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Inclusions This International Standard specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices. NOTE Although the scope of this International Standard is limited to medical devices, it specifies...
Inclusions This International Standard specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices. NOTE Although the scope of this International Standard is limited to medical devices, it specifies...
Inclusions This International Standard specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices. NOTE Although the scope of this International Standard is limited to medical devices, it specifies...
This Technical Specification gives definitions of terms in the field of sterilization technology. This Technical Specification does not provide requirements for the validation and routine control of a sterilization process, but is intended to contribute fundamentally towards mutual...
1.1 Inclusions This International Standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and...
This document provides guidance for health care product manufacturers in the selection and qualification of polymeric materials, ceramics, and metals for use in health care products sterilized by the following methods: • Radiation (gamma, electron beam, or x-ray) • Ethylene oxide (EO) •...
ISO/TS 11139:2005 does not provide requirements for the validation and routine control of a sterilization process, but is intended to contribute fundamentally towards mutual understanding amongst those preparing and using International Standards in the field of sterilization...
This Technical Specification gives definitions of terms in the field of sterilization technology. This Technical Specification does not provide requirements for the validation and routine control of a sterilization process, but is intended to contribute fundamentally towards mutual...
This Technical Specification gives definitions of terms in the field of sterilization technology. This Technical Specification does not provide requirements for the validation and routine control of a sterilization process, but is intended to contribute fundamentally towards mutual...
This standard specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be resterilizable and medical devices intended to be sterilized by the processor. This standard specifies requirements for the...
This AAMI TIR provides additional guidance to augment ANSI/AAMI/ISO 11135:2014. This TIR addresses some of the physical aspects of ethylene oxide (EO) sterilization and provides guidance on sterilization equipment, considerations for preconditioning, how to calculate relative...
This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. NOTE Although the scope of this part of ISO 11137 is limited to medical devices, it specifies requirements and provides...
This technical information report (TIR) addresses various microbiological aspects of the development and validation of an ethylene oxide (EO) sterilization process. It does not cover the various factors that can have an effect on the bioburden of the product and on the sterilization...
This document provides guidance on the requirements of ISO 11135 that apply when parametric release is used to release the product after exposure to the sterilization process. It provides a path for transition of existing cycles, as well as a path for the development and implementation of a...
This document provides guidance on the requirements of ISO 11135 that apply when parametric release is used to release the product after exposure to the sterilization process. It provides a path for transition of existing cycles, as well as a path for the development and implementation of a...
ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may...
Inclusions This International Standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and...
Inclusions This International Standard specifies requirements for the development, validation, and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and...
The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. This in-depth guide details all steps from prevalidation planning to final...
Particular requirements for equipment used to disinfect heat-sensitive products by means of steam at below 80°C and without the addition of formaldehyde.
