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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/Amd 2:2018 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 Änderung 2 (ISO 11137-1:2006/Amd 2:2018) This amendment A2 modifies the European Standard EN ISO 11137-1:2015; it was approved by CEN on 4 November 2019. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment into the relevant national standard without any alteration. The European Standard EN ISO 11137-1:2015 has the status of a Swedish Standard. This document contains the official English version of EN ISO 11137-1:2015. This standard supersedes the Swedish Standard SS-EN ISO 11137-1:2006, edition 1 and SS-EN ISO 11137-1:2006 / A1:2013, edition 1.

Iso 11137-1

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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.

The amendment mainly includes the revision of normative references, terms and definitions. Furthermore, the English language version has been revised to achieve consistent terminology.

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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. 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. buy nf en iso 11137-1 : 2016 sterilization of health care products - radiation - part 1: requirements for development, validation and routine control of a sterilization process for medical devices from sai global buy din en iso 11137-1:2015-11 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) from sai global This part of ISO 11137 specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.

Iso 11137-1

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Purchase your copy of BS EN ISO 11137-1:2015+A2:2019 as a PDF download or hard copy directly from the official BSI Shop. All BSI British Standards available online in electronic and print formats. 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. Supersedes ISO/DIS 11137-1.

Iso 11137-1

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Iso 11137-1

Requirements for development, validation and routine control of a sterilization process for medical devices: Status: Current: Publication Date: 31 July 2015: Normative References(Required to achieve compliance to this 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): Available format(s): FOR 1ST EDITION AMENDMENT 2 SEE - Nov. 1, 2018 ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. By decision of the CEN Technical Bureau (Resolution CEN/BT C52/2015), Annexes ZA, ZB and ZC and the European Preface have been updated and published in June 2015 as a new edition EN ISO 11137-1:2015. en iso 11137-1 : 2015 Superseded View Superseded By Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

EN ISO 11137-2:  17 nov. 2016 — 11137 (1). En bild från 15 november 2006 – Söderhamn, Hälsingland.
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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/Amd 2:2018 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 Änderung 2 (ISO 11137-1:2006/Amd 2:2018) This amendment A2 modifies the European Standard EN ISO 11137-1:2015; it was approved by CEN on 4 November 2019. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment into the relevant national standard without any alteration. The European Standard EN ISO 11137-1:2015 has the status of a Swedish Standard.