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YY/T 1411-2023: Dentistry - Test methods for dental unit waterline biofilm treatment
Status: Valid YY/T 1411: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1411-2023 | English | 309 |
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Dentistry - Test methods for dental unit waterline biofilm treatment
| Valid |
YY/T 1411-2023
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| YY/T 1411-2016 | English | 399 |
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Dentistry--Essential characteristics of test methods for the evaluation of treatment methods intended to improve or maintain the microbiological quality of dental unit procedural water
| Obsolete |
YY/T 1411-2016
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PDF similar to YY/T 1411-2023
Basic data | Standard ID | YY/T 1411-2023 (YY/T1411-2023) | | Description (Translated English) | Dentistry - Test methods for dental unit waterline biofilm treatment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.20 | | Word Count Estimation | 16,169 | | Date of Issue | 2023-03-14 | | Date of Implementation | 2024-05-01 | | Older Standard (superseded by this standard) | YY/T 1411-2016 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the method of type inspection, which is mainly used to evaluate the effectiveness of the treatment methods for preventing, inhibiting the formation or removal of biofilm in the waterway system of the dental unit under laboratory conditions. This document does not apply to equipment conveying sterile treated water or sterile solutions, nor does it apply to lines, pipes or hoses conveying compressed air in dental units. This document does not set limits on the corresponding microbiological indicators. The method is not applicable in clinical conditions. Nor does this document establish test methods for the assessment of any adverse side effects that may arise from the treatment. The test methods provided in this document can be used to test other dental devices that deliver non-sterile water to the oral cavity. | YY/T 1411-2023: Dentistry - Test methods for dental unit waterline biofilm treatment---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.
ICS11:060:20
CCSC33
Pharmaceutical Industry Standard of the People's Republic of China
Replacing YY/T 1411-2016
Dentistry Dental Unit Waterway Biofilm
Treatment test method
(ISO 16954:2015, MOD)
Released on 2023-03-14
2024-05-01 Implementation
Released by the State Drug Administration
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 replaces YY/T 1411-2016 "Dentistry measures to improve or maintain the microbiological quality of dental treatment water treatment water
Compared with YY/T 1411-2016, except for structural adjustment and editorial changes, the main technical changes are as follows:
---Changed the scope of application (see Chapter 1, Chapter 1 of the:2016 edition);
--- Added and changed some terms and definitions (see Chapter 3, Chapter 3 of the:2016 edition);
--- Added the preparation method of test water (see 5:1);
--- Added "inoculation test water" (see 5:3);
--- Increased the provisions of the reconstruction elements of the dental unit waterway system simulation device (see 6:2:1);
--- Increased the different effects of antibacterial materials and materials that prevent microbial adhesion on the evaluation test method (see 6:2:2);
--- Increase the specific indicators of flow rate, water flow mode, test environment temperature and pre-time (see 6:3);
---Increase the residence time of water for sterility test in the waterway (see 7:2:4);
--- Increase the provisions of microbial sampling and testing (see 7:3:2 and 7:3:4);
--- Increased sampling requirements (see 8:1:1);
---Changed the method of counting viable bacteria (see 8:1:2 and 8:1:3, 9:2 of the:2016 edition);
---Changed the method of biofilm assessment (see 8:2:2, 9:3 of the:2016 edition);
--- Deleted the description of the formation and characteristics of biofilm (see 5:2:2 of the:2016 edition);
--- Deleted the management plan, plan and sampling plan (see 6:2 of the:2016 edition):
This document is modified to adopt ISO 16954:2015 "Test method for waterway biofilm treatment of dental treatment equipment in dentistry": This document is consistent with
The technical differences of ISO 16954:2015 and their reasons are as follows:
--- Replaced IEC 60601-1 with normative reference GB 9706:1 (see Chapter 3);
--- Replaced ISO 1942 (see 3:2) with the normative referenced GB/T 9937;
