ISO 16297:2020 ミルク—細菌数—代替方法の評価のためのプロトコル | ページ 2

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, 1. In particular, the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, 2 (see www.iso.org/directives ).

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents ).

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www.iso.org/iso/foreword.html .

This document was prepared by Technical Committee ISO/TC 34, Food products, Subcommittee SC 5, Milk and milk products, and the International Dairy Federation (IDF). It is being published jointly by ISO and IDF.

This second edition cancels and replaces the first edition (ISO 16297 | IDF 161:2013), which has been technically revised with the following main changes:

• the number of samples and the calculation of the lower limit of quantification has been changed and aligned with ISO 16140-2;
• an example of carry-over effect given in Figure 1 has been omitted;
• the requirements for the evaluation of the accuracy of the estimate and the accuracy profile have been clarified and aligned with ISO 16140-2;
• Annex A (informative) has been omitted.

IDF (the International Dairy Federation) is a non-profit private sector organization representing the interests of various stakeholders in dairying at the global level. IDF members are organized in National Committees, which are national associations composed of representatives of dairy-related national interest groups including dairy farmers, dairy processing industry, dairy suppliers, academics and governments/food control authorities.

ISO and IDF collaborate closely on all matters of standardization relating to methods of analysis and sampling for milk and milk products. Since 2001, ISO and IDF jointly publish their International Standards using the logos and reference numbers of both organizations.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. IDF shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents ).

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

This document was prepared by the IDF Standing Committee on Statistics and Automation and ISO Technical Committee ISO/TC 34, Food products, Subcommittee SC 5, Milk and milk products. It is being published jointly by IDF and ISO.

The work was carried out by the IDF/ISO Action Team (S18) of the Standing Committee on Statistics and Automation under the aegis of its project leaders, Mrs V. Tzeneva (NL) and Mrs I. Andersson (SE).

Introduction

Any quantitative measurement in microbiology should consider that there is a requirement for the microbiological state in a sample to be regarded as one point within the coordinates of a multidimensional system, which is to be projected on to the one-dimensional scale of the method applied, i.e. plate count, flow cytometry. Aspects such as flora (types and numbers of microorganisms and their distribution), growth phase, sub-lethal damage, metabolic activity, and history, influence to a greater or lesser extent any parameter that is measured. It is evident that any projection of an n-dimensional situation onto a one-dimensional scale is bound to provide a picture of the real situation that is rather restricted. In this respect, one has to bow to the inevitable, regardless of which method of measurement is preferred.

The term “anchor method” in this document means a method internationally recognized by experts, used in legislation or by agreement between the parties. There are requirements for evaluation of an alternative method to refer to the anchor method and to be based on the examination of suitable samples for its intended use.

1 Scope

This document specifies a protocol for the evaluation of instrumental alternative methods for total bacterial count in raw milk from animals of different species.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 5725-1, ISO 5725-2, ISO 8196-1 | IDF 128‑1, ISO 8196-2 | IDF 128‑2, ISO 8196-3 | IDF 128‑3 and ISO 16140-1 apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

Bibliography