Standard
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AS ISO 7218:2025
[Current]AS ISO 7218:2025 identically adopts ISO 7218:2024, which specifies general requirements and gives guidance on microbiological examinations
Published: 14/03/2025
Pages: 83
Table of contents
Cited references
Content history
Table of contents
Header
About this publication
Preface
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Premises
4.1 General
4.2 Biosafety considerations
4.3 Laboratory design
4.4 Laboratory areas
4.4.1 General
4.4.2 Areas associated with samples and testing
4.4.3 General areas
4.5 Layout and fittings of the premises
4.5.1 Objectives
4.5.2 Fittings
4.5.3 Other arrangements for laboratory premises
4.5.4 Cleaning and disinfection
5 Personnel
5.1 General
5.2 Competence
5.3 Verification of ongoing staff competence
5.4 Hygiene
6 Equipment and consumables
6.1 General
6.2 Sterilization and other heating equipment
6.2.1 General
6.2.2 Autoclave
6.2.2.1 Description
6.2.2.2 Use
6.2.2.3 Maintenance
6.2.2.4 Calibration and verification
6.2.3 Culture media preparator
6.2.3.1 Description
6.2.3.2 Use
6.2.3.3 Maintenance
6.2.3.4 Calibration and verification
6.2.4 Steamers, including boiling-water baths
6.2.4.1 Description
6.2.4.2 Use
6.2.4.3 Maintenance
6.2.5 Sterilizing oven
6.2.5.1 Description
6.2.5.2 Use
6.2.5.3 Maintenance
6.2.5.4 Calibration and verification
6.2.6 Microwave oven
6.2.6.1 Description
6.2.6.2 Use
6.2.6.3 Maintenance
6.2.6.4 Verification
6.2.7 Hotplate, induction cooker and heating mantle
6.2.7.1 Description
6.2.7.2 Use
6.2.7.3 Maintenance
6.2.8 Gas burner or wire incinerator
6.2.8.1 Description
6.2.8.2 Use
6.2.8.3 Maintenance
6.3 Temperature controlled equipment and monitoring devices
6.3.1 General
6.3.2 Incubator
6.3.2.1 Description
6.3.2.2 Use
6.3.2.3 Maintenance
6.3.2.4 Verification
6.3.3 Thermostatically controlled bath
6.3.3.1 Description
6.3.3.2 Use
6.3.3.3 Maintenance
6.3.3.4 Verification
6.3.4 Heating blocks
6.3.4.1 Description
6.3.4.2 Use
6.3.4.3 Maintenance
6.3.4.4 Verification
6.3.5 Refrigerators and cold-storage rooms
6.3.5.1 Description
6.3.5.2 Use
6.3.5.3 Maintenance and cleaning
6.3.5.4 Verification
6.3.6 Freezer and deep freezer/ultra-low temperature freezer
6.3.6.1 Description
6.3.6.2 Use
6.3.6.3 Maintenance
6.3.6.4 Verification
6.3.7 Temperature-monitoring devices, including automatic recorders
6.3.7.1 Description
6.3.7.2 Use
6.3.7.3 Maintenance
6.3.7.4 Calibration and verification
6.3.8 Balances and gravimetric diluters
6.3.8.1 Description
6.3.8.2 Use and tolerance
6.3.8.3 Maintenance
6.3.8.4 Calibration and verification
6.4 Defined volume inoculation equipment
6.4.1 Pipettes and pipettors
6.4.1.1 Description
6.4.1.2 Use
6.4.1.3 Maintenance
6.4.1.4 Calibration and verification
6.4.2 Dispensers
6.4.2.1 Dispenser for culture media and reagents
6.4.2.1.1 Description
6.4.2.1.2 Use
6.4.2.1.3 Cleaning and maintenance
6.4.2.1.4 Verification
6.4.3 Spiral platers
6.4.3.1 Description
6.4.3.2 Use
6.4.3.3 Maintenance
6.4.3.4 Verification
6.4.4 Serial diluters
6.4.4.1 Description
6.4.4.2 Use
6.4.4.3 Maintenance
6.4.4.4 Calibration and verification
6.5 Protective cabinets
6.5.1 Description
6.5.2 Use
6.5.3 Cleaning and disinfection
6.5.4 Maintenance and inspection
6.6 Homogenizers, blenders, mixers and shakers
6.6.1 Homogenizers and blenders
6.6.1.1 Description
6.6.1.2 Use
6.6.1.3 Maintenance
6.6.2 Vortex mixers
6.6.2.1 Description
