| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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052
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Date of Entry 07/15/2019
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FR Recognition Number
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14-533
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| Standard | |
ISO TS 19930 First edition 2017-12
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 |
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Scope/AbstractISO/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. |
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| Extent of Recognition
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Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Relevant FDA Guidance and/or Supportive Publications*
ANSI/AAMI ST67:2011/(R)2017 Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile".
ANSI/AAMI/ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices.
ANSI/AAMI/ISO 11137-1:2006/(R)2010, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013)].
ANSI/AAMI/ISO 11137-2:2013, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose.
ANSI/AAMI/ISO 11137-3:2017, Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control.
ANSI/AAMI/ISO 20857:2010/(R)2015, Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
ANSI/AAMI/ISO 17665-1:2006/(R)2013, Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and control of a sterilization process for medical devices.
ANSI/AAMI/ISO TIR 17665-2:2009, Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1:2006.
ANSI/AAMI/ISO TIR 17665-3:2014, Sterilization of health care products - Moist Heat - Guidance on the designation of a medical product to a product family and processing category for steam sterilization.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
