The activities of the year were mainly joint experiments with the European research organization IBRG based on the evaluation of the JIS method. At the same time, in order to accumulate the data necessary for the ISO proposal, the necessary experiments were carried out in the experimental institutions in Japan. Furthermore, at the ISO/C61 conference in the Netherlands next month, it is ready to submit "Presentation for Antibacterial Experiments".

The above is my explanation of the operation mechanism of the Antimicrobial Products Technology Association and the international standardization of antibacterial test methods.

In the future, I hope that everyone will continue to understand and support the activities of SIAA. At the same time, I wish the colleagues of CIAA are prosperous.

- International standardization for antibacterial experimental methods -

First of all, I would like to sincerely thank the China Association of Antibacterial Materials and Products Industry, so that I can once again have the opportunity to communicate with my Chinese colleagues after last year’s President Kawamoto.

Today I mainly introduce the SIAA operating mechanism and the ISOization of antibacterial experimental methods.

The order of the introduction is the same as the published outline. You can refer to the order of the outlines.

1. History of the Antimicrobial Products Technology Association (SIAA).

First, give an introduction to the history of SIAA

It was founded in May 1993 by nine silver-containing antibacterial agents from its predecessor, the Research Society for Inorganic Antimicrobial Agents Containing Silver.

The background of its establishment is that plastic products using inorganic antibacterial agents are gradually being promoted in the market in order to prevent plastic deterioration caused by organic antibacterial agents commonly used in traditional industries. However, the standards for antibacterial use in the market at that time made the development of the antibacterial market very irregular.

Later, with the safety of antibacterial agents and their products and the research and standardization of testing methods (also known as filming method, later JIS standard), in June 1998, new inorganic antibacterial agents and organic antibacterial agents Manufacturers, antibacterial testing organizations, and scholars participated in the "Japan Antimicrobial Technology Association".

At the same time, in Japan, the cross-infection in hospital caused by MRSA and the food poisoning caused by pathogenic Escherichia coli O-157 were reported by the media. At the same time, a large number of consumers have also become the rising voice of antibacterial. On the other hand, the National Life Center also accused the quality of antibacterial products from being guaranteed, and the Ministry of Economy, Trade and Industry (then the Ministry of International Trade and Industry) also bears the pressure to establish quality standards for antibacterial products.

It is our antibacterial product technology association that undertakes this historical mission.

At present, the association has a total of 135 members, almost all the antibacterial products related units except fiber products.

In addition, antibacterial fiber products have also been supervised by evaluation methods developed by the JAFET group.

The basic concept is to use self-management and information disclosure as the basic principle, to publish the safety and quality standards for antibacterial and antibacterial products, and to give the SIAA logo to the manufacturers' self-registered products, so that consumers can purchase with peace of mind. Antibacterial products provide an important basis.

2. Operational Mechanism of the Antimicrobial Products Technology Association

Now make a brief introduction to the specific operating machine of SIAA.

1 member

First, make a description of the qualifications of the members.

There are 4 members. At first, there were only three types of regular members, sponsored members, and special members. Later, the associate membership system was added.

A positive member is a core member of the SIAA. It is required to be included in the membership fee and annual membership fee. At the same time, the management responsible person and the member with independent registration rights should be set up (more on this later).

The president, vice president and executive directors are selected from these regular members and special members. Executive directors and directors are selected by regular members, sponsored members and special members. At the same time, the regular members also have the voting rights of the General Conference. All members are actively expanding the antibacterial market.

Sponsored members are mainly experimental testing institutions. These members are required to have the antibacterial test conditions and complete quality assurance system for implementing JIS. Recently, these members also include testing organizations that have JNAL certification qualifications to be described later.

Special members are mainly composed of antibacterial experts, that is, professors from universities and other scholars. The purpose is to become a member of the association who wants to make various constructive suggestions for the operation of SIAA.

The newly established associate members are mainly composed of members of the circulation field who do not have the conditions of a positive member and are interested in the association. However, they cannot participate in the operation of the association.

2 self-certification and self-registration

The following is a detailed description of the SIAA's main operating method, self-certification and self-registration system.

The logo not only represents the SIAA Association, but also marks the Antimicrobial Article that has passed Self-imposed Authorization.

In this regard, it is different from the general association, so SIAA has a unique convenience.

At present, the era of product Liability has been entered into by the manufacturer. The SIAA only requires self-management and self-assurance under the basic guidelines of the SIAA.

Therefore, at the time of membership, it is required to perform the duties of selecting the “management responsibility of antibacterial agents and antibacterial products” and “self-registration quality and safety”.

It is also understandable from the text that the person responsible for management should be the person responsible for the antibacterial products (antibacterial agents) of the member companies concerned.

When registering at SIAA, there is only one person. When a member company has multiple antibacterial products produced by various antibacterial products divisions, there may be more than one management responsibility person to become a joint member.

