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YY/T 0726-2020 English PDF

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YY/T 0726-2020: Instrumentation for use in association with non-active surgical implants - General requirements
Status: Valid

YY/T 0726: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0726-2020English339 Add to Cart 4 days [Need to translate] Instrumentation for use in association with non-active surgical implants - General requirements Valid YY/T 0726-2020
YY/T 0726-2009English634 Add to Cart 3 days [Need to translate] Instrumentation for use in association with non-active surgical implants-General requirements Obsolete YY/T 0726-2009

PDF similar to YY/T 0726-2020


Standard similar to YY/T 0726-2020

YY/T 0809.10   YY/T 0647   YY/T 0752   YY/T 0727.2   YY/T 0727.1   

Basic data

Standard ID YY/T 0726-2020 (YY/T0726-2020)
Description (Translated English) Instrumentation for use in association with non-active surgical implants - General requirements
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C35
Classification of International Standard 11.040.40
Word Count Estimation 18,152
Date of Issue 2020-06-30
Date of Implementation 2021-06-01
Issuing agency(ies) State Drug Administration

YY/T 0726-2020: Instrumentation for use in association with non-active surgical implants - General 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.
Instrumentation for use in association with non-active surgical implants - Gerneral requirements ICS 11.040.40 C35 People's Republic of China Pharmaceutical Industry Standard Replace YY/T 0726-2009 General requirements for passive surgical implant combination devices 2020-06-30 released 2021-06-01 implementation Issued by the State Drug Administration

Table of contents

Foreword Ⅰ 1 Scope 1 2 Normative references 1 3 Terms and definitions 2 4 Expected performance 2 5 Design attributes 2 6 Material selection 3 7 Design evaluation 3 8 Manufacturing 3 9 Sterilization 3 10 Packaging 4 11 Information provided by the manufacturer 4 Appendix A (informative appendix) Typical device application examples and approved materials used to manufacture devices 7 Reference 13

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY/T 0726-2009 "General Requirements for Devices Used in Combination with Passive Surgical Implants", and is compatible with YY/T 0726-2009 In comparison, the main technical changes except for editorial changes are as follows. ---The name of the standard is changed from "General Requirements for Devices Combined with Passive Surgical Implants" to "Devices Combined with Passive Surgical Implants" common enquiries"; ---Added the terms and definitions of "related implants" (see 3.1); --- "Design attributes" added "compatibility between the device and the contained drugs or shared drugs." [(See Chapter 5 1)]; ---Modified the "material selection" requirements (see Chapter 6); ---Delete the annotation content in the "General Provisions" of "Design Evaluation" (see 7.1 of the.2009 edition); ---Modified the requirements of "clinical evaluation" (see 7.3, 7.3 of the.2009 edition); --- Deleted the content of the comment in "manufacturing" (see Chapter 8 of the.2009 edition) ---Modified the "sterilization" requirements (see Chapter 9, Chapter 9 of the.2009 edition); ---Modified the content of "Information Provided by Manufacturer" (see Chapter 11, Chapter 11 of the.2009 Edition), and added "Label" (see 11.2); --- Deleted the cobalt-based coating materials of "instruments with blades" (see A.3.1.4, A.3.1.4 of the.2009 edition); ---Modified the requirements of aluminum alloy materials for "devices with passive contact" (see A.3.4.4, A.3.4.4 of the.2009 edition); ---Increase the approved part of the grades of materials used to manufacture devices (see Table A.1~Table A.4, Table A.1~Table A.4 of the.2009 edition). This standard uses the redrafting method to amend and adopt ISO 16061.2015 "General Requirements for Passive Surgical Implant Combined Devices". Compared with ISO 16061.2015, this standard has the following technical differences. --- Regarding normative references, this standard has made adjustments with technical differences to adapt to my country's technical conditions and adjustments. The situation is collectively reflected in Chapter 2 "Normative Reference Documents", and the specific adjustments are as follows. ● Replace ISO 8601 with GB/T 7408 which is equivalent to adopting international standards; ● Replace ISO 17665-1 with GB/T 18278.1 which is equivalent to the international standard; ● Replace ISO 11135 with GB/T 18279.1 and GB/T 18279.2 which are equivalent to international standards; ● Replace ISO 11137-1 with GB/T 18280.1 which is equivalent to adopting international standards; ● Replace ISO 11137-2 with GB/T 18280.2 which is equivalent to the international standard; ● Replace ISO 11137-3 with GB/T 18280.3 which is equivalent to adopting international standards; ● Replace ISO 11607-1 with GB/T 19633.1 which is equivalent to the international standard; ● Replace ISO 11607-2 with GB/T 19633.2, which is equivalent to the international standard; ● Replace ISO 14155 with YY/T 0297 which is equivalent to the international standard; ● Replace ISO 14971 with YY/T 0316 which is equivalent to the international standard; ● Replace ISO 17664 with YY/T 0802 which is equivalent to adopting international standards; ● Added reference to GB/T 16886.1 (ISO 10993-1.2009, IDT); --- Use ISO 15223-1.2016 instead of ISO 15223-1.2012 [see 11.2c), e), f), g), h) and 11.3h), l)]. ---According to my country's standard usage habits, the reference to the chapters after deleting the clauses [see Chapter 4, Chapter 5, Chapter 6, 7.1, 11.3r)] Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Standardization Technical Committee for Surgical Implants and Orthopedic Devices (SAC/TC110). This standard was drafted. Tianjin Medical Device Quality Supervision and Inspection Center, Tianjin Urology Research Institute. The main drafters of this standard. Li Jia, Li Libin, Zhang Wenhui, Gu Hanqing, Hu Weiying. The previous versions of the standard replaced by this standard are as follows. ---YY/T 0726-2009. General requirements for passive surgical implant combination devices

