YY/T 1691-2020Dentistry—Torque transmitter for handpieces (English PDF)

Foreword

This Standard was drafted in accordance with the rules provided in GB/T 1.1-2009.

This Standard adopts the re-drafting law to modify the adoption of ISO 17509:2016 Dentistry - Torque Transmitter for Handpieces (English version).

In comparison with ISO 17509:2016, the main technical differences are as follows:

---The Foreword part of ISO is deleted.

---In accordance with the habits of Chinese expression, the sequence of paragraphs in "Scope" is adjusted.

---In terms of Normative References, this Standard makes adjustments, so as to adapt to China's technical conditions and facilitate the implementation of this Standard. The condition of the adjustments is intensively reflected in Chapter 2 "Normative References". See the specific adjustments below:

lambda GB/T 4340.1, which is adopted in the modification, is used to replace ISO 6507-1 (see 6.3);

lambda GB/T 6062, which is equivalently adopted, is used to replace ISO 3274 (see 6.1);

lambda GB/T 9937 (all parts) is used to replace ISO 1942 (all parts) (see Chapter

3). The consistency between different parts of the two standards is as follows:

lambda GB/T 9937.1-2008 Dental Vocabulary - Part 1: General and Clinical Terms (ISO 1942-1:1989, IDT);

lambda GB/T 9937.2-2008 Dental Vocabulary - Part 2: Dental Materials (ISO 1942-2:1989, IDT);

lambda GB/T 9937.3-2008 Dental Vocabulary - Part 3: Dental Instruments (ISO 1942-3:1989, IDT);

lambda GB/T 9937.4-2005 Dental Vocabulary - Part 4: Dental Equipment (ISO 1942-4:1989, IDT);

lambda GB/T 9937.5-2008 Dental Vocabulary - Part 5: Terms Associated with Testing (ISO 1942-5:1989, IDT);

1 Scope

This Standard specifies the terms and definitions, classification, expected performance, performance attributes, performance evaluation, production, repetitive processing tolerance, information and test methods provided by the manufacturer of torque transmitters. This type of torque transmitter is used as an auxiliary device to be connected to a dental handpiece, which is used to place oral implants during oral implant surgeries and perform further operations on the connecting parts in the craniofacial region.

This Standard is applicable to torque transmitters that implant implants into or remove implants from the patient's oral cavity. The torque transmitter is connected to a power-driven system equipped with a torque control function. This Standard does not include dental implants or components connected to dental implants. This Standard is not applicable to the power-driven system itself.

2 Normative References

The following documents are indispensable to the application of this document. In terms of references with a specified date, only versions with a specified date are applicable to this document. In terms of references without a specified date, the latest version (including all the modifications) is applicable to this document.

GB/T 4340.1 Metallic Materials - Vickers Hardness Test - Part 1: Test Method (GB/T 4340.1-2009, ISO 6507-1:2005, MOD)

GB/T 6062 Geometrical Product Specifications (GPS) - Surface Texture: Profile Method - Nominal Characteristic of Contact (stylus) Instruments (GB/T 6062-2009, ISO 3274:1996, IDT)

GB/T 9937 Dental Vocabulary (all parts) [ISO 1942 (all parts)]

GB/T 10610 Geometrical Product Specifications (GPS) - Surface Texture: Profile Method - Rules and Procedures for the Assessment of Surface Texture (GB/T 10610- 2009, ISO 4288:1996, IDT)

YY/T 0967.1-2015 Dental Rotary Instruments - Shanks - Part 1: Shanks Made of Metals (ISO 1797-1:1992, MOD)

YY/T 1474 Medical Devices - Application of Risk Management to Medical Devices

6 Performance Attributes

10 Information Provided by the Manufacturer

Applicable to Chapter 11 in YY/T 1486-2016.

The shape and dimensions of the connecting part of the implant or its connecting parts and the torque transmitter shall at least be included in the label information.

When appropriate, the manufacturer's name or registered trademark shall be marked on the device or related auxiliary devices.

11 Test Methods