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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