YY/T 1478-2016 Traceability information of disinfection and sterilization reusable medical devices
1 Scope
This standard specifies the necessary traceability information for reusable medical devices during cleaning, disinfection and sterilization.
This standard does not apply to the provisions on traceability information of other links in the processing process of reusable medical devices, such as recycling, classification, and storage.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB 8599 Technical requirements for large steam sterilizers - Automatic type
GB/T 32309 Hydrogen peroxide low temperature plasma sterilizer
YY 0503 Ethylene oxide sterilizer
YY 0646 Small steam sterilizers - Automatic type
YY/T 0679 Low temperature steam and formaldehyde sterilizers for medical purposes
YY/T 0734.1 Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (YY/T 0734.1-2009, ISO 15883-1:2006, NEQ)
YY/T 0802 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (YY/T 0802-2010, ISO 17664: 2004, IDT)
YY 1007 Vertical steam sterilizers
YY 1275 Dry heat (heated air) sterilizers
YY 0992 Endoscopic washing station
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
processing
preparations, including cleaning, disinfection and sterilization, that shall be made to new or used medical devices to meet the requirements of their intended use
[YY/T 0802-2010, Definition 2.6]
3.2
instrument set
general term for a complete set of devices and their packaging that are combined according to the purpose of use and have specific functions
4 Identification of reusable medical devices
4.1 The information of reusable medical devices shall comply with the requirements of YY/T 0802.
4.2 In the case that reusable medical devices are cleaned, disinfected and sterilized, the devices, instrument combinations or instrument sets shall be uniquely identified.
4.3 The identification may be in the form of text or bar code, radio frequency identification (RFID), etc., and shall not affect the cleaning, disinfection, sterilization and use function of the instrument, instrument combinations or instrument sets.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Identification of reusable medical devices
5 Traceability information of cleaning and disinfection processing
6 Traceability information of sterilization processing
7 Management of traceability information of disinfection and sterilization of reusable medical devices
