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ISO DIS 25424 - STERILIZATION OF HEALTH CARE PRODUCTS - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES Organization: ISO
Date: 2017-01-12
Description: Such requirements are given in EN 556-1. This standard does not specify a quality management system for the control of all stages of production of medical devices.
SNV - SN EN ISO 25424 - STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES Organization: SNV
Date: 2011-09-01
Description: Such requirements are given in EN 556-1. This standard does not specify a quality management system for the control of all stages of production of medical devices.
CEN - EN ISO 25424 - STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES Organization: CEN
Date: 2011-06-01
Description: Such requirements are given in EN 556-1. This standard does not specify a quality management system for the control of all stages of production of medical devices.
ISO 25424 - STERILIZATION OF MEDICAL DEVICES — LOW TEMPERATURE STEAM AND FORMALDEHYDE — REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES - FIRST EDITION Organization: ISO
Date: 2009-09-01
Description: Such requirements are given in EN 556-1. This standard does not specify a quality management system for the control of all stages of production of medical devices.
ISO 11135 - STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES - SECOND EDITION Organization: ISO
Date: 2014-07-15
Description: National and/or regional regulations for the provision of medical devices might require the implementation of a full quality management system and the assessment of that system by a third party. This International Standard does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities.
CEN - EN ISO 11135 - STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES Organization: CEN
Date: 2014-07-01
Description: National and/or regional regulations for the provision of medical devices might require the implementation of a full quality management system and the assessment of that system by a third party. This International Standard does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities.
DIN - DIN EN ISO 11135 - STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014) Organization: DIN
Date: 2014-10-01
Description: National and/or regional regulations for the provision of medical devices might require the implementation of a full quality management system and the assessment of that system by a third party. This International Standard does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities.
SNV - SN EN ISO 11135 - STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES Organization: SNV
Date: 2014-10-01
Description: National and/or regional regulations for the provision of medical devices might require the implementation of a full quality management system and the assessment of that system by a third party. This International Standard does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities.
AAMI 11135 - STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES Organization: AAMI
Date: 2014-01-01
Description: National and/or regional regulations for the provision of medical devices might require the implementation of a full quality management system and the assessment of that system by a third party. This International Standard does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities.

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