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DIN EN ISO 11607-1:2014-11
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PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006 + AMD 1.:2014)
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IEC 61010-2-040:2015
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Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
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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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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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VDE 0411-2-040 : 2016
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SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 2-040: PARTICULAR REQUIREMENTS FOR STERILIZERS AND WASHER-DISINFECTORS USED TO TREAT MEDICAL MATERIALS (IEC 61010-2-040:2015)
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DIN EN ISO 13485:2016-08
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Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
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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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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 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes
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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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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
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ISO 22442-1:2015
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Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
|
|
ISO/IEC Guide 99:2007
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International vocabulary of metrology Basic and general concepts and associated terms (VIM)
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ISO 11140-1:2014
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Sterilization of health care products Chemical indicators Part 1: General requirements
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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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|
VDE 0411-1 : 2011
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SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS
|
|
ISO/TS 11139:2006
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Sterilization of health care products Vocabulary
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DIN EN ISO 11607-2:2014-11
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PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES (ISO 11607-2:2006 + AMD 1.:2014)
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|
ISO 10993-17:2002
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Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
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|
DIN EN ISO 11737-2:2010-04
|
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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DIN EN ISO 9000:2015-11
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QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY (ISO 9000:2015)
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DIN EN ISO 22442-2:2016-05
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Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015)
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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
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|
ISO 10012:2003
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Measurement management systems — Requirements for measurement processes and measuring equipment
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ISO 9001:2015
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Quality management systems — Requirements
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|
ISO 22442-2:2015
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Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
|
|
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)
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|
DIN EN ISO 22442-3:2008-03
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MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS
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DIN EN ISO 18472:2006-10
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STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
|
|
ISO 9000:2015
|
Quality management systems — Fundamentals and vocabulary
|
|
DIN EN ISO 9001:2015-11
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QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015)
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|
ISO 11140-5:2007
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Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
|
|
DIN EN 61010-1 : 2011
|
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS
|
|
ISO 11138-1:2017
|
Sterilization of health care products — Biological indicators — Part 1: General requirements
|
|
ISO 22442-3:2007
|
Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
|
|
DIN EN ISO 15883-1:2014-10
|
WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006 + AMD 1:2014)
|
|
DIN EN ISO 11737-1:2009-09
|
STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS
|
|
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/IEC 90003:2014
|
Software engineering Guidelines for the application of ISO 9001:2008 to computer software
|
|
ISO 14161:2009
|
Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
|
|
IEC 61010-1:2010+AMD1:2016 CSV
|
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
|
|
ISO 11138-4:2017
|
Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes
|
|
DIN EN ISO 10993-17:2009-08
|
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
|
|
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 61010-2-040 : 2016
|
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 2-040: PARTICULAR REQUIREMENTS FOR STERILIZERS AND WASHER-DISINFECTORS USED TO TREAT MEDICAL MATERIALS (IEC 61010-2-040:2015)
|
|
DIN EN ISO 11138-4:2015-10 (Draft)
|
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 4: BIOLOGICAL INDICATORS FOR DRY HEAT STERILIZATION PROCESSES (ISO 11138-4:2017)
|
|
DIN EN ISO 11140-1:2015-03
|
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
|
|
DIN EN ISO 22442-1:2016-05
|
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
|
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