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YY/T 1120-2021: Dentistry - Operating lights
Status: Valid YY/T 1120: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1120-2021 | English | 359 |
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Dentistry - Operating lights
| Valid |
YY/T 1120-2021
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| YY/T 1120-2009 | English | 599 |
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Dentistry. Operating lights
| Obsolete |
YY/T 1120-2009
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| YY 1120-1999 | English | 319 |
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Dental operating light
| Obsolete |
YY 1120-1999
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PDF similar to YY/T 1120-2021
Basic data | Standard ID | YY/T 1120-2021 (YY/T1120-2021) | | Description (Translated English) | Dentistry - Operating lights | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C33 | | Word Count Estimation | 19,135 | | Issuing agency(ies) | State Drug Administration | YY/T 1120-2021: Dentistry - Operating lights---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 - Operating lights
ICS 11.060.20
C33
People's Republic of China Pharmaceutical Industry Standards
Replace YY/T 1120-2009
Dental light
(ISO 9680.2014, MOD)
Released on 2021-03-09
2023-05-01 implementation
Issued by the National Medical Products Administration
Table of contents
Foreword Ⅲ
Introduction Ⅴ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Category 2
5 Requirements 2
6 Sampling 6
7 Experiment 6
8 Manufacturer's instructions 9
9 Packaging 10
10 Mark 10
Appendix A (informative appendix) Conversion formula 12
Appendix B (Normative Appendix) Normal absorption of camphorquinone 13
Reference 14
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 1120-2009 "Dental Lamps", compared with YY/T 1120-2009, the main technical changes
as follows.
---Modified the scope and expanded consideration of various light sources, including light-emitting diodes (LED) (see Chapter 1, Chapter 1 of the.2009 edition);
---Modified the normative reference documents (see Chapter 2, Chapter 2 of the.2009 edition);
---Modified the requirements for the adjustment range of illuminance, deleted the requirement for the upper limit of the minimum illuminance, and modified the lower limit of the maximum illuminance to
15000lx (see 5.2.1, 5.2.1 of the.2009 edition);
---Modified the requirements of the illumination spot, clearly defined the minimum size and shape of the B area, and increased the maximum illuminance by 10%, 50% and 75%
Requirements for the measurement, drawing and reporting of isoilluminance lines (see 5.2.2, 5.2.2 of the.2009 edition);
---Modified the CIE chromaticity coordinates of vertex 1 in Table 1, and set this vertex in the Planckian curve of CIE1960 uniform chromaticity space
Within 0.02 of the line (see 5.2.5, 5.2.5 of the.2009 edition);
---Added the requirements and test methods for compatibility with light-curing repair materials (see 5.2.10 and 7.3.11);
---Modified the requirements of the control force (see 5.3.4.3, 5.3.4.3 of the.2009 edition);
---Revised the requirements of spatters (see 5.3.5, 5.3.5 of the.2009 edition);
---Modified the electrical safety requirements (see 5.5, 5.5 in the.2009 edition);
---Added availability requirements (see 5.6);
---Modified the test conditions (see 7.1, 7.2 of the.2009 edition);
--- The part of the electrical safety test method is deleted, due to the reference to GB 9706.1-2020 (see 7.2 of the.2009 edition);
---Modified the requirements of the operating instructions and technical instructions (see 8.3, 8.4, 8.3, 8.4 of the.2009 edition);
---Modified the requirements for the external marking of the dental lamp powered by the grid (see 10.1, 10.1 in the.2009 edition);
---Added the requirements for the internal marking of the dental lamp (see 10.2);
---Added the requirements for graphical symbols (see 10.3);
---Added the requirements for the insulation color of the wire (see 10.4);
---Added the requirements for indicator lights and buttons (see 10.5);
---Revised references.
This standard uses the redrafting method to modify and adopt ISO 9680.2014 "Dental Lamps".
Compared with ISO 9680.2014, there are technical differences between this standard.
The vertical single line (|) of the setting is marked, and the specific technical differences and the reasons are as follows.
---Regarding normative references, this standard has made adjustments with technical differences to adapt to my country's technical conditions and adjustments.
The situation is collectively reflected in Chapter 2 "Normative Reference Documents", and the specific adjustments are as follows.
● Replace ISO 1942 (all parts) with GB/T 9937 (all parts), the degree of consistency between the parts of the two standards
as follows.
◆ GB/T 9937.1-2008 Oral Vocabulary Part 1.Basic and Clinical Terms (ISO 1942-1.1989,
IDT);
◆ GB/T 9937.2-2008 Dental Vocabulary Part 2.Dental Materials (ISO 1942-2.1989, IDT);
◆ GB/T 9937.3-2008 Dental Vocabulary Part 3.Dental Devices (ISO 1942-3.1989, IDT);
◆ GB/T 9937.4-2005 Dental Terminology Part 4.Dental Equipment (ISO 1942-4.1989, IDT);
◆ GB/T 9937.5-2008 Dental Terminology Part 5.Terminology Related to Testing (ISO 1942-5.1989, IDT).
