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34、rticular purpose.Registered trade-mark of Canadian Standards AssociationReviewed byNational Standard of CanadaPublished in September 2012 by Canadian Standards AssociationA not-for-profit private sector organization5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-
35、747-4044Visit our Online Store at shop.csa.caPrepared byInternational Organization for StandardizationApproved byStandards Council of CanadaCAN/CSA-Z15001:12Anaesthetic and respiratory equipment Compatibility with oxygenCAN/CSA-Z15001:12Anaesthetic and respiratory equipment Compatibility with oxygen
36、CSA/4 Canadian Standards Association September 2012CAN/CSA-Z15001:12Anaesthetic and respiratory equipment Compatibility with oxygenCSA PrefaceThis is the first edition of CAN/CSA-Z15001, Anaesthetic and respiratory equipment Compatibility with oxygen, which is an adoption, with Canadian deviations,
37、of the identically titled ISO (International Organization for Standardization) Standard 15001 (second edition, 2010-06-01). This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Perioperative Safety, under the jurisdiction of the CSA Strategic Steering Committee on Healt
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42、, table, and/or figure number;(c) wording of the proposed change; and(d) rationale for the change.CAN/CSA-Z15001:12Anaesthetic and respiratory equipment Compatibility with oxygenSeptember 2012 Canadian Standards Association CSA/5Canadian deviations2 Normative referencesAdd the followingThe following
43、 National Standard of Canada, published by the Canadian Standards Association, is an adoption of an ISO Standard. The requirements of the CSA Standard shall take precedence over the International Standard on which it is based; any reference in CAN/CSA-Z15001 to the International Standard shall be re
44、placed by a reference to the equivalent Canadian Standard.CSA (Canadian Standards Association)CAN/CSA-ISO 14971:07Medical devices Application of ri sk management to medical devicesASTM (American Society for Testing and Materials)G 93-03 (2011)Standard Practice for Cleaning Methods and Cleanliness Le
45、vels for Material and Equipment Used in Oxygen-Enriched Environments4 Cleanliness4.1*Replace this clause with the followingUnless otherwise specified in particular device standards, surfaces of components that come into contact with oxygen during normal operation or single fault condition shall be c
46、leaned for oxygen service in accordance with ASTM G 93, as follows:a) For low-pressure applications, up to 1400 kPa (200 psi), the nonvolatile residue shall be less than 550 mg/m2(55 mg/ft2), corresponding with Level E in Clause 11.4.3 of ASTM G 93.b) For high-pressure applications, above 1400 kPa (
47、200 psi), the nonvolatile residue shall be less than 66 mg/m2(6 mg/ft2), corresponding with Level C in Clause 11.4.3 of ASTM G 93.This International Standard does not specify quantifiable cleaning procedures or validation methods for them in relation to the values in Items a) and b) above. However,
48、Annex A gives examples of known cleaning procedures and Annex B gives examples of methods for validation of cleaning procedures.Reference numberISO 15001:2010(E)ISO 2010INTERNATIONAL STANDARD ISO15001Second edition2010-06-01Anaesthetic and respiratory equipment Compatibility with oxygen Matriel dane
49、sthsie et de ranimation respiratoire Compatibilit avec loxygne ISO 15001:2010(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobes licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe i
