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Process Challenge Devices^® (PCD^®)

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Process Challenge Devices® (PCD®)

PCD EZTest EZG6 selbstentwickelnde biologische Indikatoren (SCBI)

PCD-EZTest-EZG6-SCBI-002

PCD-EZTest-EZG6-SCBI-003

Process Challenge Devices^® (PCD^®) certified to ISO 13485 quality systems for medical devices. Available across 6 resistance types, these PCDs ensure success of terminal sterilization cycles of medical devices, and can be used for both validation and routine monitoring of EO sterilization cycles.

Each PCD combines specific biological indicators with proprietary barrier pouches to achieve consistent, validated resistance levels for ethylene oxide (EO) sterilization, plus one specialized option for hydrogen peroxide (H₂O₂) sterilization.

Why choose Mesa Labs PCDs?

Each PCD has a defined resistance value, with all components resistance tested using an ISO 18472 compliant resistometer, ensuring complete confidence in every PCD.
Manufactured under an ISO 13485 certified quality system
Helps to achieve compliance with ISO 11135.
Patented packaging of a variety of B. atrophaeus biological indicators (BI) to match your process.
Broad resistance levels and BI types to meet different cycle configurations.
Faster turnaround with self-contained biological indicators (SCBI).

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Produkte

Technische Daten

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Produkte

Nominal D Values by PCD Type and BI Configuration

PCD	Bare Strip or Disc	Strip in Glassine	SCBI
PCD Type 3	3min	4min	5min
PCD Type 5	4min	5min	13min
PCD Type 7	9min	14min	26min
PCD Type 6	12min	17min	35min
PCD Type 4	21min	32min	50min
PCD Type 2	28min	37min	58min

Typ 2 (höchste Resistenz)

PCD^® 2.1 Mesa BI-Scheibe, 1 bis 10006 mm (D-Wert: 28)

PCD^® 2.12 Mesa BI-Streifen, SGMG/6 (D-Wert: 28)

PCD^® 2.13 Mesa EZTest EZG/6 SCBI (D-Wert: 58)

PCD^® 2.2 Steris BI-Sporenstreifen, NA005 (D-Wert: 28)

PCD^® 2.5 Mesa BI Sporenstreifen in Glassine, SGMG/6 (D-Wert: 37)

PCD^®2.6 3M Attest™ 1264-S SCBI (D-Wert: 58)

PCD^® 2.7 Steris BI Sporenstreifen in Glassine, NA005 (D-Wert: 37)

PCD^®2.9 3M Attest™ 1294-S RRBI (D-Wert: 58)

Typ 3 (geringste Resistenz)

PCD^® 3.13 Mesa EZTest EZG/6 SCBI (D-Wert: 3)

PCD^® 3.2 Steris BI Sporenstreifen, NA 005 (D-Wert: 3)

PCD^® 3.5 Mesa BI Sporenstreifen in Glassine, SGMG/6 (D-Wert: 4)

PCD^®3.6 3M Attest™ 1264-S SCBI (D-Wert: 5)

PCD^®3.9 3M Attest™ 1294-S RRBI (D-Wert: 5)

Typ 4 (mittlere Resistenz)

PCD^® 4.1 Mesa BI-Scheibe, 1 bis 10006 mm (D-Wert: 21)

PCD^® 4.13 Mesa EZTest EZG/6 SCBI (D-Wert: 50)

PCD^® 4.2 Steris BI-Sporenstreifen, NA005 (D-Wert: 21)

PCD^® 4.5 Mesa BI Sporenstreifen in Glassine, SGMG/6 (D-Wert: 32)

PCD^®4.6 3M Attest™ 1264-S SCBI (D-Wert: 50)

PCD^® 4.7 Steris BI Sporenstreifen in Glassine, NA005 (D-Wert: 32)

PCD^®4.9 3M Attest™ 1294-S RRBI (D-Wert: 50)

Typ 5 (geringe Resistenz)

PCD^® 5.1 Mesa BI-Scheibe, 1 bis 10006 mm (D-Wert: 4)

PCD^® 5.13 Mesa EZTest EZG/6 SCBI (D-Wert: 13)

PCD^® 5.2 Steris BI-Sporenstreifen, NA005 (D-Wert: 4)

PCD^® 5.5 Mesa BI Sporenstreifen in Glassine, SGMG/6 (D-Wert: 5)

PCD^®5.62 3M Attest™ 1264-S SCBI (D-Wert: 13)

PCD^®5.92 3M Attest™ 1294-S RRBI (D-Wert: 13)

Typ 6 (mittlere Resistenz)

PCD^® 6.1 Mesa BI-Scheibe, 1 bis 10006 mm (D-Wert: 12)

PCD^® 6.13 Mesa EZTest EZG/6 SCBI (D-Wert: 35)

PCD^® 6.2 Steris BI-Sporenstreifen, NA005 (D-Wert: 12)

PCD^® 6.5 Mesa BI Sporenstreifen in Glassine, SGMG/6 (D-Wert: 17)

PCD^®6.6 3M Attest™ 1264-S SCBI (D-Wert: 35)

PCD^® 6.7 Steris BI Sporenstreifen in Glassine, NA005 (D-Wert: 17)

PCD^®6.9 3M Attest™ 1294-S RRBI (D-Wert: 35)

Typ 7 (mittlere Resistenz)

PCD^® 7.1 Mesa BI-Scheibe, 1 bis 10006 mm (D-Wert: 9)

PCD^® 7.13 Mesa EZTest EZG/6 SCBI (D-Wert: 26)

PCD^® 7.2 Steris BI-Streifen, NA005 (D-Wert: 9)

PCD^® 7.5 Mesa BI Sporenstreifen in Glassine, SGMG/6 (D-Wert: 14)

PCD^®7.6 3M Attest™ 1264-S SCBI (D-Wert: 26)

PCD^® 7.7 Steris BI-Sporenstreifen in Glassine, NA 005 (D-Wert: 14)

PCD^®7.9 3M Attest™ 1294-S RRBI (D-Wert: 26)

Typ 8

PCD^® 8.13 Mesa EZTest EZH/6 SCBI H2O2-Zyklen

Technische Daten

Produktetikett: Polyolefin-Kunststoff mit abnehmbarem, druckempfindlichem Reagenzglasetikett.

Mounting Card: PVC plastic with a pressure sensitive adhesive strip for external mounting on sterilizer load boxes.

Packaging: Corrugated shippers with appropriate cushioning for damage-free transport

Documentation Package (Every Lot):

Certificate of Quality Conformance
BI manufacturer's Certificate of Analysis
Traceability to ISO certified laboratory testing
Fraction Negative method validation data

Regulatory Compliance:

Manufactured under ISO-13485 certified quality system
BIER vessel confirmation for all D-value claims
Validation guideline reference for implementation

Storage and Handling:

Expiry based on BI manufacturer's certificate
Environmental conditions per BI specifications
Protective packaging prevents contamination and damage

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