ISO/TS 5441:2024 バイオリスク管理アドバイザーの能力要件 | ページ 6

3.1

attribute

inherent characteristic of a person

3.2

biorisk culture

set of values, beliefs and patterns of behaviour instilled and facilitated in an open and trusting environment by individuals throughout the organization who work together to support or enhance best practice for laboratory biosafety and biosecurity

Note 1 to entry: This culture is crucial for the success of biorisk management and is built from mutual trust and the active engagement of all personnel across the organization, with a clear commitment from the organization’s management.

3.3

biorisk management advisor

competent individual(s) providing unbiased advice, guidance, and assurance on biorisk management issues, reporting directly to the responsible senior management

3.4

competence

ability to apply knowledge, skills, and attributes to achieve intended results

Note 1 to entry: Competence is a specific combination of knowledge, skill, attributes and experience.

Note 2 to entry: The necessary knowledge and skills can vary from organization to organization and over time.

Note 3 to entry: An effective combination of competencies comprises overall competence.

3.5

competent biorisk management advice

guidance or recommendations based on knowledge, skills and experience that accurately identify risks related to biological material, the potential consequences of these risks, the likelihood of their occurrence and mitigation strategies to reduce the risks to acceptable levels in a context meeting relevant regulatory requirements, standards, and their respective specifications

3.6

containment

set of measures, including practices, safety equipment and facility safeguards, that protect laboratory workers, the community, and the environment from exposure to biological material when stored or handled

3.7

containment level

set of standard microbiological practices, special practices, safety equipment, and laboratory facilities, including a composite of facility design and construction, equipment, practices, and operational procedures organized and characterized by the degree of protection provided to personnel, the environment, and the community

Note 1 to entry: Special practices address any unique risks associated with the handling of agents requiring increasing levels of containment. Appropriate safety equipment and laboratory facilities enhance worker and environmental protection.

Note 2 to entry: While containment levels can be a logical starting point for the handling and containment of biological agents in many countries, a correspondence between pathogenic microorganisms and laboratory biosafety levels is established for ease of administration. This thinking should not lead to the misconception that the risk group of a biological agent directly corresponds to the containment level of a laboratory. In fact, the actual risk of a given scenario is influenced not only by the agent being handled, but also by the procedure being performed and the competence of the laboratory personnel engaging in the laboratory activity.

Note 3 to entry: In most international systems, containment measures appropriate to protect humans, animals, plants, and the environment from exposure to biological materials are based on a category approach to cover the spectrum of risk to be managed.

3.8

dual-use potential

3.9

knowledge

outcome of the assimilation of information through learning

Note 1 to entry: Knowledge is the body of facts, principles, theories, and practices that is related to a field of work or study.

[SOURCE: CEN Guide 14]^[3]

3.10

knowledgeable

intelligent and well informed

3.11

management system

set of interrelated or interacting elements of an organization to establish policies and objectives, as well as processes to achieve those objectives

Note 1 to entry: A management system can address a single discipline or several disciplines.

Note 2 to entry: The management system elements include the organization’s structure, roles, and responsibilities, planning and operation.

Note 3 to entry: The management system of an organization establishes, documents, implements, and maintains that it is capable of supporting and demonstrating the quality and consistent achievement of the requirements of its biorisk management programme.

Note 4 to entry: A biorisk management system addresses the control of biorisk(s).

3.12

management system standard

MSS

standard for a management system

3.13

participate

take part in an action or endeavour

3.14

programme

set of related measures or activities with a particular long-term aim

Note 1 to entry: The terms"management system" and"programme" refer to biorisk management in this document.

Note 2 to entry: The term"biorisk management system" applies only to the context for which it is used.

3.15

risk group

RG

classification of biological agents based upon each agent’s characteristics and epidemiological profile

Note 1 to entry: The higher the risk, the higher the likelihood that the agent will cause and spread infection in humans or animals in the country, and/or the more severe the consequences of that infection will be to individual and public health, if it were to occur.

Note 2 to entry: Risk Group 1 (no or low individual and community risk): A microorganism that is unlikely to cause human or animal disease.

Note 3 to entry: Risk Group 2 (moderate individual risk, low community risk): A pathogen that can cause human or animal disease but is unlikely to be a serious hazard to laboratory personnel, the community, livestock or the environment. Laboratory exposures may cause serious infection, but effective treatment and preventive measures are available and the risk of spread of infection is limited.

Note 4 to entry: Risk Group 3 (high individual risk, low community risk): A pathogen that usually causes serious human or animal disease but does not ordinarily spread from one infected individual to another. Effective treatment and preventive measures are available.

Note 5 to entry: Risk Group 4 (high individual and community risk): A pathogen that usually causes serious human or animal disease and that can be readily transmitted from one individual to another, directly or indirectly. Effective treatment and preventive measures are not usually available.

[SOURCE: WHO Laboratory Safety Manual 4th Edition 2020]^[2]

3.16

senior management

individual or group(s) who directs and controls an organization including strategic level management positions

Note 1 to entry: Senior management are sometimes referred to, within organizations, as executive management, top management, upper management and higher management.

3.17

skills