1、CAN/CSA-Z316.6-14Sharps injury protection Requirements and test methods Sharps containers(ISO 23907:2012, MOD)CAN/CSA-Z316.6-14(ISO 23907:2012, MOD)National Standard of Canada ISO 2012. CSA Group 2014. All rights reserved. Unauthorized reproduction is strictly prohibited.Legal Notice for StandardsCa
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22、 “CSA Group”Cette Norme Nationale du Canada est disponible en versions franaise et anglaise.TMA trade-mark of the Canadian Standards Association, operating as “CSA Group”National Standard of CanadaPublished in March 2014 by CSA GroupA not-for-profit private sector organization5060 Spectrum Way, Suit
23、e 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4044Visit our Online Store at shop.csa.caICS 11.040.99Prepared byInternational Organization for StandardizationCAN/CSA-Z316.6-14Sharps injury protection Requirements and test methods Sharps containers(ISO 23907:2012, MOD)Reviewed byAp
24、proved byCAN/CSA-Z316.6-14Sharps injury protection Requirementsand test methods Sharps containersCSA/4 2014 CSA Group March 2014CAN/CSA-Z316.6-14Sharps injury protection Requirements and test methods Sharps containers(ISO 23907:2012, MOD)CSA PrefaceThis is the fourth edition of CAN/CSA-Z316.6, Sharp
25、s injury protection Requirements and test methods Sharps containers, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 23907 (first edition, 2012-09-01). This fourth edition of CAN/CSA-Z316.6 is its first as an ado
26、ption of an International Standard. It supersedes the previous edition, published in 2007 under the title Evaluation of single-use and reusable medical sharps containers for biohazardous and cytotoxic waste. For brevity, this Standard will be referred to as “CAN/CSA-Z316.6” throughout.This Standard
27、is considered suitable for use for conformity assessment within the stated scope of the Standard.This Standard was reviewed for Canadian adoption by the CSA Subcommittee on Sharps Containers, under the jurisdiction of the CSA Technical Committee on Medical Laboratory Quality Systems and the CSA Stra
28、tegic Steering Committee on Health Care Technology (b) relevant clause, table, and/or figure number;(c) wording of the proposed change; and(d) rationale for the change.CAN/CSA-Z316.6-14Sharps injury protection Requirementsand test methods Sharps containersMarch 2014 2014 CSA Group CSA/5Canadian devi
29、ationsIntroductionReplace the first sentence of the first paragraph with the followingSingle-use and reusable sharps containers are designed for the containment and disposal of sharps such as scalpel blades, trocars, hypodermic needles, and syringes.Replace the second paragraph with the followingThi
30、s Standard covers single-use and reusable sharps containers. Sharps containers meeting the requirements of this Standard are considered to be safe for the purposes of(a) handling and disposal, in the case of single-use sharps containers; and(b) handling and decontamination, in the case of reusable s
31、harps containers.1ScopeReplace the first paragraph with the followingThis Standard specifies requirements for single-use and reusable sharps containers intended to hold potentially hazardous sharps medical waste with or without sharps protection features, e.g., scalpel blades, trocars, hypodermic ne
32、edles, and syringes.Replace the third paragraph with the followingFor supplementary requirements applicable to reusable sharps containers, see Annex BA. This Standard is not applicable to outer containers used in the transportation of filled single-use sharps containers.2 Normative referencesAdd the
33、 followingWhere reference is made to CSA Group publications, such reference shall be considered to refer to the latest edition and all amendments published to that edition. This Standard refers to the following publications, and the years shown indicate the latest editions available at the time of p
34、rinting:CSA GroupZ317.10-09Handling of waste materials in health care facilities and veterinary health care facilitiesThe following Standards are published by CSA Group. The requirements of these CSA Group Standards shall take precedence over the International Standards on which they are based; any
35、reference in CAN/CSA-Z316.6 to the International Standard shall be replaced by a reference to the equivalent Canadian Standard.CAN/CSA-ISO 14971:07 (R2012)Medical devices Application of risk management to medical devicesU.S. Department of TransportationSpecifications for Packagings. 49 Code of Feder
