GB 18281.1-2015
Sterilization of health care products.Biological indicators.Part 1:General requirements (English Version)

Standard No.

GB 18281.1-2015

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

Latest

GB 18281.1-2015

Replace

GB 18281.1-2000

Scope

This part applicable to GB 18281 specifies the general requirements for the production, labeling, testing methods and performance of biological indicators (including carrier, test bacteria suspension) and other components intended to confirm and monitor the sterilization cycle. The basic requirements of this part are applicable to other parts of GB 18281. The requirements for biological indicators used in special sterilization processes are specified in other parts of GB 18281. This section applies to biological indicators without special requirements. Not Applicable This section does not apply to detection systems that rely on physical methods to remove microorganisms, such as filtration processes or physical and/or mechanical methods such as the use of washer-disinfectors or circulating steam to remove microorganisms. However, this section shall contain the content of the corresponding microbiological test system.

GB 18281.1-2015 Referenced Document

• GB 18278.1-2015 Damp heat for sterilization of healthcare products - Part 1: Requirements for development, validation and routine control of sterilization processes for medical devices*， 2017-01-01 Update
• GB 18279.1-2015 Sterilization of health care products.Ethylene oxide.Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
• GB 18280.1-2015 Sterilization of health care products.Radiation.Part 1: Requirements for development,validation and routine control of a sterilization process for medical devices*， 2015-12-31 Update
• GB 18280.2-2015 Sterilization of health care products.Radiation.Part 2: Establishing the sterilization dose*， 2015-12-31 Update
• GB/T 18279.2-2015 Sterilization of health care products.Part 2:Guidance on the application of GB 18279.1
• GB/T 18280.3-2015 Sterilization of health care products.Radiation.Part 3:Guidance on dosimetric aspects*， 2015-12-31 Update
• GB/T 19633.1-2015 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems*， 2016-09-01 Update
• GB/T 19633.2-2015 Packaging for terminally sterilized medical devices.Part 2:Validation requirements for forming, sealing and assembly processes
• GB/T 19973.1-2015 Sterilization of medical devices.Microbiological methods.Part 1:Determination of a population of microorganisms on products
• GB/T 24628-2009 Sterilization of health care products.Biological and chemical indicators.Test equipment
• GB/T 7408-2005 Data elements and interchange formats-Information interchange-Representation of dates and times
• YY/T 0287-2003 Medical devices-Quality management systems-Requirements for regulatory purposes
• YY/T 0466.1-2009 Medical devices.Symbols to be used with medical device labels,labelling and information to be supplied.Part 1:General requirements

GB 18281.1-2015 history

• 2015 GB 18281.1-2015 Sterilization of health care products.Biological indicators.Part 1:General requirements
• 2000 GB 18281.1-2000 Sterilization of health care products--Biological indicators--Part 1: General

GB 18281.1-2015 -All Parts