GB 18281.5-2015
Biological indicators for sterilization of healthcare products - Part 5: Biological indicators for formaldehyde sterilization by low temperature steam (English Version)

Standard No.: GB 18281.5-2015
Language: Chinese, Available in English version
Release Date: 2017
Published By: General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Latest: GB 18281.5-2015

Scope: This part of GB18281 specifies the general requirements for the test methods of microorganisms, bacterial suspensions, bacterial contamination carriers, biological indicators and biological indicators using low-temperature steam formaldehyde as a sterilant to evaluate the effect of sterilization treatment. Note 1: See ISO 14937 for the requirements for the control and validation of the low-temperature steam formaldehyde sterilization process. Note 2: See national or regional regulations for workplace safety requirements.

GB 18281.5-2015 Referenced Document

ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements

2017 GB 18281.5-2015 Biological indicators for sterilization of healthcare products - Part 5: Biological indicators for formaldehyde sterilization by low temperature steam