Artikel

6 ISO-Typen chemischer Indikatoren für die Dampfsterilisation

Chemische Indikatoren für Autoklaven und Dampfsterilisatoren spielen in Sterilitätssicherungsprogrammen eine entscheidende Rolle. Es gibt viele Arten chemischer Indikatoren, beispielsweise Bowie-Dick-Testpackungen und chemische Indikatorstreifen.

2018-11-08

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Wichtige Erkenntnisse:

Chemische Indikatoren überprüfen die Sterilisationsbedingungen in Autoklaven und Dampfsterilisatoren.
ISO 11140-1:2014 definiert sechs Typen von CIs, jeweils mit spezifischen Verwendungszwecken und Leistungsmerkmalen.
Typ 1 bestätigt die Exposition; Typ 2 (Bowie-Dick) testet die Effizienz der Luftentfernung.
Die Typen 3–6 erhöhen die Spezifität, wobei Typ 5 und Typ 6 alle wichtigen Parameter verfolgen.
Wählen Sie den richtigen Indikator basierend auf Prozess, Überwachungsanforderungen und Vorschriften.

Alle chemischen Indikatoren sind so konzipiert, dass sie auf physikalische Bedingungen innerhalb der Sterilisationskammer reagieren. Dadurch wird bestätigt, dass ein Autoklav oder Dampfsterilisator ordnungsgemäß funktioniert. Außerdem wird dadurch bestätigt, dass die Bedingungen für eine Sterilisation erfüllt sind.

Standards für chemische Indikatoren

Die Internationale Organisation für Normung (ISO) gibt zahlreiche Normen für Sterilisationsprozesse heraus. Chemische Indikatoren müssen diesen Herstellungs- und Anwendungsstandards sowie Leitfäden entsprechen.

ISO 11140-1:2014 entspricht:

BS EN ISO 11140-1:2009
ANSI/AAMI/ISO 11140-1:2014

ISO 11140-1:2014 ersetzt vorherige Normen:

EN867-1
ANSI/AAMI ST60:1996

Der aktuelle Standard ist ISO 11140-1:2014. Er definiert 6 verschiedene Arten von chemischen Indikatoren für die Sterilisation.

6 ISO-Typen chemischer Indikatoren für die Dampfsterilisation

ISO 11140-1:2014 klassifiziert chemische Indikatoren für Autoklaven und Sterilisatoren wie folgt:

Typ 1: Prozessindikatoren
Typ 2: Indikatoren für spezifische Anwendungen
Typ 3: Indikatoren für eine einzige kritische Prozessvariable
Typ 4: Indikatoren für mehrere kritische Prozessvariablen
Typ 5: Integrierende Indikatoren (Integratoren)
Typ 6: Emulierende Indikatoren (Zyklusüberprüfungsindikatoren)

Die Typen sind nicht nach Wichtigkeit geordnet. Typ 1 ist nicht besser als Typ 6. Jeder Typ bezeichnet lediglich Leistungsmerkmale und den Verwendungszweck chemischer Indikatoren.

ISO 11140-1:2014, Abschnitt 4.1
„Die verwendete Klassifizierungsstruktur dient ausschließlich dazu, die Eigenschaften und den Verwendungszweck jedes Indikatortyps bei Verwendung gemäß den Vorgaben des Herstellers zu kennzeichnen. Diese Einteilung hat keine hierarchische Bedeutung.“

Da die Leistungsanforderungen unterschiedlich sind, sollten chemische Indikatoren nur einem Typ entsprechen. Diese Tabelle fasst die verschiedenen ISO-Typen chemischer Indikatoren zusammen. Sie enthält außerdem Anwendungsbeispiele und für jeden Typ verfügbare Produkte von STERIS Life Sciences. Verwenden Sie sie, um den richtigen chemischen Indikator zur Überwachung bestimmter Sterilisationsprozesse auszuwählen.

