ISO/TS 20658:2017 医療研究所—サンプルの収集、輸送、受け取り、および取り扱いの要件 | ページ 6

3.1

arterial puncture

procedure (3.13) that involves the collection of blood from arteries by puncturing the skin

3.2

biobank

entity that performs biobanking (3.3)

Note 1 to entry: A biobank encompasses staff, facilities and procedures (e.g. management systems) and includes service providers, as well as repositories of biological materials.

3.3

biobanking

process (3.14) of receiving, collecting, storing and distributing biological materials from human, animal, plant and microorganisms, as well as related information and data, for the purpose of research and development

Note 1 to entry: Some or all of the following activities may also be included: processing, testing and analysing.

Note 2 to entry: For the purpose of this document, this definition only includes human materials procured solely for diagnostic and treatment purposes, e.g. surgical pathology archives.

3.4

capillary puncture

procedure (3.13) that involves the collection of blood from capillaries by puncturing the skin

3.5

cleaning

process (3.14) to remove any type of contamination, visible or not

[SOURCE: ISO 15190:2003, 3.5]

3.6

decontamination

procedure (3.13) that eliminates or reduces microbial or toxic agents to a safe level with respect to the transmission of infection or other adverse effects

[SOURCE: ISO 15190:2003, 3.7]

3.7

disinfection

process (3.14) of reducing the number of microorganisms, but not usually bacterial spores, without necessarily killing or removing all organisms

[SOURCE: ISO 15190:2003, 3.9]

3.8

examination processes

analytical phase

set of operations having the object of determining the value or characteristics of a property

Note 1 to entry: Laboratory examinations are also often called assays or tests.

[SOURCE: ISO 15189:2012, 3.7, modified — Notes to entry 2 and 3 have been omitted.]

3.9

hand hygiene

general term referring to any action of hand cleansing

[SOURCE: WHO Guidelines on Hand Hygiene in Health Care, 2009]

3.10

medical laboratory

clinical laboratory

laboratory for the biological, microbiological, immunological, chemical, immunohaematological, haematological, biophysical, cytological, pathological, genetic or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, management, prevention and treatment of disease in, or assessment of the health of, human beings, and which may provide a consultant advisory service covering all aspects of laboratory investigation including the interpretation of results and advice on further appropriate investigation

Note 1 to entry: These examinations also include procedures for determining, measuring or otherwise describing the presence or absence of various substances or microorganisms.

[SOURCE: ISO 15189:2012, 3.11]

3.11

post-examination processes

post-analytical phase

processes (3.14) following the examination, including review of results, retention and storage of clinical material, sample and waste disposal, as well as formatting, releasing, reporting and retention of examination results

[SOURCE: ISO 15189:2012, 3.14]

3.12

pre-examination processes

pre-analytical phase

processes (3.14) that start, in chronological order, from the clinician’s request and include the examination request, preparation and identification of the patient, collection of the primary sample(s) and transportation to and within the laboratory and end when the analytical examination begins

[SOURCE: ISO 15189:2012, 3.15]

3.13

procedure

specified way to carry out an activity or a process (3.14)

[SOURCE: ISO 9000:2015, 3.4.5]

3.14

process

set of interrelated or interacting activities that use inputs to deliver an intended result

Note 1 to entry: Inputs to a process are generally outputs of other processes and outputs of a process are generally the inputs to other processes.

[SOURCE: ISO 9000:2015, 3.4.1]

3.15

personal protective equipment

materials used to form a barrier to prevent contamination of a person by chemical or biological substances

Note 1 to entry: This includes, but is not limited to, lab coats, gowns, gloves, face shields and goggles.

3.16

sample

primary sample

discrete portion of a body fluid, breath, hair or tissue taken for examination, study or analysis of one or more quantities or properties assumed to apply for the whole

Note 1 to entry: Global Harmonization Task Force (GHTF) uses the term specimen in its harmonized guidance documents to mean a sample of biological origin intended for examination by a medical laboratory.

Note 2 to entry: In some ISO and CEN documents, a specimen is defined as “a biological sample derived from the human body.”

Note 3 to entry: In some countries, the term “specimen” is used instead of primary sample (or a subsample of it), which is the sample prepared for sending to, or as received by, the laboratory and which is intended for examination.

Note 4 to entry: The term “sample” is used in this document to include both the primary sample (specimen) and sample (aliquot).

[SOURCE: ISO 15189:2012, 3.16, modified — Note 4 to entry has been added.]

3.17

sample collection

process of obtaining a primary sample (3.16)

3.18

venipuncture

procedure (3.13) that involves the collection of venous blood by penetrating a vein with a needle or other collection apparatus