YY/T 1971.1-2025Dentistry - Portable dental equipment for use in non-permanent healthcare environment - Part 1: General requirements (English PDF)

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents".

Drafting.

This document is Part 1 of YY/T 1971 "Portable dental devices for non-permanent medical settings in dentistry".

YY/T 1971 has published the following parts.

---Part 1: General Requirements.

This document is modified to adopt ISO 23402-1:2020 "Dentistry - Portable dental devices for non-permanent medical settings - Part 1" Part. General Requirements. The technical differences between this document and ISO 23402-1:2020, and the reasons therefor, are as follows.

---IEC 60601-1:2012 (see Chapters 3, 4, 5, 9, and 10) has been replaced with the normatively referenced GB 9706.1-2020.

The degree of consistency between them is modified to adapt to my country's technical conditions and increase operability;

---ISO 1942 has been replaced with the normatively referenced GB/T 9937 (see Chapter 3) to adapt to my country's technical conditions and increase operability.

Actual nature;

---IEC 80601-2-60 (see Chapters 4 and 5) has been replaced with the normatively referenced GB 9706.260 to adapt to my country's technical requirements.

Add components to increase operability;

---IEC 60529:1989/Amd1.1999 (see 5.2.9.2, 5.2.9.3) has been replaced by the normatively referenced GB/T 4208-2017.

5.2.9.4), to adapt to my country's technological conditions and increase operability;

---ISO 4180:2019 (see 5.2.9.2, 5.2.9.3, 5.2.9.4) has been replaced by the normatively referenced GB/T 4857.17-2017.

Adapt to my country's technological conditions and increase operability;

---IEC 62366-1 (see 5.2.2, 5.5.2) has been replaced with the normatively referenced YY/T 1474 to adapt to my country's technical conditions, and has been improved.

Increase operability;

---ISO 21530 (see 5.5.4) has been replaced with the normatively referenced YY/T 1400 to adapt to my country's technical conditions and increase operability.

Actual nature;

---The test method in 5.2.8 has been changed to adopt the method specified in GB/T 14710 to adapt to my country's national conditions and increase operability.

The following editorial changes have been made to this document.

---The URLs referenced in the ISO and IEC terminology databases have been removed;

---Note 5.2.4 has been deleted;

---Added a title to version 5.2.9.4;

---References have been added.

Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents.

This document was proposed by the National Medical Products Administration.

This document was prepared by the National Technical Committee on Standardization of Dental Materials and Instruments, Subcommittee on Dental Equipment and Instruments (SAC/TC99) SC1) is under the jurisdiction of the State.

Introduction

YY/T 1971 "Portable dental devices for non-permanent medical environments" is proposed to consist of three parts.

---Part 1: General Requirements. The aim is to standardize the general requirements for portable dental devices used in non-permanent medical settings.

Require.

---Part 2: Portable Dental Treatment Devices. The aim is to standardize portable dental treatments for use in non-permanent medical settings.

Machine requirements.

---Part 3: Portable Suction Devices. The aim is to standardize portable suction devices for use in non-permanent medical settings.

Require.

Portable dental devices for non-permanent medical settings Dental Equipment Part 1: General Requirements

1 Scope

This document specifies the general requirements for portable dental devices used in non-permanent medical settings and describes the corresponding test methods.

This document applies to the design and manufacture of portable dental devices for non-permanent medical settings, including portable dental treatment units.

Portable dental patient chairs, portable dentist chairs, portable dental lights, portable suction devices, and portable air compressors.

Other portable dental devices.

Note. The following sections of this document specify particular requirements for certain types of portable dental devices used in non-permanent medical settings.

This document is not intended for use in non-permanent medical settings or is not designed for disassembly, folding, or packaging for non-permanent medical purposes.

Non-mobile dental equipment transported between treatment environments, wearable dental devices (such as headlights and magnifying glasses), mobile dental equipment, or portable dental equipment.

Dental equipment. Furthermore, this document does not consider non-mobile devices that can be installed in mobile dental facilities (such as vehicle-mounted or containerized mobile dental clinics).

Requirements for dynamic dental equipment.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.

For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.

This document.

GB/T 4208-2017 Degrees of protection provided by enclosures (IP code) (IEC 60529:2013, IDT) GB/T 4857.17-2017 Packaging - Basic Tests for Transport Packaging - Part 17: General Rules for Preparing Performance Test Programs (ISO 4180:2009, MOD) 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.Particular requirements for basic safety and basic performance of dental equipment (GB 9706.260-2020,IEC 80601-2-60:2012,MOD) GB/T 9937 Terminology in Dentistry (GB/T 9937-2020, ISO 1942:2009, MOD) GB/T 14710 Environmental requirements and test methods for medical electrical appliances YY/T 1400 Dental Science - Determination of the resistance of surface materials of dental equipment to chemical disinfectants (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)

3 Terms and Definitions

The terms and definitions defined in GB 9706.1-2020 and GB/T 9937, as well as the following terms and definitions, apply to this document.

dental equipment

Facilities, machines, instruments and accessories used in dental treatment and/or related procedures.