In short, the management responsible for the safety of antibacterial products (antibacterial agents)? quality? Antibacterial evaluation? There are all responsibilities for identification and use, and there should be a certain status and necessary knowledge in the enterprise.

Those who are responsible for management are required to participate in the seminar and have the obligation to participate in the off-the-job training on a regular basis. The content of the seminar included extensive knowledge about antibacterial. At the same time, regardless of whether or not the SIAA logo is attached, there is an obligation to register itself. Of course, ensuring the safety and antibacterial properties of the products to be mentioned later is one of the contents of the registration, and the information will be disclosed online, providing consumers with the necessary information to purchase antibacterial products with peace of mind.

3 safety standards

Second, the security is specified.

Basically, the initial registration can be carried out when four items of safety of the antibacterial agent are confirmed.

First, the LD50 value for acute oral toxicity must be greater than 2000 mg/kg.

This indicator indicates that it is treated as a generic agent for non-virulence or poison. In the past, the maximum dose of 5000mg/Kg was achieved, but considering that the Animal Care Association opposed the animal experiment to only achieve a maximum dose of 2000mg/Kg. Recently, studies have been conducted on the same evaluation method using microorganisms only without animal experiments.

The primary irritation index of the skin is "no irritating response or weak irritant", that is, the PII value is less than 2. Previously, this experiment was used to evaluate the effect on the skin. Later, on the market, metals such as nickel were found to cause problems such as skin allergies, and skin sensitization experiments were initiated.

Variability is an experiment to observe the presence or absence of variability, and of course requires a negative.

Skin allergies are also allergic to the test and must also be negative.

In addition to the above four SIAA safety regulations, there are also some necessary safety guarantees required by laws and regulations, depending on the use of the antimicrobial agent.

Recently, there have been cases where a cellular toxicity test is required.

The safety of the antibacterial agent used in the antibacterial processed product must be used below the test concentration, and when the safety is confirmed by diluting with a diluent, it must be used at 1/2 or less of the confirmed concentration. In other words, a 200% safety rate is required to be the most important point in the design of antimicrobial products.

4 antibacterial performance standards

The following is a description of the standards for antimicrobial performance.

The requirements for the antimicrobial properties of antimicrobial agents must in principle be evaluated in terms of minimum developmental inhibitory concentration (MIC). Its MIC value below 800 μg/ml can be recognized as an antibacterial agent.

On the other hand, the antibacterial property of the antibacterial processed product is a method according to JIS Z 2801 5.2.1, that is, the experimental result antibacterial activity value must be greater than 2.0.

The antibacterial processed products in these experiments must also be tested for antibacterial durability experiments such as water resistance and light resistance under the conditions of use of the simulated antibacterial processed products.

This JIS standard method is an antibacterial processed product-antibacterial test method that is applied to antibacterial processed products in various fields by arranging the film method which is originally used to evaluate the antibacterial properties of plastic surfaces. The antibacterial effect was formulated on December 20, 2000.

The background is the "Antibacterial Processing Products Guide - Development of New Regulations" issued by the Ministry of Economy, Trade and Industry (the then Ministry of Commerce and Industry) in May 1999. The experimental method of antibacterial effect should be applied to the antibacterial treatment of various antibacterial processed products. JIS Z 2801, a specific method for expressing the effect of the method of the Japanese Industrial Standards (JIS).

This JIS standard method is not only a standardization of historical test methods, but also characterized by the development of an antibacterial effect.

That is to say, JIS Z 2801 5. 1 contains the contents of the previously developed antibacterial test method for fibers JIS L 1902.

Therefore, SIAA's JIS Z 2801 as its own test method also illustrates the concept of SIAA. That is, JIS is "anyone can do the same test as long as they have certain equipment", that is, a method for consumers to evaluate antibacterial processed products on the market. On the other hand, SIAA as a group of manufacturers (producers? sellers) is very important for the quality management of antibacterial processed products produced and sold, and also includes the management part of design quality. That is to say, the design quality of the antibacterial experiment is also taken into consideration while designing the safety and performance specifications of the antibacterial agent used.

This is the "non-processed test piece" in the "Independent Specification for Quality and Safety" prescribed by the SIAA. It must be a product that has not been subjected to antibacterial processing. The unprocessed test piece must be made of the same materials and processing methods as the experimental sample. Of course, when the unprocessed sample piece is not available, it can be replaced by a sample prepared by the same processing method using a homogenous material having a chemical composition and structure. In this case, the composition of the unprocessed sample must be indicated in the test method. ※Here, homogeneous materials refer to materials with the same chemical composition and chemical structure. That is to say, the manufacturer must compare the antibacterial effect of the unprocessed test piece and the processed test piece before making a judgment on whether or not the antibacterial property is obtained.

