DIN EN ISO 10524-4:2008-09
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PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 4: LOW-PRESSURE REGULATORS |
DIN EN ISO 18113-4:2013-01
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING (ISO 18113-4:2009) |
DIN HDBK 267/2 : 2ED 2014
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DIN HDBK 475 : 2ED 2013
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DIN EN ISO 13017:2016-05
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DENTISTRY - MAGNETIC ATTACHMENTS (ISO 13017:2012 + AMD.1:2015) |
DIN EN ISO 8835-3:2011-02
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INHALATIONAL ANAESTHESIA SYSTEMS - PART 3: TRANSFER AND RECEIVING SYSTEMS OF ACTIVE ANAESTHETIC GAS SCAVENGING SYSTEMS |
DIN EN ISO 18113-3:2013-01
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE (ISO 18113-3:2009) |
DIN EN ISO 26722:2016-02
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WATER TREATMENT EQUIPMENT FOR HAEMODIALYSIS APPLICATIONS AND RELATED THERAPIES (ISO 26722:2014) |
DIN EN ISO 11135:2014-10
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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) |
DIN EN ISO 13408-7:2015-11
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ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS (ISO 13408-7:2012) |
DIN EN ISO 10524-1:2006-05
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PRESSURE REGULATORS FOR USE WITH MEDICAL GAS - PART 1: PRESSURE REGULATORS AND PRESSURE REGULATORS WITH FLOW-METERING DEVICES |
DIN EN ISO 5840-3:2013-06
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Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013) |
DIN EN ISO 8836:2015-02
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Suction catheters for use in the respiratory tract (ISO 8836:2014); German version EN ISO 8836:2014 |
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 11979-5:2010-11
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Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006) |
DIN EN ISO 22442-1:2016-05
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Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
DIN EN ISO 21969:2010-04
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High-pressure flexible connections for use with medical gas systems (ISO 21969:2009) |
DIN EN ISO 11137-3:2015-08 (Draft)
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STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL (ISO 11137-3:2017) |
VDI 5703:2015-09
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Systematical development for a model-based testing of medical devices |
VDI 5700 Blatt 1:2015-04
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Reprocessing hazards - Risk management in reprocessing of medical devices - Measures for risk control |
DIN 820-120:2012-09
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STANDARDIZATION - PART 120: GUIDELINES FOR THE INCLUSION OF SAFETY ASPECTS IN STANDARDS (ISO/IEC GUIDE 51:1999) |
DIN EN ISO 11608-5:2013-01
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Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012) |
DIN EN ISO 26782:2010-02
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Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009 + Cor. 1:2009) (includes Corrigendum AC:2009) |
DIN EN ISO 80601-2-72:2016-04
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Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015) |
DIN EN ISO 15621:2016-06 (Draft)
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ABSORBENT INCONTINENCE AIDS FOR URINE AND/OR FAECES - GENERAL GUIDELINES ON EVALUATION (ISO 15621:2017) |
DIN HDBK 267-5 : 1ED 2016
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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 23907:2013-01
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SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - SHARPS CONTAINERS (ISO 23907:2012) |
DIN EN ISO 15002:2008-11
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FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
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 13958:2016-03
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CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014) |
DIN EN ISO 14155:2012-01
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CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011 + COR. 1:2011) |
DIN EN ISO 18113-2:2013-01
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE (ISO 18113-2:2009) |
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 23747:2015-12
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ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS (ISO 23747:2015) |
DIN EN ISO 17510-2:2009-07
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SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES |
DIN EN ISO 22803:2006-01
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Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004) |
DIN EN ISO 7494-2:2015-08
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Dentistry - Dental units - Part 2: Air, water, suction and wastewater systems (ISO 7494-2:2015) |
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 4074:2016-05
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NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS (ISO 4074:2015) |
DIN EN ISO 19054:2006-09
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RAIL SYSTEMS FOR SUPPORTING MEDICAL EQUIPMENT (ISO 19054:2005 + AMD1:2016) |
DIN EN ISO 11979-9:2014-12
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OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006 + AMD.1:2014) |
DIN EN ISO 10993-18:2009-08
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Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005); German version EN ISO 10993-18:2009 |
DIN EN ISO 16672:2015-12
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Ophthalmic implants - Ocular endotamponades (ISO 16672:2015) |
DIN EN ISO 10993-12:2012-10
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Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012) |
DIN EN ISO 9680:2015-02
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Dentistry - Operating lights (ISO 9680:2014) |
DIN EN ISO 10651-2:2011-06
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LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
VDI 5702 Blatt 1:2017-04
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Medical device software - Medical SPICE Process assessment model |
VDI 5700 Blatt 2:2017-06
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Reprocessing hazards - Risk management in reprocessing of medical devices - Trainings |
VDI 4007:2012-06
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Reliability goals - Determination, check, review, certificate |
VDI 4003:2007-03
