ISO 17664-1:2021 ヘルスケア製品の処理—医療機器の処理のために医療機器メーカーから提供される情報—パート1：クリティカルおよびセミクリティカルな医療機器 | ページ 6

3.1

cleaning

removal of contaminants to the extent necessary for further processing or for intended use

Note 1 to entry: Cleaning consists of the removal of adherent soil (e.g. blood, protein substances and other debris) from the surfaces, crevices, serrations, joints and lumens of a medical device by a manual or automated process that prepares the items for safe handling and/or further processing.

[SOURCE: ISO 11139:2018, 3.46, modified — Note 1 to entry has been added.]

3.2

disinfecting agent

physical or chemical agent that is able to reduce the number of viable microorganisms

3.3

disinfection

process to reduce the number of viable microorganisms to a level previously specified as being appropriate for a defined purpose

3.4

manual cleaning

removal of contaminants from an item to the extent necessary for further processing or for intended use without the use of an automated process

[SOURCE: ISO 11139:2018, 3.159]

3.5

medical device

[SOURCE: ISO 13485:2016, 3.11]

3.6

medical device manufacturer

natural or legal person with responsibility for design and/or manufacture of a medical device 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 or on their behalf by another person(s)

Note 1 to entry: Attention is drawn to the fact that the provisions of national or regional regulations can apply to the definition of manufacturer.

[SOURCE: ISO 11139:2018, 3.167, modified — Notes 1 to 7 to entry have been deleted and a new Note 1 to entry has been added.]

3.7

packaging system

combination of a sterile barrier system (3.15) and protective packaging (3.10)

3.8

processing

<preparation of medical devices (3.5) > activity to prepare a new or used health care product for its intended use

Note 1 to entry: For the purposes of this document, processing includes cleaning, disinfection and sterilization (if necessary and applicable).

Note 2 to entry: For the purposes of this document, a health care product refers to a medical device.

3.9

processor

<preparation of medical devices (3.5) > organization and/or individual with the responsibility of carrying out actions necessary to prepare a new or reusable health care product for its intended use

Note 1 to entry: For the purposes of this document, a health care product refers to a medical device.

[SOURCE: ISO 11139:2018, 3.216, modified — Note 1 to entry has been added.]

3.10

protective packaging

configuration of materials designed to prevent damage to the sterile barrier system (3.15) and its contents from the time of their assembly until the point of use

[SOURCE: ISO 11607-1:2019, 3.14]

3.11

reusable medical device

medical device (3.5) designated or intended by the medical device manufacturer (3.6) as suitable for processing (3.8) and reuse

Note 1 to entry: This is not a medical device that is designated or intended by the manufacturer for single use only.

[SOURCE: ISO 11139:2018, 3.236]

3.12

service life

number of processing (3.8) cycles and/or lifetime that a medical device (3.5) can be subjected to and remain suitable and safe for its intended use

3.13

single-use medical device

medical device (3.5) designated or intended by the medical device manufacturer (3.6) for one-time use only

Note 1 to entry: A single-use medical device is not intended to be further processed and used again.

3.14

sterile

free from viable microorganisms

[SOURCE: ISO 11139:2018, 3.271]

3.15

sterile barrier system

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

3.16

sterility assurance level

probability of a single viable microorganism occurring on an item after sterilization (3.17) , expressed as the negative exponent to the base 10

3.17

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.

3.18

sterilizing agent

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

3.19

terminal process

final step of processing (3.8) to render a medical device (3.5) safe and ready for its intended use

3.20

validation

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

[SOURCE: ISO 9000:2015, 3.8.13, modified — the notes to entry have been deleted.]

3.21

verification

confirmation, through the provision of objective evidence, that specified requirements have been fulfilled

[SOURCE: ISO 11139:2018, 3.314, modified — Notes 1 and 2 to entry have been deleted.]

3.22

washer-disinfector

equipment designed to clean and disinfect product

Note 1 to entry: See the ISO 15883 series.

[SOURCE: ISO 11139:2018, 3.319, modified — abbreviated term WD removed and Note 1 to entry added.]