YY/T 0513.3-2020 Active Industry standards-Medicine

YY/T 0513.3-2020 Allogeneic grafts—Part 3:Demineralized bone grafts

YY/T 0513.3-2020 Allogeneic grafts—Part 3:Demineralized bone grafts

Publish Date: 2020-02-21 Implement Date: 2021-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0513.3-2020
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices
ICS Name: Surgical implants, prostheses, and orthoses
Publish Date: 2020-02-21
Implement Date: 2021-01-01
Pages: 13 pages

Scope

This part of YY/T 0513 specifies the terminology and definitions, specifications, requirements, test methods, labels, instructions, packaging, transportation, and storage requirements for demineralized bone.
This part is applicable to demineralized bone products prepared from human bone tissue.

Development Information

Word Count: 24 Thousand words Pages: 13 pages

Same series standard

Replace the following standards

YY/T 0513.3-2009

Referenced Standards

YY/T 1680-2020 Allogeneic grafts—In vivo evaluation of osteoinductive potential for materials containing demineralized bone 《中华人民共和国药典》2015版(第四部) GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity GB/T 16886.3-2008 Biological evaluation of medical devices—Part 3:Tests for genotoxicity,carcinogenicity and reproductive toxicity GB/T 16886.3-2019 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity GB/T 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity 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 16886.10-2000 Biological evaluation of medical devices—Part 10:Tests for irritation and sensitization GB/T 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.11-2011 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.20-2015 Biological evaluation of medical devices—Part 20:Principles and methods for immunotoxicology testing of medical devices GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials,sterile barrier systems and packaging systems YY/T 0033-2000 Good manufacture practice for sterile medical devices YY 0236-1996 Drug packaging composite film (General) YY/T 0033-1990 Sterile medical device production management specifications YY 0033-2000 Sterile medical device production management regulations

Related Standards

Contact Us