Medicines and Related Substances Act, 1965
R 385
Occupational Health and Safety Act, 1993 (Act No. 85 of 1993)Code of PracticeNational Code of Practice for Electrical Machinery in Hazardous LocationsRegulatory requirements for explosion-protected apparatusAnnexesAnnex A (normative) : Upgrading and maintenance of EPA certificates for factories |
Annex A
(normative)
Upgrading and maintenance of EPA certificates for factories
| A.1 | In South Africa, all explosion protection equipment (EPA) used on the surface (Groups II and III) shall be covered by an IA certificate. This includes machines; to qualify for certification a machine shall be made up of equipment with valid certification. The requirements given in A.2 to A.19 cover the validity of IA certificates. |
| A.2 | All IA certificates issued shall have a validity period of 10 years for manufacturing purposes. EPA having been manufactured under a valid IA certificate will not be affected when the certificate expires; in other words, such products will be considered to still have valid certification. An IA certificate based on overseas certification will be valid, depending on the continued validity of the overseas equipment certification as well as product quality assurance, for a maximum period of three years.It is the responsibility of the IA certificate holder to ensure that an updated quality system certificate is submitted to the relevant ATL if the validity period is less than three years. |
For renewal of certification, a new IA certificate number shall be issued. For certification of modifications affected to equipment within the validity cycle, a supplement may be issued if the original certifier is involved; otherwise a new certificate shall be issued.
| A.3 | If,during a validity period or if the equipment is in service after its certificate has expired,the product is modified or changed to an extent that it requires re-evaluation, this shall be done by an ATL and re-certified. This re-evaluation or re-certification (or both) shall take into account the current edition of the national standard used for certification and the complete product shall meet the requirements of that standard. |
| A.4 | During the validity period of IA certificates the product may be manufactured or supplied either under the batch test method or under an approved product certification scheme irrespective of changes to the national standard, provided that the product does not change from the original certified design and that no unsafe condition that affects the product is identified in the original edition of the standard used for certification. |
| A.5 | Repairs and overhauls shall be carried out in such a way that they will not invalidate the IA certificate. Repairs and overhauls carried out by a party other than the certificate holder, where the repairer or over-hauler is not in possession of the certification documents,shall be carried out in such a manner that the product meets the minimum requirements of the applicable national standards to which the product was originally certified, or any more recent edition (see annex D for specific requirements). |
A repair facility shall either be certified under an approved product certification scheme to repair or overhaul specific EPA, or shall submit repaired products for batch testing. A declaration of conformance (DOC) shall be issued by the repairer with each repaired product.
A repairer of Ex equipment that is a member of a product certification scheme shall operate in accordance with an appropriate quality system such as SANS 9001. The requirements of the IECEx operational document No.Ex OD014 Version 2 (see bibliography) can be used as a guideline, land are based on SANS 9001, with the addition of specific repair requirements for Ex equipment.
| A.6 | Should a product be modified or changed in such a way that it no longer complies with the certified design, it shall be re-submitted to an ATL for re-evaluation. This re-evaluation shall take into account the current national standard and the product shall comply with that standard. This applies to newly manufactured as well as second-hand products. |
| A.7 | Existing IA certificates: |
| (a) | before 1998 are no longer valid ,and |
| (b) | after 1998 (only IA certificates), shall not be valid after October 2015. |
New IA certificates shall have a validity period of 10 years from the date of issue. The date of issue and the date of expiry shall be stated on new certificates.
| A.8 | A product still in production shall be submitted for re-certification to an ATL before the IA certificate expires so as to achieve re-certification before the expiry date. The product will be re-assessed or tested (or both) and will be re-certified to the current edition of the national standard. Where the current edition of the national standard dictates that a product shall be upgraded or changed, the onus is on the manufacturer or supplier of the product to institute such upgrades or changes as to ensure that the product complies with the current national standard, as required for re-certification. |
| A.9 | Where a product with a valid IA certificate is found to be unsafe for use, the certificate holder shall take appropriate steps to rectify the design of such a product and re-certify such rectified products. Unsafe products already supplied shall be recalled and both the regulatory body and the ATL (and approved certification body for mark holders) that issued the certificate shall be notified. |
| A.10 | In cases where any system safety parameter of an intrinsically safe apparatus is changed, consideration shall be given to the safety of the loops in which the apparatus is used, and such loops shall be re-certified. |
NOTE If a change to loop equipment results in incompatible safety parameters in accordance with a certification standard, the ATL may consider the use of risk assessment methods (SANS 31010) and a concession may be issued.
