YY/T 0734.4-2016Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive medical devices, etc. (English PDF)

Foreword

YY/T 0734 "cleaning sterilizer" is divided into five parts.

- Part 1. General requirements, terms and tests;

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

- Part 3. Requirements and tests for cleaning and disinfection of waste heat disinfectants for human waste containers;

- Part 4. Requirements and tests for cleaning and disinfection of non - intrusive medical devices for damp heat disinfection;

- Part 5. Requirements and tests for cleaning and disinfecting chemical disinfection of medical devices such as non-invasive and non-invasive medical devices. This section is part 4 of YY/T 0734.

This part is drafted in accordance with the rules given in GB/T 1.1-2009.

This section is the same as ISO 15883-6.:2011 "Cleaning Sterilizer Part 6. For non-intrusive, non-critical medical devices and medical equipment Line wet heat disinfection of the cleaning and disinfection requirements and test "(English version) of the consistency is not equivalent. The main differences between this section and ISO 15883-6.:2011 are.

--- adjust the standard structure;

- Added the contents of Chapters 6 and 7 of this section and supplemented some of the test methods;

--- Deleted terms with Part 2 (such as cleaning temperature, cleaning temperature range, etc.) and so on;

--- Appendix A relating to inspection rules is deleted.

1 Scope

This part of YY/T 0734 specifies the special requirements for cleaning and disinfecting non-intrusive and other medical devices. this Class cleaning sterilizers ensure that the level of disinfection is maintained by cleaning and moist heat sterilization (A0 value is not less than 60). At the same time, the cleaning process is critical Automatic recording of process parameters does not require a separate recording system.

This part requires the use of the general requirements specified in YY/T 0734.1-2009.

This part of the required cleaning disinfection for non-invasive (ie, non-penetrating skin or non-contact mucosal surface) and other medical devices Cleaning and disinfection.

The requirements of this section do not apply to cleaning sterols as defined in the range YY/T 0734.2, YY/T 0734.3, nor are they applicable to endoscopes Cleaning and disinfection, the medical equipment specified in this section does not include power equipment, luminal instruments and other interventional devices.

NOTE: Damp heat disinfection of the load can be achieved by hot water rinsing, exposure to steam or a combination of both.

2 Normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.

Cleaning and disinfecting - Part 1. General requirements, Terminology definitions and tests - YY/T 0734.1-2009

YY/T 0734.2 Cleaning and disinfecting equipment - Part 2. Cleaning and disinfection requirements for heat and disinfection of surgical and anesthesia equipment And test

YY/T 0734.3 Cleaning and disinfecting equipment - Part 3. Cleaning and disinfecting requirements for hygienic disinfection of human waste containers test ISO /T S15883-5 Cleaning and disinfecting - Part 5. Test contaminants and test methods for the verification of cleaning effects (Washer-disin-fectors-Part 5. Testsoilsandmethodsfordemonstratingcleaningefficacy)

3 Terms and definitions YY/T

Definitions and the following terms and definitions apply to this document.

4 Requirements