loading
DS/EN 285 - Sterilization – Steam sterilizers – Large sterilizers
January 5, 2016 - DS

This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this...

ISO DIS 11139 - Sterilization of health care products - Vocabulary - terms used in sterilization and related equipment and process standards
June 5, 2017 - ISO

This International Standard defines terms in the field of sterilization of healthcare products used in the standards developed by ISO TC198 "Sterilization of healthcare products", CEN TC204 "Sterilization of medical devices", and CEN TC102 "Sterilizers and...

BS 3970-3 - Sterilizing and disinfecting equipment for medical products. Part 3: Specification for steam sterilizers for wrapped goods and porous loads
June 29, 1990 - BSI

Particular requirements for equipment used to sterilize wrapped items (such as instruments and utensils) and porous materials (e.g. towels and bed linen). To be read in conjunction with BS 3970:Part 1

CSA Z314.13 - Recommended Standard Practices for Emergency (Flash) Sterilization
January 1, 2001 - CSA

This Standard provides recommended practices for emergency sterilization in health care facilities. The term "emergency sterilization", as used herein, is synonymous with "flash sterilization" and sterilization by the "unwrapped method". These recommended practices are...

DS/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
July 11, 2011 - DS

ISO 25424:2009 specifies requirements for the development, validation and routine control of a Low Temperature Steam and Formaldehyde (LTSF) sterilization process for medical devices. ISO 25424:2009 is intended to be applied by process developers, manufacturers of sterilization...

AAMI TIR20 - PARAMETRIC RELEASE FOR ETHYLENE OXIDE STERILIZATION
January 1, 2001 - AAMI

Parametric release is the declaration of adequacy of routine processing for a validated sterilization process based solely on measurement and documentation of physical process parameters rather than results of biological indicator or product sterility evaluation. This technical information...

BS 3970-2 - Sterilizing and Disinfecting Equipment for Medical Products - Part 2: Specification for Steam Sterilizers for Aqueous Fluids in Sealed Rigid Containers
September 30, 1991 - BSI

Requirements, additional to those in Part 1, for sterilizers in which heat transfer is effected by saturated steam under phase-boundary conditions. To be read in conjunction with BS 3970-1

BS 3970-4 - Sterilizing and disinfecting equipment for medical products - Part 4: Specification for transportable steam sterilizers for unwrapped instruments and utensils
July 31, 1990 - BSI

Requirements for equipment, used in clinics and surgeries and by therapists, to sterilize implements that are likely to pierce the skin. The equipment requires no plumbing or permanent connection to an electrical supply. To be read in conjunction with BS 3970-1

A-A-30162 - TUBING, STERILIZATION
May 28, 1992 - NPFC

The General Services Administration has authorized the use of this commercial item description. This commercial item description describes combination paper/plastic sterilization tubing for use in steam and ethylene oxide sterilization, and closed with a heat sealer or with...

CSA Z314.23 - Chemical sterilization of reusable medical devices in health care settings
January 1, 2016 - CSA

This Standard specifies essential elements for using chemical processes to sterilize medical devices in health care settings, with the object of achieving an adequate level of sterility assurance and minimizing the risk of injury to health care setting personnel and patients. Note:...

BS 3970-1 - Sterilizing and disinfecting equipment for medical products - Part 1: Specification for general requirements
June 29, 1990 - BSI

For sterilizers used in hospitals and other medical, clinical and ancilliary institutions.

AAMI TIR28 - Product adoption and process equivalence for ethylene oxide sterilization
January 1, 2016 - AAMI

This TIR addresses medical devices that are processed by ethylene oxide (EO) sterilization using conventional or parametric product release. The document applies to the following situations for the sterilization of medical devices: a) a new product is being added to the...

A-A-54526 - INDICATOR, STERILIZATION
November 23, 1991 - NPFC

The General Services Administration has authorized the use of this Commercial Item Description as a replacement for MIL-I-36789, which is cancelled. This Commercial Item Description covers one type of sensitized paper or fabric test record for determination of air elimination from within a...

A-A-53450 - WRAPPER, STERILIZATION
April 29, 1988 - NPFC

The General Services Administration has authorized the use of this Commercial Item Description. This Commercial Item Description covers a disposable wrapper suitable for wrapping surgical supplies for sterilization by autoclaving.

CSA Z314.3 - Effective sterilization in health care settings by the steam process
January 1, 2014 - CSA

This Standard specifies essential elements for using steam to sterilize medical devices in health care settings, with the object of achieving an adequate level of sterility assurance and minimizing the risk of injury to health care setting personnel and patients. Notes: 1) The term...

DS 2451-13 - Infection control in the health care sector - Part 13: Requirements for reprocessing of reusable medical equipment
December 16, 2011 - DS

This standard for retreatment of sterilizable medical equipment in health care sector gives some requirements for products, processes etc.

AAMI ST58 - Chemical sterilization and high-level disinfection in health care facilities
January 1, 2013 - AAMI

General This recommended practice provides guidelines for the selection and use of liquid chemical sterilants (LCSs)/highlevel disinfectants (HLDs) and gaseous chemical sterilizers that have been cleared for marketing by the U.S. Food and Drug Administration (FDA) for use in hospitals and...

DIN EN 14180 - Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
September 1, 2014 - DIN

This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only. These sterilizers are primarily used for the sterilization...

DS/EN 14180 - Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
June 18, 2014 - DS

This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only. These sterilizers are primarily used for the sterilization...

AAMI ST41 - Ethylene oxide sterilization in health care facilities: Safety and effectiveness
January 1, 2008 - AAMI

General This recommended practice provides guidelines for EO sterilization processing in hospitals and other health care facilities. These guidelines are intended to promote sterility assurance and to assist health care personnel in the proper use of processing equipment. These...

Advertisement