ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.

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Product Details; Document History Product Details Published: 04/01/2020 Number of Pages: 68 File Size: 1 file , 2.6 MB ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment. BS EN ISO 11137-2 was developed to establish the right sterilisation dose for medical equipment. This international standard takes an in-depth look at the methods aligned with the two approaches in ISO 11137-1:2008, including dose setting to get a product specific dose; and dose substantiation to confirm a preselected dose of 25kG or 15kGy.

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Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment. ISO 11137-1:2006 covers radiation processes employing irradiators using the radionuclide 60 Co or 137 Cs, a beam from an electron generator or a beam from an X-ray generator.

=. Ytors motståndskraft: EN 12720:2009+A1:2013, EN 15186 3, EN ISO 105-E04:2013.

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Iso 11137

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Iso 11137

Micro-Serve laboratory has many  Standards EN 552 and ISO 11137, covering radiation sterilization, are technically equivalent in their requirements for the selection of the sterilization dose. Dose  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  Jun 26, 2017 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  Apr 13, 2006 BS EN ISO. 11137-1:2006. Sterilization of health care products —. Radiation —.
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Radiation. This part of ISO 11137 also describes methods that can be used to carry out sterilization dose audits in accordance with ISO 11137-1:2006, Clause 12.
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ISO 11137-2:2012 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose. ISO 11137-2:2011 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.

Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number. Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. Varetype: Standard. Språk: Engelsk. Utgave: 1 (2006-04-19) Erstatter: ISO 11137:1995 Tilbaketrukket.