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YY/T 0058-2015Dentistry—Patient chair (English PDF)

牙科学 病人椅

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

March 2, 2015

Implementation date

January 1, 2016

Scope

YY/T 0058-2015 is the English-translated version of 牙科学 病人椅.

YY/T 0058-2015 is the Chinese pharmaceutical industry standard for the dental patient chair, of every construction, whether operated by hand, driven by power or moved in some other way, and whether the chair works on its own or together with the dental unit.

It sets the requirements and the test methods for it, covering the dimensions and the movements and their ranges, the load the chair must carry and its stability, the safety of the moving parts and the protection against crushing, the controls and the emergency stop, the upholstery and the surfaces and the electrical safety. Issued on 2 March 2015, it has applied since 1 January 2016.

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Document preview — YY/T 0058-2015

National Standard of the People's Republic of China

ICS
11.060.20
Classification
C 33
Replacing
YY/T 0058-2004

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Foreword
  • Introduction
  • 1 Scope
  • 2 Normative references
  • 3 Terms and Definitions

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.

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

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.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

Editions of YY/T 0058

EditionTitleRevisionStatus
YY/T 0058-2015Dentistry—Patient chaircurrent editionCurrent
YY/T 0058-2004Dentistry—Patient chairprevious editionSuperseded

This page sells the current edition, YY/T 0058-2015. Earlier editions are listed for reference only.

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