11.080 消毒和灭菌 标准查询与下载
共找到 245 条与 消毒和灭菌 相关的标准，共 17 页
Sterilization of health care products－Chemical indicators－Part 2：Test equipment and methods
- ICS
- 11.080
- CCS
- 发布
- 2002-06-11
- 实施
Packaging for terminally sterilized medical devices
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- 11.080
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- 发布
- 2002-03-25
- 实施
Packaging for terminally sterilized medical devices
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- 11.080
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- 发布
- 2002-03-25
- 实施
Sterilization of health care products-chemical indicators-Part 1：General requirements
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- 11.080
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- 发布
- 2002-03-07
- 实施
本标准适用于纯环氧乙烷气体或环氧乙烷气体与其它稀释气体之混合物在 20℃ 至 65℃ 的温度下进行减菌后，评估有关试验微生物与生物指示剂等灭菌质量性能的特殊规定。
Sterilization of health care products-biological indicators-part 2：Biological indicators for ethylene oxide sterilization
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- 11.080
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- 发布
- 2002-03-07
- 实施
- 2002-03-07
标准适用于灭菌循环中用来确效与监控的生物指示剂与悬浮液的一般制造、生产、标示与功能需求。备考：本标准之后续部分规范特定灭菌程序生物指示剂的特殊需求。本标准不包含直接已接种试验微生物或接种过之产品的回收程序，也不包含使用上超过一株或一种微生物载体的生物指示
Sterilization of health care products-biological indicators-part 1：General
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- 11.080
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- 发布
- 2002-03-07
- 实施
- 2002-03-07
本标准适用于试验微生物与生物指示剂的特定要求，其目的用于评估减菌温度超过 l00℃ 的湿热灭为程序的性能。
Sterilization of health care products-biological indicators-part 3：Biological indicators for moist heat sterilization
- ICS
- 11.080
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- 发布
- 2002-03-07
- 实施
- 2002-03-07
Sterilization of health care products-biological indicators-part 3：Biological indicators for moist heat sterilization
- ICS
- 11.080
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- 发布
- 2002-03-07
- 实施
Sterilization of health care products-biological indicators-part 2：Biological indicators for ethylene oxide sterilization
- ICS
- 11.080
- CCS
- 发布
- 2002-03-07
- 实施
Sterilization of health care products-biological indicators-part 1：General
- ICS
- 11.080
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- 发布
- 2002-03-07
- 实施
本标准规定对于藉由物质的物理和（或）化学变化以显示曝露于灭菌程序指示剂的性能要求。备考 l.指示剂用于监控一个或多个参数是否达成灭菌程序之要求，或用于灭菌设备之特定试验。本标准亦包含检测指示剂是否合格的准则。2.相关的试验方法及设备参见本标准的第二部分。3.（
Sterilization of health care products-chemical indicators-Part 1：General requirements
- ICS
- 11.080
- CCS
- 发布
- 2002-03-07
- 实施
- 2002-03-07
1. Domaine d?application 1.1 Cette norme énonce les points essentiels d?un programme d?utilisation de la vapeur pour stériliser les dispositifs médicaux dans les établissements de santé afin d?atteindre un niveau adéquat de stérilité et de réduire au minimum les risques d?accident pour le personnel qui utilise le matériel de stérilisation à la vapeur. Notes: 1) Les «établissements de santé» sont notamment les hôpitaux, 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. 2) La figure 1 illustre le domaine d?application de cette norme dans le cadre du retraitement des dispositifs médicaux réutilisables. 3) Pour toutes sortes de renseignements utiles concernant les petits établissements et les cliniques, consulter la publication CSA PLUS 1112. 1.2 Cette norme énonce des exigences visant: a) les aires de travail; b) les compétences et la formation du personnel; c) la préparation et l?emballage des dispositifs médicaux nécessitant une stérilisation; d) le chargement et le fonctionnement des stérilisateurs; e) l?entreposage des dispositifs médicaux stérilisés; f) l?assurance de la stérilité, notamment la préparation et l?utilisation de paquets de contrôle; g) l?évaluation des produits (produits stérilisables et matériaux d?emballage); h) l?entretien et l?assurance de la qualité des stérilisateurs. 1.3 Cette norme ne vise pas: a) la stérilisation d?urgence (stérilisation rapide); Note : Voir la norme CSA Z314.13. b) la construction ni le rendement des stérilisateurs à la vapeur; Note: Voir la norme CSA Z314.7. c) les laveurs/stérilisateurs; d) la décontamination des dispositifs médicaux réutilisables avant leur stérilisation. Note: Voir la norme CSA Z314.8. 1.4 Dans cette norme, le terme "doit" indique une prescription; "devrait" indique une recommandation ou ce qu?il est conseillé mais non obligatoire de faire et "peut" une possibilité ou un conseil. Les notes qui accompagnent les articles ne comprennent pas de prescriptions ni de recommandations. Elles servent à séparer du texte les explications ou les renseignements qui ne font pas proprement partie de la norme. Les notes au bas des figures et des tableaux font partie de ceux-ci et peuvent être rédigées comme des prescriptions. Les légendes des figures font également partie de la figure.
Effective steam sterilization in healthcare facilities
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- 11.080
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- 发布
- 2002-02-01
- 实施
Specifies requirements and test methods for hoists and body support units for the transfer of disabled persons.
Hoists for the transfer of disabled persons - Requirements and test methods
- ICS
- 11.080
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- 发布
- 2002
- 实施
Urine collection bags.part 2: requirements and test methods
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- 11.080
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- 发布
- 2001-08-10
- 实施
1. Scope 1.1 This Standard is intended to assist health care facilities using ethylene oxide as a sterilant, installing new ethylene oxide sterilization equipment, or modifying existing equipment in meeting government regulations on exposure and worker safety respecting the use of ethylene oxide gas. This Standard addresses basic issues associated with the safe use or operation of ethylene oxide sterilizers. It does not cover safety issues that are specific to individual equipment models or to individual health care facilities. 1.2 This Standard provides information to assist health care facilities in devising work practices that will maximize employee safety when using ethylene oxide sterilizers and ancillary equipment. 1.3 This Standard includes installation and ventilation design criteria and performance specifications for ethylene oxide sterilization areas, aeration areas, and container handling and storage areas. 1.4 This Standard does not address sterilizer efficacy, which is dealt with in CSA Standard Z314.2. 1.5 In this Standard, "shall" indicates a mandatory requirement; "should" indicates a recommendation or that which is advised but not mandatory; and "may" indicates an advisory or optional statement. Notes accompanying clauses do not include mandatory or alternative requirements. The purpose of a note accompanying a clause is to separate from the text explanatory or informative material that is not properly a part of the Standard. Notes to figures and tables are considered part of the figure or table and are written as mandatory requirements. Legends to figures are also considered mandatory requirements.
Installation, Ventilation, and Safe Use of Ethylene Oxide Sterilizers in Health Care Facilities
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- 11.080
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- 发布
- 2001-01-01
- 实施
1. Scope 1.1 This Standard provides recommended practices for emergency sterilization in health care facilities. The term "emergency sterilization", as used herein, is synonymous with "flash sterilization" and sterilization by the "unwrapped method". These recommended practices are intended to increase assurance of sterility and to assist health care personnel in the proper use of processing equipment. 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) Comprehensive guidance for small, office-based facilities can be found in CSA Special Publication PLUS 1112. (3) Emergency sterilization may be performed in various areas of the health care facility, including the operating room, labour/delivery room, emergency/trauma room, and other areas where steam sterilizers are located. 1.2 This Standard specifically addresses (a) functional and physical design criteria for areas of health care facilities 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 dynamic air removal-type sterilizers for emergency sterilization; and (e) quality assurance. 1.3 The following areas are not addressed in this Standard: (a) specific construction and performance criteria for steam sterilizers; and (b) guidelines for steam sterilization by the wrapped method. Note: See Appendix A for information on sterilizers for emergency sterilization. 1.4 In this Standard, "shall" indicates a mandatory requirement; "should" indicates a recommendation or that which is advised but not mandatory; and "may" indicates an advisory or optional statement. Notes accompanying clauses do not include mandatory or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material that is not properly a part of the Standard. Notes to figures and tables are considered part of the figure or table and may be written as mandatory requirements; legends to figures are also considered part of the requirements of the figure.
Recommended Standard Practices for Emergency (Flash) Sterilization
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- 11.080
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- 发布
- 2001-01-01
- 实施
1. Scope 1.1 This Standard outlines essential elements in a program for using steam to sterilize medical devices in health care facilities, with the object of achieving an adequate level of sterility assurance and minimizing the risk of injury to the operators of steam sterilization equipment. 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) Figure 1 shows the scope of this Standard within the reprocessing of reusable medical devices. (3) Comprehensive guidance for small, office-based facilities can be found in CSA Special Publication PLUS 1112. 1.2 This Standard includes requirements for (a) work areas; (b) personnel qualifications and training; (c) preparation and packaging of medical devices requiring sterilization; (d) sterilizer loading and operation; (e) storage of sterilized medical devices; (f) sterility assurance, including test pack construction and use; (g) product evaluation for sterilizable medical devices and packaging materials; and (h) maintenance and sterilizer quality assurance. 1.3 This Standard does not apply to (a) emergency (flash) sterilization; Note: See CSA Standard Z314.13. (b) construction and performance of steam sterilizers; Note: See CSA Standard CAN/CSA-Z314.7. (c) washer/sterilizers; or (d) decontamination of reusable medical devices prior to sterilization. Note: See CSA Standard Z314.8. 1.4 In this Standard, "shall" indicates a mandatory requirement; "should" indicates a recommendation or that which is advised but not mandatory; and "may" indicates an advisory or optional statement. Notes accompanying clauses do not include mandatory or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material that is not properly a part of the Standard. Notes to figures and tables are considered part of the figure or table and may be written as mandatory requirements; legends to figures are also considered part of the requirements of the figure.
Effective Sterilization in Health Care Facilities by the Steam Process
- ICS
- 11.080
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- 发布
- 2001-01-01
- 实施
Safety requirements for electrical equipment for measurement control and laboratory use. Part 2-043: Particular requirements for autoclaves and sterilizers using either hot air or hot inert gas for the treatment of medical materials, and for laboratory pr
- ICS
- 11.080
- CCS
- 发布
- 2000-12-11
- 实施
Safety requirements for electrical equipment for measurement, control and laboratory use. Part 2-042: Particular requirements for autoclaves and sterilizers using toxic gas for the treatment of medical materials, and for laboratory processes (IEC 61010-2-
- ICS
- 11.080
- CCS
- 发布
- 2000-12-11
- 实施
