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YY/T 1400-2016Dentistry - Materials used for dental equipment surfaces - Determination of resistance to chemical disinfectants (English PDF)

牙科学 牙科设备表面材料耐受化学消毒剂的测定

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

March 23, 2016

Implementation date

January 1, 2017

Scope

YY/T 1400-2016 is the English-translated version of 牙科学 牙科设备表面材料耐受化学消毒剂的测定.

YY/T 1400 is the test that decides whether a dental unit survives its own hygiene routine. It specifies how to determine the resistance of materials used on dental equipment surfaces to chemical disinfectants: the plastics, coatings and upholstery that are wiped down between every patient, several times an hour, for years.

Disinfectant damage shows as crazing, discolouration, tackiness or loss of strength, and it is the most common reason a chair or a delivery unit looks worn long before it stops working.

The method gives a manufacturer a way to qualify a surface material and a purchaser a way to compare claims. For a manufacturer of dental units, cabinetry or handpiece housings selling into China, this is the standard behind a disinfectant compatibility statement.

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Document preview — YY/T 1400-2016

National Standard of the People's Republic of China

ICS
11.060.20
Classification
C33

Issued by: National Medical Products Administration

Contents

  • 1 Scope
  • 2 Normative reference documents
  • 3.3 Borosilicate Glass Properties (Borosilicateglass3.3-Properties)
  • 4 Sampling

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. This standard uses the translation method equivalent to ISO 21530..2004 "dental dental equipment surface materials resistant to chemical disinfectant Set "(English version). And the normative references cited in this document cited in the international documents have a consistent correspondence between the following documents. GB/T 6682 Analytical laboratory water specifications and test methods (GB/T 6682-2008, ISO 3696. 1987, MOD)

--- GB/T 9937 (all parts) Oral vocabulary [ISO 1942 (all parts)] Properties of HG/T 3115 Borosilicate Glass 3.3 (HG/T 3115-1998, ISO 3585..1991, IDT) This standard has made the following editorial changes. - Some edits have been made in accordance with the requirements of GB/T 1.1; - Explain the preamble of international standards. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Dermatology and Equipment Equipment Standardization Technical Committee of Dental Equipment and Instruments Subcommittee (SAC/TC99 / SC1). The drafting of this standard. the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Shandong Xinhua Medical Devices Limited company. The main drafters of this standard. Li Shining, Liu Xiaolin, Zhou Yuxin.

All materials used on the exterior and touchable surfaces of dental equipment are subject to aerosols, splashes and droplets during normal use. Pollution. When disinfected with the relevant disinfectant recommended by the dental equipment manufacturer, these materials should be able to withstand this disinfection without Degenerate or discolored. Dental Dental Equipment Surface Materials Resistance to chemical disinfectants

1 Scope

YY/T 1400 is the test that decides whether a dental unit survives its own hygiene routine. It specifies how to determine the resistance of materials used on dental equipment surfaces to chemical disinfectants: the plastics, coatings and upholstery that are wiped down between every patient, several times an hour, for years. Disinfectant damage shows as crazing, discolouration, tackiness or loss of strength, and it is the most common reason a chair or a delivery unit looks worn long before it stops working. The method gives a manufacturer a way to qualify a surface material and a purchaser a way to compare claims. For a manufacturer of dental units, cabinetry or handpiece housings selling into China, this is the standard behind a disinfectant compatibility statement.

This standard specifies three test methods for determining the characteristics of chemical disinfectants that are expected to require disinfection of the external surface of dental equipment. Soaking test, spray test, contact test. The choice of which test method to use is determined by the experimenter. This standard does not address the effectiveness of disinfectants in bacteria, viruses and fungi. This standard does not specify the test material in the resistance reagent test, the stress on the determination of the possible impact.

2 Normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.

ISO 554 standard and atmospheric pressure specifications for regulation and/or testing (Standardatmospheresforconditioning and/ortes- ting-specifications

ISO 1942 Dentistry-Vocabulary ISO 2812-

1 Coatings and varnishes - Determination of resistance to liquids - Part 1. Liquid penetrants other than water (Paintsand varnishes-Determination ofresistancetoliquids-Part 1. Immersioninliquidsotherthanwater) ISO 3585

3.3 Borosilicate Glass Properties (Borosilicateglass3.3-Properties)

ISO 3696. 1987 Analysis of laboratory water specifications and test methods (Waterforanalyticallaboratoryuse-Specifica- tionandtestmethods)

3 terms and definitions

The terms and definitions defined in ISO 1942 apply to this document.

4 Sampling

All tests described in this standard are type tests. As far as possible from the dental equipment on behalf of the representative of the sample, a complete test. The sample is as flat as possible. The following sampling side Choose one of the law.

a) the use of new parts of dental equipment;

a) it is not possible to use standard samples and samples made from semi-finished products (eg thick plates, sheets or balls);

c) Specimens may also be made by cutting (eg, cutting or sawing) unprocessed parts or semi-finished products, but requiring new edges and new surfaces of the specimen to be The original surface of the same nature. On the new edge and the new surface of the area formed should be protected, the new area should account for the sample area A smaller proportion. All samples should be free of dirt and grease.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.

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