • 4.Classification and Uses
  • 5.Verification methods and evaluation requirements
  • 6.Routine monitoring methods and evaluation requirements
  • Appendix B (Informative) Parameters Corresponding to Saturated Steam Temperature and Pressure
  • Appendix C (Informative) Verification Methods for the Biosafety of Exhaust Ports

1 Scope

This document specifies the classification and uses, validation methods, and evaluation criteria for small-scale pressure steam sterilizers (hereinafter referred to as "small-scale sterilizers").

Requirements, daily monitoring methods, and evaluation criteria.

This document applies to sterilizers with a sterilization chamber volume not exceeding 60 L.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are listed below.

For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.

This document.

GB/T 33420 Test Method for Biological Indicators in Pressure Steam Sterilization

3 Terms and Definitions

The following terms and definitions apply to this document.

3.1 Small pressure steam sterilizer

A pressure steam sterilizer with a volume not exceeding 60 L.

Type B of sterilization cycle

Used for sterilizing packaged or unpackaged solid loads, hollow loads, porous loads, etc.

3.3 Type N of sterilization cycle

Used for sterilizing unpackaged solid loads in cycles.

3.4 Type S of sterilization cycle

Used for the cycle of special loads specified by the sterilization manufacturer.

Note. Includes unpackaged solid loads and at least one of the following load types. porous loads, small quantities of porous strips, hollow loads, single-packaged items, and multi-layered packages.

Loading.

3.5 Full load

The maximum allowable loading capacity should be arranged according to the instructions provided by the sterilization equipment manufacturer.

3.6 B-D test material bowie-dick test system

Indicators that integrate B-D test paper or pressure/temperature sensor components with the load for B-D testing.

Note. Common types include disposable B-D test kits, lumen B-D, and electronic B-D test kits.

......
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

Editions of GB/T 30690

EditionTitleRevisionStatus
GB/T 30690-2026Monitoring requirements and evaluation of sterilization effect of small pressure steam sterilizercurrent editionCurrent
GB/T 30690-2014Monitoring requirements and evaluation of sterilization effect of small pressure steam sterilizerprevious editionIn force until 1 February 2027

This page sells the current edition, GB/T 30690-2026. Earlier editions are listed for reference only.

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