Category Archives: Sterilization and disinfection in general

BS EN ISO 14161:2001 – Sterilization of health care products. Biological indicators. Guidance for the selection, use and interpretation of results

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 52 pages, A4

Manufacturer – BSI

Price – GBP 160

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Keywords – Sterilization (hygiene), Sterile equipment, Sterilizers, Medical equipment, Medical instruments, Bioassay, Biological analysis and testing, Selection, Instructions for use, Analysis
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ISO13408-2 : 2003 EDTN 1 – ISO13408-2 : 2003 Aseptic processing of health care products . Part 2: Filtration

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 11 pages

Manufacturer – ISO

Price – GBP 40

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Keywords – Sterilization and disinfection in general
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BS EN ISO 17664:2004 – Sterilization of medical devices. Information to be provided by the manufacturer for the processing of resterilizable medical devices

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 26 pages, A4

Manufacturer – BSI

Price – GBP 114

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Keywords – Sterile equipment, Medical equipment, Medical instruments, Sterilization (hygiene), Hygiene, Re-usable, Safety measures, Health and safety requirements, Instructions for use, Consumer-supplier relations, Preparation, Cleaning, Inspection, Packaging, Storage, Personnel, Training, Symbols, Test methods
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BS EN ISO 11135-1:2007 – Sterilization of health care products. Ethylene oxide. Requirements for development, validation and routine control of a sterilization process for medical devices

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 54 pages, A4

Manufacturer – BSI

Price – GBP 142

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Keywords – Medical equipment, Sterilization (hygiene), Ethylene oxide, Hygiene, Medical instruments, Sterile equipment, Performance, Performance testing, Quality control, Maintenance, Acceptance (approval), Verification, Microbiological analysis, Instructions for use, Personnel, Sterilizers, Management
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BS EN ISO 17665-1:2006 – Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 52 pages, A4

Manufacturer – BSI

Price – GBP 160

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Keywords – Medical equipment, Sterilization (hygiene), Steam, Verification, Quality control, Quality assurance, Acceptance (approval), Installation, Performance, Maintenance, Personnel, Medical instruments
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BS EN ISO 11137-1:2006 – Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 50 pages, A4

Manufacturer – BSI

Price – GBP 150

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Keywords – Medical equipment, Sterilization (hygiene), Radiation, Ionizing radiation, Gamma-radiation, Electron beams, X-rays, Radiation measurement, Verification, Quality control, Quality assurance, Medical technology, Process specification, Documents, Records (documents), Calibration, Maintenance, Medical instruments
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BS EN ISO 11137-2:2007 – Sterilization of health care products. Radiation. Establishing the sterilization dose

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 72 pages, A4

Manufacturer – BSI

Price – GBP 154

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Keywords – Medical equipment, Sterilization (hygiene), Radiation, Ionizing radiation, Gamma-radiation, Electron beams, X-rays, Radiation measurement, Verification, Quality control, Quality assurance, Medical technology, Medical instruments, Sterile equipment, Mathematical calculations,
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BS EN 552:1994 – Sterilization of medical devices. Validation and routine control of sterilization by irradiation

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 34 pages, A4

Manufacturer – BSI

Price – GBP 130

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Keywords – Medical equipment, Sterilization (hygiene), Dry sterilization, Gamma-radiation, Electron beams, Radiation, Radiation measurement, Verification, Quality control, Quality assurance, Medical technology, Process specification, Documents, Records (documents), Calibration, Maintenance, Medical instruments
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BS EN 556-2:2003 – Sterilization of medical devices. Requirements for medical devices to be designated “STERILE”. Requirements for aseptically processed medical devices

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 12 pages, A4

Manufacturer – BSI

Price – GBP 64

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Keywords – Medical equipment, Medical instruments, Sterile equipment, Sterilization (hygiene), Quality control, Controlled-atmosphere rooms, Environment (working), Microorganisms, Particulate materials, Contaminants, Contamination
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ISO13408-3 : 2006 EDTN1 – ISO 13408-3 Aseptic processing of health care products – . Part 3: Lyophilization

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 18 pages

Manufacturer – ISO

Price – GBP 52

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Keywords – Sterilization and disinfection in general
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ISO13408-4 : 2005 EDTN1 – ISO13408-4 : 2005 Aseptic processing of health care products. Part 4 : Clean-in-place technologies

Available as PDF document for immediate download, or as printed publication – yes

Number of pages –

Manufacturer – ISO

Price – GBP 57

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Keywords – Sterilization and disinfection in general
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ISO13408-5 : 2006 EDTN1 – ISO 13408-5 Aseptic processing of health care products – . Part 5: Sterilization in place