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Reliability management |
DIN EN ISO 5840-2:2016-05
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Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015) |
DIN ISO 13022:2014-06
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MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012) |
DIN EN ISO 5840-1:2015-12
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Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015) |
DIN EN ISO 12870:2015-07 (Draft)
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OPHTHALMIC OPTICS - SPECTACLE FRAMES - REQUIREMENTS AND TEST METHODS (ISO 12870:2012) |
DIN EN ISO 7396-1:2016-09
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MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016) |
DIN EN ISO 10524-3:2013-06
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PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES (ISO 10524-3:2005 + AMD 1:2013) |
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 10651-6:2011-06
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LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
DIN EN ISO 7439:2015-08
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Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015) |
DIN EN ISO 10079-3:2014-09
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Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014) |
DIN EN ISO 15001:2012-06
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Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010) |
DIN EN ISO 10993-1:2010-04
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Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009) |
DIN EN ISO 11608-1:2015-04
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Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014) |
DIN EN ISO 11979-6:2015-02
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Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014) |
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 15194:2009-10
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CERTIFIED REFERENCE MATERIALS AND THE CONTENT OF SUPPORTING DOCUMENTATION |
DIN EN ISO 11979-7:2014-12
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OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS (ISO 11979-7:2014) |
DIN HDBK 469 : 2ED 2013
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QUALITAETS- UND RISIKOMANAGEMENTSYSTEME IM GESUNDHEITSWESEN UND KONFORMITAETSBEWERTUNG VON ZERTIFIZIERUNGSSTELLEN - NORMEN UND SPEZIFIKATIONEN |
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 25539-2:2013-05
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Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012) |
DIN EN ISO 20857:2013-08
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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) |
DIN EN ISO 5359:2015-02
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ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014) |
DIN EN ISO 7405:2013-12
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DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008 + AMD. 1:2013) |
DIN EN ISO 9170-1:2016-09 (Draft)
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TERMINAL UNITS FOR MEDICAL GAS PIPELINE SYSTEMS - PART 1: TERMINAL UNITS FOR USE WITH COMPRESSED MEDICAL GASES AND VACUUM |
DIN EN ISO 80369-1:2015-09 (Draft)
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SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 1: GENERAL REQUIREMENTS |
DIN EN ISO 15197:2015-12
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IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013) |
DIN EN ISO 14630:2013-03
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Non-active surgical implants - General requirements (ISO 14630:2012) |
DIN EN ISO 10079-1:2016-05
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MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT (ISO 10079-1:2015) |
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 16201:2006-12
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Technical aids for persons with disability - Environmental control systems for daily living (ISO 16201:2006) |
DIN EN ISO 10079-2:2014-09
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Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014); German version EN ISO 10079-2:2014 |
DIN EN ISO 10993-13:2010-11
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Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010) |
DIN EN ISO 11979-8:2016-04 (Draft)
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OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017) |
DIN ISO 10083:2008-12
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OXYGEN CONCENTRATOR SUPPLY SYSTEMS FOR USE WITH MEDICAL GAS PIPELINE SYSTEMS |
DIN EN ISO 15223-1:2015-08 (Draft)
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MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03) |
DIN EN ISO 18113-5:2013-01
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING (ISO 18113-5:2009) |
DIN EN ISO 12417-1:2016-02
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CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015) |
DIN EN ISO 18113-1:2013-01
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009) |
DIN EN ISO 80369-20:2015-09
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Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369-20:2015); German version EN ISO 80369-20:2015 |
DIN EN ISO 9170-2:2009-09
|
TERMINAL UNITS FOR MEDICAL GAS PIPELINE SYSTEMS - PART 2: TERMINAL UNITS FOR ANAESTHETIC GAS SCAVENGING SYSTEMS |
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 5367:2015-02
|
Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014) |
DIN EN ISO 80601-2-69:2014-12
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Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014) |
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 11608-7:2015-08 (Draft)
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NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT (ISO 11608-7:2016) |
DIN EN ISO 23908:2013-10
|
SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - SHARPS PROTECTION FEATURES FOR SINGLE-USE HYPODERMIC NEEDLES, INTRODUCERS FOR CATHETERS AND NEEDLES USED FOR BLOOD SAMPLING (ISO 23908:2011) |
DIN EN ISO 23640:2015-12
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS (ISO 23640:2011) |
DIN EN ISO 7396-2:2007-07
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Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007) |
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 10535:2007-04
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Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006) |
DIN EN ISO 10451:2010-11
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Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010) |