GB/T 35267.4-2025Washer-disinfectors - Part 4: Endoscope washer-disinfectors (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1: Structure and drafting rules for standardization documents" Drafting.

This document is part 4 of GB/T 35267 "Washer-disinfectors". GB/T 35267 has been published in the following parts.

--- Part 4: Endoscope cleaning and disinfection equipment.

This document replaces GB/T 35267-2017 "Endoscope Cleaner-Disinfector". Compared with GB/T 35267-2017, except for structural adjustment and compilation in addition to logical changes, the main technical changes are as follows.

--- Added some terms and definitions (see Chapter 3, Chapter 3 of the 2017 edition);

--- Deleted "Structure and Working Conditions" (see Chapter 4 of the 2017 edition);

--- Added "General" (see 4.1);

--- Changed "detection system" to "leak test" and changed the relevant content (see 4.2, 5.1 of the 2017 edition);

--- Changed the cleaning requirements (see 4.3, 5.3 of the 2017 edition);

--- Changed the disinfection requirements (see 4.4, 5.4 of the 2017 edition);

--- Changed the requirements for rinsing (rinsing after disinfection) (see 4.5, 5.5 of the 2017 edition);

--- Added the requirement for drying the rinse water (see 4.6);

--- Changed the drying requirements (see 4.7.1, 4.7.3, 5.6 of the 2017 edition);

--- Changed the requirements for air filters (see 4.6.2, 5.9 of the 2017 edition);

--- Changed the requirements for self-disinfection (see 4.8, 5.7 of the 2017 edition);

--- Added requirements for water treatment equipment (see 4.9);

--- Added requirements for materials---design, manufacturing and construction (see 5.1);

--- Added requirements for equipment pipeline perfusion system (see 5.2);

--- Added requirements for ventilation and drainage systems (see 5.3);

--- Added temperature control requirements (see 5.4);

--- Added requirements for chemical agents (see 5.5);

--- Added requirements for process validation (if any) (see 5.6);

--- Changed the requirements for the measurement system (see 5.7, 5.15 of the 2017 edition);

--- The test method has been changed (see Chapter 6, Chapter 7, Chapter 6 of the 2017 edition);

--- Changed the information that the manufacturer should provide (see Chapter 8, 5.29 of the 2017 edition);

--- Changed the marking and instruction manual (see Chapter 9, Chapter 7 of the 2017 edition);

--- Changed the provisions on packaging, transportation and storage (see Chapter 10, Chapter 8 of the 2017 edition);

--- Changed the cleaning effect test (see Appendix C, Appendix A of the 2017 edition);

--- Added microbial contamination test for rinsing water after disinfection (see Appendix D);

--- Added microbiological evaluation methods for liquid delivery system disinfection (see Appendix E);

--- Added the microbial quantity test for the final rinse water treatment device (see Appendix F);

--- Added "Establishing an endoscope type test group" (see Appendix H).

This document is modified to adopt ISO 15883-4:2018 "Washer-disinfectors – Part 4: Washer-disinfectors for chemical disinfection of heat-sensitive endoscopes".

Requirements and Tests for Poison Devices.

Compared with ISO 15883-4:2018, this document has many structural adjustments. The structural number changes between the two documents are shown in the table below.

See Appendix A for the table.

This document has many technical differences compared to ISO 15883-4:2018.

A list of these technical differences and their reasons is given in Appendix B.

The following editorial changes were made to this document.

--- In order to coordinate with the existing standards, the name of the standard is changed to "Washer-disinfector Part 4: Endoscope washer-disinfector";

--- Deleted the following from Chapter 1 "Scope" of ISO 15883-4:2018."Also specifies type testing, engineering testing, verification (installation, first methods required for operation and performance qualification at installation), routine control and monitoring, and requalification after periodic and necessary maintenance, Instrumentation and Instructions";

--- Deleted Note 1 in Chapter 1 "Scope" of ISO 15883-4:2018;

--- Deleted 4.1.1c) and 4.1.1f) in ISO 15883-4:2018);

---Adjust the two sub-images in Figure 2 into two separate images;

--- Deleted Annex A (informative) "Overview of activities covered by this document" in ISO 15883-4:2018;

--- Deleted Appendix F (informative) "Additional instructions for microbiological testing of chemical disinfection processes" in ISO 15883-4:2018;

--- Deleted the section number and title of Appendix G (informative) "G.1 Specification drawings" in ISO 15883-4:2018.