6.6.2.2 Use
6.6.2.3 Maintenance
6.6.2.4 Verification
6.7 Stills, deionizers and reverse-osmosis units
6.7.1 Description
6.7.2 Use
6.7.3 Maintenance
6.7.4 Verification
6.8 Separation and concentration equipment
6.8.1 Immunomagnetic separator (IMS)
6.8.1.1 Description
6.8.1.2 Use
6.8.1.3 Maintenance
6.8.1.4 Verification
6.8.2 Centrifuge
6.8.2.1 Description
6.8.2.2 Use
6.8.2.3 Maintenance
6.8.2.4 Calibration and verification
6.8.3 Filtration systems
6.9 Modified atmosphere equipment
6.9.1 Description
6.9.2 Use
6.9.3 Maintenance
6.9.4 Verification
6.10 Other equipment
6.10.1 pH meter
6.10.1.1 Description
6.10.1.2 Use
6.10.1.3 Maintenance
6.10.1.4 Calibration and verification
6.10.2 Colony-counting device
6.10.2.1 Description
6.10.2.2 Use
6.10.2.3 Maintenance
6.10.2.4 Verification
6.10.3 Timers and timing devices
6.10.3.1 Description
6.10.3.2 Use
6.10.3.3 Maintenance
6.10.3.4 Verification
6.10.4 Optical microscope
6.10.4.1 Description
6.10.4.2 Use
6.10.4.3 Maintenance
6.10.5 Glass washers, glassware and other laboratory ware
6.10.5.1 Glass washer
6.10.5.1.1 Description
6.10.5.1.2 Use
6.10.5.1.3 Maintenance
6.10.5.1.4 Verification
6.10.5.2 Glassware and other laboratory ware
6.10.5.2.1 Description
6.10.5.2.2 Use
6.10.5.2.3 Maintenance
6.10.5.2.4 Verification
6.10.6 Disposable equipment and consumables
6.10.7 Other equipment and software
7 Sterilization/decontamination and disposal of laboratory materials
7.1 Sterilization
7.1.1 General
7.1.2 Sterilization by dry heat
7.1.3 Sterilization by moist heat (steam)
7.2 Decontamination and disinfection
7.2.1 Decontamination of glassware and materials before use
7.2.2 Decontamination of glassware and materials after use
7.3 Waste management
7.4 Washing
8 Preparation and use of culture media and reagents
9 Laboratory samples
9.1 Sampling techniques and sampling plans
9.1.1 General
9.1.2 Sampling
9.2 Sample transport
9.3 Sample receipt
9.4 Sample handling
9.4.1 General
9.4.2 Storage before examination
9.4.3 Test portions
9.4.4 Storage of laboratory samples after examination
9.5 Pre-testing of samples
10 Examination
10.1 Hygienic precautions during sample preparation and examination
10.1.1 General
10.1.2 Basic precautions
10.1.3 Sample handling
10.1.4 Sample handling tools and implements
10.1.5 Spillages
10.1.6 Process controls
10.1.7 Aerosols
10.1.8 Molecular methods
10.2 Preparation of initial suspension and dilutions
10.2.1 General
10.2.2 Concentration
10.2.2.1 Centrifugation or membrane filtration
10.2.2.2 Immunoseparation
11 Enumeration (quantitative) methods
11.1 General
11.2 Enumeration using a solid medium
11.2.1 General
11.2.2 Pour plate technique
11.2.3 Surface plating techniques
11.2.3.1 General
11.2.3.2 Spread plate method
11.2.3.3 Spiral plate method
11.2.3.3.1 General
11.2.3.3.2 Preparation of culture medium plates
11.2.3.3.3 Plating procedure
11.2.4 Enumeration of yeasts and moulds
11.2.5 Incubation
11.2.6 Calculation and expression of results obtained with solid culture media
11.2.6.1 Plate counts
11.2.6.2 Spiral plating
11.2.6.3 Counting yeast and mould colonies
11.2.6.4 Expression of results
11.2.7 Calculations for enumeration methods
11.2.7.1 General
11.2.7.2 Plate count calculations
11.2.7.2.1 General
11.2.7.2.2 Plate count calculation: General case (counting of total colonies or typical colonies without confirmation)
11.2.7.2.3 Plate count calculation: Count after confirmation
