HOME   Cart(0)   Quotation   About-Us Policy PDFs Standard-List
www.ChineseStandard.net Database: 189759 (19 Oct 2025)

YY/T 0954-2015 English PDF

US$399.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 0954-2015: Nonactive surgical implants--Type Ⅰ collagen implants--Specific requirements
Status: Valid

YY/T 0954: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0954-2015English399 Add to Cart 4 days [Need to translate] Nonactive surgical implants--Type Ⅰ collagen implants--Specific requirements Valid YY/T 0954-2015
YY/T 0954-2015English399 Add to Cart 4 days [Need to translate] Nonactive surgical implants--Type Ⅰ collagen implants--Specific requirements Valid YY/T 0954-2015

PDF similar to YY/T 0954-2015


Standard similar to YY/T 0954-2015

YY/T 0663.2   YY/T 0640   YY 0948   YY/T 0962   

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 19,132
Date of Issue 2015
Date of Implementation 2017-01-01
Issuing agency(ies) State Food and Drug Administration
Summary This standard applies to injectable collagen implants prepared from purified (non-crosslinked) type I collagen. This standard specifies the specific requirements and test methods for injectable collagen implants, and provides information on expected product performance, design attributes, materials, design evaluation, test methods, clinical evaluation, post-market surveillance, manufacturing, packaging, and information provided by the manufacturer. The information provided is specified.

YY/T 0954-2015: Nonactive surgical implants--Type Ⅰ collagen implants--Specific requirements

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
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

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 0954-2015_English be delivered?

Answer: Upon your order, we will start to translate YY/T 0954-2015_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 0954-2015_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 0954-2015_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.

Question 5: Should I purchase the latest version YY/T 0954-2015?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0954-2015 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.