● Replace ISO 4073 with YY/T 1285 which is equivalent to adopting international standards;
● Replace ISO 9687 with YY/T 0628 which is equivalent to adopting international standards;
● Replace ISO 15223-1 with YY/T 0466.1 which is equivalent to the international standard;
● Replace ISO 14971 with YY/T 0316 which is equivalent to the international standard;
● Replace ISO 21530 with YY/T 1400 which is equivalent to adopting international standards;
● Replace IEC 60050-845 with GB/T 2900.65, which is modified to adopt international standards;
● Replace IEC 60598-1 with GB 7000.1 which is equivalent to adopting international standards;
● Replace IEC 60601-1.2005 A1.2012 with GB 9706.1-2020, which is modified to adopt international standards;
● Replace IEC 62366 with YY/T 1474 which is equivalent to adopting international standards;
● Replace IEC 80601-2-60 with GB 9706.260 modified to adopt international standards;
● Use GB/T 5702 instead of CIE013.3;
● Replace IEC 62471.2006 with GB/T.20145-2006.
--- Modified 5.2.8 color rendering index, modified to the color rendering index of dental lamps used for general oral lighting Ra >85.
--- Modified 7.3.9 color rendering index, modified to test according to GB/T 5702.
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not bear the responsibility for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is organized by the National Dental Materials and Equipment Standardization Technical Committee Dental Equipment and Equipment Sub-Technical Committee (SAC/TC99
SC1) Centralized.
Drafting organizations of this standard. Foshan Bangning Electronic Technology Co., Ltd., Guangdong Medical Device Quality Supervision and Inspection Institute, Foshan Shengtian Medical
Medical Equipment Co., Ltd., Foshan Huachuang Medical Technology Co., Ltd.
The main drafters of this standard. Hou Zhiwen, Wu Yiming, Liu Sisheng, He Yanying, Lai Huanggui, Chen Huazhi.
The previous versions of the standard replaced by this standard are as follows.
---YY/T 1120-2009;
---YY 1120-1999;
---ZBK73005-1985.
Introduction
The purpose of this standard is to provide dentists and their assistants with the most suitable visual relaxation and comfort during work.
Cavity lamps, for example, the visual acuity is between 90% and 100% according to different areas, and will not have side effects or cause damage to their color perception.
Into excessive fatigue.
In this standard, the safety of the dental lamp is evaluated in conjunction with its power supply. This power supply can be integrated into the dental
Treatment machine or dental patient chair.
Any equipment parts recommended by the manufacturer for use with the dental light shall not cause the equipment to be unsafe.
When formulating this standard, the requirements of GB 7000.1 were considered.
This standard refers to the basic standard GB 9706.1-2020 on the safety of medical electrical equipment, and GB 9706.1-2020 is used in relevant places.
The corresponding clause number in 2020 will be explained.
The provisions of individual clauses in this standard take precedence over GB 9706.1-2020.
Only the product types specified in this standard apply.
Dental light
1 Scope
This standard specifies the requirements and test methods for dental lamps used in dental clinics to illuminate the oral cavity of patients.
Instructions for use, marking and packaging specifications.
This standard applies to dental lamps using any light source technology.
This standard does not apply to auxiliary light sources, such as the light derived from dental handpieces and dental headlights, nor does it apply to use during oral surgery.
Used surgical lamp.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document.
GB/T 2900.65 Electrical engineering terminology lighting (GB/T 2900.65-2004, IEC 60050-845.1987, MOD)
GB/T 5702 Evaluation method for color rendering of light source
GB 7000.1 Lamps Part 1.General requirements and tests (GB 7000.1-2015, IEC 60598-1.2014, IDT)
GB 9706.1-2020 Medical electrical equipment Part 1.General requirements for basic safety and basic performance (IEC 60601-1.
2012, MOD)
GB 9706.260 Medical electrical equipment Part 2-60.Specific requirements for basic safety and basic performance of dental equipment (GB 9706.260-
2020, IEC 80601-2-60.2012, MOD)
GB/T 9937 (all parts) oral vocabulary [ISO 1942 (all parts)]
GB/T.20145-2006 Photobiological safety of lamps and lamp systems (CIES009/E.2002, IDT)
YY/T 0316 Application of medical device risk management to medical devices (YY/T 0316-2016, ISO 14971.2007 correction
Version, IDT)
YY/T 0466.1 Medical devices are used for medical device labeling, marking and providing information symbols. Part 1.General requirements
(YY/T 0466.1-2016,ISO 15223-1.2012,IDT)
YY/T 0628 Graphical symbols for dentistry dental equipment (YY/T 0628-2020, ISO 9687.2015 A1.2018, IDT)
YY/T 1285 Dental equipment location information system in the work area of dental health care personnel (YY/T 1285-2015,
ISO 4073.2009, IDT)
YY/T 1400 Determination of resistance of surface materials of dental equipment to chemical disinfectants in dentistry (YY/T 1400-2016,
ISO 21530.2004, IDT)
YY/T 1474 Application of Medical Device Usability Engineering to Medical Devices (YY/T 1474-2016, IEC 62366.2007, IDT)
CIES017 ILV International Lighting Vocabulary (International Lighting Vocabulary)
3 Terms and definitions
As defined in GB 7000.1, GB 9706.1-2020, CIES017, GB/T 2900.65, GB/T 9937 and YY/T 1285 and the following
The listed terms and definitions apply to this document.
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