YY/T 0734.2-2018Washer-disinfectors - Part 2: Washer-disinfectors employing thermal disinfection for surgical instruments, anaestetic equipment, etc.—Requirements and tests (English PDF)

Foreword

YY/T 0734 "Cleaning and Disinfecting Device" consists of the following five parts.

--- Part 1. General requirements and tests;

--- Part 2. Requirements and tests for disinfection and disinfection of surgical and anesthesia equipment, etc.

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

--- Part 4. Requirements and tests for cleaning and sterilizing devices for non-invasive medical devices;

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

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

This section replaces YY/T 0734.2-2009, compared with YY/T 0734.2-2009, except for editorial changes, major technical changes as follows.

--- Revised the scope of the standard to clarify that the load handled by the washer-disinfector is a medical device (see Chapter 1, Chapter 1 of the 2009 edition);

---Modified the requirements of the "control system" (see 4.6, 4.6 of the 2009 version);

--- Revised the cleaning effect test method (see 5.2.1, 5.2.1 of the 2009 edition);

--- Removed the "Inspection Rules" (see Chapter 6 of the 2009 edition).

This section uses the redrafting method to modify the use of ISO 15883-2:2006 "cleaning sterilizer part 2. surgical instruments, anesthesia equipment, Cleaning and sterilizer requirements and tests for wet heat sterilization of bowls, plates, containers, utensils, glassware, etc.

This section has more structural adjustments than ISO 15883-2:2006. This section and ISO 15883-2 are listed in Appendix A. The list of chapter numbers in 2006 is a checklist.

There are technical differences in this section compared to ISO 15883-2:2006, and the terms involved in these differences have been passed through the margins on the outer side of the page.

The vertical single line (|) is marked, and a list of the corresponding technical differences and their causes is given in Appendix B. This section also made the following editorial changes.

---Change the standard name;

--- Removed Appendix A of ISO 15883-2:2006.

1 Scope

This section of YY/T 0734 specifies reusable medical devices, such as surgical instruments, anesthesia devices, that are expected to be used in a single duty cycle.

Special requirements for cleaning and sterilizing devices for cleaning and moist heat sterilization.

This section requires a combination with the general requirements specified in YY/T 0734.1-2018.

Note. This section requires that the pathogenic mediator (prion protein) of infectious spongiform encephalopathy may not be guaranteed to be inactivated or removed.

2 Normative references

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

GB/T 5783 hex head bolt full thread (GB/T 5783-2016, ISO 4017:2014, MOD)

YY 0337.1 Endotracheal intubation Part 1. Commonly used cannula and fittings (YY 0337.1-2002, ISO 5361:1999, IDT)

YY 0461 Breathing line for anesthesia machine and ventilator (YY 0461-2003, ISO 5367:2000, IDT)

YY/T 0734.1-2018 Washing and sterilizing machines - Part 1. General requirements and tests (ISO 15883-1:2006, MOD)

YY/T 0978 Anesthesia storage balloon (YY 0978-2016, ISO 5362:2006, IDT)

Anesthesia and respiratory equipment - Conical joints - Part 2. Thread-bearing joints (YY 1040.2-2008,

ISO 5356-2:2006, IDT)

3 Terms and definitions

The following terms and definitions as defined in YY/T 0734.1-2018 apply to this document.