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Good Design Controls Are Critical to Avoiding FDA Issues

  • Magazine Article
  • TBMG-35783
Published 2020-01-01 by Tech Briefs Media Group in United States

Medical device companies recognize that having an emphasis on design controls helps to assure good design and engineering practices that yield high-quality solutions. This is critical when considering FDA validation and design compliance. But to accomplish this, first know what key elements should be incorporated in design controls before implementing formalized plans for their creation.

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Manufacturing and Inspection Standards for Preformed Packings (O-Rings)

A-6C2 Seals Committee
  • Aerospace Standard
  • AS871B
  • Current
Published 2019-10-17 by SAE International in United States
This specification controls surface condition, manufacturing defects and inspection requirements, and defines methods of measurement for elastomeric toroidal sealing rings (O-rings) for static (including gasket) applications.
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Automation: The Future of Medical Manufacturing

  • Magazine Article
  • TBMG-35367
Published 2019-10-01 by Tech Briefs Media Group in United States

Manufacturers in the medical industry face unique challenges in terms of product mix, throughput requirements, quality standards, and regulatory guidelines. Whether a company is developing imaging equipment, orthopedic implants, or diagnostics, the manufacturing process must be absolutely error free while delivering high throughput. Device companies are looking more and more to factory automation to ensure that they are addressing these disparate requirements.

Metal Stamping: Converting Parts for Cost Savings

  • Magazine Article
  • TBMG-35372
Published 2019-10-01 by Tech Briefs Media Group in United States

In today’s world of medical device manufacturing, cost pressures are very real. At the same time, cost savings can be just as real, especially when companies examine their manufacturing processes for greater efficiencies. One area that is gaining particular attention is metal stamping of previously machined, metal injection-molded, or laser-cut parts.

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Castings, Sand, Magnesium Alloy 5.1Y - 3.0Re - 0.70Zr (WE54A - T6) Solution and Precipitation Heat Treated

AMS D Nonferrous Alloys Committee
  • Aerospace Material Specification
  • AMS4426B
  • Current
Published 2019-09-19 by SAE International in United States
This specification covers a magnesium alloy in the form of sand castings.
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Magnesium Alloy, Sand Castings 4.0Y - 2.3Nd - 0.7Zr (WE43B - T6) Solution and Precipitation Heat Treated

AMS D Nonferrous Alloys Committee
  • Aerospace Material Specification
  • AMS4427D
  • Current
Published 2019-08-28 by SAE International in United States
This specification covers a magnesium alloy in the form of sand castings.
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Magnesium Alloy, Sand Castings 2.8Nd - 1.4Gd - 0.4Zn - 0.6Zr (EV31A - T6) Solution and Precipitation Heat Treated

AMS D Nonferrous Alloys Committee
  • Aerospace Material Specification
  • AMS4429B
  • Current
Published 2019-08-01 by SAE International in United States
This specification covers a magnesium alloy in the form of sand castings.
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Steel Castings, Sand, Corrosion and Heat Resistant 24.5Cr - 20.5Ni Solution Heat Treated

AMS F Corrosion Heat Resistant Alloys Committee
  • Aerospace Material Specification
  • AMS5365E
  • Current
Published 2019-07-30 by SAE International in United States
This specification covers a corrosion and heat resistant steel in the form of sand castings.
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Magnesium Alloy, Direct Chill Strand Cast 2.8Nd - 1.4Gd - 0.4Zn - 0.6Zr (EV31A - T6) Solution and Precipitation Heat Treated

AMS D Nonferrous Alloys Committee
  • Aerospace Material Specification
  • AMS4431
  • Current
Published 2019-05-14 by SAE International in United States
This specification covers a magnesium alloy in the form of direct chill strand cast round material up to 9.0 inch diameter and rectangular material up to 10 inch by 27.5 inch cross-section (see 8.4) for the purpose of machine from solid applications (see 8.2.1).
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Steel Castings, Vacuum Melted, Vacuum Cast, Investment, Corrosion-Resistant 13Cr - 8.0Ni - 2.2Mo - 1.1Al 195 ksi (1344 MPa) Tensile Strength (Condition H1000) Homogenized, Solution, and Precipitation Heat Treated

AMS F Corrosion Heat Resistant Alloys Committee
  • Aerospace Material Specification
  • AMS5412B
  • Current
Published 2019-05-10 by SAE International in United States
This specification covers a corrosion-resistant steel in the form of investment castings.
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Annotation ability available