Medical Equipment Sterilization Standards

This clause of Part 1 is applicable except as follows: 1.1.1 Equipment included in scope Replacement: Replace the existing text with the following: This part of IEC 61010 specifies safety requirements for electrical equipment intended for sterilization, washing, and...

This book presents vital information on international sterilization standards and guidance on practical application of these standards in the manufacturing process. It covers validation, industrial sterilization methods, emerging sterilization techniques, laboratory testing,...

This document specifies the common requirements for sterilizers used for terminal sterilization of medical devices in health care facilities. This document covers sterilizers that operate with a variety of sterilizing agents (alone or in combination) within a...

This document specifies the common requirements for sterilizers used for terminal sterilization of medical devices in health care facilities. This document covers sterilizers that operate with a variety of sterilizing agents (alone or in combination) within a...

1.1 Inclusions 1.1.1 This International Standard specifies requirements for the development, validation and routine control of a Low Temperature Steam and Formaldehyde (LTSF) sterilization process for medical devices. NOTE - Although the scope of this standard is limited to...

1.1 Inclusions 1.1.1 This document specifies requirements for the development, validation and routine control of a low temperature steam and formaldehyde (LTSF) sterilization process for medical devices using a mixture of low temperature steam and formaldehyde as sterilizing...

610100-000020-000400 1 Scope and object This clause of Part 1 is applicable except as follows: 1.1 Equipment included in scope Replacement: Replace the existing text with the following: This part of IEC 61010 specifies safety requirements for electrical equipment intended for...

This Standard specifies essential elements in implementing a program for using ethylene oxide to sterilize medical devices in health care facilities, with the object of achieving an adequate level of sterility assurance and minimizing the risk of injury to health care facility...

This International Standard specifies the test methods of the validation and the performance of the distribution packaging for medical devices that do not need sterilization. This document is intended to facilitate harmonized regulatory requirements for transport packaging of...

Equipment included This part of IEC 61010 specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials in the medical, veterinary, pharmaceutical and laboratory fields, when used under the...

Inclusions This International Standard specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices. NOTE Although the scope of this...

Inclusions This International Standard specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices. NOTE Although the scope of this...

Completely revised and updated, Fluid Sterilization by Filtration, Third Edition discusses the use of gas and fluid filtration systems in sterilization technology. Packed with information useful to both the novice and the expert, it includes line-drawing illustrations, filtration...

Inclusions This International Standard specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices. NOTE Although the scope of this...

This AAMI TIR provides guidance that augments ANSI/AAMI/ISO 11135:2014, both for medical manufacturers that use contract sterilization facilities and for contract sterilization operations. This TIR addresses how ANSI/AAMI/ISO 11135:2014 applies to contract ethylene oxide (EO)...

This standard specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be re-sterilizable and medical devices intended to be sterilized by the processor. This standard specifies requirements for...

Scope and object Equipment included in scope This part of IEC 61010 specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials in the medical, veterinary, pharmaceutical and laboratory fields,...

Equipment included in scope This part of IEC 61010 specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials in the medical, veterinary, pharmaceutical and laboratory fields, when used under...

Equipment included in scope This part of IEC 61010 specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials in the medical, veterinary, pharmaceutical and laboratory fields, when used under...

To be read in conjunction with Parts 1 and 5 of BS 3970