| Standard: | Title: |
|---|
| 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 |