Foreword

Introduction

1Scope

2Normative references

3Terms and definitions

4Performance requirements

4.1General

4.2Systems for leak testing

4.3Cleaning

4.3.1General

4.3.2Flushing

4.3.3Washing

4.3.4Post-washing rinsing

4.3.5Determination of cleaning efficacy

4.4Disinfecting

4.4.1General

4.4.2Efficacy of the disinfectant

4.4.3Temperature

4.4.4Process monitoring

4.4.5Disinfectant use

4.4.5.1General

4.4.5.2Re-use of disinfectant solutions

4.5Final rinsing

4.6Purging to remove rinse water

4.7Drying

4.8Self-disinfection

4.9Water treatment equipment

4.9.1General

4.9.2Disinfection of water treatment equipment

4.9.3Maintenance of piping

5Mechanical and process requirements

5.1Materials ― Design, manufacture and construction

5.2Device channel irrigation system

5.2.1General

5.2.2Verification of device channel irrigation by the automatic controller

5.3Venting and drainage systems

5.4Temperature control

5.4.1General

5.4.2Temperature control of the washing stage

5.4.3Temperature control of the disinfection stage

5.4.4WD with a minimum operating temperature for the washing and/or disinfection stage

5.5Process chemicals

5.6Process verification

5.7Dosing systems

6Testing for conformity

6.1General

6.2Test equipment

6.2.1General

6.2.2Pressure measurement

6.2.3Flow measurement

6.2.3.1Water

6.2.3.2Process chemical

6.3Water used for final rinsing

6.3.1Principle

6.3.2Material/procedure

6.3.3Results/acceptance criteria

6.4Hardness of water used during type testing

6.4.1Principle

6.4.2Material

6.4.3Procedure

6.5Leak test

6.5.1Principle

6.5.2Material

6.5.3Procedure

6.5.3.1Calibration

6.5.3.2Testing the pressure relief device

6.5.3.3Testing the leak tester fault and pass conditions

6.5.3.3.1Fault condition

6.5.3.3.2Pass condition

6.5.3.4Leak test for non-connection

6.5.4Results/acceptance criteria

6.5.4.1Verification of testing the pressure relief device (see 6.5.3.2)

6.5.4.2Verification of testing the leak tester “fault” and “pass” conditions

6.5.4.2.1Fault condition

6.5.4.2.2Pass condition

6.5.4.3Verification of leak test for non-connection (see 6.5.3.4)

6.6Channels non-obstruction test

6.6.1Principle

6.6.2Material

6.6.3Procedure

6.6.4Results/acceptance criteria

6.7Channels non-connection test

6.7.1Principle

6.7.2Material

6.7.3Procedure

6.7.4Result/acceptance criteria

6.8Load dryness

6.8.1Principle

6.8.2Material

6.8.3Exterior surface drying

6.8.3.1Procedure

6.8.3.2Result/Acceptance criteria

6.8.4Channel drying

6.8.4.1Procedure

6.8.4.2Result/Acceptance criteria

6.9Thermometric tests

6.9.1Test for chamber and load temperature during operating cycle

6.9.1.1Principle

6.9.1.2Material

6.9.1.3Procedure

6.9.1.4Results/acceptance criteria

6.9.2Test for operating cycle temperature limits on washing and chemical disinfection stages

