Medical Devices Guidance, Safety and Test Methods
This category contains standards that pertain to safety requirements and guidelines for sterilization of items and environments such as hospitals and laboratories.
AAMI TIR19:1998 (AAMI TIR 19:1998)
Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals, 1ed & Amendment
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
IEC 61010-2-040 Ed. 3.0 b:2020
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
IEC 61010-2-040:2020 is available as IEC 61010-2-040:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition. IEC 61010-2-040:2020 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: - sterilizers and disinfectors using steam and/or hot water as the sterilant; - sterilizers and disinfectors using toxic gas, toxic aerosol or toxic vapour as the sterilant; - sterilizers and disinfectors using hot air or hot inert gas as the sterilant; and - washer-disinfectors. This third edition cancels and replaces the second edition published in 2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: - it is established on the basis of the third edition (2010) of IEC 61010 1 and its Amendment 1 (2016); - added tolerance for stability of a.c. voltage test equipment to 6.8.3.1; - the status of a Group Safety Publication has been removed (this does not change the technical requirements in the document).
ASTM E1766-15
Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices
1.1 This test method covers a reproducible procedure for testing processes used to sterilize reusable medical devices (instruments). This test method is not designed to validate a sterilization process, but tests an established sterilization cycle or process. It is a practical test of the effectiveness of a sterilization process applied to reusable medical devices. Bacterial spores more resistant to the test sterilant than the natural bioburden of the instrument are used as the test organisms. Commercially available liquid suspensions of bacterial spores are used to inoculate the instruments.
1.2 This test method is intended for reusable medical devices cleaned in accordance with the device manufacturer's instructions and prepared for sterilization in accordance with the instructions for the sterilization process being used.
1.3 This test method assumes that cleaned, reusable medical devices will be free of visible soil but may have remaining adherent bioburden. A worst-case bioburden can be represented by suspensions of bacterial endospores, which are commercially available for monitoring chemical or physical sterilization processes. These endospores should have a verifiable resistance (D value) to the specific process and sterilant being evaluated.2
1.4 It is impractical to test for the sterility of some devices by immersion in growth medium because of their complexity, size, and availability (for long-term incubation) or adverse effects on the devices from long-term immersion. Therefore, elution, rinsing, or swabbing techniques are used to recover test organisms from inoculated devices.
ISO/TS 19930:2017
Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6
ISO/TS 19930:2017 provides guidance on identifying the aspects to be considered as part of a risk-based approach to selecting a sterility assurance level (SAL) for terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a SAL of 10−6.
In addition, this document provides
a) background information on the assurance of sterility and sterility assurance level, and
b) guidance on strategies that can allow the achievement of a maximal SAL of 10−6.
ISO/TS 19930:2017 describes the elements of a quality management system which are applied to enable the appropriate selection of a SAL for terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a SAL of 10−6.
NOTE It is not a requirement of the International Standards for development, validation and routine control of a sterilization process to have a full quality management system. Attention is drawn to the standard for quality management systems (see ISO 13485) that controls all stages of the lifecycle of health care product.
ISO/TS 19930:2017 is applicable to sterilization processes in which microorganisms are inactivated by physical and/or chemical means.
ISO/TS 19930:2017 does not apply
- to selecting a maximal SAL greater than 10−6 for health care product that is able to withstand processing to achieve maximally a SAL of 10−6;
- in cases where a maximal SAL of 10−6 is required and an alternative SAL is not allowed;
- in cases where a maximal SAL of greater than 10−6 (e.g. 10−3) has been accepted by regulatory authorities within their jurisdiction for health care product for defined use;
- to the sterilization of used or reprocessed health care product;
- to sterilization of health care product by filtration.
ISO/TS 19930:2017 does not describe detailed procedures for assessing microbial inactivation.
ISO/TS 19930:2017 does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
NOTE See also ISO 22442‑1, ISO 22442‑2 and ISO 22442‑3.
ISO/TS 19930:2017 does not supersede or modify published International Standards for particular sterilization processes. ISO/TS 19930:2017 neither recommends a SAL for a given health care product nor identifies a maximal SAL for a health care product to be labelled "sterile".
NOTE These are matters for regulatory authorities and can vary from country to country.
AAMI TIR29:2012 (R2017)
Guide for process characterization and control in radiation sterilization of medical devices
This technical information report provides additional guidance for characterizing the irradiation process and for establishing requisite process controls to ensure the irradiation system remains in a validated state. This document is intended to complement qualification and routine control activities as defined in ANSI/AAMI/ISO 11137 for gamma, X-ray, and electron beam sterilization
AAMI TIR56:2013 (R2020)
Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices
This AAMI Technical Information Report (TIR) provides information to be considered during the development, validation, and routine control of EO sterilization processes that are performed using gas diffusion within individually sealed flexible sterilization bags.
AAMI TIR39:2009 (R2017)
Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices
This technical information report provides guidance on selecting the appropriate form of microbial challenge to use in a validation process and the appropriate inoculation sites for that microbial challenge.
