20191119 - Negative assessment addressed through BT decision C168/2019 (SV)
2019-03-07-JO- under HAS assessment at PUB stage. E&Y Report was due on 03 March 2019- Awaiting for the assessment report E&Y Report
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ISO 11137-3:2017 gives guidance on meeting the requirements in ISO 11137-1 and ISO 11137-2 and in ISO/TS 13004 relating to dosimetry and its use in development, validation and routine control of a radiation sterilization process.
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This Standard describes a test protocol to determine the compatibility of materials, components, parts, and assemblies with sterilization processes. It is dedicated to test on non-flight hardware only. Any additional requirements that can be imposed by the potential use of
test samples as flight hardware are not covered in this document (e.g. handling requirements). This Standard covers the following:
• Identification of critical test parameters to establish functional integrity of the hardware.
• Typical test protocols.
• Acceptance criteria.
Statements about compatibility of materials and components with sterilization processes in this document are made in general terms only. Other factors for determination of whether a material or component is suitable for a particular mission system application include:
• The potential number of sterilization cycles to which the material/component will be subjected in their live cycle.
• The additional stresses on materials/components introduced when they have become part of a larger unit/equipment/system undergoing sterilization.
• Compatibility of sterilization processes at e.g. materials level. This compatibility does not automatically guarantee that it will perform to
its requirements in an assembly. The final application and possible interactions at higher assembly level are important considerations for qualification.
• Qualification of hardware achieved by specific sterilization parameters. They cannot be necessarily extrapolated to other sterilization parameters, not even within the same sterilization process.
• The drift in performance that can be induced by sterilization processes . This drift can cause equipments to fail to meet their specified performance requirements, even though each individual element/component remains within spec. An example of this is where ‘Select-on-test’ components are used to operate a component over a critically narrow range its full performance.
To assess ultimately the suitability/compatibility of a material or component for an application requires a full consideration of the impact of sterilization processes to which it is subjected during its whole life. This includes sterilization processes it undergoes from the time it is a standalone component/material right through to when it experiences final sterilization as part of the complete system.
This standard may be tailored for the specific characteristic and constrains of a space project in conformance with ECSS-S-ST-00.
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1.1 This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.
NOTE Although the scope of this part of ISO 11137 is limited to medical devices, it specifies requirements and
provides guidance that may be applicable to other products and equipment.
This part of ISO 11137 covers radiation processes employing irradiators using,
a) the radionuclide 60Co or 137Cs,
b) a beam from an electron generator or
c) a beam from an X-ray generator.
1.2 This part of ISO 11137 does not specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
NOTE See, for example, ISO 22442-1, ISO 22442-2 and ISO 22442-3.
1.2.1 This part of ISO 11137 does not detail specified requirements for designating a medical device as sterile.
NOTE Attention is drawn to regional and national requirements for designating medical devices as “sterile.” See, for example, EN 556-1 or ANSI/AAMI ST67.
1.2.2 This part of ISO 11137 does not specify a quality management system for the control of all stages of production of medical devices.
NOTE It is not a requirement of this part of ISO 11137 to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices might require implementation of a complete quality management system and the assessment of that system by a third party.
1.2.3 This part of ISO 11137 does not require that biological indicators be used for validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product release.
1.2.4 This part of ISO 11137 does not specify requirements for occupational safety associated with the design and operation of irradiation facilities.
NOTE Attention is also drawn to the existence, in some countries, of regulations laying down safety requirements for occupational safety related to radiation.
1.2.5 This part of ISO 11137 does not specify requirements for the sterilization of used or reprocessed
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2012-07-10 EMA: Draft for final vote received in ISO/CS (see 2012-07-10 notification in dataservice).
2012-07-03 GVN: MINOR REVISION - MINOR REVISION - MINOR REVISION - MINOR REVISION
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ISO 11137-2:2006 specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level (SAL) of 10-6. It also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2006 defines product families for dose establishment and dose auditing.
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