1 Scope

This standard specifies the general requirements for passive surgical implant combination devices, including expected performance, design attributes, material selection, design evaluation Requirements for assessment, manufacturing, sterilization, packaging and information provided by the manufacturer. This standard applies to newly produced equipment and equipment supplied after repair, and it also applies to equipment connected to the power drive system. This standard does not apply to the power drive system itself, nor does it apply to devices used in conjunction with dental implants, endodontic root implants and ophthalmic implants.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article Pieces. For undated references, the latest version (including all amendments) applies to this document. GB/T 7408 Data and interchange format information exchange date and time representation (GB/T 7408-2005, ISO 8601.2000, IDT) GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in the Process of Risk Management (GB/T 16886.1- 2011, ISO 10993-1.2009, IDT) GB 18278.1 Sterilization of medical and health care products Part 1.Development, validation and routine control requirements for the sterilization process of medical devices Seek (GB 18278.1-2015, ISO 17665-1.2006, IDT) GB 18279.1 Sterilization of medical and health care products ethylene oxide Part 1.Development, validation and routine control of the sterilization process of medical devices System requirements (GB 18279.1-2015, ISO 11135-1.2007, IDT) GB/T 18279.2 Sterilization of Medical and Healthcare Products Ethylene Oxide Part 2.GB 18279.1 Application Guide (GB/T 18279.2-2015, ISO /T S11135-2.2008, IDT) GB 18280.1 Medical and health products sterilization radiation Part 1.Medical device sterilization process development, validation and routine control requirements Seek (GB 18280.1-2015, ISO 11137-1..2006, IDT) GB 18280.2 Medical and healthcare products sterilization radiation Part 2.Establishing sterilization dose (GB 18280.2-2015, ISO 11137-2..2006, IDT) GB/T 18280.3 Medical and health care products sterilization radiation Part 3.Dose measurement guidelines (GB/T 18280.3-2015, ISO 11137-3..2006, IDT) GB/T 19633.1 Terminally sterilized medical device packaging Part 1.Requirements for materials, sterile barrier systems and packaging systems (GB/T 19633.1-2015, ISO 11607-1.2006, IDT) GB/T 19633.2 Terminally sterilized medical device packaging Part 2.Requirements for confirmation of forming, sealing and assembly process (GB/T 19633.2-2015, ISO 11607-2.2006, IDT) YY/T 0297 Clinical Investigation of Medical Devices (YY/T 0297-1997, ISO 14155.1996, IDT) YY/T 0316 Application of medical device risk management to medical devices (YY/T 0316-2016, ISO 14971.2007, IDT) YY/T 0802 Medical device sterilization manufacturer provides information on the treatment of re-sterilizable medical devices (YY/T 0802-2010, ISO 17664.2004, IDT) ISO 80000-1 Quantity and Units-Part 1.General

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