ISO 11135:2014 PDF

ISO 11135:2014 Referenced Document

EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices*， 2023-12-21 Update
IEC 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
IEC 61010-2-040:2005 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
ISO 10012:2003 Measurement management systems - Requirements for measurement processes and measuring equipment
ISO 1099 Metallic materials - Fatigue testing - Axial force-controlled method*， 2017-06-01 Update
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements
ISO 10993-3:2003 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-4:2002 Biological evaluation of medical devices - Part 4: Selection of test for interactions with blood
ISO 9000:2005 Quality management systems - Fundamentals and vocabulary
ISO 9001:2008 Quality management systems - Requirements
ISO/IEC Guide 99:2007 International vocabulary of metrology - Basic and general concepts and associated terms (VIM)

2018 ISO 11135:2014/Amd 1:2018 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices — Amendment 1: Revision of Anne
2014 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
1994 ISO 11135:1994/Cor 1:1994 Medical devices - Validation and routine control of ethylene oxide sterilization; Technical Corrigendum 1
1994 ISO 11135:1994 Medical devices; validation and routine control of ethylene oxide sterilization