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 22 pages

Manufacturer – ISO

Price – GBP 57

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Keywords – Sterilization and disinfection in general
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BS EN ISO 18472:2006 – Sterilization of health care products. Biological and chemical indicators. Test equipment and methods

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 40 pages, A4

Manufacturer – BSI

Price – GBP 130

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Keywords – Sterilization (hygiene), Medical equipment, Chemical indicators, Chemical reagents, Sterile equipment, Biological analysis and testing, Performance testing, Test equipment, Sterilizers
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BS EN ISO 15882:2003 – Sterilization of health care products. Chemical indicators. Guidance for selection, use and interpretation of results

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 28 pages, A4

Manufacturer – BSI

Price – GBP 114

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Keywords – Sterilization (hygiene), Chemical indicators, Selection, Sterilizers, Medical equipment, Classification systems
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BS EN ISO 14937:2001 – Sterilization of health care products. General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 50 pages, A4

Manufacturer – BSI

Price – GBP 150

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Keywords – Sterilization (hygiene), Sterile equipment, Sterilizers, Medical equipment, Medical instruments, Process control, Quality control, Verification
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BS EN ISO 11140-3:2007 – Sterilization of health care products. Chemical indicators. Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 32 pages, A4

Manufacturer – BSI

Price – GBP 102

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Keywords – Sterilization (hygiene), Medical equipment, Chemical indicators, Chemical reagents, Sterilizers, Steam sterilizers, Performance, Marking, Packaging, Labels, Quality control, Performance testing, Colour tests, Reflection factor, Sensitivity, Porosity, Life (durability), Air, Ageing tests
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BS EN ISO 11140-4:2007 – Sterilization of health care products. Chemical indicators. Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 46 pages, A4

Manufacturer – BSI

Price – GBP 134

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Keywords – Sterilization (hygiene), Medical equipment, Chemical indicators, Chemical reagents, Sterilizers, Steam sterilizers, Performance, Marking, Packaging, Labels, Quality control, Performance testing, Colour tests, Reflection factor, Sensitivity, Life (durability), Air, Ageing tests
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BS ISO 11140-5:2007 – Sterilization of health care products. Chemical indicators. Class 2 indicators for Bowie and Dick-type air removal tests

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 22 pages, A4

Manufacturer – BSI

Price – GBP 72

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Keywords – Sterilization (hygiene), Medical equipment, Chemical indicators, Chemical reagents, Sterilizers, Steam sterilizers, Performance, Marking, Performance testing, Colour tests, Air
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BS EN 556-1:2001 – Sterilization of medical devices. Requirements for medical devices to be designated “STERILE”. Requirements for terminally sterilized medical devices

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 12 pages, A4

Manufacturer – BSI

Price – GBP 64

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Keywords – Medical equipment, Medical instruments, Sterile equipment, Sterilization (hygiene), Quality assurance, Quality control, Marking, Microorganisms
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BS EN 15424:2007 – Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 50 pages, A4

Manufacturer – BSI

Price – GBP 134

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Keywords – Sterilization (hygiene), Medical equipment, Sterilizers, Steam sterilizers, Low temperatures, Formaldehyde, Quality control, Verification, Specification (approval), Qualification approval, Performance testing, Microbiological analysis, Packaging, Environmental engineering
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ISO13408-6 : 2005 EDTN1 – ISO13408-6 : 2005 Aseptic processing of health care products Part 6: Isolator systems

Available as PDF document for immediate download, or as printed publication – yes

Number of pages –

Manufacturer – ISO

Price – GBP 65

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Keywords – Sterilization and disinfection in general
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BS EN ISO 11138-1:2006 – Sterilization of health care products. Biological indicators. General requirements

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 50 pages, A4

Manufacturer – BSI

Price – GBP 150

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Keywords – Sterilizers, Sterilization (hygiene), Medical equipment, Biological analysis and testing, Microorganisms, Bioassay, Performance testing, Packaging, Labelling (process), Culture containers, Microbiological analysis, Culture techniques
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BS EN ISO 11138-2:2006 – Sterilization of health care products. Biological indicators. Biological indicators for ethylene oxide sterilization processes

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 16 pages, A4

Manufacturer – BSI

Price – GBP 80

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Keywords – Sterilizers, Sterilization (hygiene), Medical equipment, Biological analysis and testing, Microorganisms, Bioassay, Gas sterilizers, Ethylene oxide, Performance testing, Microbiological analysis, Organism-activity determination
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BS EN ISO 11138-3:2006 – Sterilization of health care products. Biological indicators. Biological indicators for moist heat sterilization processes