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6 ISO-Typen chemischer Indikatoren für die Dampfsterilisation


Types	What They Indicate	Application Example	STERIS Life Sciences Products
Type 1: Process	One or more critical variables in the sterilization process The unit has been directly exposed to the sterilization process	Autoclave tape or chemical indicator strips Located inside or attached to the outside of packs Provide visual confirmation of exposure to sterilization process	VERIFY™ Valueline Class 1 Steam Chemical Indicator (PCC009) Steam Indicator Tape (260010)
Type 2: Specific-Use	Defined in relevant sterilization standards for specific test procedure	Bowie-Dick test packs Test air removal in a prevacuum steam sterilization cycle	Steraffirm® Bowie-Dick Test Pack (EQC003) VERIFY™ Bowie-Dick Test Packs (EQC009, EQC010) Daily Air Removal Test–DART® (NB113, NB215) VERIFY™ Bowie-Dick Test Card (S3095)
Type 3: Single-variable	One critical variable in the sterilization process Exposure to a sterilization process at a stated value (SV) of the variable	Chemical pellet Melts at a specified temperature Demonstrates the steam sterilization process has achieved a specified temperature	Not currently available
Type 4: Multi-variable	Two or more critical variables in the sterilization process Exposure to a sterilization cycle at stated values (SVs) of the variables	Chemical indicator tubes Change color only when exposed to a given temperature for a specified time in a steam sterilization application	Steraffirm™ Sterilizer Control Tube, Steam at 121°C/250°F for 15 minutes (PCC024), or 12 minutes (PCC025)
Type 5: Integrating (Integrators)	All critical variables in the sterilization process Stated values (SVs) meet or exceed performance requirements in the ISO 11138 series for biological indicators	Moving front indicators Respond to all critical process parameters	VERIFY™ Steam Integrating Indicator (PCC065B, PCC065, PCC064)
Type 6: Emulating (Cycle Verification)	All critical variables for specified sterilization cycles Stated values (SVs) are generated from the critical variables of the specified sterilization process	Cycle-specific indicators Typically placed in the pack, pouch or container Respond to all critical process parameters for a specified sterilization cycle	Steraffirm™ Steam Class 6 Emulating Indicators, Steam for 121°C/ 250°F for 15 minutes (PCC012)

Types

Type 1: Process

What They Indicate

One or more critical variables in the sterilization process

The unit has been directly exposed to the sterilization process

Application Example

Autoclave tape or chemical indicator strips

Located inside or attached to the outside of packs

Provide visual confirmation of exposure to sterilization process

STERIS Life Sciences Products

VERIFY™ Valueline Class 1 Steam Chemical Indicator (PCC009)

Steam Indicator Tape (260010)

Types

Type 2: Specific-Use

What They Indicate

Defined in relevant sterilization standards for specific test procedure

Application Example

Bowie-Dick test packs

Test air removal in a prevacuum steam sterilization cycle

STERIS Life Sciences Products

Steraffirm® Bowie-Dick Test Pack (EQC003)

VERIFY™ Bowie-Dick Test Packs (EQC009, EQC010)

Daily Air Removal Test–DART® (NB113, NB215)

VERIFY™ Bowie-Dick Test Card (S3095)

See Full Table (de-DE)

Types

Type 3: Single-variable

What They Indicate

One critical variable in the sterilization process

Exposure to a sterilization process at a stated value (SV) of the variable

Application Example

Chemical pellet

Melts at a specified temperature

Demonstrates the steam sterilization process has achieved a specified temperature

STERIS Life Sciences Products

Not currently available

Types

Type 4: Multi-variable

What They Indicate

Two or more critical variables in the sterilization process

Exposure to a sterilization cycle at stated values (SVs) of the variables

Application Example

Chemical indicator tubes

Change color only when exposed to a given temperature for a specified time in a steam sterilization application

STERIS Life Sciences Products

Steraffirm™ Sterilizer Control Tube, Steam at 121°C/250°F for 15 minutes (PCC024), or 12 minutes (PCC025)

Types

Type 5: Integrating (Integrators)

What They Indicate

All critical variables in the sterilization process

Stated values (SVs) meet or exceed performance requirements in the ISO 11138 series for biological indicators

Application Example

Moving front indicators

Respond to all critical process parameters

STERIS Life Sciences Products

VERIFY™ Steam Integrating Indicator (PCC065B, PCC065, PCC064)

Types

Type 6: Emulating (Cycle Verification)

What They Indicate

All critical variables for specified sterilization cycles

Stated values (SVs) are generated from the critical variables of the specified sterilization process

Application Example

Cycle-specific indicators

Typically placed in the pack, pouch or container

Respond to all critical process parameters for a specified sterilization cycle

STERIS Life Sciences Products

Steraffirm™ Steam Class 6 Emulating Indicators, Steam for 121°C/ 250°F for 15 minutes (PCC012)

