Secondary effects of antibacterial efficacy such as fungal resistance, odour prevention and biodeterioration are not covered by this standard.

NOTE 1 For the product so determined that the test method for textile products should be applied from their usage, shape, etc, clause 10 (Quantitative test) of JIS L 1902 may be applied.

NOTE 2 The International Standard corresponding to this Standard and the symbol of degree of correspondence are as follows.

ISO 22196 : 2007 Plastics – Measurement of antibacterial activity on plastics surfaces (MOD)

In addition, symbols which denote the degree of correspondence in the contents between the relevant International Standards and JIS and IDT (identical), MOD (modified), and NEQ (not equivalent) according to ISO/IEC Guide 21-1.

This Standard is applicable to plastic products, metal products, ceramic products and the like, and does not cover textiles, soft foamed materials such as sponges, and products utilizing such materials.

For those cabinets having an exhaust duct integrated in the main body, the exhaust duct and the external exhaust blower are also included.

The Class II biological safety cabinets which have been conventionally specified in this Standard (Type A, Type B1, Type B2 and Type B3) are given in Annex 5.

Validity of specification given in Annex 5, however, will expire on October 20th, 2010.

Note (1) The cabinets, as referred to in this scope, are the safety cabinets satisfying the requirements established by the Minister of Health, Labour and Welfare based on the Enforcement Regulation of the Act on Prevention of Infectious Diseases and Medical Treatment for Patients with Infections Diseases (Ministerial Ordinance No. 99 of the Ministry of Health and Welfare in 1998).

This document is applicable to medical laboratories. It is also intended to be used by in vitro diagnostic developers and manufacturers, as well as by institutions and organizations supporting SARS-CoV-2 research and diagnostics.

This document does not apply to environmental samples.

Self-testing is excluded from this document.

— comparing to a maximum concentration of an identified or unidentified constituent in an extract (see ISO 10993-18);

— supporting toxicological equivalence;

— comparing to a maximum exposure dose estimate of an identified constituent (see ISO 10993-17).

NOTE Constituent is defined in 3.1.

ISO 10993-18 specifies how to convert TTC (µg/d) into a concentration (µg/ml).

TTC is not applicable to constituents with adequate toxicity data for deriving a tolerable intake (TI) value (see ISO 10993-17).

The TTC values established in this document are protective for carcinogens, systemic toxicants, and reproductive toxicants (see Clause 5). This document does not include TTC values for other biological endpoints assessed as part of the biological evaluation of a medical device, per ISO 10993-1, for example:

— cytotoxicity;

— irritation;

— sensitization;

— hemocompatibility;

— material mediated pyrogenicity;

— local effects that occur in tissues at the site of contact between a medical device and the body (e.g. the observations from implantation studies).

The TTC values in this document do not apply to potential exposure via gas pathways of medical devices. For application of TTC for constituents present/released from these devices, see the ISO 18562 series.

The TTC values presented in this document are not applicable for the safety assessment of cohort of concern (see 5.3).