SN EN ISO 7218 : 2007 AMD 1 2013

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
   6.6 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 Confirmatory 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
   15.1 Internal quality control
   15.2 Reference strains
   15.3 External quality assessment (proficiency testing)
Annex A (informative) - Properties of some disinfectants
Annex B (normative) - Determination of most probable number
                      (MPN)
Bibliography

Provides general requirements and guidance/options intended for three main uses: - implementation of ISO/TC 34/SC 9 or ISO/TC 34/SC 5 standards for detection or enumeration of microorganisms, named hereafter 'specific standards'; - good laboratory practice 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 Annex B of ISO/IEC 17025:2005 for the accreditation of a microbiological laboratory by national organizations).