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Vorgeschlagene Inhalte

Technischer Tipp

Risikominderung durch Autoklaven-Luftentfernungstests

Das Vorhandensein von Luft in einem Sterilisationszyklus im Autoklaven kann sich negativ auf die Dampfdurchdringung und den Dampfkontakt mit den zu sterilisierenden Materialien auswirken. Die Kondensation von gesättigtem Dampf auf einer Oberfläche ist wichtig, um Mikroorganismen abzutöten, die auf der Materialoberfläche vorhanden sein können. Die tägliche Verwendung des STERIS Steraffirm® Bowie-Dick-Testpakets bestätigt die ausreichende Luftentfernung und Dampfdurchdringung im Autoklaven und gewährleistet die Einhaltung internationaler Vorschriften und der aktuellen Good Manufacturing Practices (cGMPs).

Technischer Tipp

Checkliste: Positiver biologischer Indikator bei der Dampfsterilisation

Durch die Verwendung biologischer Indikatoren (BI) im Dampfsterilisationsprozess mit Autoklaven lässt sich bestätigen, dass die Bedingungen zum Abtöten von Mikroorganismen erfüllt sind. Der BI wird dem Sterilisationsprozess ausgesetzt und anschließend inkubiert, um festzustellen, ob Endosporen überleben. Wenn keine Sporen überleben oder wachsen, ist der Test bestanden. Ein erfolgreiches Testergebnis zeigt, dass der Sterilisator eine große Anzahl hochresistenter Bakteriensporen wirksam abtötet.

Artikel

Dampfsterilisation: Die Bedeutung von Luftentfernung und -überprüfung

In diesem Artikel wird auf die Bedeutung der Luftentfernung und -überprüfung eingegangen, einschließlich Testdetails, Vorschriften und Standards sowie Risikominderung bei der Dampfsterilisation.

1 of 3

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Types

What They Indicate

Application Example

STERIS Life Sciences Products

Type 1: Process

One or more critical variables in the sterilization process

The unit has been directly exposed to the sterilization process

Autoclave tape or chemical indicator strips

Located inside or attached to the outside of packs

Provide visual confirmation of exposure to sterilization process

VERIFY™ Valueline Class 1 Steam Chemical Indicator (PCC009)

Steam Indicator Tape (260010)

Type 2: Specific-Use

Defined in relevant sterilization standards for specific test procedure

Bowie-Dick test packs

Test air removal in a prevacuum steam sterilization cycle

Steraffirm® Bowie-Dick Test Pack (EQC003)

VERIFY™ Bowie-Dick Test Packs (EQC009, EQC010)

Daily Air Removal Test–DART® (NB113, NB215)

VERIFY™ Bowie-Dick Test Card (S3095)

Type 3: Single-variable

One critical variable in the sterilization process

Exposure to a sterilization process at a stated value (SV) of the variable

Chemical pellet

Melts at a specified temperature

Demonstrates the steam sterilization process has achieved a specified temperature

Not currently available

Type 4: Multi-variable

Two or more critical variables in the sterilization process

Exposure to a sterilization cycle at stated values (SVs) of the variables

Chemical indicator tubes

Change color only when exposed to a given temperature for a specified time in a steam sterilization application

Steraffirm™ Sterilizer Control Tube, Steam at 121°C/250°F for 15 minutes (PCC024), or 12 minutes (PCC025)

Type 5: Integrating (Integrators)

All critical variables in the sterilization process

Stated values (SVs) meet or exceed performance requirements in the ISO 11138 series for biological indicators

Moving front indicators

Respond to all critical process parameters

VERIFY™ Steam Integrating Indicator (PCC065B, PCC065, PCC064)

Type 6: Emulating (Cycle Verification)

All critical variables for specified sterilization cycles

Stated values (SVs) are generated from the critical variables of the specified sterilization process

Cycle-specific indicators

Typically placed in the pack, pouch or container

Respond to all critical process parameters for a specified sterilization cycle

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Wichtige Erkenntnisse:

Standards für chemische Indikatoren

6 ISO-Typen chemischer Indikatoren für die Dampfsterilisation

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Types

What They Indicate

Application Example

STERIS Life Sciences Products

Type 1: Process

One or more critical variables in the sterilization process The unit has been directly exposed to the sterilization process

Autoclave tape or chemical indicator strips Located inside or attached to the outside of packs Provide visual confirmation of exposure to sterilization process

VERIFY™ Valueline Class 1 Steam Chemical Indicator (PCC009) Steam Indicator Tape (260010)

