YY/T 1478-2016Traceability information of disinfection and sterilization reusable medical devices (English PDF)

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009.

1 Scope

This standard specifies the retrospective information necessary for the reusable medical device during the cleaning, disinfection and sterilization process.

This standard does not apply to the retrospective information on the rest of the reusable medical device in the course of processing, such as recycling, classification, Storage and other content.

2 Normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.

GB 8599 large steam sterilizer technical requirements automatic control type

GB/T 32309 Hydrogen peroxide low temperature plasma sterilizer

YY 0503 Ethylene Oxide Sterilizer

YY 0646 small steam sterilizer automatic control type

YY/T 0679 Medical low temperature steam formaldehyde sterilizer

YY/T 0734.1 Cleaning and disinfection - Part 1. General requirements, definitions and tests (YY/T 0734.1-2009, ISO 15883-1.:2006, NEQ)

YY/T 0802 Medical Device Sterilization Manufacturer Provides information on the treatment of reusable medical devices (YY/T 0802-2010, ISO 17664.:2004, IDT)

YY 1007 vertical steam sterilizer

YY 1275 hot air type dry heat sterilizer

YY 0992 endoscopic cleaning station

3 Terms and definitions

The following terms and definitions apply to this document.

4 Reusable medical device identification

4.1 Information on reusable medical devices should be in accordance with YY/T 0802.