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

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)

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. 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 … 2015-11-01 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. en iso 11137-1 : 2015 Superseded View Superseded By Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Förvaring och förpackning. En st. per förseglad PE-innerpåse,  TS EN ISO 11137-1 Sterilisering av sanitetsutrustning - Strålning - Del 1: Krav för utveckling, validering och rutinstyrning av steriliseringsprocessen för medicinsk  Sistema di Qualità Totale: EN ISO 9001:2008, EN ISO 13485:2003/AC:2009, Specifiche conformi: “Tipo A” ISO 11608-2, EN ISO 11137-1:2006, EN ISO  No evidence of delayed dermal contact sensitization as per ISO 10993-10. Viral Penetration: Passes Ansell's ISO 11137-1 · ISO 13485 · ISO 14001 · ISO 9001. EN 374 delar 1, 2, 3 produktstandarder EN 420.

SS-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en iso 11137-1 : 2015 Superseded View Superseded By Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

It also defines product families for establishing sterilization doses and gives details on a sterilization dose audit. It complements BS EN ISO 11137-1:2015 Sterilization of health care products. ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies).

Sterilization by irradiation is based on ISO 11137-1:2006 Sterilization of Health Care Products (Radiation - Part 1) focused on the requirements for development, validation and routine control of a 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. 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. ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.

Standard Svensk standard · SS-EN ISO 11137-1:2015/A2:​2019. Sterilisering av sjukvårdsprodukter - Strålning - Del 1: Krav på utveckling,  Standard ISO standard · ISO 11137-1:2006/Amd 2:2018. Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and​  8 juli 2015 — (ISO 11137-1:2006, including Amd 1:2013). This preview is downloaded from www.sis.se.
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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 11137-1:2015.

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.
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BS EN ISO 11137-1:2015+A2:2019: Title: Sterilization of health care products. Radiation. 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)

ISO 13485.