--- Replaced ISO 7494-1 with normative referenced YY/T 1043:1 (see Chapter 3);
--- Replaced ISO 7494-2 (see 3:4) with the normative referenced YY/T 1043:2;
--- Replaced ISO 3696:1995 with the normative reference GB/T 6682-2008 (see 5:1:1:1);
--- Replaced ISO 10523 with the normative reference GB/T 22592 (see 5:1:4);
---Changed the American Culture Collection Center (ATCC) series standard strain number to China Medical Bacteria Collection Management Center (CMCC) series
List the standard strain number (see 5:2), based on 1100 and 9203 in the Pharmacopoeia of the People's Republic of China (2020, Volume 4);
---Deleted ATCC's regulations on isolated sources:
The following editorial changes have been made to this document:
---In accordance with the requirements of GB/T 1:1-2020, the content of the suspended paragraph in Chapter 6 is separately listed as 6:1 content, and the original article numbers 6:1 and 6:2 are sequentially
Extended to 6:2 and 6:3;
--- Change the "test method for biofilm removal (7:2)" in the second paragraph of 6:1 to "test method for biofilm removal (7:3)",
There is an error in the original text in ISO 16954:2015:
Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying patents:
This document is proposed by the State Drug Administration:
This document is sponsored by the Dental Equipment and Instrument Subcommittee of the National Dental Materials and Equipment Standardization Technical Committee (SAC/
TC99/SC1) centralized:
YY/T 1141-2023
This document was drafted by: Guangdong Medical Device Quality Supervision and Inspection Institute, Sino Medical Devices Group Co:, Ltd:, Huaxikou, Sichuan University
School of Dental Medicine, Zhejiang New Asia Medical Technology Co:, Ltd:, Guangdong Fuken Technology Industry Co:, Ltd:, Peking University Stomatological Hospital:
The main drafters of this document: Yang Lifeng, Li Mengjie, He Zhuohua, Zhao Lijun, Shu Rui, Chen Xianming, Lei Kangning, Chen Xiaochi, Zhong Jing:
The release status of previous versions of this document and the documents it replaces are as follows:
---First published as YY/T 1411-2016 in:2016;
--- This is the second revision:
YY/T 1141-2023
Dentistry Dental Unit Waterway Biofilm
Treatment test method
1 Scope
This document provides a method of type testing, mainly used to evaluate the biofilm in the waterway system of the dental unit under laboratory conditions
The effectiveness of treatments to prevent, inhibit their formation or remove:
This document does not apply to equipment for conveying sterile treated water or sterile solutions, nor does it apply to equipment for conveying compressed air in dental units
Pipes, pipes or hoses:
This document does not set limits on the corresponding microbiological indicators: The method is not applicable in clinical conditions: This document was also not created for
Test methods to assess any adverse side effects that may be caused by the treatment:
The test methods provided in this document can be used to test other dental devices that deliver non-sterile water to the oral cavity:
2 Normative references
The contents of the following documents constitute the essential provisions of this document through normative references in the text: Among them, dated references
For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to
this document:
GB/T 6682-2008 Analytical Laboratory Water Specifications and Test Methods (ISO 3696:1987, MOD)
GB 9706:1 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance (GB 9706:1-2020,
IEC 60601-1:2012, MOD)
GB/T 9937 Terminology in Dentistry (GB/T 9937-2020, ISO 1942-2009, MOD)
GB/T 22592 General Rules for Determination of pH Value of Water Treatment Agents (GB/T 22592-2008, ISO 10523:1994, NEQ)
YY/T 1043:1 Dentistry Dental Units Part 1: General Requirements and Test Methods (YY/T 1043:1-2016,
ISO 7494-1:2011, MOD)
YY/T 1043:2 Dentistry Dental Treatment Machine Part 2: Air, Water, Suction and Wastewater Systems (YY/T 1043:2-2018,
ISO 7494-2:2015, IDT)
3 Terms and Definitions
The following terms and definitions defined in GB 9706:1, GB/T 9937, YY/T 1043:1 and YY/T 1043:2 apply to this
document:
3:1
Biofilm biofilm
A complex of bacterial clumps and extracellular matrix tightly adhered to the surface of an object:
3:2
Dental treatment machine dentalunit
Equipment for dental treatment that is composed of interconnected dental equipment and instruments to form a functional combination:
[Source: GB/T 9937-2020,2:86]
YY/T 1141-2023
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