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CSA Z314.1-09
Ethylene oxide sterilizers for health care facilities - Fifth Edition
Organization:
CSA - CSA Group
Year: 2013
Abstract: This Standard applies to ethylene oxide sterilizers that have automatic controls and are intended for general-purpose use in health care facilities.
Notes:
(1) The term "health care facilities" includes, but is not limited to, hospitals, nursing homes, extended-care facilities, clinics, medical and dental offices, and health units in industry.
(2) This Standard is intended for manufacturers of ethylene oxide sterilizers. Tests involving modifications to the sterilizer controls or safety features can present hazards to those who do not possess specialized testing equipment and the expertise to conduct the tests.
This Standard specifies minimum construction, performance, testing, and labelling requirements to ensure that
(a) the environment in the sterilizing chamber is effective in sterilizing products; and
(b) personnel using the equipment are protected from hazards associated with ethylene oxide.
This Standard does not provide requirements for the following:
(a) pre- or post-sterilization procedures;
(b) machine operators;
(c) venting of waste gases used in the sterilization process; and
(d) tests to indicate the probability of product sterility.
In CSA Standards, "shall" is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the standard; "should" is used to express a recommendation or that which is advised but not required; "may" is used to express an option or that which is permissible within the limits of the standard; and "can" is used to express possibility or capability. Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material. Notes to tables and figures are considered part of the table or figure and may be written as requirements. Annexes are designated normative (mandatory) or informative (non-mandatory) to define their application.
Notes:
(1) The term "health care facilities" includes, but is not limited to, hospitals, nursing homes, extended-care facilities, clinics, medical and dental offices, and health units in industry.
(2) This Standard is intended for manufacturers of ethylene oxide sterilizers. Tests involving modifications to the sterilizer controls or safety features can present hazards to those who do not possess specialized testing equipment and the expertise to conduct the tests.
This Standard specifies minimum construction, performance, testing, and labelling requirements to ensure that
(a) the environment in the sterilizing chamber is effective in sterilizing products; and
(b) personnel using the equipment are protected from hazards associated with ethylene oxide.
This Standard does not provide requirements for the following:
(a) pre- or post-sterilization procedures;
(b) machine operators;
(c) venting of waste gases used in the sterilization process; and
(d) tests to indicate the probability of product sterility.
In CSA Standards, "shall" is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the standard; "should" is used to express a recommendation or that which is advised but not required; "may" is used to express an option or that which is permissible within the limits of the standard; and "can" is used to express possibility or capability. Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material. Notes to tables and figures are considered part of the table or figure and may be written as requirements. Annexes are designated normative (mandatory) or informative (non-mandatory) to define their application.
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| contributor author | CSA - CSA Group | |
| date accessioned | 2017-09-04T18:12:15Z | |
| date available | 2017-09-04T18:12:15Z | |
| date copyright | 2009.01.01 (R 2013) | |
| date issued | 2013 | |
| identifier other | HCBQHFAAAAAAAAAA.pdf | |
| identifier uri | http://mapnamagz.yabesh.ir/std;query=authoF23793FDFCDCAC4/handle/yse/195287 | |
| description abstract | This Standard applies to ethylene oxide sterilizers that have automatic controls and are intended for general-purpose use in health care facilities. Notes: (1) The term "health care facilities" includes, but is not limited to, hospitals, nursing homes, extended-care facilities, clinics, medical and dental offices, and health units in industry. (2) This Standard is intended for manufacturers of ethylene oxide sterilizers. Tests involving modifications to the sterilizer controls or safety features can present hazards to those who do not possess specialized testing equipment and the expertise to conduct the tests. This Standard specifies minimum construction, performance, testing, and labelling requirements to ensure that (a) the environment in the sterilizing chamber is effective in sterilizing products; and (b) personnel using the equipment are protected from hazards associated with ethylene oxide. This Standard does not provide requirements for the following: (a) pre- or post-sterilization procedures; (b) machine operators; (c) venting of waste gases used in the sterilization process; and (d) tests to indicate the probability of product sterility. In CSA Standards, "shall" is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the standard; "should" is used to express a recommendation or that which is advised but not required; "may" is used to express an option or that which is permissible within the limits of the standard; and "can" is used to express possibility or capability. Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material. Notes to tables and figures are considered part of the table or figure and may be written as requirements. Annexes are designated normative (mandatory) or informative (non-mandatory) to define their application. | |
| language | English | |
| title | CSA Z314.1-09 | num |
| title | Ethylene oxide sterilizers for health care facilities - Fifth Edition | en |
| type | standard | |
| page | 37 | |
| status | Active | |
| tree | CSA - CSA Group:;2013 | |
| contenttype | fulltext |