SANS 10338-2009 Homologation of respiratory equipment《呼吸设备的审批》.pdf

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1、 Collection of SANS standards in electronic format (PDF) 1. Copyright This standard is available to staff members of companies that have subscribed to the complete collection of SANS standards in accordance with a formal copyright agreement. This document may reside on a CENTRAL FILE SERVER or INTRA

2、NET SYSTEM only. Unless specific permission has been granted, this document MAY NOT be sent or given to staff members from other companies or organizations. Doing so would constitute a VIOLATION of SABS copyright rules. 2. Indemnity The South African Bureau of Standards accepts no liability for any

3、damage whatsoever than may result from the use of this material or the information contain therein, irrespective of the cause and quantum thereof. ISBN 978-0-626-19234-1 SANS 10338:2009 Edition 1.1 Any reference to SABS 0338 is deemed to be a reference to this standard (Government Notice No. 1373 of

4、 8 November 2002)SOUTH AFRICAN NATIONAL STANDARD Homologation of respiratory equipment Published by SABS Standards Division 1 Dr Lategan Road Groenkloof Private Bag X191 Pretoria 0001 Tel: +27 12 428 7911 Fax: +27 12 344 1568 www.sabs.co.za SABS This standard may only be used and printed by approved

5、 subscription and freemailing clients of the SABS. SANS 10338:2009 Edition 1.1 Table of changes Change No. Date Scope Amdt 1 2009 Amended to change the designation of SABS standards to SANS standards, to include reference to harmonization of standards and to the NRCS as approving authority, to repla

6、ce reference to the “SABS” with “National Regulator for Compulsory Specifications” or “test laboratory” (where applicable), to substitute references to the Standards Act with references to the National Regulator for Compulsory Specifications Act (where relevant), to update information relating to le

7、vy payments, to delete information regarding pre-production testing, and uncontrolled respiratory equipment and breathing apparatus, to update contact details, to delete reference to the SABS mark scheme, and to update referenced documents. Foreword This South African standard was approved by Nation

8、al Committee SABS SC 94B, Personal protective equipment Respiratory equipment, in accordance with procedures of the SABS Standards Division, in compliance with annex 3 of the WTO/TBT agreement. This document was published in February 2009. This document supersedes SABS 0338:1999 (first edition). Thi

9、s document was written in order to support a specific South African Regulation and, of necessity, includes references to South African legislation. It therefore might not be suitable for direct application in other jurisdictions where conflicting legislation exists. Amdt 1 This document is reference

10、d in the following South African legislation: Mine Health and Safety Act, 1996 (Act No. 29 of 1996); Occupational Health and Safety Act, 1993 (Act No. 85 of 1993). Furthermore, please note that the National Regulator for Compulsory Specifications (NRCS) is the approving authority with regard to this

11、 standard. Amdt 1 A vertical line in the margin shows where the text has been technically modified by amendment No. 1. Annexes A, B, C, D and E are for information only. This standard may only be used and printed by approved subscription and freemailing clients of the SABS.SANS 10338:2009 Edition 1.

12、1 1 Contents Page Foreword 1 Scope . 3 2 Definitions 3 3 Homologation procedure 4 4 Homologation conditions 5 Annex A (informative) Homologation documentation for respiratory equipment . 8 Annex B (informative) Recommended flow chart for homologation procedure . 13 Annex C (informative) Information

13、regarding South African compulsory specifications for respiratory equipment and for breathing apparatus 14 Annex D (informative) Traceability record form for respiratory equipment 20 Annex E (informative) Bibliography 21 This standard may only be used and printed by approved subscription and freemai

14、ling clients of the SABS.SANS 10338:2009 Edition 1.1 2 This page is intentionally left blank This standard may only be used and printed by approved subscription and freemailing clients of the SABS.SANS 10338:2009 Edition 1.1 3 Homologation of respiratory equipment 1 Scope This standard covers genera

15、l provisions for the homologation of respiratory equipment, for which a compulsory specification or South African national standard has been approved, for the protection of the body against harmful substances that might enter through the respiratory system and for the protection of the body against

16、oxygen-deficient atmospheres. This standard does not cover equipment designed for the protection of the body against nuisance dust or against dust levels below the Occupational Exposure Levels (OEL). 2 Definitions For the purposes of this standard, the following definitions apply: 2.1 audit a system

