YY/T 0127.4-2023 Active Industry standards-Medicine

YY/T 0127.4-2023 Biological evaluation of medical devices used in dentistry—Part 4:Bone implant test

YY/T 0127.4-2023 Biological evaluation of medical devices used in dentistry—Part 4:Bone implant test

Publish Date: 2023-11-22 Implement Date: 2024-12-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Price: $ 39

Out of stock

Basic Information

Standard Code: YY/T 0127.4-2023

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Dental instruments, equipment, and materials

ICS Name: Dental materials

Publish Date: 2023-11-22

Implement Date: 2024-12-01

Pages: 16 pages

Scope

This document describes the bone implantation test method for oral medical devices. This document is applicable to evaluating the biological response of tissues to oral medical devices that are intended to be in contact with oral bone tissue for a long or permanent period of time.

Development Information

Word Count: 23 Thousand words Pages: 16 pages

Same series standard

YY/T 0127.19-2023 Biological evaluation of medical devices used in dentistry—Part 19:Subacute and subchronic systemic toxicity test:implant route

Replace the following standards

YY/T 0127.4-2009 Oral medical device biocontamination evaluation. The second unit: test methods, Bone implant test

Referenced Standards

ISO 10993-2 GB/T 13810-1997 Wrought titanium and titanium alloy for surgical implants GB/T 13810-2007 Wrought titanium and titanium alloy for surgical implants GB/T 13810-2017 Wrought titanium and titanium alloy for surgical implants GB/T 16886.2-2000 Biological evaluation of medical devices—Part 2:Animal welfare requirements GB/T 16886.2-2011 Biological evaluation of medical devices—Part 2:Animal welfare requirements GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.6-2015 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.12-2000 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2005 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.2-2026 Biological evaluation of medical devices—Part 2:Animal welfare requirements

Related Standards

GB/T 6387-1986 Replaced

GB/T 6387-1986 Vocabulary of dental materials

Publish Date: 1986-05-14

YY 0270-2003 Replaced

YY 0270-2003 Dentistry—Denture base polymers

Publish Date: 2003-06-20

YY 0462-2003 Replaced

YY 0462-2003 Dental gypsum products

Publish Date: 2003-06-20

YY 0463-2003 Replaced

YY 0463-2003 Dental phosphate-bonded casting investments

Publish Date: 2003-06-20

YY 1042-2003 Replaced

YY 1042-2003 Dentistry—Polymer-based filling,restorative and luting materials

Publish Date: 2003-06-20

YY 0493-2004 Replaced

YY 0493-2004 Dentistry—Elastomeric impression materials

Publish Date: 2004-11-08