GB/T 18282.6-2026Sterilization of health care products - Chemical indicators - Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers (English PDF)

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents".

Drafting.

This document is Part 6 of GB (GB/T) 18282.GB/T 18282 has the following parts published.

---GB/T 18282.1-2025 Chemical Indicators for Sterilization of Medical and Health Products Part 1: General Rules;

---GB 18282.3-2009 Chemical Indicators for Sterilization of Medical and Health Products - Part 3: For Class BD Vapor Permeation Testing Class II indicator systems;

---GB 18282.4-2009 Chemical Indicators for Sterilization of Medical and Health Products Part 4: For Use with Alternative BD Class Steam Infiltration Type II indicators for penetration testing;

---GB 18282.5-2015 Chemical Indicators for Sterilization of Medical and Health Products - Part 5: For Class BD Air Exclusion Testing Class II indicators;

The test includes two types of indicators and process challenge devices.

This document is modified to adopt ISO 11140-6:2022 "Chemical indicators for sterilization of healthcare products – Part 6: Use in small steam sterilizers".

Two types of indicators and process challenge devices for testing the performance of sterilization equipment.

Compared with ISO 11140-6:2022, this document has undergone many structural adjustments. A comparison of the structural numbering changes between the two documents is provided below.

See Appendix A for the table.

This document differs significantly from ISO 11140-6:2022.The relevant clauses are indicated in the margins using vertical markers.

Straight lines (|) are marked. A summary of these technical differences and their reasons can be found in Appendix B.

The following editorial changes have been made to this document.

---The warning section before the range has been removed;

---The vacuum depth in cycle 3 of section 4.3.4.1 of ISO 11140-6:2022 has been modified;

---Added a note referring to Appendix I (see 4.6.1);

---The clause "This symbol should not be translated or used" in section 6.1.1 of ISO 11140-6:2022 has been removed;

---The clause "This symbol should not be translated or used" in section 6.1.2 of ISO 11140-6:2022 has been removed;

---The clause "This symbol should not be translated or used" in section 6.1.3 of ISO 11140-6:2022 has been removed;

---The saturated vapor content of non-condensable gases in 100 mL of vapor condensate in Annex A of ISO 11140-6:2022 has been modified;

---The background information regarding EN867-5 and EN285:2006 A2.2009 in Annex G of ISO 11140-6:2022 has been removed.

The description section of ISO TS17665-2:2009;

---The window size parameter and maximum pressure for failure conditions in Annex G of ISO 11140-6:2022 have been modified;

---The window size parameter in Annex G.4.3 of ISO 11140-6:2022 has been changed;

---The minimum pressure obtained under successful conditions in Annex G.4.4 of ISO 11140-6:2022 has been modified;

---The maximum pressure displayed for failure conditions in Annex G.4.5 of ISO 11140-6:2022 has been changed;

---The window size parameter in G.4.6 of Annex G in ISO 11140-6:2022 has been changed;

--- EN13060:2014 A1.2018 has been replaced with YY/T 0646-2022, which is used for informational reference.

Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents.

This document was proposed by the National Medical Products Administration.

This document is under the jurisdiction of the National Technical Committee on Standardization of Disinfection Technology and Equipment (SAC/TC200).

Introduction

GB (GB/T) 18282 "Chemical Indicators for Sterilization of Medical Products" is the fundamental and universal standard for chemical indicators in my country.

Standard. GB (GB/T) 18282 aims to establish the performance requirements and/or test methods for indicators and indicator systems, and is proposed to consist of five parts.

---Part 1: General Rules. The purpose is to establish the performance requirements and/or testing methods for chemical indicators.

---Part 3: Class II Indicator Systems for Class BD Vapor Permeability Testing. The aim is to establish a system for class BD vapor permeability testing...

The performance of the two-category indicator system tested was evaluated for sterilizers used for sterilizing packaged and porous loads.

---Part 4: Class II Indicators for Alternative BD Class Vapor Permeability Testing. The aim is to establish alternative indicators for BD class vapor permeability testing.

The Class II indicator system for vapor permeation testing is used to perform performance tests on sterilizers used for both packaged and porous load sterilization.

---Part 5: Class II Indicators for Class BD Air Purging Tests. The purpose is to establish indicators for use in Class BD air purging tests.

