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ISO Standards

There are thousands of ISO standards, with standards for both general industry and specifics, such as ISO 7 – pipe threads where pressure-tight joints are made on the threads, or ISO 4087 – Micrographics – Microfilming of newspapers for archival purposes on 35 mm microfilm. Each industry may have many ISO standards that they conform to. Listed below are a few of the more popular or relevant (to my work history) ISO standards.

 

Quality Management

ISO 9000 Family – Quality Management Standards

ISO 31000 – Risk Management

 

Safety

ISO 45000 – Occupational Health and Safety

 

Environmental Management (Controlled environments and similar)

ISO 14001 – Environmental Management Systems

ISO 14644 – Cleanrooms and associated controlled environments

 

Environmental / Testing

ISO 5667 – Water Quality – Sampling

ISO 8199 Water quality – general requirements and guidance for microbiological examinations by culture

ISO 21501-4 – Particle Measuring Systems

ISO 8573 – Compressed Air

ISO 21703 Surface active agents – Microbiology – Microbiological test methods for liquid hand dishwashing

 

Medicinal and Medical Devices

ISO 10993 Biological evaluation of medical devices

ISO 13408 – Aseptic processing of health care products

ISO 13485 – Medical Devices

ISO 11737 – Sterilization of Medical Devices

ISO 11607 Packaging for terminally sterilized medical devices

ISO 15378 – Primary packaging materials for medicinal products

ISO 16142 Medical Devices – Recognized essential principles of safety and performance of medical devices

ISO 17665 Sterilization of health care products

ISO 16775 Packaging for terminally sterilized medical devices

ISO 14971 Medical devices – Application of risk management to medical devices

ISO 24971 Guidance on application of ISO 14971

ISO/TR 80002 Medical device software

ISO 8536 Infusion equipment for medical use

ISO 22442 Medical devices utilizing animal tissues and their derivatives

ISO 14708 Implants for surgery – Active implantable medical devices

ISO 18190 Anesthetic and respiratory equipment – General requirements for airways and related equipment

ISO 28620 Medical devices – Non-electrically driven portable infusion devices

ISO 6717 In vitro diagnostic medical devices – Single use containers for the collection of specimens from humans other than blood

ISO 10651 Lung ventilators for medical use

ISO 80601 Medical electrical equipment

ISO 20417 Medical devices – Information to be supplied by the manufacturer

ISO/IEC Guide 63 – guide to the development and inclusion aspects of safety in International Standards for medical devices

 

 

Sterility

ISO 10993 Biological evaluation of medical devices

ISO 11737 Sterilization of Medical Devices

ISO 14937 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 14160 Sterilization of health care products – Liquid chemical sterilizing agents for single use medical devices utilizing animal tissues and their derivatives requirements for characterization and the development, validation and routine control of a sterilization process for medical devices

ISO 11135 Sterilization of health care products – Ethylene oxide

ISO 21387 Sterilization of medical devices – Guidance on requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release

ISO 11137 Sterilization of health care products – Radiation

ISO 11138 Sterilization of health care products – Biological indicators

ISO 11140 Sterilization of health care products – Chemical indicators

ISO 13408 Aseptic processing of health care products

ISO 15882 Sterilization of health care products – Chemical indicators

ISO/TS 13004 Sterilization of health care products – Radiation – Substantiation of selected sterilization dose; Method VDmaxSD

ISO 15883 Washers and disinfectors

ISO 17665 Sterilization of health care products – Moist Heat

ISO 20857 Sterilization of health care products – Dry heat

ISO 22421 Sterilization of health care products – Common requirements for sterilizers for terminal sterilization of medial devices in health care facilities

ISO 22441 Sterilization of health care products – Low temperature vaporized hydrogen peroxide

ISO 25424 Sterilization of health care products – Low temperature steam and formaldehyde …… medical devices

 

Food & Agriculture

ISO 22000 – Food Safety Management

ISO 7218 Microbiology of food and animal feeding stuffs – general requirements and guidance for microbiological examinations

ISO 11133 Microbiology of food, animal feed and water – preparation, production, storage and performance testing of culture media

ISO 6887 Microbiology of the food chain – Preparation of test samples, initial suspension and decimal dilutions for microbiological examination

 

Cosmetics

ISO 21148- Cosmetics – Microbiology – General instructions for microbiological examination

 

Information Technology

ISO/IEC 27001 – Information Security Management