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YY/T 0954-2015

Chinese Standard: 'YY/T 0954-2015'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 0954-2015English379 Add to Cart Days<=4 Nonactive surgical implants--Type Ⅰ collagen implants--Specific requirements Valid YY/T 0954-2015
YY/T 0954-2015Chinese19 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

   

BASIC DATA
Standard ID YY/T 0954-2015 (YY/T0954-2015)
Description (Translated English) Nonactive surgical implants--Type �� collagen implants--Specific requirements
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C45
Classification of International Standard 11.040.40
Word Count Estimation 19,186
Date of Issue 2015-03-02
Date of Implementation 2017-01-01
Quoted Standard GB/T 16886.1; GB/T 16886.3; GB/T 16886.4; GB/T 16886.5; GB/T 16886.6; GB/T 16886.10; GB/T 16886.11; GB/T 16886.12; GB/T 16886.17; GB/T 16886.18; YY/T 0640-2008; YY/T 0771.1; YY/T 0771.2; YY/T 0771.3; YBB 0006; YBB 0007; YBB 0008; YBB 0009; YBB 0010
Drafting Organization China Institute of Food and Drug test
Administrative Organization National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices (SAC/TC 110)
Regulation (derived from) SFDA Announcement No. 8 of 2015; SFDA Announcement No. 106 of 2019
Proposing organization State Food and Drug Administration
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the special requirements for injectable collagen implants. It is prepared from purified (non-crosslinked) type I collagen. This standard specifies the technical requirements and inspection methods of implants. It also specifies the product's expected performance, design attributes, materials, design evaluation, inspection methods, clinical evaluation, post-market supervision, manufacturing, packaging, and information provided by the manufacturer. At the same time, taking into account the safety factors of planting Jing. The implants specified in this standard are suitable for clinical use in facial dermal and/or subcutaneous injections to eliminate or reduce facial wrinkles and depressions caused by various causes.

YY/T 0954-2015
Nonactive surgical implants--Type Ⅰ collagen implants--Specific requirements
ICS 11.040.40
C45
People's Republic of China Pharmaceutical Industry Standard
YY 0954-2015
Passive surgical implant type Ⅰ collagen implant
2015-03-02 released
2017-01-01 Implementation
Issued by the State Food and Drug Administration
Contents
Foreword Ⅲ
1 Scope 1
2 Normative references 1
3 Terms and definitions 2
4 Expected performance 2
5 Design attributes 2
6 Material 2
7 Design Evaluation 3
8 Inspection method 4
9 Clinical evaluation 6
10 Post-market surveillance 6
11 Manufacturing 6
12 Packaging 7
13 Information provided by the manufacturer 7
Appendix A (Normative Appendix) Determination of Collagen Content 9
Appendix B (Normative Appendix) Determination of Total Contaminated Protein 11
Appendix C (Normative Appendix) Trace Element Analysis 13
Appendix D (Normative Appendix) Melting Point Determination 14
Appendix E (Normative Appendix) Tryptophan Check 15
YY 0954-2015
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Certain contents of this standard may involve patents. The issuer of this document does not assume responsibility for identifying these patents.
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices (SAC/TC110).
This standard was drafted by. China Food and Drug Administration.
The main drafters of this standard. Ke Linnan, Fu Bufang, Wang Jian, Tang Jinglong, Chen Dandan, Feng Xiaoming, Wang Chunren.
YY 0954-2015
Passive surgical implant type Ⅰ collagen implant
1 Scope
This standard specifies the special requirements for injectable collagen implants (hereinafter referred to as implants), which are purified (non-crosslinked)
Type Ⅰ collagen is prepared from raw materials.
This standard specifies the technical requirements and inspection methods of implants. Also on the product's expected performance, design attributes, materials, design evaluation, inspection methods
Methods, clinical evaluations, post-market surveillance, manufacturing, packaging, and information provided by the manufacturer are specified. Also consider the safety of the implant
Total factors.
The implants specified in this standard are suitable for clinical use in facial dermal and/or subcutaneous injections to eliminate or alleviate various causes
Causes facial wrinkles and depressions.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For the cited documents without date, the latest version (including all amendments) applies to this document.
GB/T 16886.1 Biological evaluation of medical devices Part 1.Evaluation and testing in the process of risk management
GB/T 16886.3 Biological evaluation of medical devices Part 3.Genotoxicity test, carcinogenicity test and reproductive toxicity test
GB/T 16886.4 Biological evaluation of medical devices Part 4.Selection of test for interaction with blood
GB/T 16886.5 Biological evaluation of medical devices Part 5.In vitro cytotoxicity test
GB/T 16886.6 Biological evaluation of medical devices Part 6.Local response test after implantation
GB/T 16886.10 Biological evaluation of medical devices Part 10.Irritation and delayed-type hypersensitivity test
GB/T 16886.11 Biological evaluation of medical devices Part 11.Systemic toxicity test
GB/T 16886.12 Biological evaluation of medical devices Part 12.Sample preparation and reference samples
GB/T 16886.17 Biological evaluation of medical devices Part 17.Establishment of allowable limits for leachables of medical devices
GB/T 16886.18 Biological evaluation of medical devices Part 18.Chemical characterization of materials
YY/T 0640-2008 General requirements for passive surgical implants
YY/T 0771.1 Animal tissues and derivatives used in the manufacture of medical devices. Part 1.Risk analysis and management
YY/T 0771.2 Animal tissues and derivatives used in the manufacture of medical devices. Part 2.Source, collection and handling control
YY/T 0771.3 Animal tissues and derivatives used in the manufacture of medical devices. Part 3.Removal and removal of viruses and infectious agents
(Or) confirmation of inactivation
YBB0006 Borosilicate glass needle tube for prefilled syringe
YBB0007 Chlorobutyl rubber piston for pre-filled syringe
YBB0008 Bromobutyl rubber piston for pre-filled syringe
YBB0009 Stainless steel injection needle for prefilled syringe
YBB0010 Polyisoprene rubber needle cap for prefilled syringe
YBB0011 pre-filled syringe assembly (with injection needle)
Pharmacopoeia of the People's Republic of China (2010 edition)
ISO 14155 (all parts) Clinical investigation of medical devices (Clinicalinvestigation of medical devices for human
subjects)
YY 0954-2015
Related standard:   YY 0954-2015  YY 0948-2015
Related PDF sample:   YY 0954-2015  YY 0948-2015
   
 
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