Type 2: Specific-Use

Defined in relevant sterilization standards for specific test procedure

Bowie-Dick test packs Test air removal in a prevacuum steam sterilization cycle

Steraffirm® Bowie-Dick Test Pack (EQC003) VERIFY™ Bowie-Dick Test Packs (EQC009, EQC010) Daily Air Removal Test–DART® (NB113, NB215) VERIFY™ Bowie-Dick Test Card (S3095)

Type 3: Single-variable

One critical variable in the sterilization process Exposure to a sterilization process at a stated value (SV) of the variable

Chemical pellet Melts at a specified temperature Demonstrates the steam sterilization process has achieved a specified temperature

Not currently available

Type 4: Multi-variable

Two or more critical variables in the sterilization process Exposure to a sterilization cycle at stated values (SVs) of the variables

Chemical indicator tubes Change color only when exposed to a given temperature for a specified time in a steam sterilization application

Steraffirm™ Sterilizer Control Tube, Steam at 121°C/250°F for 15 minutes (PCC024), or 12 minutes (PCC025)

Type 5: Integrating (Integrators)

All critical variables in the sterilization process Stated values (SVs) meet or exceed performance requirements in the ISO 11138 series for biological indicators

Moving front indicators Respond to all critical process parameters

VERIFY™ Steam Integrating Indicator (PCC065B, PCC065, PCC064)

Type 6: Emulating (Cycle Verification)

All critical variables for specified sterilization cycles Stated values (SVs) are generated from the critical variables of the specified sterilization process

Cycle-specific indicators Typically placed in the pack, pouch or container Respond to all critical process parameters for a specified sterilization cycle

Steraffirm™ Steam Class 6 Emulating Indicators, Steam for 121°C/ 250°F for 15 minutes (PCC012)

Types

Type 1: Process

What They Indicate

One or more critical variables in the sterilization process The unit has been directly exposed to the sterilization process

Application Example

Autoclave tape or chemical indicator strips Located inside or attached to the outside of packs Provide visual confirmation of exposure to sterilization process

STERIS Life Sciences Products

VERIFY™ Valueline Class 1 Steam Chemical Indicator (PCC009) Steam Indicator Tape (260010)

Types

Type 2: Specific-Use

What They Indicate

Defined in relevant sterilization standards for specific test procedure

Application Example

Bowie-Dick test packs Test air removal in a prevacuum steam sterilization cycle

STERIS Life Sciences Products

Steraffirm® Bowie-Dick Test Pack (EQC003) VERIFY™ Bowie-Dick Test Packs (EQC009, EQC010) Daily Air Removal Test–DART® (NB113, NB215) VERIFY™ Bowie-Dick Test Card (S3095)

Types

Type 3: Single-variable

What They Indicate

One critical variable in the sterilization process Exposure to a sterilization process at a stated value (SV) of the variable

Application Example

Chemical pellet Melts at a specified temperature Demonstrates the steam sterilization process has achieved a specified temperature

STERIS Life Sciences Products

Not currently available

Types

Type 4: Multi-variable

What They Indicate

Two or more critical variables in the sterilization process Exposure to a sterilization cycle at stated values (SVs) of the variables

Application Example

Chemical indicator tubes Change color only when exposed to a given temperature for a specified time in a steam sterilization application

STERIS Life Sciences Products

Steraffirm™ Sterilizer Control Tube, Steam at 121°C/250°F for 15 minutes (PCC024), or 12 minutes (PCC025)

Types

Type 5: Integrating (Integrators)

What They Indicate

All critical variables in the sterilization process Stated values (SVs) meet or exceed performance requirements in the ISO 11138 series for biological indicators

Application Example

Moving front indicators Respond to all critical process parameters

STERIS Life Sciences Products

VERIFY™ Steam Integrating Indicator (PCC065B, PCC065, PCC064)

Types

Type 6: Emulating (Cycle Verification)

What They Indicate

All critical variables for specified sterilization cycles Stated values (SVs) are generated from the critical variables of the specified sterilization process

Application Example

Cycle-specific indicators Typically placed in the pack, pouch or container Respond to all critical process parameters for a specified sterilization cycle

STERIS Life Sciences Products

6 ISO-Typen chemischer Indikatoren für die Dampfsterilisation

One or more critical variables in the sterilization process

The unit has been directly exposed to the sterilization process

Autoclave tape or chemical indicator strips

Located inside or attached to the outside of packs

Provide visual confirmation of exposure to sterilization process

VERIFY™ Valueline Class 1 Steam Chemical Indicator (PCC009)