36、al Regulations (CFR), Part 178. Ch. 1 (10-1-11 edition) Subpart M. Testing of Non-bulk Packagings and Packages. Section 178.608. Vibration standard.CAN/CSA-Z316.6-14Sharps injury protection Requirementsand test methods Sharps containersCSA/6 2014 CSA Group March 20143 Terms and definitionsAdd the fo
37、llowing definitions3.16Abiohazard material that can be contaminated with viable micro-organisms (including prion protein material) or toxins that have the capability under specific circumstances to cause disease or illness.3.16Bbiomedical waste waste generated within a health care or veterinary faci
38、lity that requires special handling and disposal because it presents a particular risk of disease transmission.Notes: 1) See Annex A of CSA Z317.10 for information on the principles of disease transmission.2) The terms “biohazard” and “biomedical waste” are often used interchangeably.3.16Ccytotoxic
39、having a deleterious effect upon cells.Note: This term is commonly used in reference to pharmaceuticals used in the treatment of cancer (e.g., antineoplastics, chemotherapy agents).3.16Ddecontamination a process that renders a sharps container free of visible soiling and safe for reuse (fully functi
40、onal and free of soil and organic matter).Note: See Clause BA.5.3.16Eincineration the destruction of one or more waste chemicals or pathogenic constituents through the burning, pyrolysis, or gasification of combustible waste, reducing the volume of waste.Note: The process can include energy or fuel
41、production.3.16Fprion protein a protein present in many human and animal organs and tissues, including the brain, spinal cord, and eyes.Note: An abnormal form of prion protein is believed to be the agent that causes the transmissible spongiform encephalopathies, a group of central nervous system dis
42、eases that includes bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.3.16Grepresentative sharps representative quantities of unused 1 to 60 mL syringes without needles.3.16Hreusable sharps container a container designed or intended by the manufacturer to be suitable for reprocessing an
43、d reuse. Reusable sharps containers are not designed or intended by their manufacturers for single use.4Requirements4.2.3.2 Requirements for the apertureReplace the note with a third paragraph in this clauseA risk assessment shall address the risk of overfilling, e.g., to determine if a requirement
44、for a mechanism that passively prevents overfilling is necessary for sharps containers used in public access areas.CAN/CSA-Z316.6-14Sharps injury protection Requirementsand test methods Sharps containersMarch 2014 2014 CSA Group CSA/74.2.4 Resistance to penetrationReplace this clause with the follow
45、ingWhen tested in accordance with Clause 5.3, the force needed to penetrate test specimens shall be not less than 20 N.Add the following clauses4.2.6A Environmental implicationsThe materials used in the construction of sharps containers shall be assessed for potential environmental implications duri
46、ng manufacture, distribution, use, and ultimate disposal.4.2.6B Colour-codingSharps containers shall be colour-coded(a) yellow for biohazardous medical sharps; and(b) red for cytotoxic medical sharps and any other sharps requiring or intended for incineration.Note: It is essential that sharps contai
47、ners be colour-coded so that the waste they contain can be recognized and appropriately classified as non-anatomical biomedical waste requiring special handling.4.2.6C Needle unwindersContainers shall not have notches or similar mechanisms for unwinding or removing needles from syringes.5 Test metho
48、dsAdd the following paragraph below the title of Clause 5Whenever a test on any sharps container could impact the result of any subsequent test on the same container, previously untested containers shall be used for each test specified in Clause 5.5.4.2 Procedure5.4.2.1Add the following sentence to
49、this clauseRepeat the test at 18 2 C for sharps containers that are not intended to be placed in secondary transport containers.5.4.2.4Replace the second sentence with the followingFollow steps a) to d) for each of the following orientations: base, side wall, adjacent side wall, and bottom corner.5.4.2.5Replace the first an
