YY/T 0734.1-2018 English PDFUS$999.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0734.1-2018: Washer-disinfectors. Part 1: General requirements and tests Status: Valid YY/T 0734.1: Historical versions
Basic dataStandard ID: YY/T 0734.1-2018 (YY/T0734.1-2018)Description (Translated English): Washer-disinfectors. Part 1: General requirements and tests Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C47 Classification of International Standard: 11.080.10 Word Count Estimation: 50,552 Date of Issue: 2018-11-07 Date of Implementation: 2019-11-01 Older Standard (superseded by this standard): YY/T 0734.1-2009 Quoted Standard: GB 4793.1; GB/T 7307; GB/T 18268.1; GB/T 16839.1-1997; GB/T 16839.2-1997; GB/T 30121-2013; ISO/TS 15883-5-2005; IEC 61010-2-040-2005 Adopted Standard: ISO 15883-1-2006+Amd 1-2014, MOD Regulation (derived from): Announcement No. 87 of 2018 by the State Drug Administration Issuing agency(ies): State Drug Administration Summary: This standard specifies the terms and definitions, general requirements, test methods, signs and instructions for use, packaging, transportation and storage of automatically controlled cleaning and disinfecting devices and their accessories. This standard applies to cleaning and disinfecting devices that can be used for cleaning and disinfecting reusable medical devices and items in medical institutions. The requirements and tests for cleaning sterilizers for special loads are specified by the board section of YY/T 0734 or other standards. YY/T 0734.1-2018: Washer-disinfectors. Part 1: General requirements and tests---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.Washer-disinfectors.Part 1. General requirements and tests ICS 11.080.10 C47 People's Republic of China Pharmaceutical Industry Standard Replacing YY/T 0734.1-2009 Washing and sterilizing machines - Part 1. General requirements and tests (ISO 15883-1.2006 Amendment 1.2014, Washer-disinfectors- Part 1. Generalrequirements, termsanddefinitionsandtests, MOD) Published on.2018-11-07 2019-11-01 implementation State Drug Administration issued ContentForeword I 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Requirements 4 5 Test methods 17 6 signs and instructions for use 23 7 Packaging, transportation and storage 24 Appendix A (informative) Structural changes in this section compared to ISO 15883-1.2006 and its amendment 1.2014 25 Appendix B (informative) The technical differences between this part and ISO 15883-1.2006 and its amendment 1.2014 and its causes 29 Appendix C (informative) A0 Concept - equivalent lethality of damp heat disinfection 31 Appendix D (Normative Appendix) Example of cleaning effect test method 34 Appendix E (Normative) Test Methods for Detection and Evaluation of Residual Protein Contaminants 43ForewordThe 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. Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. This part is proposed by the State Drug Administration. This part is under the jurisdiction of the National Disinfection Technology and Equipment Standardization Technical Committee (SAC/TC200). This section drafted by. Shandong Xinhua Medical Devices Co., Ltd., Guangdong Medical Device Quality Supervision and Inspection Institute, Kunshan ultrasound system Instrument Co., Ltd., Ballymann Medical Equipment (Shanghai) Co., Ltd. The main drafters of this section. Chen Yu, Qu Daoyin, Hu Changming, Yan Peng, Xu Weixiong, Wang Hongmin, Huang Hongxin, Zhu Lingyan, Zhang Yang. The previous versions of the standards replaced by this section are. ---YY/T 0734.1-2009. Washing and sterilizing machines - Part 1. General requirements and tests1 ScopeThis 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 referencesThe following documents are indispensable for the application of this document. For dated references, only the dated version applies to this article. Pieces. 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 definitionsThe following terms and definitions apply to this document. 3.1 A0 value A0value The equivalent time in seconds at 80 °C during wet heat sterilization, taking a Z value of 10 °C. Note. See Appendix C. 3.2 Automatic controller automaticcontroler The device for each stage of processing is sequentially performed according to a preset process variable. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0734.1-2018_English be delivered?Answer: Upon your order, we will start to translate YY/T 0734.1-2018_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. 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Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.Question 5: Should I purchase the latest version YY/T 0734.1-2018?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0734.1-2018 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically. |
