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Solution

ISO 80369 Testing Laboratory Setup

Plan ISO 80369 laboratory capability from required application standards, reference interfaces, methods, fixtures, measurement equipment, calibration and controlled records.

Submit for Engineering ReviewReview Standards
ISO 80369 laboratory bench with reference products fixtures and measurement equipment
Laboratory capability planning

Standard, interface, method, fixture, measurement and records reviewed together.

Planning principle

Build from required test capabilities, not from a fixed equipment package

Define the application families and methods the laboratory must perform, then select the reference interfaces, fixtures, measurement channels and controlled records needed for that scope.

  1. 01Application coverage
  2. 02Standard and connector family
  3. 03Reference products and gauges
  4. 04Method and fixture coverage
  5. 05Measurement equipment
  6. 06Calibration and records
Laboratory scope

Plan capability in connected workstreams

A laboratory plan should show how each application standard connects to the required reference product, method, fixture and measurement channel.

Standard and family coverage

Prioritize the connector families the laboratory must support now and which families may be added later.

  • ISO 80369-7 Luer
  • ISO 80369-3 enteral
  • IEC 80369-5 limb cuff
  • ISO 80369-6 neuraxial

Reference interfaces and gauges

Select each reference connector or gauge from the tested DUT side, interface and applicable figure or product role.

  • Male / female DUT
  • Slip / lock relationship
  • Reference connector role
  • Gauge or dimensional check

Test-method coverage

Map the required result to the correct method setup before selecting instruments.

  • Leakage and vacuum leakage
  • Axial separation
  • Unscrewing torque
  • Dimensional or material checks

Fixtures and assembly conditions

Control alignment, holding and assembly so the selected method can be performed repeatably.

  • Holding fixture
  • Assembly device
  • Adapters
  • Defined setup condition

Measurement equipment

Confirm pressure, vacuum, force or torque channels against the selected method and fixture arrangement.

  • Measured quantity
  • Range discussion
  • Control mode
  • Report output

Calibration, documents and expansion

Plan calibration or verification records and preserve a clear path for future capability additions.

  • Calibration scope
  • Manuals and drawings
  • Report requirements
  • Expansion priorities
Configuration decisions

Information required before final equipment selection

Coverage
Application standards, connector families and methods required at launch
DUT
Connector side, interface, sample geometry and available drawings
Setup
Reference interface, gauge, fixture and assembly condition
Measurement
Pressure, vacuum, force, torque or dimensional result
Records
Calibration, verification, manual, drawing and report needs
Expansion
Additional connector families or methods planned later
Engineering review

Submit the planned laboratory scope for engineering review

KingPo can review the capability map and identify the products, interfaces and open technical questions before quotation.

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  • Application standards
  • Connector families and DUT sides
  • Required test methods
  • Existing equipment
  • Fixture and adapter needs
  • Calibration and document requirements