11.2.7.2.4 Plate count calculation, special case: No colonies detected
11.2.7.2.5 Plate count calculation, special case: More than the maximum number of typical colonies
11.2.7.2.6 Plate count calculation, special case: Presence of presumptive colonies with more than the maximum number of total (typical and atypical) colonies
11.2.7.2.7 Plate count calculation, special case: Lowered limit of determination (plating a set of Petri dishes)
11.2.7.3 Spiral plate calculations
11.2.7.3.1 General
11.2.7.3.2 General case (counting of total colonies or typical colonies without confirmation)
11.2.7.3.3 Spiral plate calculation: Count after confirmation
11.2.7.3.4 Spiral count calculation, special case: No colonies detected
11.2.7.3.5 Spiral count calculation, special case: More than the maximum number of typical colonies
11.3 Enumeration using liquid media
11.3.1 Principle
11.3.2 General MPN procedure
11.3.3 Limitations of MPN
11.3.4 Inoculation procedure
11.3.5 Choice of MPN configuration
11.3.5.1 General
11.3.5.2 Single dilution system
11.3.5.3 Multiple dilution system
11.3.5.4 Symmetric dilution system
11.3.5.5 Non-symmetric dilution system
11.3.6 Incubation
11.3.7 Interpretation and expression of results
11.3.8 Determination of MPN values using MPN calculators
11.3.9 Rarity categories
11.4 Estimates of uncertainty of test results
12 Detection (qualitative) methods
12.1 General
12.2 Principle
13 Confirmation and identification methods
13.1 General
13.2 Preparation of a pure culture
13.3 Confirmation methods
13.3.1 Latex agglutination test
13.3.2 Nucleic acid hybridization or molecular amplification methods
13.3.3 Slide agglutination tests
13.4 Identification methods
13.4.1 Biochemical galleries
13.4.2 DNA sequencing
13.4.3 Mass spectrometry
14 Selection and characterization of control microorganisms
14.1 General
14.2 Characterization of microorganisms
14.2.1 General
14.2.2 Phenotypic characterization
14.2.3 Molecular characterization
14.3 Selection of control microorganisms
15 Test report
16 Laboratory quality control in microbiology
16.1 General
16.2 Internal quality control
16.2.1 General
16.2.2 Process controls
16.2.2.1 General
16.2.2.2 Blank samples
16.2.2.3 Positive control organisms
16.2.2.4 Negative control organisms (atypical and non-target)
16.2.2.5 Negative control organisms (inhibition)
16.2.2.6 Process control test microorganisms
16.2.2.7 Miscellaneous process controls
16.2.3 Replicate testing
16.2.4 Spiked samples
16.2.5 IQC assessment using control charts
16.3 External quality assessment
17 Validation and verification of microbiological methods
17.1 General
17.2 Performance characteristics
17.3 Validation
17.4 Verification
Annex A
Annex B
B.1 Confidence intervals for colony count technique
B.2 Special cases with low numbers
Annex C
C.1 Gram’s stain (modified Hucker technique)
C.1.1 General
C.1.2 Solutions
C.1.3 Crystal violet solution
C.1.3.1 Composition
C.1.3.2 Preparation
C.1.4 Iodine solution
C.1.4.1 Composition
C.1.4.2 Preparation
C.1.5 Safranin solution
C.1.5.1 Composition
C.1.5.2 Preparation
C.1.6 Staining technique
C.1.7 Interpretation
C.2 Detection of oxidase
C.2.1 General
C.2.2 Reagent for the detection of oxidase
C.2.2.1 Composition
C.2.2.2 Preparation
C.3 Detection of catalase
C.3.1 General
C.3.2 Reagent for detection of catalase
C.4 Performance testing for quality assurance of general confirmation tests
Bibliography
Cited references in this standard