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List of ICS fields 01 Generalities. Terminology. Standardization. Documentation 03 Services. Company organization, management and quality. Administration. Transport.

Sociology 07 Mathematics. Natural Sciences 11 Health care technology 13 Environment. Health protection. Safety 17 Metrology and measurement. Physical phenomena 19 Testing Analytical chemistry, see 71.040 21 Mechanical systems and components for general use 23 Fluid systems and components for general use Measurement of fluid flow, see 17.120 25 Manufacturing engineering 27 Energy and heat transfer engineering 29 Electrical engineering 31 Electronics 33 Telecommunications. Audio and video engineering 35 Information technology. Office machines 37 Image technology 39 Precision mechanics. Jewellery 43 Road vehicles engineering 45 Railway engineering 47 Shipbuilding and marine structures 49 Aircraft and space vehicle engineering 53 Materials handling equipment 55 Packaging and distribution of goods 59 Textile and leather technology 61 Clothing industry 65 Agriculture 67 Food technology 71 Chemical technology 73 Mining and minerals 75 Petroleum and related technologies 77 Metallurgy 79 Wood technology 81 Glass and ceramics industries 83 Rubber and plastic industries 85 Paper technology 87 Paint and colour industries 91 Construction materials and building 93 Civil engineering 95 Military engineering 97 Domestic and commercial equipment. Entertainment. Sports

11 Health care technology

11.020 Medical sciences and health care facilities in general Including quality and environmental management in health care technology IT application in health care technology, see 35.240.80 11.040 Medical equipment 11.060 Dentistry 11.080 Sterilization and disinfection 11.100 Laboratory medicine 11.120 Pharmaceutics 11.140 Hospital equipment Including hospital beds, surgical tables, medical garments, medical gloves, containers for sharp disposal, etc. 11.160 First aid Including kits, equipment, facilities and medical transport for first aid 11.180 Aids for disabled or handicapped persons Including aids for elderly people 11.200 Birth control. Mechanical contraceptives 11.220 Veterinary medicine Including equipment specific to veterinary medicine 11.020 Medical sciences and health care facilities in general Including quality and environmental management in health care technology IT application in health care technology, see 35.240.80 IWA 1:2005 Quality management systems -- Guidelines for process improvements in health service organizations ISO/IEC Guide Guide to the development and inclusion of safety 63:1999 aspects in International Standards for medical devices ISO/TR 11991:1995 Guidance on airway management during laser surgery of upper airway ISO/ASTM Practice for blood irradiation dosimetry 51939:2005 ISO 11134:1994 Sterilization of health care products -CHF 99 Requirements for validation and routine control -- Industrial moist heat sterilization

ISO 11135:1994

Medical devices -- Validation and routine control of ethylene oxide sterilization

ISO 11135:1994/Cor 1:1994 ISO 11137:1995 Sterilization of health care products -Requirements for validation and routine control -- Radiation sterilization ISO 11137:1995/Cor 1:1997 ISO 11137:1995/Amd 1:2001 Selection of items for dose setting ISO 11138-1:1994 Sterilization of health care products -Biological indicators -- Part 1: General ISO 11138-2:1994 Sterilization of health care products -Biological indicators -- Part 2: Biological indicators for ethylene oxide sterilization ISO 11138-3:1995 Sterilization of health care products -Biological indicators -- Part 3: Biological indicators for moist heat sterilization ISO/TS 11139:2001 Sterilization of health care products -Vocabulary ISO 11140-1:2005 Sterilization of health care products -Chemical indicators -- Part 1: General requirements ISO 11140-2:1998 Sterilization of health care products -Chemical indicators -- Part 2: Test equipment and methods ISO 11140-3:2000 Sterilization of health care products -Chemical indicators -- Part 3: Class 2 indicators for steam penetration test sheets ISO 11140-4:2001 Sterilization of health care products -Chemical indicators -- Part 4: Class 2 indicators for steam penetration test packs ISO 11140-5:2000 Sterilization of health care products -Chemical indicators -- Part 5: Class 2 indicators for air removal test sheets and packs ISO 11737-1:1995 Sterilization of medical devices -Microbiological methods -- Part 1: Estimation of population of microorganisms on products ISO 11737-2:1998 Sterilization of medical devices -Microbiological methods -- Part 2: Tests of sterility performed in the validation of a sterilization process ISO 11737-3:2004 Sterilization of medical devices -Microbiological methods -- Part 3: Guidance on evaluation and

