Confidentiality Level D

Provisions for Test Managers
1. Objective
These detailed rules stipulate the duties of test managers and the contents of the test manager
training session and follow-up training session, in order to facilitate the dissemination of more
appropriate antibacterial and antifungal evaluation methods, enhancement of antibacterial andantifungal evaluation skills, and more appropriate implementation of antibacterial and antifungal
tests by member companies consequently.

2. Definition of Test Managers
Test managers refer to those who evaluate and test the antibacterial and antifungal performancesof their companies’ products registered with SIAA, or those who manage and supervise people
who implement such evaluations and tests.

3. Appointment and Duties of Test Managers(1) Each manufacturer registering its antibacterial or antifungal agent with this society shallappoint a test manager internally at the time of admission and describe so in the admission
application to notify this fact to this society. Product manufacturers shall appoint a test
manager as needed.
(2) Test managers shall evaluate the antibacterial or antifungal performance of the antibacterial orantifungal product or antibacterial or antifungal agent for which a control manager has
requested an evaluation, using the requested method.
(3) Test managers may describe MIC and MBC data of an antibacterial agent obtained bythemselves through a test in the “Admission/Voluntary Registration Data Sheet Concerning
Quality and Safety I (Antibacterial Agents)” as their companies’ data, when registering it withthis society. In addition, they may also describe the MIC value or antifungal test result
obtained by themselves through a test in the “Antifungal Agent Positive List Entry Sheet” and“Admission/Voluntary Registration Data Sheet Concerning Quality and Safety III (AntifungalProducts)” as their companies’ data (related to Note 1) of Term 5, K07).
(4) Test managers shall immediately answer questions from a control manager concerning themethod of evaluating an antibacterial or antifungal product or an antibacterial or antifungalagent.
(5) Test managers shall continually enhance their own knowledge and skills necessary for theantibacterial evaluation of antibacterial products and agents and the antifungal evaluation ofantifungal products and agents. To enhance their expert knowledge, to develop and maintaintheir skills related to antibacterial tests or antifungal tests, and to gain relevant information,
they shall participate in follow-up training sessions held by this society at least once every twoyears.

4. Certification of Test Managers(1) Test manager certification shall be given to a person who meets one of the following criteria
by this society’s chairperson:
1) A person who has completed a test management training session (hereinafter referred to as“training session”)
2) A person who has one or more years of practical experience in handling ofmicroorganisms, antibacterial tests, or antifungal tests (a written certificate must besubmitted)
3) A person who has graduated from a short college course or from an equivalent or higher
school after completing microbiology-related courses (the certificate of graduation must besubmitted)
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Confidentiality Level D(2) If the Board of Directors judges that a test manager has defamed this society or had committed
an act that contradicts the objective of these detailed rules, the chairperson of this society shallwithdraw the certification as a test manager.

5. Test Management Training Session and Follow-Up Training Session(1) A training session shall provide a lecture on the knowledge necessary for the antibacterial or
antifungal evaluation of antibacterial and antifungal products, and antibacterial and antifungal
agents, as well as practical training.
(2) A follow-up training session shall provide training on the knowledge that develops test
managers’ expertise and is useful for member companies, concerning test methods, relevantlaws, regulations and systems, the topics attracting attention inside and outside SIAA when
this training session is held, quality control, and so on.
(3) A training session and follow-up training session shall be held basically once every two years
and shall be alternately held in other operating years.
(4) Those who meet one of the following criteria may receive training.
1) Those belonging to a member’s corporation
2) Those nominated in writing by a member (representative)(5) Subjects of training sessions and follow-up training sessions shall be selected and determinedfrom among the following through consultation between the committee in charge of planningand operation, as stipulated in Term 6, and the Secretariat, based on (1) and (2).
1) Basic knowledge about microbiology2) Basic knowledge about antibacterial agent (inorganic (silver etc.), organic, photocatalytic,antibacterial stainless steel)3) Basic knowledge about antibacterial products (material, treatment methods, instructions)4) Explanation on relevant laws, regulations, rules and systems
5) This society’s voluntary specifications and voluntary registration
6) MIC and MBC test methods
7) Antibacterial power test method (JIS Z2801, shaking method and others)
8) Fungal growth test, fungal resistance test (JIS, ISO, IEC)
9) Antivirus test method (ISO 21702)
10) Test methods related to industrial sterilization coating materials (JIS Z 2811)
11) Introduction of uncertainties of test methods and their case examples
12) New efforts of this society13) Other subjects and skills deemed necessary

6. Planning and operation of Training Sessions and Follow-Up Training Sessions
The training sessions and follow-up training sessions shall be planned and operated by theEngineering and System Committee, and the Secretariat shall provide support and involve inoffice works.

7. Public Announcement of Training Sessions and Follow-Up Training Sessions
Date and time, place and other necessary matters for implementing a training session andfollow-up training session shall be publicly announced on the web page of this society, via e-mailto member companies, and elsewhere at least 3 months before its implementation.

8. Session Registration Procedures
A person who wants to participate in a training session and/or follow-up training session shallsubmit a separately formulated application form, filled in with necessary matters, to the Secretariat.

Formulated : June 24, 1998
Amended: November 30, 1998
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Confidentiality Level D

Amended: June 22, 2000
Amended: june 22, 2001
Amended: December 17, 2009
Amended: December 13, 2013
Amended: March 20, 2014
Amended: October07，2019
Amended: May 18, 2020
Amended: December 14, 2021

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