Sterilization of health care products. Ethylene oxide. Requirements for development, validation and routine control of a sterilization process for medical devices— 54 стр.
Quality management systems. Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations— 56 стр.
Conformity assessment. Requirements for bodies providing audit and certification of management systems. Competence requirements for auditing and certification of quality management systems— 18 стр.
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.
Textiles. Seam tensile properties of fabrics and made-up textile articles. Determination of maximum force to seam rupture using the grab method— 20 стр.
Textiles. Seam tensile properties of fabrics and made-up textile articles. Determination of maximum force to seam rupture using the strip method— 18 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.
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)
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)
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)
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006 + Cor 1:2007) (consolidated 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)
Textiles - Seam tensile properties of fabrics and made-up textile articles - Part 1: Determination of maximum force to seam rupture using the strip method (ISO 13935-1:2014)
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)
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 + Amd 1:2018) (consolidated version)
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)
Textiles - Tensile properties of fabrics - Part 1: Determination of maximum force and elongation at maximum force using the strip method (ISO 13934-1:2013)
Textiles - Seam tensile properties of fabrics and made-up textile articles - Part 2: Determination of maximum force to seam rupture using the grab method (ISO 13935-2:2014)
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)
Textiles - Test methods for nonwovens - Part 18: Determination of breaking strength and elongation of nonwoven materials using the grab tensile test (ISO 9073-18:2007)
Semiconductor devices - Micro-electromechanical devices -- Part 25: Silicon based MEMS fabrication technology - Measurement method of pull-press and shearing strength of micro bonding area (IEC 62047-25:2016) (english version)
Geotechnical investigation and testing - Field testing - Part 1: Electrical cone and piezocone penetration test (ISO 22476-1:2012+Cor 1:2013) (consolidated version)
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)