YY/T 1486-2016Dentistry-General requirements for instruments and related accessories used in dental implant placement and treatment (English PDF)

3.1 Short-term use of transientusage

In any clinical operation, the continuous use time of each component does not exceed 60min.

3.2 Devices

3.2.1 Invasive surgical instruments

In surgery, an instrument that penetrates the human body through the body surface.

3.2.2 Dental implant instrumentation

Invasive surgical instrument for short-term use in the preparation of bone tissue and maxillofacial tissue in the maxillofacial area for dental implant placement and subsequent related treatments.

3.2.3 Accessory used in dental implant placement and treatment

Non-invasive surgical instruments that are used for short-term direct or indirect contact with the human body for dental implant placement and subsequent related treatments.

3.3 Stainless steel

3.3.1 Stainless steel

Steel, the main alloying element is Cr, the Cr content is not less than 10.5% (mass fraction), the C content is not more than 1.2% (mass fraction), and its The most important characteristic is corrosion resistance.

3.3.2 Austenitic stainless steel

Corrosion-resistant steel, the C content is not more than 0.2% (mass fraction), the Cr content is not less than 16% (mass fraction), the typical composition is 18% (mass fraction) of Cr and more than 8% (mass fraction) of Ni cannot be hardened by heat treatment.

3.3.3 Martensitic stainless steel

Low and medium carbon corrosion-resistant steel, C content not less than 0.1% (mass fraction), Cr content 12%~19% (mass fraction), can be hardened by quenching and tempering process.

3.3.4 Precipitation hardening stainless steel

Precipitates (very fine intermetallic compounds, carbides, or Laves phases) can be precipitated by aging treatment at lower temperatures, while The resulting high-strength corrosion-resistant steel.

4.1 Intended use

This standard classifies devices for dental implants according to the intended use specified by the manufacturer as follows.

--- Type 1.power-driven equipment;

--- Type 2.manual instruments.

4.2 Organizational contacts

This standard classifies dental implant devices as follows according to the main organizations expected to be in contact with in the working environment.

---1 category. hard tissue;

---2 categories. soft tissue;

--- Category 3.Unorganized contact.

4.3 Reuse

According to the expected number of uses, this standard classifies dental implant devices as follows.

--- Group 1.Multiple use;

---Group 2.Single use.

8.1 General

The device should be evaluated in conjunction with the design purpose of the implant system to demonstrate that it achieves its intended performance (see Clause 5). clinical Pre-assessment and risk analysis according to ISO 14971 to demonstrate safety.

If devices are to be reused, the suitability of these devices for sterilization should be assessed.

NOTE: In some cases, a clinical evaluation is also required.

8.2 Preclinical evaluation

If preclinical testing of the device is required, the conditions of intended use should be simulated.

8.3 Clinical evaluation

If a clinical investigation is carried out, it shall be conducted in accordance with the requirements of ISO 14155.

9.1 General

Devices shall be manufactured in accordance with specifications for the required performance characteristics (see Clause 6).

Note: The application of the quality management system should be described in ISO 13485.

9.2 Technical Documentation

The manufacturer's technical documentation shall at least include the information required in Chapters 4 to 8, Chapters 10 and 11.

10.1 Sterile products

Devices marked with "STERILE" should comply with the relevant regional or national regulations. The sterilization process should be validated and routinely controlled.

10.2 Non-sterile products

For non-sterile devices, the manufacturer shall specify at least one suitable sterilization method that will not affect the functional safety of the product. if not Multiple sterilizations are allowed, and a statement should be given (see Chapter 11, 11.4c).

10.3 Reuse of information

For devices that are not sterile or that are claimed to be resterilizable, the manufacturer shall provide information on the processing of these devices in accordance with ISO 17664.

11.1 General

All packages must have a label stating their full contents. If the label does not list all the contents of the package, all List of contents. If symbols are used, they shall comply with the requirements of ISO 15223-1.

11.2 Device identification

Dental implant devices and related auxiliary devices shall be marked with the following information.

a) The name or registered trademark of the manufacturer;

b) batch number (batch number) or serial number, if applicable;

c) reference number (catalogue/entry number), if applicable;

d) specification instructions required for safe selection or use;

e) depth marking, where applicable;

f) Color code, where applicable.

If the marking would affect the expected performance, or the device is too small to be legible, this information should be indicated on the label.

Note: "Easy to recognize" means visible without magnification.

11.3 Packaging labeling

The label on the package should at least contain the following information.

a) the name and address of the manufacturer;

b) batch number (batch number) or serial number, as applicable;

c) reference number (catalogue/entry number), where applicable;

d) Devices intended for single use shall be marked with the words "single use" or a symbol label consistent with ISO 15223-1.

In addition, if the device provided by the manufacturer is sterile, the following information should be given on its packaging label.

a) Sterilization validity period;

b) "STERILE" symbol consistent with ISO 15223-1;

c) Symbols for the sterilization process used in accordance with ISO 15223-1.

11.4 Instructions for use

Instructions for use shall be provided if the device cannot be used safely without them.

If the manufacturer provides instructions for the use of devices for implant implantation and treatment, the instructions for use shall contain at least the following information.

a) the name and address of the manufacturer;

b) the date of issue of the instruction manual;

c) if the device is specified for single use only, information on the known properties of the device for repeated use and technical reasons known to the manufacturer; elements may pose risks.

It is at the discretion of the manufacturer whether to provide other information to users in electronic form (such as web pages, DVDs).

A.1 Materials

When selecting materials for implant devices, the nature of their direct or indirect contact with the human body should be considered.

The materials specified in Annex A are suitable for the manufacture of devices.

A.2 Stainless steel

Specifications for the chemical composition of stainless steel shall comply with the requirements of ISO 15510, where applicable. The design of stainless steel shall comply with the requirements of ISO 15510, where applicable.