Foreword

Introduction

1Scope

2Normative references

3Terms and definitions

4General requirements

5Indicator system format

6Performance requirements

7Packaging and labelling

8Quality assurance

Annex ADetermination of strength after steam sterilization (normative)

A.1Apparatus

A.2Procedure

Annex BEstimation of visual difference between colour of the substrate and the changed (or unchanged) indicator system by determination of relative reflectance density (normative)

B.1Principle

B.2Apparatus

B.3Measurement

B.3.1Illumination

B.3.2Measuring instrument

B.3.2.1General

B.3.2.2Optical geometry

B.3.2.3Spectral response

B.3.2.4Calibration

B.3.2.5Background

B.4Test method

B.4.1Sample conditioning

B.4.2Procedure

B.5Test report

Annex CDetermination of indicator colour change on exposure to dry saturated steam (normative)

C.1Apparatus

C.2Procedure

Annex DDetermination of indicator colour change on exposure to dry heat (normative)

D.1Apparatus

D.2Procedure

Annex EAccelerated ageing of test samples (normative)

Annex FDetermination of transfer of indicator to standard test pack on processing (normative)

F.1Apparatus

F.2Procedure

Annex GDetermination of shelf life of the product (normative)

Annex HSteam exposure apparatus (normative)

H.1General

H.2Instrumentation

H.3Indicator, controller and recorder sensors

H.4Operating cycle — Stages and control options required

H.4.1Cycle stages

H.4.2Control options required

Annex IDetermination of sensitivity of the indicator to the presence of air (normative)

I.1Apparatus

I.2Procedure

Annex JAir injection system (normative)

Annex KStandard test pack (normative)

Bibliography