Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices— 54 стр.
Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices— 52 стр.
BS EN ISO 14160. Sterilization of health care products. Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives. Requirements for characterization, development, validation and routine control of a sterilization process for medical devices— 48 стр.
Sterilization of health care products. General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices— 52 стр.
Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices— 72 стр.
Sterilization of health care products. Moist heat. Guidance on the designation of a medical device to a product family and processing category for steam sterilization— 60 стр.
Sterilization of health care products. Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives. Requirements for characterization, development, validation and routine control of a sterilization process for medical devices— 44 стр.
BS EN ISO 10993-18. Biological evaluation of medical devices. Part 18. Chemical characterization of medical device materials within a risk management process— 71 стр.
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009 + Cor 1:2010) (consolidated version)
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 + Cor.:2006 + Cor.:2007 + A1:2012) (english version)
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011)
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2017)
Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15)
Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
