GB/T 19973.1-2023

Active

Sterilization of health care products—Microbiological methods—Part 1:Determination of a population of microorganisms on products

医疗保健产品灭菌 微生物学方法 第1部分:产品上微生物总数的确定

Standard Type
GBT
ICS
11.080.01
CCS
C47
Status
Active
Issue Date
2023-03-17
Implementation
2024-10-01
Centralized Committee
国家药监局
Issuing Authority
国家市场监督管理总局、国家标准化管理委员会

Application Summary AI generated

This standard specifies methods for determining the total number of viable microorganisms on or in a health care product, including sampling, extraction, and enumeration techniques. It is applied in the medical device and pharmaceutical industries during sterilization validation, routine monitoring, and quality control to ensure products meet bioburden limits before sterilization. The standard is used by manufacturers and testing laboratories to assess microbial contamination levels on devices, packaging, or raw materials.

Related Standards

Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.