17、atic investigation that assesses compliance with established procedures, instructions, standards and other specified requirements 2.2 homologation the confirmation by the National Regulator for Compulsory Specifications that the applicant, manufacturer or importer has provided the National Regulator

18、 for Compulsory Specifications with the following specific evidence in respect of a specified model of respiratory equipment: Amdt 1 a) acceptable evidence (such as certificates of compliance, test reports or approval certificates) that shows that all relevant tests have been conducted in accordance

19、 with the relevant compulsory specification (see annex E) or the relevant South African national standard, with successful results under appropriate controls in respect of the specified model of respiratory equipment; b) sufficient data to enable a relevant model of respiratory equipment and its com

20、ponents to be identified and related to (a) above; c) relevant samples for the conducting of whatever tests and inspections that are considered appropriate by the National Regulator for Compulsory Specifications, to verify any or all of the evidence provided; Amdt 1 d) details that show that the qua

21、lity management system applied by the manufacturer or importer complies with the requirements of SANS 9001 or with specific requirements of the National Regulator for Compulsory Specifications; Amdt 1 This standard may only be used and printed by approved subscription and freemailing clients of the

22、SABS.SANS 10338:2009 Edition 1.1 4 e) agreement by the manufacturer or importer, to permit conformity-of-production audits by the National Regulator for Compulsory Specifications or its appointed agent, at the relevant manufacturing, assembling and test facilities; and Amdt 1 f) agreement by the man

23、ufacturer or importer to supply the National Regulator for Compulsory Specifications, free of charge, with samples for testing purposes Amdt 1 2.3 respiratory protective equipment equipment that can be classified into two categories: 2.3.1 respirators air purifying devices in which the inhaled air i

24、s drawn through a medium that removes the harmful substances, the nature of the medium depending on the contaminant 2.3.2 breathing apparatus apparatus that supplies a user with respirable air from a source that is independent of his environment 3 Homologation procedure 3.1 The applicant shall submi

25、t an application, in writing, to the National Regulator for Compulsory Specifications at Groenkloof, Pretoria, well in advance of the date upon which homologation is required (which is preferably 90 days beforehand), in order to allow for testing time and to ensure satisfactory integration with the

26、applicants own introduction programme. The application shall indicate the following: Amdt 1 a) the model and description; b) the type (in respect of the compulsory specification); c) the manufacturers name and, where applicable, the name of the importer; d) the applicants name; e) the requested homo

27、logation date; f) the sample availability date; g) the intended model introduction date; h) the contact persons name, telephone number and telefax number; and i) an order (with order number) requesting homologation on the specified product. 3.2 On receipt of the application, or on request, the Natio

28、nal Regulator for Compulsory Specifications will issue the necessary homologation documentation (see examples in annex A) for completion by the applicant. The documentation covers: Amdt 1 a) the applicants details; b) the submitted sample details; c) the compliance summary of evidence; and d) the pr

29、oduction conformance summary of evidence. This standard may only be used and printed by approved subscription and freemailing clients of the SABS.SANS 10338:2009 Edition 1.1 5 3.3 The applicant shall submit the following to the National Regulator for Compulsory Specifications at Groenkloof, Pretoria

30、 Amdt 1 a) the completed homologation documentation; b) a copy of the relevant certificates of compliance, test reports or approval certificates regarding the model of respiratory protective equipment; c) a specified number of samples, complete with packaging and additional information, as required

31、by the National Regulator for Compulsory Specifications for homologation; Amdt 1 d) a copy of the certificate of accreditation for the quality system introduced by the manufacturer; or else, details regarding compliance with the specific requirements of the National Regulator for Compulsory Specific

32、ations; and Amdt 1 e) an official order that covers the costs of homologation. 3.4 The National Regulator for Compulsory Specifications will review the homologation documentation and will return the documentation to the applicant, should any problems be identified. Should the problems be of such a n

33、ature that homologation is not possible, the National Regulator for Compulsory Specifications will issue a letter advising that the application for homologation has been rejected. Amdt 1 3.5 Upon receipt of the correctly completed homologation documentation, the National Regulator for Compulsory Spe

34、cifications will confirm the date for the inspection or test of the sample. Samples shall be delivered to the National Regulator for Compulsory Specifications premises at Groenkloof, Pretoria, or at such other premises as agreed upon by the National Regulator for Compulsory Specifications. Amdt 1 3.

