Best Selling Top Selling Standards at Publicacoes Internacionais 2011 – Original Standard , Norma Original ( ISO 9001 ; IPC A610 ; ISO 14971 ; ASME Y14.5 ; ASTM D4169 ; ISO 13485 ; 21CFR (800-1299) ; ASTM F88 ; ASQ Z1.4 ; ISO/IEC 17025 ; BS EN 980 ; IEC 60601-1 ; IPC/EIA J STD 001 ; ASTM A967 ; ASTM E18 ; ISO 10993-1 ; ISO 9000 ; BS EN 1041 ; IPC A600 ; ASTM F1980 ; AS 9100 ; ISO 15223-1 ; ISO 19011 ; 93/42/EEC ; ASTM A240 ; IEC 60601-1-2 )

Quality management systems — Requirements

Acceptability of Electronic Assemblies

Medical devices — Application of risk management to medical devices

Geometric dimensioning and tolerancing

Standard Practice for Performance Testing of Shipping Containers and Systems

Medical devices — Quality management systems — Requirements for regulatory purposes

Code of Federal Regulations – Title 21—Food and Drugs (Parts 800 to 1299)

Standard Test Method for Seal Strength of Flexible Barrier Materials

Sampling Procedures and Tables for Inspection by Attributes

General requirements for the competence of testing and calibration laboratories

Symbols for use in the labelling of medical devices

Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

Requirements for Soldered Electrical and Electronic Assemblies

Standard Specification for Chemical Passivation Treatments for Stainless Steel Parts

Standard Test Methods for Rockwell Hardness of Metallic Materials

Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process

Quality management systems — Fundamentals and vocabulary

Information supplied by the manufacturer of medical devices

Acceptability of Printed Boards

Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

Quality Management Systems – Requirements for Aviation, Space and Defense Organizations

Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements

Guidelines for quality and/or environmental management systems auditing

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications

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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