ISO 11737-1:2018
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products

Standard No.

ISO 11737-1:2018

Release Date

2018

Published By

International Organization for Standardization (ISO)

Status

Be replaced

Replace By

ISO 11737-1:2018/Amd 1:2021

Latest

ISO 11737-1:2018/Amd 1:2021

ISO 11737-1:2018 Referenced Document

• ASTM D4855-97 Standard Practice for Comparing Test Methods
• ISO 10012:2003 Measurement management systems - Requirements for measurement processes and measuring equipment
• ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
• ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
• ISO 11137-3:2017 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
• ISO 11138-2:2017 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
• ISO 11139 Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards — Amendment 1: Amended and additional terms and definitions
• ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
• ISO 13022:2012 Medical products containing viable human cells - Application of risk management and requirements for processing practices
• ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
• ISO 14160:2011 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr
• ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
• ISO 15189:2012 Medical laboratories - Requirements for quality and competence
• ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
• ISO 20857:2010 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
• ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
• ISO 7870-2:2013 Control charts - Part 2: Shewhart control charts
• ISO 7870-4:2011 Control charts - Part 4: Cumulative sum charts
• ISO 9000:2015 Quality management systems - Fundamentals and vocabulary
• ISO 9001:2015 Quality management systems - Requirements
• ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories
• ISO/IEC 90003:2014 Software engineering - Guidelines for the application of ISO 9001:2008 to computer software

ISO 11737-1:2018 history

• 2021 ISO 11737-1:2018/Amd 1:2021 Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1
• 2018 ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
• 2007 ISO 11737-1:2006/Cor 1:2007 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products; Technical Corrigendum 1
• 2006 ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
• 1995 ISO 11737-1:1995 Sterilization of medical devices - Microbiological methods - Part 1: Estimation of population of microorganisms on products