In the products that appear on the market, in extreme cases, "products that have an antibacterial effect without adding an antibacterial agent" may appear. It is well known that some types of resins have an antibacterial effect per se. Such an article exhibits an antibacterial effect when it appears on the market as a name of an antibacterial processed product, and it is difficult for consumers to distinguish between them and a processed article incorporating an antibacterial agent. On the other hand, since the safety of the substance of the antibacterial effect component is not registered, it is easy for the consumer to purchase an article without safety.

This situation is in violation of the basic policy of the SIAA. “Association members should provide consumers with antibacterial processed products of high quality and safety, must state the necessary guidelines for self-management, and develop more sound and nationals in the associated industry. The purpose of improving the quality of life.

Now, explain why the antibacterial activity value is above 2.0. SIAA has put a lot of effort into the reproducibility of antibacterial experiments. For example, the cover tape is placed in a plastic sealed bag, which is the best material that has no effect on bacteria and keeps the bacterial liquid between the test piece and the tape uniform. At the same time, the bacteria were stabilized with 1/500 NB of medium. These bacterial liquids are also formulated without using purified water which may affect the physiological activity of the antibacterial activity. Further, with respect to the antibacterial activity value, the statistical error factor is set to 2.0 or more due to the scattering caused by the exclusion of the experimental operation and the microbial treatment. Others, such as the availability of experimental conditions, are limited by experimental results of unprocessed test pieces. SIAA also established an antibacterial experiment management system for the implementation of this antibacterial experiment. This system requires manufacturers to set up antibacterial experiment managers in the company. The antibacterial experiment manager has the expertise and skills to receive the training, and plays an important role in the quality management of antibacterial processed products (antibacterial agents).

3. SIAA logo

The following is a description of the SIAA logo.

The meaning of the mark is "the type, processing method, and processing part of the antibacterial agent used for the product by attaching the SIAA mark to the antibacterial processed product, performing the antibacterial evaluation by the JIS Z 2801 method, and the self-management of the guide. Such as marking, in order to enable consumers to choose antibacterial processed products with good quality and safety, to achieve a more sound development of the related industry and improve the quality of life of the people.

Here is an example of the SIAA logo, in which the type of antibacterial agent, processing method, processing part and registration number are indicated in the basic mark.

Many times, members have adopted the safety standards set by the Antimicrobial Products Technology Association and the products after the durability test. Please have the JNLA-certified antibacterial testing mechanism mentioned later, and ensure the antibacterial by JIS Z 2801 method. After self-registration of antibacterial processed products after performance, the SIAA logo can be used.

The most characteristic feature of this mark is that the antibacterial processed product is not the "JIS-developed product (the seven paragraphs of the 19th article of the Industrial Standardization Law) [JIS mark designated product]", but it is the unique mark indicating "JIS Z 2801 antibacterial fit".

From this perspective, we very much hope that while the reputation of the Antimicrobial Products Technology Association is increasing, the SIAA logo can also become a symbol of consumer trust, thus promoting the healthy development of the antibacterial processed products industry.

4. JNLA system

Next, a brief introduction to the JNLA system.

The experimental institution certification system is a program operated by IAJAPAN and implemented based on the industrial standardization law.

In other words, it is a program that is determined by the chairman of the independent legal person product evaluation technical organization (NITE) to have an experimental organization capable of implementing the JIS-defined (or cited) experimental technical ability of the non-established product.

This certification procedure is based on the international standard ISO/IEC requirements, and IAJAPAN identifies the experimental organization with ISO/IEC 17025 as the certification standard. The identified experimental institution may issue a test result certificate containing the identified test method with the identified test method.

Since IAJAPAN is the International Mutual Certification Agreement (MRA) signing agency, this specification is universal in the international arena.

5. ISOization of antibacterial test methods

Finally, talk about the international standardization (ISO) problem of antibacterial experimental methods.

It is very important for Japan to formulate international standards as a sponsor.

JIS Z 2801, which is an antibacterial test method, is a method developed in Japan for antibacterial experiments such as plastics. This Japanese Industrial Standard (JIS) International Standardization (ISO) is also a very important issue for SIAA. This is a work that must be done from the Japanese antibacterial market to the international antibacterial market. Therefore, SIAA established the ISO Preparation Committee in 2000 to coordinate and make some preparations for the ISOization of JIS and related departmental agencies. Furthermore, in 2003, the ISO-based three-year plan was launched. At the same time as the establishment of the ISO Promotion Committee, SIAA obtained an ISO budget from the Ministry of Industry and Economy. At the same time, the ISO Domestic Research Committee, which is a third party organization, has also been established, and has begun to collect relevant opinions and suggestions from a professional perspective.

If the progress is smooth, the ISO/TC61 proposal will be proposed in 2004, the final draft will be made in 2005, and the ISOization work will be completed in 2006. Of course, we must work hard to overcome the difficulties involved. To this end, with the approval of 19 countries of P-Members, it is also very important to obtain the approval of China, one of the 14 member states of O-members. We very much hope to receive the assistance of CIAA colleagues.

[China Antibacterial Fabric Network ]