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Spec:
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Title:
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ISO-9001
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Quality management systems -- Requirements
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IPC-A-610
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Acceptability of Electronic Assemblies
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ISO-14971
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Medical devices -- Application of risk management to medical devices
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ASME-Y14.5
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Geometric dimensioning and tolerancing
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ASTM-D4169
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Standard Practice for Performance Testing of Shipping Containers and Systems
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ISO-13485
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Medical devices -- Quality management systems -- Requirements for regulatory purposes
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21CFR(800-1299)
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Code of Federal Regulations - Title 21--Food and Drugs (Parts 800 to 1299)
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ASTM-F88
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Standard Test Method for Seal Strength of Flexible Barrier Materials
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ASQ-Z1.4
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Sampling Procedures and Tables for Inspection by Attributes
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ISO/IEC-17025
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General requirements for the competence of testing and calibration laboratories
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BS-EN-980
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Symbols for use in the labelling of medical devices
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IEC-60601-1
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Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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IPC/EIA-J-STD-001
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Requirements for Soldered Electrical and Electronic Assemblies
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ASTM-A967
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Standard Specification for Chemical Passivation Treatments for Stainless Steel Parts
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ASTM-E18
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Standard Test Methods for Rockwell Hardness of Metallic Materials
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ISO-10993-1
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Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
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ISO-9000
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Quality management systems -- Fundamentals and vocabulary
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BS-EN-1041
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Information supplied by the manufacturer of medical devices
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IPC-A-600
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Acceptability of Printed Boards
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ASTM-F1980
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Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
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AS-9100
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Quality Management Systems - Requirements for Aviation, Space and Defense Organizations
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ISO-15223-1
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Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
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ISO-19011
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Guidelines for quality and/or environmental management systems auditing
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93/42/EEC
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Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
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ASTM-A240
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Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications
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IEC-60601-1-2
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Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
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