Introduction

GB/T 35267 "Cleaning Disinfectors" is a general and specific standard for cleaning disinfectors, aiming to provide cleaning disinfectors and their accessories.

The relevant provisions of the parts, such as terms and definitions, general requirements, test methods, marking and instructions, packaging, transportation and storage, are planned to consist of 7 parts.

constitute.

--- Part 1: General requirements and tests. The purpose is to provide general requirements and tests for cleaning and disinfection equipment.

--- Part 2: Requirements and tests for cleaning and disinfecting equipment for moist heat disinfection of surgical and anesthesia instruments.

Requirements and testing for washer-disinfectors for moist heat disinfection of, for example, surgical and anaesthesia instruments.

--- Part 3: Requirements and tests for washer-disinfectors for moist heat disinfection of human waste containers.

Requirements and testing for washer-disinfectors for moist heat disinfection of bulk waste containers.

--- Part 4: Endoscope cleaning and disinfection equipment. The purpose is to provide requirements and tests for endoscope cleaning and disinfection equipment.

--- Part 5: Performance requirements and test methods for cleaning effect. The purpose is to provide performance requirements for cleaning effect of cleaning disinfectors and testing methods.

--- Part 6: Requirements and tests for cleaning and disinfecting equipment for wet heat disinfection of non-invasive medical devices. The purpose is to provide Requirements and testing for washer-disinfectors for moist heat disinfection of non-invasive and other medical devices.

--- Part 7: Requirements and tests for cleaning and disinfecting equipment for chemical disinfection of non-invasive medical devices that are not heat resistant. Purpose to provide requirements and tests for cleaning and disinfecting equipment for chemical disinfection of non-invasive medical devices that are not heat resistant.

The washer-disinfectors detailed in this document are intended to process instruments that can be immersed in water or aqueous solutions.

Instructions for use. It is necessary to protect the relevant parts of the device from immersion in advance.

The requirements for cleaning and disinfecting equipment for other applications are described in detail in other parts of GB/T 35267.

For safety requirements for cleaning and disinfecting equipment, see GB 4793.4.

Washer-disinfector

Part 4: Endoscope washer-disinfectors

1 Scope

This document specifies the requirements, test methods, etc. for flexible endoscope cleaner-disinfectors (hereinafter referred to as "cleaner-disinfectors").

This document applies to cleaning and disinfecting devices that automatically clean and disinfect flexible endoscopes.

This document is not applicable to the cleaning and disinfection of heat-resistant medical devices (including endoscopic accessories) that can be disinfected or sterilized using moist heat.

The performance requirements specified in this document may not ensure the inactivation or removal of the causative agent (prion) of transmissible spongiform encephalopathies.

NOTE 1 Washer-disinfectors conforming to this document can also be used for other heat-resistant reusable medical devices, provided that the medical device manufacturer recommends and confirms that the device is suitable for use with other reusable medical devices.

The disinfection method is effective for cleaning and chemical disinfection of heat-labile reusable medical devices.

NOTE 2 If prions are thought to be present, special attention should be paid to the selection of disinfectants and cleaning agents to ensure that all chemicals do not react with prions.

should be avoided, thus not inhibiting the inactivation or removal effect.

NOTE 3 This document may be used as a basis for developing specifications for washer-disinfectors by potential users and manufacturers, including manufacturers of endoscopes, cleaning products and disinfection products.

2 Normative references

The contents of the following documents constitute the essential clauses of this document through normative references in this document.

For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to this document.

GB 4793.4 Safety requirements for electrical equipment for measurement, control and laboratory use Part 4: Sterilizers for processing medical materials and special requirements for washer-disinfectors (GB 4793.4-2019, IEC 61010-2-040:2005, IDT) GB/T 38497-2020 Method for evaluating the disinfection effect of endoscopes GB/T 42062 Application of medical device risk management to medical devices (GB/T 42062-2022, ISO 14971:2019, IDT) YY/T 0734.1-2018 Washer-disinfector Part 1: General requirements and tests (YY/T 0734.1-2018, ISO 15883-1.

2006 Amendment1.2014,MOD) Pharmacopoeia of the People's Republic of China (2020 Edition) Volume 4

3 Terms and definitions

The following terms and definitions apply to this document.

airbreak

A physical barrier in the water supply pipe that prevents water from flowing back through the equipment.

[Source. ISO 11139:2018, 3.8] 3.2 Module block A set of channels forming part of an endoscope, with specified length, diameter and interconnections.

[Source. ISO 11139:2018, 3.30]