Medicines and Related Substances Act, 1965
R 385
Occupational Health and Safety Act, 1993 (Act No. 85 of 1993)Guidance NotesPressure Equipment Regulations, 2009Regulation 4 - Duties of Manufacturers |
(1) | The manufacturer shall have an obligation to ensure that all equipment designed and manufactured for use in the Republic shall be conformity assessed and subjected to the requirements set out in SANS 347. |
(2) | Subject to the requirements set out in the relevant health and safety standard incorporated into this Regulation under section 44 of the Act, the manufacturer shall ensure that the pressure equipment as manufactured, modified, inspected, tested or repaired is safe and without risks to health when properly used. |
(3) | Subject to the requirements of this regulation a manufacturer shall issue a certificate of manufacture for all pressure equipment supplied, with a verification signature by an approved inspection authority when so required. |
(4) | Subject to the requirements of this regulation a manufacturer shall comply with any other duty assigned to the manufacturer in these regulations. |
(5) | A manufacturer who determines that pressure equipment in use has a latent defect shall advise the chief inspector in writing forthwith thereof and of measures being taken to correct the defect. |
Notes:
(a) | The certificate of manufacture must declare conformance to the Pressure Equipment Regulations. The Certificate of Manufacture is equivalent to the Certificate of Conformity as stated in SANS 347. |
(b) | Categorization may be done by another party (for example the user) provided the manufacturer formally accepts such categorisation and maintains full responsibility for compliance. |
(c) | The certificate of manufacture, has the same meaning as certificate of conformity, manufacturers data report and declaration of conformity. |
(d) | Manufacturers shall ensure that for refrigeration and air conditioning systems an approved health and safety standard is used. |
(e) | Locally manufactured pressure equipment that are ASME or CE marked for use in the Republic shall also undergo a conformity assessment review, to ensure the additional requirements of PER are met, and shall be verified by an AIA where applicable. |
(f) | Where it has been agreed that the user’s original design is to be used on a total replacement in accordance with Regulation 6 guide note (i), a comprehensive method statement on the entire construction shall be mutually agreed to by the user, manufacturer and AIA. Cognisance of any applicable code revisions should be considered. |
(g) | No pressure vessel or steam generator shall be manufactured, modified or repaired to the RSA/CI/OHSA certification requirements by a Manufacturer who’s Quality Management System is not accredited by an approved Certification Body in-accordance with Annex C of SANS 347 from the date of gazette of the PER Revision 2 Guide Notes. |