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ISO 11137-1:2006
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Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
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ISO 15883-1:2006
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Washer-disinfectors Part 1: General requirements, terms and definitions and tests
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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)
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ISO 11607-2:2006
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Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
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ISO 15882:2008
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Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
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ISO 15510:2014
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Stainless steels Chemical composition
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ISO 11737-2:2009
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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
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ISO 11737-1:2006
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Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
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ASTM A 959 : 2016 : REDLINE
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Standard Guide for Specifying Harmonized Standard Grade Compositions for Wrought Stainless Steels
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ISO 15730:2000
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Metallic and other inorganic coatings — Electropolishing as a means of smoothing and passivating stainless steel
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DIN EN ISO 17664:2016-06 (Draft)
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PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES (ISO 17664:2017)
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ISO 5832-3:2016
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Implants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
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ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes
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ISO 14937:2009
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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
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DIN EN ISO 1043-1:2016-09
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PLASTICS - SYMBOLS AND ABBREVIATED TERMS - PART 1: BASIC POLYMERS AND THEIR SPECIAL CHARACTERISTICS (ISO 1043-1:2011 + AMD.1:2016)
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DIN EN ISO 11137-1:2015-11
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STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, INCLUDING AMD 1:2013)
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DIN EN ISO 14971:2013-04
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MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
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ISO 7405:2008
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Dentistry Evaluation of biocompatibility of medical devices used in dentistry
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ISO 11135-1:2007
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Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
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DIN EN ISO 17665-1:2006-11
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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)
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|
DIN EN ISO 5832-3:2015-06 (Draft)
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IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 3: WROUGHT TITANIUM 6-ALUMINIUM 4-VANADIUM ALLOY (ISO 5832-3:2016)
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|
ISO 18472:2006
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Sterilization of health care products Biological and chemical indicators Test equipment
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|
ISO 16061:2015
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Instrumentation for use in association with non-active surgical implants General requirements
|
|
ISO 1942:2009
|
Dentistry Vocabulary
|
|
DIN EN ISO 11135-1:2007-08
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
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|
ISO 10993-1:2009
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Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
|
|
ISO 5832-2:1999
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Implants for surgery Metallic materials Part 2: Unalloyed titanium
|
|
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)
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|
ISO 7153-1:2016
|
Surgical instruments Materials Part 1: Metals
|
|
ISO 14155:2011
|
Clinical investigation of medical devices for human subjects Good clinical practice
|
|
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 1942:2011-03
|
Dentistry - Vocabulary (ISO 1942:2009, Corrected version 2010-03-01)
|
|
ISO 14971:2007
|
Medical devices Application of risk management to medical devices
|
|
ISO 11607-1:2006
|
Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
|
|
ISO 15223-1:2016
|
Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
|
|
ISO 15883-2:2006
|
Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
|
|
ISO 1043-1:2011
|
Plastics — Symbols and abbreviated terms — Part 1: Basic polymers and their special characteristics
|
|
ISO 17664:2017
|
Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
|
|
DIN EN ISO 5832-2:2012-08
|
IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 2: UNALLOYED TITANIUM (ISO 5832-2:1999)
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|
ISO 17665-1:2006
|
Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
|
|
SAC GB/T 20878 : 2007
|
STAINLESS AND HEAT-RESISTING STEELS - DESIGNATION AND CHEMICAL COMPOSITION
|
|
EN 10088-1:2014
|
Stainless steels - Part 1: List of stainless steels
|
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