ISO 20857:2010 ヘルスケア製品の滅菌—乾熱—医療機器の滅菌プロセスの開発、妥当性確認、および日常的な管理の要件 | ページ 6

3.1

batch

defined quantity of product, intended or purported to be uniform in character and quality, which has been produced during a defined cycle of manufacture

[SOURCE:ISO/TS 11139:2006, definition 2.1]

3.2

bioburden

population of viable microorganisms on or in product and/or sterile barrier system

[SOURCE:ISO/TS 11139:2006, definition 2.2]

3.3

biological indicator

bi

test system containing viable microorganisms providing a defined resistance to a specified sterilization process

[SOURCE:ISO/TS 11139:2006, definition 2.3]

3.4

calibration

set of operations that establish, under specified conditions, the relationship between values of a quantity indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material, and the corresponding values realized by standards

[SOURCE:ISO/TS 11139:2006, definition 2.4]

3.5

change control

assessment and determination of the appropriateness of a proposed alteration to product or procedure

[SOURCE:ISO/TS 11139:2006, definition 2.5]

3.6

chemical indicator

non-biological indicator

test system that reveals change in one or more pre-defined process variables based on a chemical or physical change resulting from exposure to a process

[SOURCE:ISO/TS 11139:2006, definition 2.6]

3.7

correction

action to eliminate a detected nonconformity

Note 1 to entry: A correction can be made in conjunction with a corrective action (3.8) .

[SOURCE:ISO 9000:2005, definition 3.6.6]

3.8

corrective action

action to eliminate the cause of a detected nonconformity or other undesirable situation

Note 1 to entry: There can be more than one cause for a nonconformity.

Note 2 to entry: Corrective action is taken to prevent recurrence whereas preventive action (3.27) is taken to prevent occurrence.

Note 3 to entry: There is a distinction between correction (3.7) and corrective action.

[SOURCE:ISO 9000:2005, definition 3.6.5]

3.9

D value

D₁₀ value

time or radiation dose required to achieve inactivation of 90 % of a population of the test microorganism under stated conditions

Note 1 to entry: For the purposes of this International Standard, D value refers to the exposure time necessary to achieve the 90 % reduction of the population of test microorganisms.

Note 2 to entry: Adapted from ISO/TS 11139:2006.

3.10

depyrogenation

validated process designed to remove or inactivate pyrogenic material, by a specified quantity, which is monitored by inactivation of endotoxin

Note 1 to entry: For the purposes of the depyrogenation process, “inactivation” refers to loss of ability of biological material to cause a pyrogenic reaction.

3.11

depyrogenation process

series of actions or operations needed to achieve the specified requirements for removal or inactivation of pyrogens

3.12

establish

determine by theoretical evaluation and confirm by experimentation

[SOURCE:ISO/TS 11139:2006, definition 2.17]

3.13

exposure time

period for which the process parameters are maintained within their specified tolerances

[SOURCE:ISO/TS 11139:2006, definition 2.18]

3.14

F value

microbiological lethality of a sterilization process expressed in terms of the equivalent time, in minutes, at a temperature of 160 °C with reference to microorganisms with a z value of 20 °C.

Note 1 to entry: For dry heat, the F value for specific values of sterilization temperature, T , and z is referred to as F_H. Usually, F_H is the equivalent time in minutes at 160 °C delivered to product at temperature, T , assuming a z value of 20 °C. F_H can be determined by biological ( F_Bio) or physical ( F_phys) methods.

3.15

fault

one or more of the process parameters lying outside of its/their specified tolerance(s)

[SOURCE:ISO/TS 11139:2006, definition 2.19]

3.16

fraction positive

quotient derived from the number of positive tests of sterility observed and the total number of tests of sterility performed (number of positive tests of sterility plus number of negative tests of sterility)

3.17

health care product(s)

medical device(s), including in vitro diagnostic medical device(s), or medicinal product(s), including biopharmaceutical(s)

[SOURCE:ISO/TS 11139:2006, definition 2.20]

3.18

inactivation

loss of ability of microorganisms to grow and/or multiply

[SOURCE:ISO/TS 11139:2006, definition 2.21]

Note 1 to entry: For purposes of depyrogenation processes, “inactivation” refers to loss of ability of biologic material to cause a pyrogenic reaction.

3.19

inoculated carrier

supporting material on or in which a defined number of test microorganisms have been deposited

3.20

installation qualification

IQ

process of obtaining and documenting evidence that equipment has been provided and installed in accordance with its specification

[SOURCE:ISO/TS 11139:2006, definition 2.22]

3.21

lethal rate

L

expression of inactivation per unit time at temperature, T , expressed in terms of a reference temperature, T_ref

Note 1 to entry:L is expressed as minutes at the reference temperature, T_ref, per minute at T .

3.22

medical device

[SOURCE:ISO 13485:2003, definition 3.7]

Note 1 to entry: This definition has been developed by the Global Harmonization Task Force (GHTF 2002).

3.23

microorganism

entity of microscopic size, encompassing bacteria, fungi, protozoa and viruses

[SOURCE:ISO/TS 11139:2006, definition 2.26]

Note 1 to entry: A specific standard might not require demonstration of the effectiveness of the sterilization process in inactivating all types of microorganisms, identified in this definition, for development, validation and/or routine control of the sterilization process.

