YY/T 0734.1-2018Washer-disinfectors - Part 1: General requirements and tests (English PDF)

Foreword

The YY/T 0734 "cleaning and sterilizer" standard 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 first 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 0734.1-2009, compared with YY/T 0734.1-2009, except for editorial changes, major technical changes as follows.

--- Added "sink" and "cavity" terms and definitions (see 3.33 and 3.34);

--- Modified the term "chemical auxiliaries" (see 3.25, 3.25 of the 2009 edition);

--- Modified the definition of the term "Z value" (see 3.32, 3.32 of the 2009 edition);

--- Increased the "end rinse water should comply with the manufacturer's regulations" under normal working conditions (see 4.1);

--- Revised the requirements for "final rinse water" (see 4.6.2, 4.9.6 for the 2009 edition);

--- Revised the "Materials, Appearance and Structure" (see 4.2, 4.8 of the 2009 edition) to make it clearer;

---Modified the "water tank" to "sink and final rinse tank" and modified the relevant content (see 4.10, 4.9 of the 2009 edition);

--- Added "continuous treatment and cleaning sterilizer without door" (see 4.11.5);

--- Added "desktop washer-disinfector" (see 4.11.6);

--- Added "process verification system" (see 4.17);

--- Increased electromagnetic compatibility requirements (see 4.34.2);

--- Revised some test methods (see 5.3, 5.10, 5.11, 5.13, 2009 editions 5.2, 5.9, 5.10, 5.12);

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

--- Revised the requirements of the "Marking and Instruction Manual" (see Chapter 6, Chapter 7 of the 2009 edition).

This section uses the redrafting method to modify the use of ISO 15883-1:2006 "wash sterilizer Part 1. General requirements, definition of terms And the test and its amendments 1.2014.

This section has more structural adjustments than ISO 15883-1:2006 and its amendment 1.2014, which is listed in Appendix A.

It is divided into ISO 15883-1:2006 and its amendment 1.2014 chapter number comparison list.

This section has technical differences compared to ISO 15883-1:2006 and its amendment 1.2014, and the terms involved in these differences have been adopted.

The vertical single line (|) at the margin of the outer margin is marked, and the corresponding technical difference and its cause are given in Appendix B. Watch list. This section also made the following editorial changes.

--- The outer margin of the clause modified by Adoption Modification 1.2014 is marked with a vertical double line (|);

---Change the standard name;

--- Added Appendix D to this section;

--- Removed Appendix A of ISO 15883-1:2006;

--- Removed Appendix D of ISO 15883-1:2006.

1 Scope

This part of YY/T 0734 specifies the terms and definitions, general requirements, test methods, and methods for automatic control of washer-disinfectors and their accessories.

Logo and instruction manual, packaging, transportation and storage. This section applies to areas such as reusable medical devices and medical institutions.

The cleaning and disinfecting device for cleaning and disinfecting the items. The requirements and tests for cleaning sterilizers for special loads are determined by YY/T 0734 Some of his or other standards.

Note 1. If prion protein is thought to be present, special attention must be paid to the choice of disinfectant and detergent to ensure that the chemical used does not counteract the prion protein. It should not inhibit the inactivation or removal effect.

Note 2. The performance requirements specified in this section may not ensure the inactivation or removal of the causative agent (prion protein) of infectious spongiform encephalopathy.

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 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1. General requirements (GB 4793.1-2007,

IEC 61010-1:2001, IDT)

GB/T 730755° unsealed pipe thread (GB/T 7307-2001, eqvISO 228-1.1994)

GB/T 18268.1 Electromagnetic compatibility requirements for electrical equipment - Part 1. General requirements (GB/T 18268.1-2010, IEC 61326-1:2005, IDT)

GB/T 16839.1-1997 Thermocouple Part 1. Indexing table (IEC 60584-1:1995, IDT)

GB/T 16839.2-1997 Thermocouple Part 2. Tolerance (IEC 60584-2:1982, IDT)

GB/T 30121-2013 Industrial Platinum Thermal Resistance and Platinum Temperature Sensing Element (IEC 60751:2008, IDT)

ISO /T S15883-5.2005 Washing and sterilizing machines - Part 5. Tests and methods for verifying cleaning effects (Washer-dis-infectors-Part 5: Testsoilsandmethodsfordemonstratingcleaningefficacy)

IEC 61010-2-040:2005 Safety requirements for electrical equipment for measurement, control and laboratory - Part 2-040.

Special requirements for material sterilizers and washer-disinfectors (Safetyrequirementsforelectricalequipmentformeasure- Ment,control,andlaboratoryuse-Part 2-040.Particularrequirementsforsterilizersandwasher-dis- Infectorsusedtotreatmedicalmaterials)

3 Terms and definitions

The following terms and definitions apply to this document.