YY/T 1822-2022Dentistry-Intra-oral mirrors (English PDF)
牙科学 口镜
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
May 18, 2022
Implementation date
June 1, 2023
Scope
YY/T 1822-2022 is the English-translated version of 牙科学 口镜.
YY/T 1822-2022 is the Chinese pharmaceutical industry standard for reusable intra-oral mirrors with a glass reflecting surface, the mouth mirrors used in every dental examination.
It sets the requirements and the test methods for the mirror itself and for its metal frame and handle: the materials and their corrosion resistance, the reflectance and the quality of the image, the resistance of the coating to repeated cleaning and sterilization, the strength of the joint between mirror, frame and handle, and the marking. Issued on 18 May 2022, it has applied since 1 June 2023.
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Document preview — YY/T 1822-2022
National Standard of the People's Republic of China
- Classification
- C 33
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Requirements
- 5 Test method
- 6 Identification and Labeling9 Reference
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 of Standardization Documents" drafted.
This document adopts the redrafting method to modify and adopt ISO 9873:2019 "Dental Mouth Mirror". Compared with ISO 9873:2019, the main technical differences include.
--- Regarding normative reference documents, this document has made adjustments with technical differences to adapt to the technical conditions of our country and the circumstances of the adjustment.
The situation is reflected in Chapter 2 "Normative References", and the specific adjustments are as follows.
- Replace ISO 724 with GB/T 196 which is modified to adopt international standard;
- Replaced ISO 965-1 with GB/T 197 which was modified to adopt international standard;
- Replace ISO 1942 with GB/T 9937 which is modified to adopt international standard;
- Replace ISO 5864 with GB/T 20666 which is modified to adopt international standard;
- Replace ISO 263 with GB/T 20670 which is modified to adopt international standard;
- Replacing ISO 17664 with YY/T 0802, which has been modified to adopt international standards.
--- Changed the description of the definition of the rod in Terms and Definitions to meet the relevant requirements of the connection strength between the frame and the rod in 4.4 (see 3.3).
Introduction
This document specifies requirements for a dental instrument commonly used in dentistry for oral viewing and retraction.
However, there are other mirrors made of different structural designs or materials, including non-glass-coated reflective surfaces with polished Metal mirror with reflective surface. The requirements for these other types of mouth mirrors will be supplemented when the standard is formulated in the future. dental mouth mirror
1 Scope
This document specifies the requirements and test methods for reusable mouth mirrors with glass-coated reflective surfaces in the oral cavity. It also specifies the mouth mirrors Requirements for metal frame and metal handle.
This document applies to intraoral reusable mirrors with glass-coated reflective surfaces.
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document.
GB/T 196 Basic Dimensions of Ordinary Threads (GB/T 196-2003, ISO 724:1993, MOD)
GB/T 197 Common thread tolerance (GB/T 197-2018, ISO 965-1:2013, MOD)
GB/T 9937 Dental Terminology (GB/T 9937-2020, ISO 1942:2009, MOD)
GB/T 20666 Unified thread tolerance (GB/T 20666-2006, ISO 5864:1993, MOD)
GB/T 20670 Unified thread diameter and number of threads series (GB/T 20670-2006, ISO 263:1973, MOD)
YY/T 0802 Treatment of medical devices Information provided by medical device manufacturers (YY/T 0802-2020, ISO 17664. 2017, MOD)
3 Terms and Definitions
The terms and definitions defined in GB/T 9937 and the following apply to this document.
3.1 Intra-oral mirror
It is a hand-held dental instrument used for oral examination and pulling, usually consisting of a mouthpiece and a mouthpiece handle.
Note. See Figure 1.
3.2 Oral shot mirrorhead
Consists of glass reflector, frame, filler (if any) and rod.
3.3 Stem
The part that connects the mirror frame to the mouth mirror handle.
3.4 Reflectingsurface
Mirror glass coating for the purpose of reflecting light.
Note 1.The reflective surface includes the rear reflective surface and the front reflective surface.
Note 2.Rear reflective surface. the reflective layer coated on the back of the mirror glass, the mirror needs to be observed through the glass.
Note 3.Front reflective surface. the reflective layer applied to the front of the mirror glass, without the need to observe the mirror through the glass.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 25 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 196General purpose metric screw threads - Basic dimensions
- GB/T 197General purpose metric screw threads -- Tolerances
- GB/T 9937Dentistry - Vocabulary
- GB/T 20666Unified screw threads -- Tolerances
- GB/T 20670Unified screw threads -- General plan
- YY/T 0802Processing of medical devices—Information to be provided by the medical device manufacturer
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Related Standards
GB/T 196-2025 — General purpose metric screw threads - Basic dimensions
GB/T 197-2018 — General purpose metric screw threads -- Tolerances
GB/T 20666-2006 — Unified screw threads -- Tolerances
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YY/T 1822-2022
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