YY/T 1463-2016Sterilization validation of medical device—Guidance on selecting a microbial challenge and inoculation sites (English PDF)

Foreword

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

1 Scope

This standard selects the appropriate microbiological challenge for the sterilization confirmation process, the appropriate site of the bacteria, the method of infection, and the recovery of the bacteria Of the technology to provide the appropriate guide.

This standard applies to medical device manufacturers for sterilization confirmation tests, and not for routine sterilization tests.

This standard does not apply to microbiological challenges or contamination processes in the confirmation or disinfection of medical device cleaning effects.

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 18279.1-2015 Sterilization of health care products Ethylene oxide - Part 1. Development, validation and identification of sterilization processes for medical devices Conventional control requirements Health care products - Sterilization - Biological indicators - Part 1. General rules GB 18281.1-2015

3 Terms and definitions

GB 18279.1 and GB 18281.1 and the following terms and definitions apply to this document.

4 Microbiological Challenge Types and Selection Criteria

4.1 When selecting specific microbes and bacteria for microbiological challenges, consider the following principles.