GB/T 19973.1-2015
Sterilization of medical devices.Microbiological methods.Part 1:Determination of a population of microorganisms on products (English Version)

Standard No.

GB/T 19973.1-2015

Language

Chinese, Available in English version

Release Date

2015

Published By

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China

Status

Be replaced 2024-10

Replace By

GB/T 19973.1-2023

Latest

GB/T 19973.1-2023

Replace

GB/T 19973.1-2005

Scope

This part of GB/T 19973 specifies the requirements for the enumeration and identification of the total number of viable microorganisms on (or in) medical devices, components, raw materials, and packaging, and provides guidance. This section does not specify requirements for the enumeration and identification of viral contamination or protozoal contamination. This standard does not specify the requirements for microbiological monitoring in the environment in which medical devices are produced.

GB/T 19973.1-2015 Referenced Document

• GB/T 19022-2003 Measurement management systems-Requirements for measurement processes and measruing equipment
• GB/T 27025-2008 General requirements for the competence of testing and calibration laboratories
• YY/T 0287-2003 Medical devices-Quality management systems-Requirements for regulatory purposes

GB/T 19973.1-2015 history

• 2023 GB/T 19973.1-2023 Microbiological methods for sterilization of healthcare products - Part 1: Determination of the total number of microorganisms on products
• 2015 GB/T 19973.1-2015 Sterilization of medical devices.Microbiological methods.Part 1:Determination of a population of microorganisms on products
• 2005 GB/T 19973.1-2005 Sterilization of medical devices.Microbiological methods.Part 1: Estimation of population of microorganisms on products

GB/T 19973.1-2015 -All Parts