YY/T 0726-2020Instrumentation for use in association with non-active surgical implants - General requirements (English PDF)

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 […]