ISO/TS 19930:2017 最大10-6の滅菌保証レベルを達成するための処理に耐えることができない最終滅菌済みの使い捨てヘルスケア製品の滅菌を保証するためのリスクベースのアプローチの側面に関するガイダンス | ページ 6

3.1

aseptic processing

handling of sterile (3.29) product, containers and/or devices in a controlled environment, in which the air supply, materials, equipment and personnel are regulated to maintain sterility

3.2

assurance of sterility

qualitative concept comprising all activities that provide confidence that product is sterile (3.29)

3.3

bioburden

population of viable microorganisms on or in product and/or sterile barrier system (3.30)

3.4

biological indicator

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

3.5

change control

assessment and determination of the appropriateness of a proposed alteration to product, process or equipment

3.6

chemical indicator

test system that reveals change in one or more pre-defined process variables (3.20) based on a chemical or physical change resulting from exposure to a process

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 9000:2015, 3.12.3]

3.8

corrective action

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

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 (3.18) is taken to prevent occurrence.

[SOURCE:ISO 9000:2015, 3.12.2, modified — “detected” and “or other undesirable situation” have been added to the definition and the Note 3 to entry has been deleted.]

3.9

development

act of elaborating a specification

3.10

establish

determine by theoretical evaluation and confirm by experimentation

3.11

fault

situation in which one or more of the process parameters (3.19) or cycle parameters is/are outside its/their specified tolerance(s)

3.12

health care product

medical device(s) (3.14) , including in vitro diagnostic medical device(s), or medicinal product(s), including biopharmaceutical(s)

3.13

load

product, equipment or materials to be processed together within an operating cycle

3.14

medical device

[SOURCE:ISO 13485:2016, 3.11, modified — The first two list items in the Note 1 to entry have been added.]

3.15

medical device manufacturer

natural or legal person with responsibility for design and/or manufacture of a medical device (3.14) with the intention of making the medical device available for use, under their name; whether or not such a medical device is designed and/or manufactured by that person themselves or on their behalf by another person(s)

[SOURCE:GHTF/SG1/N055:2009, 5.1 — modified.]

3.16

overkill approach

method of defining a sterilization process that achieves a maximal sterility assurance level (SAL) (3.32) for product substantially less than 10⁻⁶

3.17

parametric release

declaration that product is sterile (3.29) , based on records demonstrating that the process variables (3.20) were delivered within specified tolerances

3.18

preventive action

action to eliminate the cause of a potential nonconformity or other potential undesirable 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 9000:2015, 3.12.1]

3.19

process parameter

specified value for a process variable (3.20)

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

3.20

process variable

chemical or physical attribute within a cleaning, disinfection, packaging or sterilization process, changes in which can alter its effectiveness

3.21

product

tangible result of a process

3.22

requalification

repetition of part or all of validation (3.38) for the purpose of confirming the continued acceptability of a specified process

3.23

risk

combination of the probability of occurrence of harm and the severity of that harm

[SOURCE:ISO/IEC Guide 51:2014, 3.9]

3.24

risk analysis

systematic use of available information to identify hazards and to estimate the risk

[SOURCE:ISO/IEC Guide 51:2014, 3.10]

3.25

risk assessment

overall process comprising a risk analysis (3.24) and a risk evaluation (3.26)

[SOURCE:ISO/IEC Guide 51:2014, 3.11]

3.26

risk evaluation

procedure based on the risk analysis (3.24) to determine whether tolerable risk has been exceeded

[SOURCE:ISO/IEC Guide 51:2014, 3.12]

3.27

risk management

systematic application of management policies, procedures and practices to the tasks of analysing, evaluating, controlling and monitoring risk

[SOURCE:ISO 14971:2007, 2.22]

3.28

specify

stipulate in detail within an approved document

3.29

sterile

free from viable microorganisms

3.30

sterile barrier system

minimum package that minimizes the risk of ingress of microorganisms and allows aseptic presentation of the sterile (3.29) product at the point of use

3.31

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 (3.33) ].

3.32

sterility assurance level

SAL

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

Note 1 to entry: It is expressed as the negative exponent to the base 10.

Note 2 to entry: The term SAL takes a quantitative value. When applying this quantitative value to assurance of sterility, a SAL of 10⁻⁶ has a lower value but provides a greater assurance of sterility than a SAL of 10⁻³.

3.33

sterilization

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.

3.34

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.

3.35

sterilizing agent

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

3.36

terminal sterilization

process whereby product is sterilized within its sterile barrier system (3.30)

3.37

test of sterility

technical operation performed as part of development (3.9) , validation (3.38) or requalification to determine the presence or absence of viable microorganisms on product or portions thereof

3.38

validation

confirmation process, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled

Note 1 to entry: The objective evidence needed for a validation is the result of a test or other form of determination such as performing alternative calculations or reviewing documents.

Note 2 to entry: The word “validated” is used to designate the corresponding status.

Note 3 to entry: The use conditions for validation can be real or simulated

[SOURCE:ISO 9000:2015, 3.8.13]