YY 0953-2015 Active Industry standards-Medicine

YY 0953-2015 Medical carboxymethylchitosan

YY 0953-2015 Medical carboxymethylchitosan

Publish Date: 2015-03-02 Implement Date: 2017-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0953-2015
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Orthopaedic surgery, orthopaedic instruments
ICS Name: Surgical instruments and materials
Publish Date: 2015-03-02
Implement Date: 2017-01-01
Pages: 23 pages

Scope

This standard specifies the requirements for medical-grade carboxymethyl chitosan raw materials, including testing methods, inspection rules, packaging, transportation, storage, and other requirements.
This standard applies to medical-grade carboxymethyl chitosan made from chitosan or chitin, which is produced through deacetylation, carboxylation, and purification, and is used in medical device products.

Development Information

Word Count: 38 Thousand words Pages: 23 pages

Referenced Standards

GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices GB 18279-2000 Medical devices—Validation and routine control of ethylene oxide sterilization 中华人民共和国药典(二部)2010年版 GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 Packaging—Pictorial marking for handling of goods GB/T 9969-2008 General principles for preparation of instructions for use of industrial products GB 9969.1-1998 General principles for preparation of instructions for use of industrial products GB/T 14233.2-1993 Infusion, transfusion, injction equipment for medical use—Part 2:Biological test methods GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods 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 16886.12-2000 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 16886.17-2005 Biological evaluation of medical devices—Part 17:Establishment of allowable limits for leachable substances YY/T 0313-1998 Package,lable,transport and storage for medical polymer products YY/T 0313-2014 Medical polymer products—Requirement for package and information supplied by manufacturer YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements YY/T 0771.1-2020 Medical devices utilizing animal tissues and their derivatives—Part 1:Application of risk management YY/T 0771.2-2020 Medical devices utilizing animal tissues and their derivatives—Part 2:Controls on sourcing,collection and handling YY/T 0771.3-2009 Animal-derived medical devices - Part 3: Verification of removal and inactivation of viruses and transmissible spongiform encephalopathy (TSE) factors GB/T 191-2025 Graphical symbols marking for handling and storage of packages GB/T 16886.17-2025 Biological evaluation of medical devices—Part 17:Toxicological risk assessment of medical device constituents GB/T 14233.2-2025 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods

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