Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes -- Amendment 1— 8 стр.
Anaesthetic and respiratory equipment. Heat and moisture exchangers (HMEs) for humidifying respired gases in humans. HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml— 16 стр.
Anaesthetic and respiratory equipment. Heat and moisture exchangers (HMEs) for humidifying respired gases in humans. HMEs for use with minimal tidal volumes of 250 ml— 30 стр.
Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment. Test method to determine the resistance to wet bacterial penetration— 26 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.
Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices— 52 стр.
Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices— 94 стр.
Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards— 60 стр.
Cardiovascular implants and artificial organs. Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)— 20 стр.
Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6— 32 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.
Packaging for terminally sterilized medical devices. Adhesive coated paper for low temperature sterilization processes. Requirements and test methods— 28 стр.
Packaging for terminally sterilized medical devices. Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5). Requirements and test methods— 22 стр.
Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery (IEC 80601-2-58:2008) (english version)
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
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)
