DIN HDBK 263 : 4ED 2014
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DIN EN ISO 7199:2015-06 (Draft)
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CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016) |
DIN EN ISO 10555-6:2017-11
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INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS (ISO 10555-6:2015) |
DIN EN ISO 11140-4:2007-07
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Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007) |
DIN EN ISO 11140-3:2009-09
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STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 3: CLASS 2 INDICATOR SYSTEMS FOR USE IN THE BOWIE AND DICK-TYPE STEAM PENETRATION TEST |
VDI 5700 Blatt 1:2015-04
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Reprocessing hazards - Risk management in reprocessing of medical devices - Measures for risk control |
DIN EN ISO 1135-5:2016-06
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TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 1135-5:2015) |
DIN EN ISO 13408-6:2013-07
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Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005 + Amd 1:2013) (includes Amendment A1:2013) |
DIN EN ISO 13408-1:2015-12
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ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013) |
DIN EN ISO 25539-3:2012-03
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Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011) |
DIN EN ISO 1135-4:2016-06
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TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015) |
DIN EN ISO 17510-1:2009-07
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Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
DIN EN ISO 16672:2015-12
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Ophthalmic implants - Ocular endotamponades (ISO 16672:2015) |
VDI 2083 Blatt 8.1:2014-10
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Cleanroom technology - Air cleanliness chemical concentration (ACC) |
DIN EN ISO 16061:2015-09
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Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
DIN EN ISO 25539-1:2015-07 (Draft)
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CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
DIN EN ISO 13408-5:2011-09
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Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006) |
DIN EN ISO 22794:2009-11
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Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15) |
DIN EN ISO 8536-10:2015-11
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INFUSION EQUIPMENT FOR MEDICAL USE - PART 10: ACCESSORIES FOR FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-10:2015) |
DIN EN ISO 8536-9:2015-11
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INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-9:2015) |
DIN EN ISO 13504:2012-10
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DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012) |
DIN EN ISO 20072:2013-10
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AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009) |
DIN EN ISO 7198:2017-07
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Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016) |
DIN EN ISO 8536-11:2015-11
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INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-11:2015) |
DIN EN ISO 14160:2011-10
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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) |
DIN EN ISO 14161:2010-03
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STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
DIN EN ISO 14630:2013-03
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Non-active surgical implants - General requirements (ISO 14630:2012) |
DIN EN ISO 14534:2015-08
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Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
DIN EN ISO 1135-3:2014-12 (Draft)
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TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016) |
DIN ISO 11040-4:2007-10
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PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015) |
DIN HDBK 268 : 3ED 2015
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NICHT AKTIVE MEDIZINPRODUKTE - HORIZONTALE, HARMONISIERTE EUROPAEISCHE NORMEN GEMAESS EU-RICHTLINIEN AUF DEM GEBIET DER MEDIZIN |
DIN EN ISO 15883-1:2014-10
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WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006 + AMD 1:2014) |
DIN EN ISO 11138-3:2015-10 (Draft)
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STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 3: BIOLOGICAL INDICATORS FOR MOIST HEAT STERILIZATION PROCESSES (ISO 11138-3:2017) |
DIN EN ISO 11138-1:2015-10 (Draft)
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STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017) |
DIN EN ISO 10451:2010-11
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Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010) |
DIN EN ISO 11737-2:2010-04
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STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS |
DIN EN ISO 8536-8:2015-11
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INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 8536-8:2015) |