ISO 11137-1:2006 covers radiation processes employing irradiators using the radionuclide 60Co or 137Cs, a beam from an electron generator or a beam from an X-ray generator.

NS-EN ISO 11137-3:2017. NS-EN ISO 11137-1:2015. NS-EN ISO 11139:2018. Standardisering. Norsk Standard; Norsk Spesifikasjon; Norsk Hurtigspesifikasjon – Covid-19

Standard history. Status. Date. Type.

Produktfördelar: -Sterilitetsnivå (SAL) på 10−6 (ISO 11137). -Förpackad i validerat smuts med prisvärda universella och fordonspecifika bagagerumsmattor från Rameder! Bagagerumsmattguide · Startsida. tillbaka. Art.-nr: 144921-11137-1 smuts med prisvärda universella och fordonspecifika bagagerumsmattor från Rameder! Bagagerumsmattguide · Startsida.

ISO 11135 / ISO 11137 / ISO 11607 - Sterilization Package ISO 11135, ISO 11137-1, ISO 11137-2, ISO 11137-3, ISO 11607-1 and ISO 11607-2. ISO 11135 / ISO 11137 / ISO 11607 - Sterilization Package is a comprehensive sterilization collection that addresses various aspects of sterilized medical devices.

This first edition, together with ISO 11137-2 and ISO 11137-3 , cancels and replaces ISO 11137:1995 . The European Standard EN ISO 11137-1:2015 has the status of a Swedish Standard.

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)

The work of preparing International Standards is normally carried out through ISO technical committees. ISO 11137-1 - 2006-04 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. This new edition of ISO 11137-1 incorporates Amendment A1 into the existing standard. The amendment mainly includes the revision of normative references, terms and definitions. Furthermore, the English language version has been revised to achieve consistent terminology. ISO 11137-1 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization pro 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. Following establishment of the sterilization dose, sterilization dose audits are performed routinely to confirm that the sterilization dose continues to achieve the desired SAL. ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.

Methods other than those given in the guidance may be used, if they are effective in achieving compliance with the requirements of ISO 11137-1, ISO 11137-2 and ISO/TS 13004. 1 Scope This document 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 of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) ISO 11137-1:2006/Amd 1:2013 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 1 EN ISO 11137-1 Requirements Documentation is in all steps based on ability to measure dose Sect. 4.3.4: “Dosimetry used in the development, validation and routine control of the sterilization process shall have measurement traceability to national or international standards and shall have a known level of uncertainty.” BS EN ISO 11137-1, 2015 Edition, July 31, 2015 - Sterilization of health care products — Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices There is no abstract currently available for this document ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. ISO 11137-1 - 2006-04 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
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Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018) ISO 11135 / ISO 11137 / ISO 11607 - Sterilization Package ISO 11135, ISO 11137-1, ISO 11137-2, ISO 11137-3, ISO 11607-1 and ISO 11607-2. ISO 11135 / ISO 11137 / ISO 11607 - Sterilization Package is a comprehensive sterilization collection that addresses various aspects of sterilized medical devices. ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.

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ISO 11137-1 was prepared by Technical Committee ISO/TC 198, Sterilization of health care product. This first edition, together with ISO 11137-2 and ISO 11137-3 , cancels and replaces ISO 11137:1995 .

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. Following establishment of the sterilization dose, sterilization dose audits are performed routinely to confirm that the sterilization dose continues to achieve the desired SAL. ISO 11737-1:2018 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. DIN EN ISO 11137-1 - 2020-04 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd.1:2013 + Amd.2:2018); German version EN ISO 11137-1:2015 + A2:2019. BS EN ISO 11137-1:2015+A2:2019: Title: Sterilization of health care products. Radiation.

ANSI/AAMI/ISO 11137:1 2006. Sterilization of health care products-Radiation- Part 1: Requirements for the development, validation and routine control of a

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.

2016 — 11137 (1).