General Sterilization Standards
General Sterilization contains standards that go over guidelines for sterilization of items and places. This category also has standards that address moist heat, dry heat, steam sterilizers and more.
AORN MAN-864F-2018
Guideline for Sterilization
One of the measures for preventing surgical site infections is to provide surgical items that are free of contamination at the time of use. This can be accomplished by subjecting them to cleaning and decontamination, followed by a sterilization process. Sterilization provides the highest level of assurance that surgical items are free of viable microbes. These recommended practices provide guidance for sterilizing items to be used in the surgical environment. Steam, ethylene oxide (EO), low-temperature hydrogen peroxide gas plasma, peracetic acid, ozone, and dry heat sterilization methods are addressed.
AORN MAN-864G-2020
Guideline for Sterilization
One of the measures for preventing surgical site infections is to provide surgical items that are free of contamination at the time of use. This can be accomplished by subjecting them to cleaning and decontamination, followed by a sterilization process. Sterilization provides the highest level of assurance that surgical items are free of viable microbes. These recommended practices provide guidance for sterilizing items to be used in the surgical environment. Steam, ethylene oxide (EO), low-temperature hydrogen peroxide gas plasma, peracetic acid, ozone, and dry heat sterilization methods are addressed.
AAMI TIR17: 2017
Compatibility of materials subject to sterilization
his technical information report provides guidance for health care product manufacturers in thequalification of polymeric materials, ceramics, and metals for use in health care products that are sterilized by the following modalities: a) radiation (gamma, electron beam, or x-ray); b) ethylene oxide; c) moist heat (steam); d) dry heat; e) hydrogen peroxide; f) nitrogen dioxide, g) peracetic acid vapor, h) liquid peracetic acid, and i) hydrogen peroxide–ozone. Annexes address the specific sterilization modality concerns.
AORN MAN-862E-2020
Guideline for Sterilization Packaging Systems
Guidelines for the evaluation, selection, and use of packaging systems for items to be sterilized.
ASTM F2559/F2559M-21
Standard Guide for Writing a Specification for Sterilizable Peel Pouches
1.1 This guide defines the requirements and considerations for flexible peel pouches with one open, unsealed end that are intended to be sterilized containing medical devices. These are also known as preformed sterile barrier systems. 1.2 Pouch styles are categorized as chevron, header, and corner peel. These pouches are typically manufactured by heat sealing, or in some cases, by cohesive cold sealing. The sealing bond is intended to be peeled open to aseptically dispense the contents. 1.3 Pouch materials may be either porous, nonporous, or any combination of the two. 1.4 This guide addresses some critical printing requirements on the pouch. 1.5 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
PDA TR 48-2010
Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance
This Technical Report addresses moist heat sterilizers intended for use in the pharmaceutical, medical device and biotechnology industries. This technical report focuses on the design and operation of moist heat sterilizers, from the development of User Requirements Specifications (URS) through equipment qualification (Installation Qualification (IQ) / Operational Qualification (OQ)) and culminating with ongoing maintenance requirements. The focus of this report does not include Performance Qualification (PQ). The reader is directed to PDA Technical Report No. 1 (2007 Revision) for discussion of load cycle development and process Performance Qualification.
PDA TR 01-2007
Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control
PDA's original Technical Monograph No. 1, Validation of Steam Sterilization Cycles, published in 1978, introduced the principles of steam sterilization to an entire generation of pharmaceutical scientists and engineers. The revision retains a focus on the microbiology and engineering of moist heat sterilization and the general approach to sterilization science embodied in the original document, and updates it by including contemporary subject matter.
PDA TR 03-2013
Validation of Dry Heat Processes Used for Depyrogenation and Sterilization
This technical report provides information to the manufacturers of pharmaceutical products for validating dry-heat depyrogenation and sterilization processes. The concepts and methods presented within this technical report are not intended to be a regulatory standard, but rather as points to be considered during the validation of dry-heat processes. Other technically equivalent methods may exist and may be used if they can be supported by sound scientific methods.
PDA TR 26-2008
Sterilizing Filtration of Liquids
PDA's original Technical Report No. 26, published in 1998 described the use and validation of sterilizing filtration to a generation of pharmaceutical scientists and engineers. This revision was developed in response to enhancements in filtration technologies and recent additional regulatory requirements within the pharmaceutical industry. References to scientific publications and international regulatory documents are provided where more detail and supportive data may be found. This report underwent an eleven-week global technical peer review that included feedback from the Americas, Asia-Pacific and Europe.
PDA TR 40-2005
Sterilization Filtration of Gases
The objective of the report is to assist the reader in the selection, qualification and validation of a filter that is appropriate for the application on hand. In this report, sterilizing filtration of a process gas stream is defined as the complete removal of all microbiological contaminants, excluding viruses. Under certain circumstances, other contaminants such as viruses and plasmids can also be removed by filtration. Thus, in the pharmaceutical industry, particularly in the production of parenterals, there is a wide range of processes for which sterilizing filtration of air or other process gases is appropriate and applicable.
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UL 61010-2-040 Ed. 3-2021
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
This clause of Part 1 is applicable except as follows: Replacement: Replace the existing text with the following: 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 environmental conditions of 1.4. Examples of such equipment include the following: a) STERILIZERS and disinfectors using steam and/or hot water as the sterilant; b) STERILIZERS and disinfectors using toxic gas, toxic aerosol or toxic vapour as the sterilant; c) STERILIZERS and disinfectors using hot air or hot inert gas as the sterilant; and d) WASHER-DISINFECTORS
ANSI/AAMI ST55:2016
Table-top Steam Sterilizers
This standard establishes minimum construction and performance requirements for small tabletop steam sterilizers that use saturated steam as the sterilizing agent and that have a volume less than or equal to 56.63 liters (2 cubic feet).
