Non-Tariff Barriers

Non-Tariff Measure

NTM classification

B9: TBT Measures n.e.s. 

Date when the measure came into force

05 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

6.6.4 Report
6.6.4.1 Class I
Report
a) each velocity reading and its location;
b) the average of the velocity readings taken;
c) maximum and minimum velocity readings; and
d) percentage variations from the average of the maximum and minimum readings.
6.6.4.2 Class II
6.6.4.2.1 Downflow Report
a) the pressure drop across the filter system;
b) each velocity reading and its location;
c) the average of the velocity readings taken;
d) maximum and minimum velocity readings; and
e) percentage variations from the average of the maximum and minimum readings.

6.6.4.2.2 Inflow
Report
a) the pressure drop across the exhaust filter system;
b) exhaust airflow velocity (m/s);
c) dimensions of the exhaust duct and work-access aperture; and
d) mean inward airflow velocity (m/s).

6.6.4.3 Class III
Report
a) inflow velocity, right glove port (m/s);
b) inflow velocity, left glove port (m/s);
c) exhaust airflow velocity (m/s);
d) dimensions of exhaust duct; and
e) inlet airflow rate (m^/min).
8.1 Documentation and information
The following documentation and information shall be provided by the manufacturer:
a) installation instructions, including recommendations as to the siting (location) of the cabinet in the laboratory;
b) operating instructions;

c) maintenance instructions that shall include at least the following:
1) instructions for the maintenance and replacement of filters, including a statement of the need for appropriate decontamination of the cabinet;
2) reference to the need to clean and disinfect surfaces in the work zone at regular intervals;
3) a warning regarding cleaning agents and other materials known to be incompatible with sealing materials and finishes;
4) a reference to the size of the HEPA-filters; and
5) a reference to appropriate performance checks; the frequency of such checks and the acceptance/rejection criteria for such checks, and the test methods. 

Reference of the measure

Regulation 6.6.4 and 8.1 

Measure also domestic

Yes 

Products affected by the measure.

Description

Microbiological safety cabinets (classes I, II And III) 

Countries/Regions affected by the measure.

Description

All countries