YY/T 0513.2-2020 Active Industry standards-Medicine

YY/T 0513.2-2020 Allogeneic grafts—Part 2:Deep-frozen bone grafts and freeze-dried bone grafts

YY/T 0513.2-2020 Allogeneic grafts—Part 2:Deep-frozen bone grafts and freeze-dried bone grafts

Publish Date: 2020-06-30 Implement Date: 2021-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0513.2-2020
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: 2020-06-30
Implement Date: 2021-06-01
Pages: 13 pages

Scope

This part of YY/T 0513 specifies the terms and definitions, product classification, models and specifications, raw material requirements, and external factor control for deep-cryogenic frozen and freeze-dried bones, as well as the requirements for testing methods, labels, instructions, packaging, transportation, and storage.
This part applies to deep-cryogenic frozen and freeze-dried 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 0513.2-2009

Referenced Standards

中华人民共和国药典(2015年版四部) 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

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