3.24

operational qualification

OQ

process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational procedures

[SOURCE:ISO/TS 11139:2006, definition 2.27]

3.25

parametric release

declaration that product is sterile, based on records demonstrating that the process parameters were delivered within specified tolerances

[SOURCE:ISO/TS 11139:2006, definition 2.29]

3.26

performance qualification

PQ

process of obtaining and documenting evidence that the equipment, as installed and operated in accordance with operational procedures, consistently performs in accordance with predetermined criteria and thereby yields product meeting its specification

[SOURCE:ISO/TS 11139:2006, definition 2.30]

3.27

preventive action

action to eliminate the cause of a potential nonconformity or other undesirable potential situation

Note 1 to entry: There can be more than one cause for a potential nonconformity.

Note 2 to entry: Preventive action is taken to prevent occurrence whereas corrective action (3.8) is taken to prevent recurrence.

[SOURCE:ISO 9000:2005, definition 3.6.4]

3.28

process challenge device

PCD

item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process

[SOURCE:ISO/TS 11139:2006, definition 2.33]

3.29

process parameter

specified value for a process variable

Note 1 to entry: The specification for a sterilization process includes the process parameters and their tolerances.

[SOURCE:ISO/TS 11139:2006, definition 2.34]

3.30

process variable

condition within a sterilization process, changes in which alter microbicidal effectiveness

[SOURCE:ISO/TS 11139:2006, definition 2.35]

3.31

product

result of a process

[SOURCE:ISO 9000:2005, definition 3.4.2]

Note 1 to entry: For the purposes of sterilization standards, product is tangible and can be raw material(s), intermediate(s), sub-assembly(ies) and health care product(s)

3.32

product family

group or subgroup of product characterized by similar attributes such as mass, material, construction, shapes, lumens and/or packaging and that present a similar challenge to the sterilization process

3.33

requalification

repetition of part of validation for the purpose of confirming the continued acceptability of a specified process

[SOURCE:ISO/TS 11139:2006, definition 2.40]

3.34

specify

stipulate in detail within an approved document.

[SOURCE:ISO/TS 11139, definition 2.42]

3.35

spore log reduction

SLR

factor, expressed as the logarithm to base 10, describing the reduction in the number of spores on a biological indicator produced by exposure to specified conditions

3.36

sterile

free from viable microorganisms

[SOURCE:ISO/TS 11139:2006, definition 2.43]

3.37

sterile barrier system

minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at the point of use

[SOURCE:ISO/TS 11139:2006, definition 2.44]

3.38

sterility

state of being free from viable microorganisms

Note 1 to entry: In practice, no such absolute statement regarding the absence of microorganisms can be proven. See sterilization (3.40) .

[SOURCE:ISO/TS 11139:2006, definition 2.45]

3.39

sterility assurance level

SAL

probability of a single viable microorganism occurring on an item after sterilization

Note 1 to entry: The term SAL takes a quantitative value, generally 10⁻⁶ or 10⁻³. When applying this quantitative value to assurance of sterility, an SAL of 10⁻⁶ has a lower value but provides a greater assurance of sterility than an SAL of 10⁻³.

[SOURCE:ISO/TS 11139:2006, definition 2.46]

3.40

sterilization

validated process used to render product free from viable microorganisms

Note 1 to entry: In a sterilization process, the nature of microbial inactivation is exponential and thus, the survival of a microorganism on an individual item can be expressed in terms of probability. While this probability can be reduced to a very low number it can never be reduced to zero. See sterility assurance level (3.39) .

[SOURCE:ISO/TS 11139:2006, definition 2.47]

3.41

sterilization load

product to be, or that has been, sterilized together using a given sterilization process

Note 1 to entry: In dry heat processing, a sterilization load might be subjected to depyrogenation (see 3.10) in a given sterilization system (see 3.43).

[SOURCE:ISO/TS 11139:2006, definition 2.48]

3.42

sterilization process

series of actions or operations needed to achieve the specified requirements for sterility

Note 1 to entry: This series of actions includes pre-treatment of product (if necessary), exposure under defined conditions to the sterilizing agent and any necessary post treatment. The sterilization process does not include any cleaning, disinfection or packaging operations that precede sterilization.

[SOURCE:ISO/TS 11139:2006, definition 2.49]

3.43

sterilization system

sterilizer and ancillary equipment associated with delivering the sterilization process

Note 1 to entry: In dry heat processing, a sterilization system might be used for depyrogenation (3.10) .

3.44

sterilizing agent

physical or chemical entity, or combination of entities, having sufficient microbicidal activity to achieve sterility under defined conditions

[SOURCE:ISO/TS 11139:2006, definition 2.50]

3.45

survivor curve

graphical representation of the inactivation of a population of microorganisms with increasing exposure to a microbicidal agent under stated conditions

[SOURCE:ISO/TS 11139:2006, definition 2.51]

3.46

terminal sterilization

process whereby product is sterilized within its sterile barrier system

[SOURCE:ISO/TS 11139:2006, definition 2.52]

3.47

validation

documented procedure for obtaining, recording and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications

[SOURCE:ISO/TS 11139:2006, definition 2.55]

3.48

z value

temperature change required to effect a ten fold change in D value, expressed in degrees Celsius