6.9.2.1Principle

6.9.2.2Material

6.9.2.3Procedure

6.9.2.4Results/acceptance criteria

6.10Chemical dosing tests for single-dose containers

6.10.1Principle

6.10.2Material

6.10.3Procedure

6.10.4Results/acceptance criteria

6.11Tests of cleaning efficacy

6.11.1General

6.11.2Principle

6.11.3Material

6.11.3.1Load carrier

6.11.3.2Test loads

6.11.3.3Test soils

6.11.4Procedure

6.11.5Results/acceptance criteria

6.12Tests of disinfection efficacy

6.12.1General

6.12.2Preliminary tests on chemical disinfectants

6.12.2.1Principle

6.12.2.2Material

6.12.2.2.1Disinfectants

6.12.2.2.2Neutralizing agent

6.12.2.2.3Test organisms

6.12.2.3Procedure

6.12.2.3.1Concentration

6.12.2.3.2Temperature

6.12.2.3.3Contact time

6.12.2.3.4Water quality

6.12.2.3.5Neutralization

6.12.2.3.6Presentation of test organisms

6.12.2.3.7Detection of test organisms

6.12.2.4Results/acceptance criteria

6.12.3Self-disinfection tests

6.12.3.1Type test

6.12.3.1.1Principle

6.12.3.1.2Material

6.12.3.1.3Procedure

6.12.3.2Operational and routine test

6.12.3.2.1Principle

6.12.3.2.2Material

6.12.3.2.3Procedure

6.12.3.2.4Results/acceptance criteria

6.12.4Test of microbial quality of final rinse water treatment equipment

6.12.4.1Type test

6.12.4.1.1Principle

6.12.4.1.2Material

6.12.4.1.3Procedure

6.12.4.1.4Results

6.12.4.1.5Acceptance criteria

6.12.4.2Operational tests

6.12.5Disinfection of liquid transport systems following failure of water treatment equipment

6.12.5.1Type test

6.12.5.1.1Procedure

6.12.5.1.2Results/acceptance criteria

6.12.5.2Operational and routine test

6.12.5.2.1Principle

6.12.5.2.2Material/procedure

6.12.5.2.3Results/acceptance criteria

6.12.6Chemical disinfection of the load

6.12.6.1Type test

6.12.6.2Operational qualification

6.12.6.3Performance qualification and routine test

7Documentation and inspection

8Information to be supplied by the manufacturer

9Marking, labelling and packaging

10Information to be requested from the purchaser by the manufacturer

Annex ASummary of activities covered by this document (informative)

A.1General

A.2Before installation of the WD

A.3Installation and operation of the WD

Annex BMicrobiological testing of the efficacy of chemical disinfection of the load (normative)

B.1Principle

B.2Material

B.2.1Test organisms

B.2.2Test pieces

B.2.3Suspension media

B.2.4Inoculum

B.2.5Microsyringe

B.2.6Neutralization solution

B.2.7Recovery medium

B.3Procedure

B.3.1General

B.3.2Recovery method

B.3.3Evaluation of initial inoculum

B.3.4Evaluation of physical removal using endospores as an indicator organism

B.3.5Evaluation of disinfection efficacy

B.4Results

Annex CSummary of test programmes (normative)

C.1General

Annex DMethods for microbiological evaluation of disinfection of liquid transport system (normative)

D.1Principle

D.2Material

D.2.1Microorganisms

D.2.2Culture medium

D.2.3Washer-disinfector

D.2.3.1Sampling cycle

D.2.3.2Contamination cycle

D.2.4Connection of the WD to the external tank

D.3Procedure

D.3.1External tank disinfection

D.3.2Verification of absence of microbicidal residue in the external tank after disinfection

D.3.3Preparation of the contamination solution

D.3.4Contamination of the WD via the water supply network

D.3.5Determination of the WD contamination level

D.3.6Establishment of the efficacy of the disinfection of the liquid transport system

D.3.6.1Method 1

D.3.6.2Method 2

D.4Results/acceptance criteria

Annex ETests for microbial contamination of final rinse water (normative)

E.1Principle

E.2Material

E.3Procedure

E.3.1Sampling technique

E.3.2Test for aerobic mesophilic bacteria

E.3.3Test for environmental (atypical) Mycobacterium sp.

E.4Results/Acceptance criteria

Annex FAdditional notes on microbiological testing of chemical disinfection processes (informative)

F.1Difficulties with microbial testing

F.2Verification of the disinfection process

F.3Validation of the test method

Annex GTypical specifications of trumpet valves and connection ports (informative)

G.1Specification diagrams

Annex HEstablishing endoscope type test groups (normative)

H.1General

H.2Establishing endoscope type test groups

H.2.1General

H.2.2Procedure

H.3Choosing relevant endoscope type test groups for type testing

H.4Definition of relevant surrogate devices and endoscopes for type testing

H.5Procedure for new endoscopes

H.6List of endoscope blocks

Annex IEstablishing endoscope product families (informative)

I.1General

I.2Classification of endoscope product families

I.2.1Endoscope product family 1

I.2.2Endoscope product family 2

I.2.3Endoscope product family 3

Bibliography