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 )

ISO-9001
Quality management systems — Requirements

IPC-A-610
Acceptability of Electronic Assemblies

ISO-14971
Medical devices — Application of risk management to medical devices

ASME-Y14.5
Geometric dimensioning and tolerancing

ASTM-D4169
Standard Practice for Performance Testing of Shipping Containers and Systems

ISO-13485
Medical devices — Quality management systems — Requirements for regulatory purposes

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

ASTM-F88
Standard Test Method for Seal Strength of Flexible Barrier Materials

ASQ-Z1.4
Sampling Procedures and Tables for Inspection by Attributes

ISO/IEC-17025
General requirements for the competence of testing and calibration laboratories

BS-EN-980
Symbols for use in the labelling of medical devices

IEC-60601-1
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

IPC/EIA-J-STD-001
Requirements for Soldered Electrical and Electronic Assemblies

ASTM-A967
Standard Specification for Chemical Passivation Treatments for Stainless Steel Parts

ASTM-E18
Standard Test Methods for Rockwell Hardness of Metallic Materials

ISO-10993-1
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process

ISO-9000
Quality management systems — Fundamentals and vocabulary

BS-EN-1041
Information supplied by the manufacturer of medical devices

IPC-A-600
Acceptability of Printed Boards

ASTM-F1980
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

AS-9100
Quality Management Systems – Requirements for Aviation, Space and Defense Organizations

ISO-15223-1
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements

ISO-19011
Guidelines for quality and/or environmental management systems auditing

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

ASTM-A240
Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications

IEC-60601-1-2
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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