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EN 12442-3 : 2000
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ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS |
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ISO 11135:2014
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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 |
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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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ISO 10993-2:2006
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Biological evaluation of medical devices — Part 2: Animal welfare requirements |
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ISO 14630:2012
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Non-active surgical implants General requirements |
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ISO/IEC Guide 51:2014
|
Safety aspects Guidelines for their inclusion in standards |
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ISO 8601:2004
|
Data elements and interchange formats Information interchange Representation of dates and times |
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ISO 532:1975
|
Acoustics Method for calculating loudness level |
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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 11607:2003
|
Packaging for terminally sterilized medical devices |
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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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EN 12442-1 : 2000
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ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
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ISO 11134:1994
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Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization |
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ISO 14971:2007
|
Medical devices Application of risk management to medical devices |
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MIL-STD-1629 Revision A:1980
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PROCEDURES FOR PERFORMING A FAILURE MODE, EFFECTS AND CRITICALITY ANALYSIS |
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ISO 11137:1995
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Sterilization of health care products Requirements for validation and routine control Radiation sterilization |
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IEC 60651:1979+AMD1:1993+AMD2:2000 CSV
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Sound level meters |
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EN ISO 14160:2011
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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) |
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EN 12442-2 : 2000
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ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING |