共找到 245 条与 消毒和灭菌 相关的标准,共 17 页
1 Domaine d'application 1.1 La présente norme définit les éléments essentiels d'un programme de stérilisation à la vapeur d'articles médicaux visant à assurer une stérilisation adéquate du matériel dans les hôpitaux et autres établissements similaires, tout en réduisant au minimum les risques d'accident pour les préposés à l'utilisation de l'équipement de stérilisation. Note. Les établissements similaires comprennent les maisons de repos, les établissements de soins prolongés, les cliniques médicales, les cabinets de médecins et de dentistes ainsi que les infirmeries en milieu industriel et tout autre établissement hospitalier privé. Pour des raisons pratiques, le terme « hôpital » est utilisé dans cette norme. 1.2 Inclusions Cette norme énonce les exigences régissant : a) la préparation et l'emballage d'objets nécessitant une stérilisation ; b) le chargement et le fonctionnement des stérilisateurs ; c) l'entreposage des objets stérilisés ; d) l'assurance de la stérilité ; e) le contrat d'achat visant les objets stérilisables et les matériaux d'emballage ; et f) l'entretien et l'assurance de la qualité des stérilisateurs. 1.3 Exclusions a) Cette norme ne s'applique pas aux stérilisateurs rapides et aux laveurs-stérilisateurs. Note. Consulter la norme CAN/CSA-Z314.13. b) Cette norme ne comprend pas les exigences particulières régissant la fabrication et la performance des stérilisateurs à la vapeur. Note. Consulter la norme CAN/CSA-Z314.7. 1.4 Les valeurs indiquées en unités SI (métriques) sont les valeurs normalisées. Les valeurs figurent entre parenthèses ne sont fournies qu'à titre d'information. 1.5 Dans cette norme, les termes « doit et doivent » indiquent une exigence. Les termes « devrait et devraient » indiquent une recommandation. Les remarques qui accompagnent les articles présentent des renseignements ou des explications qui ne font pas strictement partie de la norme.
Effective steam sterilization in hospitals
1.1 General This Standard provides recommended practices for emergency sterilization in hospitals and similar health care facilities. These recommendations are intended to increase assurance of sterility and to assist health care personnel in the proper use of processing equipment. Notes: (1) "Similar health care facilities" includes nursing homes, extended-care facilities, clinics, and medical and dental offices. For convenience, the shorter term "hospital" is used herein. (2) Emergency sterilization may be performed in various areas of the hospital, including the operating room, labour/delivery room, emergency/trauma room, and other areas where steam sterilizers are located. (3) "Emergency sterilization", as used herein, is synonymous with "flash sterilization" and sterilization by the "unwrapped method". 1.2 Inclusions This Standard specifically addresses (a) functional and physical design criteria for areas of hospitals where emergency sterilization is carried out; (b) staff qualifications, education, and other personnel considerations; (c) sterilization processing procedures; (d) the use and maintenance of gravity-displacement and prevacuum sterilizers for emergency sterilization; and (e) quality assurance. 1.3 Exclusions The following are not addressed in this Standard: (a) specific construction and performance criteria for steam sterilizers; (b) guidelines for steam sterilization by the wrapped method; and (c) "table-top" sterilizers. 1.4 The values given in SI (metric) units shall be considered the standard values. The values given in parentheses are included for information only. 1.5 In this Standard, the word "shall" indicates a mandatory requirement; "should" indicates a recommendation which is advised but is not mandatory. Notes accompanying clauses provide explanatory or informative material that is not properly a part of this Standard.
Recommended Standard Practices for Emergency (Flash) Sterilization
1.1 This standard specifies criteria for assessment of efficacy of antimicrobial agents intended for use on environmental surfaces in health care facilities and premises where food is prepared, manufactured or stored and for use on medical devices. Such agents are classified as drugs under the Food and Drugs Act and Regulations. 1.2 This standard is not adequate to assess efficacy of antimicrobial agents under reuse conditions. ForC [Cproducts with claims for reuse additional testing under simulated or actual reuse conditions should be performed.
Assessment of Efficacy of Antimicrobial Agents for Use on Environmental Surfaces and Medical Devices
Addresses the construction of in-house prepared (a) air detection (Bowie-Dick) test packs for prevacuum steam sterilizers; and (b) installation and routine biological challenge test packs for steam and ethylene oxide sterilizers.
Performance Requirements of Test Packs for Use in Hospitals
Applies to ethylene oxide sterilizers intended for use in hospitals and similar health care facilities.
Ethylene Oxide Sterilizers for Hospitals
Defines essential elements for using ethylene oxide to sterilize products in hospitals and similar health care facilities with the object of achieving an adequate level of sterility assurance and minimizing the risk of injury to patients and to the health and safety of hospital staff.
Effective Sterilization in Hospitals by the Ethylene Oxide Process
Décrit la marche à suivre pour traiter en toute sécurité le matériel médical et chirurgical réutilisable, avant la stérilisation ou la désinfection.
Processing of reusable medical and surgical equipment
Applies to all health care facilities using ethylene oxide as a sterilant, installing new ethylene oxide sterilization equipment or modifying existing ethylene oxide sterilization equipment.
Installation and Ventilation of Ethylene Oxide Sterilizers in Health Care Facilities
Defines essential elements in a sterility assurance program for medical devices.
Industrial Sterilization of Medical Devices by the Ethylene Oxide Process
Defines essential elements in a sterility assurance program for medical devices.
Industrial Sterilization of Medical Devices by the Steam Process
Audit Checklist for Use with CSA Standard CAN3-Z314.3-M84 (Effective Sterilization in hospitals by the Steam Process)
Définit les éléments essentiels d'un programme axé sur l'utilisation de la vapeur pour la stérilisation des produits médicaux dans les hôpitaux et les services de santé analogues non industriels. Elle vise à assurer la sécurité du personnel utilisant ce procédé de stérilisation, un dégré adèquat de stérilité et à minimiser le risque de blessures aux malades.
Effective steam sterilization in hospitals
Spécifie les exigences minimales de construction et de rendement afin d'assurer l'efficacité des stérilisateurs à la vapeur et la sécurité du personnel utilisant ce matériel.
Steam sterilizers used in hospitals
Audit Checklist for Use with CSA Standard CAN3-Z314.2-M84 (Effective Sterilization in Hospitals by the Ethylene Oxide Process)
Defines essential elements in a program for using ethylene oxide to sterilize products in hospitals and similar non-industrial facilities with the object of achieving an adequate level of sterility assurance and minimizing the risk of injury to patients and to the health and safety of hospital staff that is attendant on the use of this compound.
Effective Sterilization in Hospitals by the Ethylene Oxide Process
Applies to ethylene oxide sterilizers intended for use in hospitals and similar non-industrial facilities.
Ethylene Oxide Sterilizers for Hospitals
Industrial Sterilization of Medical Devices by the Steam Process
Industrial Sterilization of Medical Devices by the Ethylene Oxide Process
Effective Sterilization in Hospitals by the Steam Process
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