11.080.01 消毒和灭菌综合 标准查询与下载
共找到 873 条与 消毒和灭菌综合 相关的标准，共 59 页
This document specifies the requirements for test equipment to be used to: — test biological indicators for steam, ethylene oxide gas and dry heat sterilization processes for conformity to the requirements given in ISO 11138 series; — test chemical indicators for steam, ethylene oxide gas, dry heat and vaporized hydrogen peroxide sterilization processes for conformity to the requirements given in ISO 11140-1:2014. This document also provides informative methods useful in characterizing the performance of biological and chemical indicators for intended use and for routine quality control testing. This document does not specify requirements for test equipment for processes specifically for testing chemical and biological indicators intended to monitor isolator and room biodecontamination processes at atmospheric pressure. resistometers specified in this document, and these resistometers are used in conjunction with the test methods specified in the appropriate parts of ISO 11138 series and ISO 11140 series. Resistometers for low temperature steam and formaldehyde indicators are not included in this document. Test methods using laboratory apparatus for low temperature steam and formaldehyde are included in ISO 11138-5:2017. Test equipment for testing Type 2 (e.g. Bowie Dick) chemical indicators are specified in ISO 11140-3:2007,
Sterilization of health care products - Biological and chemical indicators - Test equipment
- ICS
- 11.080.01
- CCS
- 发布
- 2018-08-00
- 实施
Sampling methods for radiation sterilization verification dose experiments and sterilization dose audits of medical devices
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2018-06-26
- 实施
- 2019-07-01
Method for setting radiation sterilization dose of medical devices
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2018-06-26
- 实施
- 2019-07-01
Sterilization of health care products — Ethylene oxide
- ICS
- 11.080.01
- CCS
- 发布
- 20180615
- 实施
- 20180615
Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ISO 11135－1
- ICS
- 11.080.01
- CCS
- 发布
- 20180615
- 实施
- 20180615
本标准适用于天津市范围内承担预防接种工作任务的接种门诊。
Guidelines for Disinfection in Vaccination Clinics
- ICS
- 11.080.01
- CCS
- C 05
- 发布
- 2018-06-07
- 实施
- 2018-07-08
This part of ISO 11140 specifies the requirements for Class 2 indicators for Bowie and Dick-type air removal tests used to evaluate the effectiveness of air removal during the pre-vacuum phase of pre-vacuum steam sterilization cycles. Additionally, this part of ISO 11140 includes test methods and equipment used to meet these performance requirements.
Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
- ICS
- 11.080.01
- CCS
- 发布
- 2018-06-01
- 实施
This part of ISO 11140 specifies the performance for a Class 2 indicator to be used as an alternative to the Bowie and Dick-type test for steam sterilizers for wrapped health care goods (instruments, etc., and porous loads). NOTE The Bowie and Dick-type test is used for routine testing of steam sterilizers and validation of steam sterilization processes. An indicator complying with this part of ISO 11140 incorporates a specified material which is used as a test load. This test load may, or may not, be re-usable. This part of ISO 11140 does not specify requirements for the test load, but specifies the performance of the indicator in combination with the test load with which it is intended to be used. The indicator specified in this part of ISO 11140 is intended to identify poor steam penetration but does not necessarily indicate the cause of this poor steam penetration. This part of ISO 11140 does not include test methods to establish the suitability of these indicator systems for use in sterilizers in which the air removal stage does not include evacuation below atmospheric pressure.
Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
- ICS
- 11.080.01
- CCS
- 发布
- 2018-06-01
- 实施
This part of ISO 11140 specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g. instruments and porous materials. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1. Indicators complying with this part of ISO 11140 are intended for use in combination with the standard test pack as described in EN 285. This part of ISO 11140 does not consider the performance of the standard test pack, but does specify the performance of the indicator systems.
Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
- ICS
- 11.080.01
- CCS
- 发布
- 2018-06-01
- 实施
Aseptic processing of health care products. Sterilizing filtration
- ICS
- 11.080.01
- CCS
- C10
- 发布
- 2018-04-10
- 实施
- 2018-04-10
This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection and/or sterilization to ensure that the device is safe and effective for its intended use. This includes information for processing prior to use or reuse of the medical device. The provisions of this document are applicable to medical devices that are intended for invasive or other direct or indirect patient contact. Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable: a) initial treatment at the point of use; b) preparation before cleaning; c) cleaning; d) disinfection; e) drying; f) inspection and maintenance; g) packaging; h) sterilization; i) storage; j) transportation. This document excludes processing of the following: - non-critical medical devices not intended for direct patient contact; - textile devices used in patient draping systems or surgical clothing;- medical devices specified by the manufacturer for single-use only and supplied ready for use.
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017); German version EN ISO 17664:2017
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2018-04-01
- 实施
Product families and process categories for moist heat sterilization of medical devices
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2018-01-19
- 实施
- 2019-01-01
Aseptic processing of health care products — Part 2: Sterilizing filtration
- ICS
- 11.080.01
- CCS
- 发布
- 2018-01-09
- 实施
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
- ICS
- 11.080.01
- CCS
- 发布
- 2018-01-01
- 实施
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices — Amendment 1: Revision of Anne
- ICS
- 11.080.01
- CCS
- 发布
- 2018
- 实施
- 0000-00-00
Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6
- ICS
- 11.080.01
- CCS
- 发布
- 2017-12-01
- 实施
Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6
- ICS
- 11.080.01
- CCS
- 发布
- 2017-11-23
- 实施
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2017-10-00
- 实施
Aseptic processing of health care products－Part 1：General requirements
- ICS
- 11.080.01
- CCS
- 发布
- 2017-09-29
- 实施
Aseptic processing of health care products－Part 6：Isolator systems
- ICS
- 11.080.01
- CCS
- 发布
- 2017-09-29
- 实施
