ISO 7218:2007 gives general requirements and guidance/options intended for three main uses: implementation of ISO TC34/SC9 or TC34/SC5 standards for detection or enumeration of microorganisms; good laboratory practices for food microbiological laboratories (the purpose is not to detail them in this International Standard, manuals are available for that purpose); guidance for accreditation of food microbiological laboratories (this International Standard describes the technical requirements according to Appendix B of ISO/IEC 17025:2005 for the accreditation of a microbiological laboratory by national organizations). ISO 7218:2007 covers examination for bacteria, yeasts and moulds and can be used if supplemented with specific guidance for prions, parasites and viruses. It does not cover the examination for toxins or other metabolites (e.g. amines) from microorganisms. It applies to the microbiology of food, animal feeding stuffs, the food production environment and the primary production environment. The purpose of ISO 7218:2007 is to help to ensure the validity of food microbiology examinations, to assist in ensuring that the general techniques used for conducting these examinations are the same in all laboratories, to help achieve homogeneous results in different laboratories, and to contribute towards the safety of the laboratory personnel by preventing risks of infection.
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Sisällysluettelo
Foreword
Introduction
1 Scope
2 Normative references
3 Premises
3.1 General
3.2 Safety considerations
3.3 Laboratory design
3.4 Laboratory areas
3.5 Layout and fittings of the premises
3.6 Cleaning and disinfection
4 Staff
4.1 General
4.2 Competence
4.3 Verification of on-going staff competence
4.4 Hygiene
5 Apparatus and equipment
5.1 General
5.2 Protective cabinets
5.3 Balances and gravimetric diluters
5.4 Homogenizers, blenders and mixers
5.5 pH meter
5.6 Autoclave
5.7 Media preparator
5.8 Incubator
5.9 Refrigerator, cold-storage room
5.10 Freezer and deep freezer
5.11 Thermostatically controlled bath
5.12 Steamers, including boiling-water baths
5.13 Sterilizing oven
5.14 Microwave oven
5.15 Glass washer
5.16 Optical microscope
5.17 Gas burner or wire incinerator
5.18 Dispenser for culture media and reagents
5.19 Vortex mixer
5.20 Colony-counting device
5.21 Equipment for culture in a modified atmosphere
5.22 Centrifuge
5.23 Hotplate and heating mantle
5.24 Spiral plater
5.25 Stills, deionizers and reverse-osmosis units
5.26 Timers and timing devices
5.27 Pipettes and pipettors
5.28 Thermometers and temperature-monitoring devices, including automatic recorders
5.29 Immunomagnetic separator
5.30 Filtration system
5.31 Other equipment and software
6 Preparation of glassware and other laboratory materials
6.1 Preparation
6.2 Sterilization/decontamination
6.3 Disposable equipment and materials
6.4 Storage of clean glassware and materials
6.5 Management of sterile glassware and materials
6.6 Use of decontamination and disinfection
6.7 Waste management
6.8 Washing
7 Preparation and sterilization of culture media
8 Laboratory samples
8.1 Sampling
8.2 Transport
8.3 Receipt
8.4 Storage
8.5 Test portion
9 Examination
9.1 Hygienic precautions during analysis
9.2 Preparation of initial suspension and dilutions
10 Enumeration
10.1 General
10.2 Enumeration using a solid medium
10.3 Calculation and expression of results obtained with solid media
10.4 Enumeration of yeasts and moulds
10.5 Enumeration using a liquid medium
11 Detection method (qualitative method)
11.1 General
11.2 Principle
11.3 Measurement of uncertainty
12 Confirmation methods
12.1 General
12.2 Preparation of a pure culture
12.3 Gram’s stain (modified Hucker technique)
12.4 Use of biochemical galleries for identification
12.5 Use of nucleic probes for identification
12.6 Serological methods
13 Test report
14 Validation of microbiological methods
14.1 Validation of reference methods
14.2 Validation of alternative methods
14.3 Validation of in-house methods
15 Quality assurance of results/quality control of performance
ISO 11133:2014 Microbiology of food, animal feed and water -- Preparation, production, storage and performance testing of culture media
ISO 16140-2:2016 Microbiology of the food chain -- Method validation -- Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method
ISO 22174:2005 Microbiology of food and animal feeding stuffs -- Polymerase chain reaction (PCR) for the detection of food-borne pathogens -- General requirements and definitions
ISO 11133:2014 Microbiology of food, animal feed and water -- Preparation, production, storage and performance testing of culture media
ISO 16140-2:2016 Microbiology of the food chain -- Method validation -- Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method
ISO 22174:2005 Microbiology of food and animal feeding stuffs -- Polymerase chain reaction (PCR) for the detection of food-borne pathogens -- General requirements and definitions
ISO 6887-1:1999 Microbiology of food and animal feeding stuffs -- Preparation of test samples, initial suspension and decimal dilutions for microbiological examination -- Part 1: General rules for the preparation of the initial suspension and decimal dilutions
ISO 6887-2:2003 Microbiology of food and animal feeding stuffs -- Preparation of test samples, initial suspension and decimal dilutions for microbiological examination -- Part 2: Specific rules for the preparation of meat and meat products
ISO 6887-3:2003 Microbiology of food and animal feeding stuffs -- Preparation of test samples, initial suspension and decimal dilutions for microbiological examination -- Part 3: Specific rules for the preparation of fish and fishery products
ISO 6887-4:2003 Microbiology of food and animal feeding stuffs -- Preparation of test samples, initial suspension and decimal dilutions for microbiological examination -- Part 4: Specific rules for the preparation of products other than milk and milk products, meat and meat products, and fish and fishery products
ISO 8199:2005 Water quality -- General guidance on the enumeration of micro-organisms by culture
ISO 835:2007 Laboratory glassware -- Graduated pipettes
ISO 8655-1:2002 Piston-operated volumetric apparatus -- Part 1: Terminology, general requirements and user recommendations
ISO 8655-2:2002 Piston-operated volumetric apparatus -- Part 2: Piston pipettes
ISO 8655-3:2002 Piston-operated volumetric apparatus -- Part 3: Piston burettes
ISO 8655-4:2002 Piston-operated volumetric apparatus -- Part 4: Dilutors
ISO 8655-5:2002 Piston-operated volumetric apparatus -- Part 5: Dispensers
ISO 8655-6:2002 Piston-operated volumetric apparatus -- Part 6: Gravimetric methods for the determination of measurement error
ISO 8655-7:2005 Piston-operated volumetric apparatus -- Part 7: Non-gravimetric methods for the assessment of equipment performance
ISO/TS 19036:2006 Microbiology of food and animal feeding stuffs -- Guidelines for the estimation of measurement uncertainty for quantitative determinations