ISO 14159:2002 機械の安全性—機械の設計に関する衛生要件 | ページ 6

3.1

associated equipment

all equipment associated with a machine, not defined as machinery (3.13), that is essential to the functioning of the machine for it to hygienically process a product (e.g. fittings, piping, tubing)

3.2

bond

joining of materials with an adhesive

3.3

cleaning in place

cleaning (3.4) of equipment by impingement or circulation of flowing chemical solutions, cleaning liquids and water rinses into, onto and over surfaces in equipment or systems without dismantling and designed for the purpose

3.4

cleaning

removal of soil (see 3.31)

3.5

cleanable

designed to be freed from soil

3.6

consumer

end user of the product (including domestic animals)

3.7

corrosion resistant material

material having the property to maintain its original surface characteristics for its intended life time when exposed to the conditions encountered in the environment of intended use, including exposed contact with product, cleaning, disinfection, pasteurization or sterilization conditions

3.8

crevice

sharp, cleft-like, irregular opening of small depth which adversely affects cleanability

3.9

dead space

space wherein a product, cleaning or disinfecting agents, or soils can be trapped, retained, or not completely removed during the operation of cleaning

3.10

disinfection

process applied to a clean surface which is capable of reducing the numbers of vegetative micro-organisms, but not necessarily their spores, to a level considered safe for product production

3.11

hygiene

taking of all measures during product handling, preparation and processing to ensure its suitability for use by humans or domestic animals

3.12

joint

junction of two or more pieces of material

3.13

machinery

assembly of linked parts or components, at least one of which moves, with appropriate machine actuators, control and power circuits, joined together for a specific application, in particular for the processing, treatment, moving or packaging of a material

Note 1 to entry: The term machinery also covers an assembly of machines.

[SOURCE:ISO 12100-1:—, 3.1]

3.14

manual cleaning

cleaning by manual means when the machinery is open, or partially or totally disassembled

3.15

micro-organism (relevant)

bacteria, fungi, yeasts, moulds, spores and viruses that are able to contaminate, multiply or survive in the product and are able to be harmful or adversely affect product quality

3.16

non-toxic materials

materials which, under the intended conditions of their use, will not cause the product to be harmful to humans or domestic animals

3.17

non-absorbant materials

materials which, under the intended conditions of their use, do not retain substances with which they come into contact, so as to have no adverse affect on the hygiene of the product

3.18

pasteurization

process that inactivates all relevant micro-organisms except some microbial spores

3.19

pasteurizable

designed to be capable of being pasteurized

3.20

pest

mammals, birds, reptiles, vermin and insects which can adversely influence the product

3.21

practical test

documented set of procedures and parameters used to determine an evaluation

3.22

product

any substance intended to be applied or taken into humans or domestic animals (e.g. by ingestion, injection, topical application, insertion)

3.23

product contact surface

machinery surfaces which are exposed to the product and from which the product or other materials can drain, drip, diffuse or be drawn into (self-returned) the product or product container

3.24

non-product contact surface

all other exposed machinery surfaces including ここで, applicable, the splash area (3.32)

3.25

readily accessible

location which can be reached by an employee from the floor, a platform or other permanent work area

3.26

readily removable

designed to be separated from the machine with or without the use of simple hand tools

3.27

seal

closure of an aperture so as to effectively prevent the entry or passage of unwanted matter

3.28

self-draining

combination of design, construction, installation and surface finish so as to prevent the retention of liquid except for normal surface wetting

3.29

sensors

devices or instrumentation attached to machinery for process monitoring/control

3.30

smooth

condition of a surface which satisfies hygienic requirements and is without surface defects (e.g. crevices) capable or retaining soil

3.31

soil

any unwanted matter

3.32

splash area

area composed of surfaces where product may come into contact and does not return to the product

3.33

sterilization

process that inactivates all micro-organisms and relevant microbial spores

3.34

sterilizability

designed to be capable of being sterilized