Steam Indicator Tape (260010)

Bowie-Dick test packs

Test air removal in a prevacuum steam sterilization cycle

Steraffirm® Bowie-Dick Test Pack (EQC003)

VERIFY™ Bowie-Dick Test Packs (EQC009, EQC010)

Daily Air Removal Test–DART® (NB113, NB215)

VERIFY™ Bowie-Dick Test Card (S3095)

One critical variable in the sterilization process

Exposure to a sterilization process at a stated value (SV) of the variable

Chemical pellet

Melts at a specified temperature

Demonstrates the steam sterilization process has achieved a specified temperature

Two or more critical variables in the sterilization process

Exposure to a sterilization cycle at stated values (SVs) of the variables

Chemical indicator tubes

Change color only when exposed to a given temperature for a specified time in a steam sterilization application

All critical variables in the sterilization process

Stated values (SVs) meet or exceed performance requirements in the ISO 11138 series for biological indicators

Moving front indicators

Respond to all critical process parameters

All critical variables for specified sterilization cycles

Stated values (SVs) are generated from the critical variables of the specified sterilization process

Cycle-specific indicators

Typically placed in the pack, pouch or container

Respond to all critical process parameters for a specified sterilization cycle

One or more critical variables in the sterilization process

The unit has been directly exposed to the sterilization process

Autoclave tape or chemical indicator strips

Located inside or attached to the outside of packs

Provide visual confirmation of exposure to sterilization process

VERIFY™ Valueline Class 1 Steam Chemical Indicator (PCC009)

Steam Indicator Tape (260010)

Bowie-Dick test packs

Test air removal in a prevacuum steam sterilization cycle

Steraffirm® Bowie-Dick Test Pack (EQC003)

VERIFY™ Bowie-Dick Test Packs (EQC009, EQC010)

Daily Air Removal Test–DART® (NB113, NB215)

VERIFY™ Bowie-Dick Test Card (S3095)

One critical variable in the sterilization process

Exposure to a sterilization process at a stated value (SV) of the variable

Chemical pellet

Melts at a specified temperature

Demonstrates the steam sterilization process has achieved a specified temperature

Two or more critical variables in the sterilization process

Exposure to a sterilization cycle at stated values (SVs) of the variables

Chemical indicator tubes

Change color only when exposed to a given temperature for a specified time in a steam sterilization application

All critical variables in the sterilization process

Stated values (SVs) meet or exceed performance requirements in the ISO 11138 series for biological indicators

Moving front indicators

Respond to all critical process parameters

All critical variables for specified sterilization cycles

Stated values (SVs) are generated from the critical variables of the specified sterilization process

Cycle-specific indicators

Typically placed in the pack, pouch or container

Respond to all critical process parameters for a specified sterilization cycle

6 ISO-Typen chemischer Indikatoren für die Dampfsterilisation

One or more critical variables in the sterilization process

The unit has been directly exposed to the sterilization process

Autoclave tape or chemical indicator strips

Located inside or attached to the outside of packs

Provide visual confirmation of exposure to sterilization process

VERIFY™ Valueline Class 1 Steam Chemical Indicator (PCC009)

Steam Indicator Tape (260010)

Bowie-Dick test packs

Test air removal in a prevacuum steam sterilization cycle

Steraffirm® Bowie-Dick Test Pack (EQC003)

VERIFY™ Bowie-Dick Test Packs (EQC009, EQC010)

Daily Air Removal Test–DART® (NB113, NB215)

VERIFY™ Bowie-Dick Test Card (S3095)

One critical variable in the sterilization process

Exposure to a sterilization process at a stated value (SV) of the variable

Chemical pellet

Melts at a specified temperature

Demonstrates the steam sterilization process has achieved a specified temperature

Two or more critical variables in the sterilization process

Exposure to a sterilization cycle at stated values (SVs) of the variables

Chemical indicator tubes

Change color only when exposed to a given temperature for a specified time in a steam sterilization application

All critical variables in the sterilization process

Stated values (SVs) meet or exceed performance requirements in the ISO 11138 series for biological indicators

Moving front indicators

Respond to all critical process parameters

All critical variables for specified sterilization cycles

Stated values (SVs) are generated from the critical variables of the specified sterilization process

Cycle-specific indicators

Typically placed in the pack, pouch or container

Respond to all critical process parameters for a specified sterilization cycle