Products Designed for ISO 11171 Compliance
Automatic liquid particle counters (LPCs) are the accepted means of determining the concentration and size distribution of contaminant particles. Individual LPC accuracy is established through calibration.
HIAC 8011+ Lab Liquid Particle Counter
• Analyze samples of hydraulic fluids, solvents & aqueous solutions
• Monitor particle contamination levels in mobile & industrial hydraulic systems
• Measure roll-off cleanliness of equipment
• Testing cleanliness of parts washing systems
HIAC PODS+ Portable Liquid Particle Counter for accurate onsite particle count data
• For field-based fluid power applications and more—accommodates fuels, glycols, organics & water-based fluids
• Sample fluids from 1 - 425cSt without dilution
• Battery powered – process particle count data in < 60 seconds.
• Flow path cleans in seconds eliminating sample carry-over
Helping researchers and labs maintain compliance with standards
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行业标准与法规要求
- USP<643>
- IVDR 2022 is a marathon, not a sprint. We’ll help you go the distance.
- 21 CFR Part 11 - Data Integrity
- Maintaining Data Integrity: Understanding FDA ALCOA Guidance
- European Pharmacopoeia EP 2.2.44
- EU GMP Annex 1
- EU GMP Annex 11
- ICH Q2
- ISO 21501
- ISO Regulations
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IVD-Regulation (IVDR)
- IVDR compliant software*
- Building IVDR compliant panels for haematological disorders
- Laboratory Developed Test (LDT) vs IVD Validation Workflow
- Potential Impacts of EU IVD-Regulation on the Clinical Flow Cytometry Lab
- Key Considerations to Validate a Flow Cytometry Assay According to ISO 15189 Requirements
- Regulatory Entities: Separation with Cooperation
- USP 1046
- USP 1047
- USP <645>
- USP <788>, <787> and EP2.9.19
- USP <790>
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ISO 11171
- Understanding ISO 11171: The NIST Traceable Particle Counter Calibration Standard
- The Evolution of ISO 11171
- ISO 11171 Standard: Guideline and Application
- Products Designed for ISO 11171 Compliance
- ISO 14644-1
- USP 787
