Non-Tariff Barriers

Non-Tariff Measure

NTM classification

B7: Product quality, safety or performance requirements 

Date when the measure came into force

02 April 2001 

Publication where the measure is specified

Government Notice R93 (Government Gazette 22014) Of 2 February 2001 

Regulation where the measure is specified

Compulsory Specification For Microbiological Safety Cabinets (Classes I, II And III) 

Country/Region applying the measure

South Africa 

The rationale of the measure

1.1 This specification covers requirements for the construction, fittings and pre-installation and post- installation performance of class I, class li and class III microbiological safety cabinets (also known as biological safety cabinets) intended to protect the operator and the environment from hazardous microbiological materials and (if so required by the customer or user or both), organic toxins and non-corrosive volatile organic agents.

NOTE - Microbiological safety cabinets are not intended to provide protection against corrosive chemical or radioactive materials.

1 .2 The specification does not cover the actual design of a safety cabinet and in no way restricts new design, provided that a microbiological safety cabinet of a new design complies with the requirements for materials, reliability, performance and safety given in this specification.

NOTE - Microbiological safety cabinets of class I, class II and class III should not be confused with laminar flow
clean workstations that usually discharge horizontally and vertically towards the operator and that do not provide
protection for an operator, but can even increase exposure to airborne hazards. 

Coded list of objectives

X: For purposes n.e.s. 

Description of the measure

4.1 Class I cabinets

4.1.1 General

4.1.1.1 A class I cabinet shall be a self-contained unit that includes at least a work space, prefilters, HEPA-filters and a blower for HEPA-filtered exhaust air. If handling of organic toxins and non-corrosive volatile organic agents is required, an activated carbon filter shall also be included.

4.1.1.2 The cabinet shall be an independent operating unit and shall be independent of any other air-circulation system.

4.1.1.3 The exhaust outlet may face in any direction, provided that it is readily accessible.

4.1 .1 .4 The work face of the work space shall include a viewing window and a work-access aperture through which an inward flow of air is maintained.

4.1.1.5 In order to contain potentially hazardous materials within the cabinet, all contaminated zones under positive air pressure shall be surrounded by zones maintained under negative pressure relative to the pressure in the work room/environment.

4.1.1.6 When a cabinet is tested in accordance with 6.8, the cabinet shall offer a protection factor of at least 1 x 10^ 5

4.1 .1.7 Under no circumstances shall a class i cabinet be upgraded to comply with the requirements of a class III cabinet.

4.1.2 Work floor

The work floor shall be rigid, flat and constructed in one piece with radiused corners to facilitate cleaning and disinfection (see 3.4.2). The front edge of the floor shall have a retaining lip of height at least 10 mm that serves to contain spillage of liquid within the cabinet.

4.1.3 Flow and distribution of air

4.1.3.1 When a smoke test is carried out in accordance with 6.5.3.3, it shall demonstrate that the direction of airflow is inwards over the entire area of the work-access aperture.

4.1.3.2 When determined in accordance with 6.6.3.1, the average velocity of the air flowing into the work-access aperture shall be in the range 0,7 m/s to 1 ,0 m/s. No single velocity reading shall differ from the average velocity by more than 20 %. 

Reference of the measure

Regulation 4.1 

Measure also domestic

Yes 

Products affected by the measure.

Description

Microbiological safety cabinets in class I 

Countries/Regions affected by the measure.

Description

All countries