CHF 81

CHF 48

CHF 112

CHF 56

CHF 99

CHF 124

CHF 75

CHF 75

ISO 13408-1:1998

ISO 13408-2:2003 ISO 13408-4:2005

ISO 13408-6:2005 ISO/TS 13409:2002

ISO 13683:1997

ISO 14160:1998

ISO 14161:2000

ISO 14937:2000

interpretation of bioburden data Aseptic processing of health care products -- Part 1: General requirements Aseptic processing of health care products -- Part 2: Filtration Aseptic processing of health care products -- Part 4: Clean-in-place technologies Aseptic processing of health care products -- Part 6: Isolator systems Sterilization of health care products -Radiation sterilization -- Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches Sterilization of health care products -Requirements for validation and routine control of moist heat sterilization in health care facilities Sterilization of single-use medical devices incorporating materials of animal origin -- Validation and routine control of sterilization by liquid chemical sterilants Sterilization of health care products -Biological indicators -- Guidance for the selection, use and interpretation of results 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

CHF 70 CHF 75

CHF 124

CHF 130

ISO 14937:2000/Cor 1:2003 ISO/TS 15843:2000 Sterilization of health care products -Radiation sterilization -- Product families and sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits ISO/TR 15844:1998 Sterilization of health care products -Radiation sterilization -- Selection of sterilization dose for a single production batch ISO 15882:2003 Sterilization of health care products -CHF 87 Chemical indicators -- Guidance for

ISO 17664:2004

selection, use and interpretation of results Sterilization of medical devices -Information to be provided by the manufacturer for the processing of resterilizable medical devices

11.100.01 Laboratory medicine in general ISO 7713:1985 Laboratory glassware -- Disposable serological pipettes ISO 12771:1997 Plastics laboratory ware -- Disposable serological pipettes ISO 12772:1997 Laboratory glassware -- Disposable microhaematocrit capillary tubes ISO 15189:2003 Medical laboratories -- Particular requirements for quality and competence ISO 15190:2003 Medical laboratories -- Requirements for safety ISO/TR 22869:2005 Medical laboratories -- Guidance on laboratory implementation of ISO 15189: 2003 ISO 15193:2002 In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -Presentation of reference measurement procedures ISO 15194:2002 In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -Description of reference materials ISO 15197:2003 In vitro diagnostic test systems -- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus ISO 15198:2004 Clinical laboratory medicine -- In vitro diagnostic medical devices -- Validation of user quality control procedures by the manufacturer ISO 17511:2003 In vitro diagnostic medical devices -- Measurement of quantities in biological samples -- Metrological traceability of values assigned to calibrators and control materials ISO 18153:2003 In vitro diagnostic medical devices -- Measurement of quantities in biological samples -- Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials ISO 19001:2002 In vitro diagnostic medical devices -- Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology 11.100.20

Biological evaluation of medical devices Medical microbiology, see 07.100.10 IS Biological O evaluation of 1 medical devices -0 Part 1: Evaluation 9 and testing 9 31: 2 0 0 3 ISO 10993-2:1992 Biological evaluation of medical devices -- Part Animal welfare requirements ISO 10993-3:2003 Biological evaluation of medical devices -- Part Tests for genotoxicity, carcinogenicity and reproductive toxicity ISO 10993-4:2002 Biological evaluation of medical devices -- Part Selection of tests for interactions with blood ISO 10993-5:1999 Biological evaluation of medical devices -- Part Tests for in vitro cytotoxicity ISO 10993-6:1994 Biological evaluation of medical devices -- Part Tests for local effects after implantation ISO 10993-7:1995 Biological evaluation of medical devices -- Part Ethylene oxide sterilization residuals 11.120.99 Other standards related to pharmaceutics Including equipment for pharmaceutical industry ISO 11418-1:2005 Containers and accessories for pharmaceutical preparations -- Part 1: Drop-dispensing glass bottles ISO 11418-2:2005 Containers and accessories for pharmaceutical preparations -- Part 2: Screw-neck glass bottles for syrups ISO 11418-3:2005 Containers and accessories for pharmaceutical preparations -- Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms ISO 11418-4:2005 Containers and accessories for pharmaceutical preparations -- Part 4: Tablet glass bottles ISO 11418-5:1997 Containers and accessories for pharmaceutical preparations -- Part 5: Dropper assemblies ISO 11418-7:1998 Containers and accessories for pharmaceutical

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4: 5: 6: 7:

preparations -- Part 7: Screw-neck vials made of glass tubing for liquid dosage forms

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