Cleanrooms and associated controlled environments -- Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration— 28 стр.
Cleanrooms and associated controlled environments. Assessment of suitability for use of equipment and materials by airborne chemical concentration— 28 стр.
Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)— 94 стр.
Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)— 76 стр.
Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes. Requirements— 30 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.
Surface chemical analysis. Determination of surface elemental contamination on silicon wafers by total-reflection X-ray fluorescence (TXRF) spectroscopy— 36 стр.
BS EN ISO 11737-2. Sterilization of medical devices. Microbiological methods. Part 2. Tests of sterility performed in the definition, validation and maintenance of a sterilization process— 30 стр.
Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the definition, validation and maintenance of a sterilization process— 28 стр.
Optics and photonics. Lasers and laser-related equipment. Test methods for specular reflectance and regular transmittance of optical laser components— 28 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.
Hydraulic fluid power. Cleanliness of components. Inspection document and principles related to contaminant extraction and analysis, and data reporting— 56 стр.