35、6 The National Regulator for Compulsory Specifications will inspect and/or test the sample and will evaluate the submitted documentation. On successful fulfilment of homologation of the model, the National Regulator for Compulsory Specifications will issue a report confirming the homologation. Shoul

36、d areas of concern be identified, the National Regulator for Compulsory Specifications will request test reports or will conduct further tests or will request that further tests be conducted. Depending on the outcome, the National Regulator for Compulsory Specifications will issue a homologation rep

37、ort and a type approval number confirming homologation, or a letter rejecting homologation. Amdt 1 4 Homologation conditions 4.1 Initial test and samples The applicant shall bear all relevant delivery, test and homologation costs. The samples delivered by the applicant for homologation shall remain

38、in the National Regulator for Compulsory Specifications possession for future reference unless otherwise agreed by the National Regulator for Compulsory Specifications (see 4.5). Amdt 1 4.2 Continued compliance checks Having carried out an initial assessment and having issued a type approval number

39、and a homologation report, the National Regulator for Compulsory Specifications may, from time to time, conduct audits at the manufacturers factory or at the importers premises on the manufacturers or importers quality management system and on the specified commodity. The National Regulator for Comp

40、ulsory Specifications may also, from time to time and free of charge, draw samples from the manufacturer or importer to determine its continual compliance with the relevant compulsory specifications. Amdt 1 This standard may only be used and printed by approved subscription and freemailing clients o

41、f the SABS.SANS 10338:2009 Edition 1.1 6 4.3 Confidentiality and disclosure The National Regulator for Compulsory Specifications or its agent will maintain the manufacturers or importers confidential information, trade secrets, or processing procedures in accordance with the provisions of section 32

42、 of the National Regulator for Compulsory Specifications Act, 2008 (Act No. 5 of 2008), of the Republic of South Africa, which reads as follows: Amdt 1 “Any person who is or was concerned in the performance of any function in terms of this Act, may not disclose any information which he or she obtain

43、ed in the performance of such a function.“ Amdt 1 Notwithstanding the provisions of the above, the National Regulator for Compulsory Specifications reserves the right to disclose a contravention of 4.4(a) hereunder if, in the sole opinion of the National Regulator for Compulsory Specifications, it i

44、s in the public interest to do so. Amdt 1 4.4 Withdrawal of homologation The National Regulator for Compulsory Specifications reserves the right to withdraw the type approval number and the homologation report, which shall then be returned to the National Regulator for Compulsory Specifications on r

45、equest, should Amdt 1 a) any non-conformities of the respiratory equipment be found with respect to the relevant compulsory specification or this standard, b) any changes be made to the homologated product, the design or the material, the packaging, the marking, additional information, or should any

46、 other changes occur that could affect compliance with the relevant compulsory specification, c) the importer neglect to advise the National Regulator for Compulsory Specifications at least 14 days in advance of any shipment arrival of any type approved product, unless a written agreement was reache

47、d between the National Regulator for Compulsory Specifications and the importer, and Amdt 1 d) the smallest package unit not instruct the user that the product has to be used subject to the relevant provisions of the Occupational Health and Safety Act, 1993 (Act No. 85 of 1993), as well as the relev

48、ant regulations pertaining to this Act, and of the Mine Health and Safety Act, 1996 (Act No. 29 of 1996). 4.5 Reference sample One sample of each type approved product will be kept by the National Regulator for Compulsory Specifications for reference purposes (see also 4.1). Expensive equipment may

49、be returned to the importer for safekeeping, for example in a safety display. Such equipment returned for safekeeping to the importer or manufacturer shall be uniquely marked by the National Regulator for Compulsory Specifications. Amdt 1 4.6 Quality maintenance 4.6.1 The manufacturer or importer undertakes to maintain the quality of the specified commodity in accordance with the requirements of the relevant compulsory specification, and acknowledges that he is aware of the fact that the sale of a non-complying commodity is an offence within the Republic of South Africa.