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ISO 13408-4:2005
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Aseptic processing of health care products — Part 4: Clean-in-place technologies
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ISO/TR 22442-4:2010
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Medical devices utilizing animal tissues and their derivatives Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes
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ASTM F 2386 : 2004
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Standard Guide for Preservation of Tissue Engineered Medical Products (TEMPs) (Withdrawn 2013)
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ISO 7010:2011
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Graphical symbols Safety colours and safety signs Registered safety signs
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ISO 13408-7:2012
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Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products
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ASTM F 2312 : 2011 : REDLINE
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Standard Terminology Relating to Tissue Engineered Medical Products
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ASTM F 2149 : 2016 : REDLINE
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Standard Test Method for Automated Analyses of Cells—the Electrical Sensing Zone Method of Enumerating and Sizing Single Cell Suspensions
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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 13408-2:2003
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Aseptic processing of health care products Part 2: Filtration
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ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes
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CFR 21(PTS800-1299) : 0
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FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
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ASTM F 2385 : 2015 : REDLINE
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Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs
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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 22442-1:2015
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Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
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ASTM F 2383 : 2011 : REDLINE
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Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs)
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ASTM F 2027 : 2016 : REDLINE
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Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
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ISO 13408-3:2006
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Aseptic processing of health care products Part 3: Lyophilization
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ISO/IEC Guide 51:2014
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Safety aspects Guidelines for their inclusion in standards
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EN 166:2001
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Personal eye-protection - Specifications
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ISO 13408-1:2008
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Aseptic processing of health care products — Part 1: General requirements
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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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ASTM F 2739 : 2016
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Standard Guide for Quantifying Cell Viability within Biomaterial Scaffolds
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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 22442-2:2015
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Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
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EN 511:2006
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Protective gloves against cold
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ASTM F 2211 : 2013
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Standard Classification for Tissue Engineered Medical Products (TEMPs)
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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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|
ISO 14155:2011
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Clinical investigation of medical devices for human subjects Good clinical practice
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ISO 22442-3:2007
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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
|
|
ISO 14971:2007
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Medical devices Application of risk management to medical devices
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|
DIN EN ISO 7010:2012-10
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GRAPHISCHE SYMBOLE - SICHERHEITSFARBEN UND SICHERHEITSZEICHEN - REGISTRIERTE SICHERHEITSZEICHEN (ISO 7010:2011/AMD 5:2014)
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EN 1251-3:2000
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Cryogenic vessels - Transportable vacuum insulated vessels of not more than 1000 litres volume - Part 3: Operational requirements
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ISO 13408-6:2005
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Aseptic processing of health care products Part 6: Isolator systems
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EN 13458-3:2003/A1:2005
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CRYOGENIC VESSELS - STATIC VACUUM INSULATED VESSELS - PART 3: OPERATIONAL REQUIREMENTS
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ISO 13408-5:2006
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Aseptic processing of health care products Part 5: Sterilization in place
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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)
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