| A.11 | Where a standard is superseded during the validity period of a certificate, then such standard shall still be deemed to apply to the product for the validity period of the certificate.In terms of batch-tested products, ATLs shall still be able to test to such standards while the certificates remain valid. |
| A.12 | Certification that covers variations in product design, or covers a range of similar products, shall show in the test report or IA certificate that each variation or design has been considered and tested where deemed necessary, and each variation or design shall be clearly stated in the test report and IA certificate. |
| A.13 | Any repairer shall attach to the product a durable, legible and noticeable label that gives at least the following information: |
| (a) | the repairer's certificate number (when operating under an approved product certification mark scheme for Ex certified equipment); |
| (b) | the IA certificate number; |
| (c) | the name of the repairer; and |
| (d) | the month and year of repair or overhaul. |
NOTE It is not intended that the need for a repair label be applicable to routine maintenance or replacement or identical parts.
| A.14 | The label fitted by the original equipment manufacturer (OEM) shall not be removed, but labels fitted by previous repairers shall be removed. If the OEM label is missing, the repairer may submit the finished product to an ATL and have the product re-certified to the current national standards. In this case, the repairer shall fit a supplier's plate displaying the new IA certificate number. |
| A.15 | When EPA subject to the relevant national legislation (see foreword) changes ownership, the seller shall provide the IA certificate plus either a mark scheme certificate or a batch test report providing proof of certification (see clause 4), to the buyer. The buyer shall ensure that the relevant documentation is submitted. The seller shall ensure that the equipment is compliant with the approved design. If these requirements are not fully met, the equipment shall be considered to be un-certified and shall be submitted to an ATL for re-testing to the approved standards and shall be issued with a new IA certificate number, in accordance with the relevant national legislation (see foreword). |
| A.16 | All records related to manufacture,repair or overhaul of Ex certified apparatus shall be kept for a minimum period of 10 years by the product certificate holder. |
| A.17 | Historically, IA certificates were not issued for some second-hand explosion-protected equipment, for one of the following reasons: |
| (a) | the equipment was sold before IA certificates became compulsory; or |
| (b) | a standard motor was converted under a certified Ex N or DIP repair mark scheme; or |
| (c) | only a test report was issued. |
| A.18 | When the equipment described in A.17 is submitted for repair or refurbishment and proof of previous national certification exists, an IA certificate shall be issued as follows: |
| (a) | For repairers operating under a mark scheme, a special IA certificate (see 3.1.21) covering that type of product shall be issued in the name of the repairer, after assessment by an ATL. |
| (b) | For repairers not operating under a mark scheme, a special IA certificate covering that particular unit (serial number) will be issued in the name of the end user after assessment by an ATL. Repairs of other units of the same type of product will require a new IA certificate to be issued after assessment by an ATL of those units. |
Otherwise the product shall be treated as a prototype.
NOTE 1 It is accepted that multiple IA certificates will be generated for the same type of product using the procedure given in A.18.
NOTE 2 Proof of previous national certification includes marking, or comparison with an identical unit for which such proof does exist and whose components can be compared by assessment and measurement.
Minimum requirements for a variety of the most common products are included in annex D. An ATL testing such equipment, as well as a future repairer repairing such equipment shall make use of a checklist based on these minimum requirements. The checklist shall be based on the current or previous edition of the relevant South African National Standard(s) at the time of repair and shall be updated when necessary. The checklist shall be supported by a detailed product description.The description shall include sketches, photos, drawings or combinations of these, to identify the equipment and its essential Ex properties.
| A.19 | A guideline for the certification of equipment forming part of intrinsically safe loops is given in annex E. |
The relevant responsible parties for certification are given in table A.1.
|
Table A.1-Parties responsible for certification
|
|
|
1 |
2 |
|
Responsible party |
Relevant clause |
|
Manufacturer or Supplier |
A.1, A.2, A.4, A.6, A.7, A.8, A.11, A.16 |
|
Repairer |
A.3, A.5, A.6, A.13, A.14, A.17 and A.18 |
|
User |
A.1, A.2, A.5, A.6, A.8, A.10, A.11, A.15, A.17, A.18 and A.19 |
|
ATL |
A.1, A.2, A.3, A.8, A.12, A.17 and A.18 |