Class II indicators are used to evaluate the air removal effectiveness of the pre-vacuum stage in a pre-vacuum sterilization cycle.

---Part 6: Class II Indicators and Process Challenge Devices for Performance Testing of Small-Scale Steam Sterilizers. The aim is to clarify the performance characteristics of small-scale steam sterilizers.

The process of testing sterilizer performance involves challenging equipment and associated chemical indicators.

This document describes the performance requirements for cavity and porous process challenge devices (PCDs), and demonstrates alternative process challenge devices compared to reference ones.

The process challenges the device to have the same performance. A sterilization unit [300mm (height) × ] cannot be accommodated for the following reasons.

A small sterilizer with a cuboid shape measuring 600mm (length) × 300mm (width) cannot be sterilized using the methods described in GB 8599-2023.

Line test.

---The chamber size of a small steam sterilizer conforming to YY/T 0646 cannot accommodate the standard test conforming to GB 8599-2023.

Bag, and

---The validity of the test is affected when the test pack occupies a large proportion of the chamber volume (more than 20% of the chamber volume).

(Accumulated time).

The indicators described in this document are intended for use with a suitable process challenge device to indicate steam permeation into the process challenge device.

Reference indicator systems and alternative indicator systems present specific challenges to air removal and vapor permeation.

The apparatus described in this document is only applicable to small steam sterilizers conforming to YY/T 0646, used for monitoring Type B cycles and certain...

S-shaped cycle vapor permeation performance.

Note. Although the cavity load test was originally designed for type testing to evaluate the performance of small steam sterilizers conforming to YY/T 0646, this test is also applicable to...

For use in other standards, such as GB 8599-2023.

Chemical indicators for sterilization of medical products Part 6: Performance Testing for Small Steam Sterilizers Type II indicators and process challenge devices

1 Scope

This document specifies the cavity and porous devices used in small steam sterilizers, as well as the associated chemical and biological indicators.

The performance indicators and corresponding test methods are described, with the aim of detecting the performance of a type B cycle and a certain performance parameters in a small steam sterilizer conforming to YY/T 0646.

The vapor permeation performance of some S-shaped cycles.

Note. The cavity and porous devices described in this document are not intended to replace cavity and porous devices in medical facilities.

The chemical indicators specified in this document for use with porous devices are for demonstrating that the porous devices in miniature steam sterilizers are adequately filled.

Sufficient vapor permeation (see YY/T 0646).

This document specifies the following requirements.

---The Reference Porous Device (RPD), as a reference device for the Alternative Porous Indicator System (APIS), can display, according to this document, [].

The two are equivalent in performance. For example, the method of determining the degree of vapor penetration of textile test packs using a temperature measuring device.

---A porous chemical indicator system with performance equivalent to a reference porous device. For example, commonly designed and manufactured commercially as a substitute...

APIS (Advanced Porous Indicator System) the chemical indicator specified in this document for use with the cavity loading device is for demonstrating its effectiveness in small steam sterilizers (see YY/T 0646).

Sufficient vapor permeation occurs within the narrow lumen (formerly Class A cavity load).

This document specifies the following requirements.

---Reference cavity device (RHD) used as a reference device in this document. For example, a cavity device with an attached chamber, through...

The vapor permeability is determined by the killing or survival of specific biological indicators placed within it.

---An alternative cavity device.

- Employs the same specific test load as the reference cavity device and uses chemical reagents specifically designed for the reference cavity test load.

Chemical indicators, such as a cavity device attached to a compartment, determine the vapor content by visual inspection of the chemical indicator.

Permeability;

- Performs identically to the reference cavity device. For example, alternative cavity devices that are typically designed and manufactured commercially.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.

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 1804 General Tolerances - Tolerances for linear and angular dimensions without specified tolerances (GB/T 1804-2000, eqv ISO 2768-1)

1989)

GB/T 6403.3 Knurling GB 8599-2023 Technical Requirements for Large-Scale Pressure Steam Sterilizers GB/T 18281.3 Biological indicators for sterilization of medical and health care products - Part 3: Biological indicators for moist heat sterilization (GB/T 18281.3-2024,ISO 11138-3:2017,IDT) GB/T 18282.1-2025 Chemical indicators for sterilization of medical and health care products – Part 1: General (ISO 11140-1:2014, IDT)