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 18 pages, A4

Manufacturer – BSI

Price – GBP 80

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Keywords – Sterilizers, Sterilization (hygiene), Biological analysis and testing, Steam sterilizers, Performance testing, Bioassay, Packaging, Medical laboratory equipment, Working range, Temperature, Pressure, Organism-activity determination
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BS EN ISO 11138-4:2006 – Sterilization of health care products. Biological indicators. Biological indicators for dry heat sterilization processes

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 18 pages, A4

Manufacturer – BSI

Price – GBP 80

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Keywords – Sterilizers, Sterilization (hygiene), Medical equipment, Biological analysis and testing, Microorganisms, Bioassay, Dry sterilization, Dry-heat tests, Performance testing, Packaging, Microbiological analysis
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BS EN ISO 11138-5:2006 – Sterilization of health care products. Biological indicators. Biological indicators for low-temperature steam and formaldehyde sterilization processes

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 16 pages, A4

Manufacturer – BSI

Price – GBP 80

CLICK HERE FOR MORE INFORMATION

Keywords – Sterilizers, Sterilization (hygiene), Medical equipment, Biological analysis and testing, Microorganisms, Bioassay, Steam sterilizers, Low temperatures, Formaldehyde, Performance testing, Packaging, Microbiological analysis
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BS EN ISO 11140-1:2005 – Sterilization of health care products. Chemical indicators. General requirements

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 40 pages, A4

Manufacturer – BSI

Price – GBP 130

CLICK HERE FOR MORE INFORMATION

Keywords – Sterilization (hygiene), Medical equipment, Chemical indicators, Chemical reagents, Sterilizers, Classification systems, Performance testing, Steam sterilizers, Dry sterilization, Gas sterilizers, Ethylene oxide, Formaldehyde, Hydrogen peroxide, Radiation, Sterile equipment
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BS EN ISO 11137-3:2006 – Sterilization of health care products. Radiation. Guidance on dosimetric aspects

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 28 pages, A4

Manufacturer – BSI

Price – GBP 102

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Keywords – Medical equipment, Sterilization (hygiene), Radiation, Ionizing radiation, Gamma-radiation, Electron beams, X-rays, Radiation measurement, Verification, Calibration, Medical technology, Medical instruments, Quality control, Quality assurance, Maintenance, Process specification
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08/30149503 DC – BS EN ISO 14161. Sterilization of health care products. Biological indicators. Guidance for the selection, use and interpretation of results

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 70 pages, A4

Manufacturer – CEN

Price – GBP 20

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Keywords – Sterilization (hygiene), Sterile equipment, Sterilizers, Medical equipment, Medical instruments, Bioassay, Biological analysis and testing, Selection, Instructions for use, Analysis
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BS EN 550:1994 – Sterilization of medical devices. Validation and routine control of ethylene oxide sterilization

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 32 pages, A4

Manufacturer – BSI

Price – GBP 114

CLICK HERE FOR MORE INFORMATION

Keywords – Medical equipment, Sterilization (hygiene), Ethylene oxide, Hygiene, Medical instruments, Sterile equipment, Performance, Performance testing, Quality control, Maintenance, Acceptance (approval), Specimen preparation, Test equipment
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BS EN ISO 14160:1998 – Sterilization of single-use medical devices incorporating materials of animal origin. Validation and routine control of sterilization by liquid chemical sterilants

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 34 pages, A4

Manufacturer – BSI

Price – GBP 114

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Keywords – Animal products, Sterilization (hygiene), Liquids, Medical equipment, Medical instruments, Sterile equipment, Disposable, Verification, Quality control, Certification (approval), Compatibility, Performance, Personnel, Maintenance, Microbiological analysis, Microorganisms, Bibliography
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BS EN 13824:2004 – Sterilization of medical devices. Aseptic processing of liquid medical devices. Requirements

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 64 pages, A4

Manufacturer – BSI

Price – GBP 160

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Keywords – Medical equipment, Hospital equipment, Sterile equipment, Sterilization (hygiene), Quality assurance systems, Quality control, Personnel, Environment (working), Verification
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05/30138310 DC – ISO 15882 ED 2. Sterilization of health care products. Chemical indicators. Guidance for selection, use and interpretation of results

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 26 pages, A4

Manufacturer – BSI

Price – GBP 20

CLICK HERE FOR MORE INFORMATION

Keywords – Sterilization (hygiene), Chemical indicators, Selection, Sterilizers, Medical equipment, Classification systems
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