US$479.00 · In stock Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0058-2015: Dentistry. Patient chair Status: Obsolete YY/T 0058: Evolution and historical versions
Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
YY/T 0058-2015 | English | 479 |
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Dentistry. Patient chair
| Obsolete |
YY/T 0058-2015
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YY/T 0058-2004 | English | 599 |
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Dental patient chair
| Obsolete |
YY/T 0058-2004
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YY/T 0058-1999 | English | 359 |
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General requirements for dental chair
| Obsolete |
YY/T 0058-1999
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PDF similar to YY/T 0058-2015
Basic data Standard ID | YY/T 0058-2015 (YY/T0058-2015) | Description (Translated English) | Dentistry. Patient chair | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | Classification of Chinese Standard | C33 | Classification of International Standard | 11.060.20 | Word Count Estimation | 12,144 | Date of Issue | 2015-03-02 | Date of Implementation | 2016-01-01 | Older Standard (superseded by this standard) | YY/T 0058-2004 | Quoted Standard | GB 9706.1-2007; GB/T 9937.1; GB/T 9937.2; GB/T 9937.3; GB/T 9937.4; GB/T 9937.5; YY/T 0628-2008; YY/T 0841; YY/T 1235; ISO 8191-1; ISO 21530 | Adopted Standard | ISO 6875-2011, MOD | Regulation (derived from) | The State Food and Drug Administration Announcement 2015 No. 8 | Issuing agency(ies) | State Food and Drug Administration | Summary | This Standard applies to a variety of structural dental patient chairs, including manual operation, a combination of power-driven or otherwise, run, or control over the way the dental patient chair. This Standard specifies requirements for dental patient chair, test methods, manufacturer information, labeling and packaging. |
YY/T 0058-2015: Dentistry. Patient chair---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.
Dentistry. Patient chair
ICS 11.060.20
C33
People's Republic of China pharmaceutical industry standards
Replacing YY/T 0058-2004
Dentistry patient chair
(ISO 6875.2011, MOD)
Issued on. 2015-03-02
2016-01-01 implementation
China Food and Drug Administration released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
Instead of the standard YY/T 0058-2004 "dental patient chair."
This standard YY /main changes compared to "dental patient chair" T 0058-2004 as follows.
--- Increasing the weight of the dental patient chair in different parts of the carrying capacity of the percentage distribution requirements in order to allow manufacturers to provide more than 135kg of
Bearing weight;
In pressure --- 7.2.2 headrest structure test method consists of "330N" replaced by "7.4% multiplied by a safety factor of 3 weight bearing patient
pressure";
--- 7.2.3 armrest vertically downward pressure by the "335N" to "670N", the level of inward outward force by a "220N" to "440N";
--- Updated the technical description and marking requirements.
This revised standard adopts ISO 6875.2011 "Dentistry patient chair."
This standard and ISO 6875.2011 The main differences are as follows.
--- According to the current domestic medical electrical equipment safety requirements for the implementation, with the GB 9706.1-2007 (IEC 60601-1. 1988,
IDT) instead of the international standard ISO 6875.2011 "Dentistry patient chair" in the IEC 60601-1.2005 Safety requirements; with
Li, delete ISO /IEC 80601-2-60.2011 "Medical electrical equipment - Part 2-60. basic security and basic dental equipment
The special requirements of this performance ", IEC 62366" Medical Device Usability Engineering in Medical Devices "and 5.1.4 availability;
--- 7.2.2 In addition to the pressure applied, followed the YY/T 0058-2004 "dental patient chair" in the 7.2.1 test
method;
--- 7.2.5 follows YY/T 0058-2004 "dental patient chair" in the test method;
--- Reserves extra YY/T 0058-2004 "dental patient chair" locking mechanism in 5.2.1.2 and 5.2.7 of the aid measures under negative
Carrier, which correspond to the additional load of this standard locking mechanism 5.2.2.2 and 5.2.6 aid measures under;
At the same time, it followed the above terms of test methods;
--- For other international standards referenced in this standard, if it has converted to our standards, the replacement of the International Standard for the standard references
The corresponding number of national or industry standards, and this standard in Chapter 2 marked on relationships.
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This standard was proposed by the China Food and Drug Administration.
This standard by the National Dental Materials and Devices Equipment Standardization Technical Committee dental equipment and instruments Technical Committee (SAC/TC99
SC1) centralized.
This standard was drafted. State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Xianyang Northwest Medical Devices
(Group) Co., Ltd., Foshan City, Tin Shing Medical Devices Co., Ltd. Ningbo Aino medical equipment.
The main drafters of this standard. Wu Ming lean, Li Wei, Zhao Lijun, Li Danrong, Peng Bo, Yang Qi.
This standard was first released in September 1986, when the merger will ZBC33017-1986 and YY 0058-1991 amended in 1999,
2004 for the third revision, this time for the Fourth Amendment.
Introduction
This standard does not contain biological hazards qualitative and quantitative testing methods, but on biological hazards that may exist for the assessment, the proposed reference
GB/T 16886.1.
Dentistry patient chair
1 Scope
This standard applies to all kinds of dental patient chair structure, including manual operation, power-driven or otherwise run the above manner or group
Co-chair control dental patient.
This standard specifies the requirements for a dental patient chair, test methods, manufacturer information, labeling and packaging.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT)
GB/T 9937 oral vocabulary (all parts) [ISO 1942 (all parts)]
YY/T 0628-2008 dental equipment Graphical symbols (ISO 9687.1993, IDT)
YY/T 0841 Medical electrical equipment after periodic testing of medical electrical equipment testing and repair (YY/T 0841-2011,
IEC 62353.2007, IDT)
YY/T 1285 dentistry oral health care personnel in the work area of dental equipment location information system (YY/T 1285-2015,
ISO 4073.2009, IDT)
ISO 8191-1 flammability assessment of equipment with decorative covering equipment - Part 1. Ignition source. low carbon coke cigarette
(Furniture-Assessmentoftheignitabilityofupholsteredfurniture-Part 1. Ignitionsource. smoulde-
ringcigarette)
ISO 21530 Dentistry Dental equipment surfaces with a material resistant to chemical disinfectants determination (Dentistry-Materialsusedfor
dentalequipmentsurfaces-Determinationofresistancetochemicaldisinfectants)
3 Terms and Definitions
GB/T 9937, GB 9706.1, YY/T 1285 and defined the following terms and definitions apply to this document.
3.1
Patient chair patientchair
Designed to support and placement of patients for dental treatment and equipment within a certain range of operation.
Category 4
4.1 Overview
This classification applies only to electric dental patient chair.
4.2 Classified by type of protection against electric shock
According to GB 9706.1-2007, dental patient chairs are classified as follows.
a) Class Ⅰ equipment, see 2.2.4 in GB 9706.1-2007.
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