Systems and software engineering -- Systems and software Quality Requirements and Evaluation (SQuaRE) -- Evaluation guide for developers, acquirers and independent evaluators— 62 стр.
Software engineering. Software product quality requirements and evaluation (SQuaRE). Requirements for quality of commercial off-the-shelf (COTS) software product and instructions for testing— 36 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.
Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices— 94 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.
BS EN ISO 29001. Petroleum, petrochemical and natural gas industries. Sector-specific quality management systems. Requirements for product and service supply organizations— 58 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. 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 16106. Transport packages for dangerous goods. Dangerous goods packagings, intermediate bulk containers (IBCs) and large packagings. Guidelines for the application of ISO 9001— 65 стр.
Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)— 98 стр.
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005 + Amd 1:2013); German version EN ISO 13408-6:2011 + A1:2013— 30 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 (ISO 14160:2011); German version EN ISO 14160:2011— 48 стр.
