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
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
What is this standard about? Dose measurement is an integral part of radiation sterilization. This standard provides guidance on the application of dose measurements (dosimetry) during all stages of the sterilization process. Who is this standard for? Sterilization equipment manufacturers Sterilization service providers Infection control professionals Other professionals responsible for sterilization Why should you use this standard? It gives guidance on dosimetry procedures relating to the development, validation and routine control of radiation sterilization processes as described in: BS EN ISO 11137-1:2015 Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices BS EN ISO 11137-2:2015 Sterilization of health care products. Radiation. Establishing the sterilization dose It also provides explanations and methods regarded as suitable for complying with requirements. What’s changed since the last update? The revised standard: Includes much more guidance on dose measurement uncertainty to help with meeting the dosimetric requirements in BS EN ISO 11137-1 and BS EN ISO 11137 -2 Introduces and formally defines the ideas of ‘direct’ and ‘indirect’ measurement Provides guidance on target doses based on measurement uncertainty considerations and process variability
Sterilization of health care products. Radiation. Guidance on dosimetric aspects of development, validation and routine control
- ICS
- 11.080.01
- CCS
- 发布
- 2017-08-31
- 实施
- 2017-08-31
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development@ validation and routine control
- ICS
- 11.080.01
- CCS
- 发布
- 2017-07-01
- 实施
This document gives guidance on meeting the requirements in ISO 11137-1 and ISO 11137-2 and in radiation sterilization process.
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
- ICS
- 11.080.01
- CCS
- C04
- 发布
- 2017-06
- 实施
Basic guarantee requirements for the safety and effectiveness of ethylene oxide sterilization
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2017-05-02
- 实施
- 2018-04-01
Sterilization of health care products. Biological indicators. Biological indicators for dry heat sterilization processes
- ICS
- 11.080.01
- CCS
- C30
- 发布
- 2017-04-30
- 实施
- 2017-04-30
Sterilization of health care products. Biological indicators. Biological indicators for low-temperature steam and formaldehyde sterilization processes
- ICS
- 11.080.01
- CCS
- C30
- 发布
- 2017-04-30
- 实施
- 2017-04-30
Sterilization of health care products. Biological indicators. Biological indicators for ethylene oxide sterilization processes
- ICS
- 11.080.01
- CCS
- C30
- 发布
- 2017-04-30
- 实施
- 2017-04-30
Sterilization of health care products. Biological indicators. Biological indicators for moist heat sterilization processes
- ICS
- 11.080.01
- CCS
- C30
- 发布
- 2017-04-30
- 实施
- 2017-04-30
Requirements for ethylene oxide subcontract sterilization
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2017-03-28
- 实施
- 2018-04-01
Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
- ICS
- 11.080.01
- CCS
- C47;C30
- 发布
- 2017-03-01
- 实施
Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
- ICS
- 11.080.01
- CCS
- C30
- 发布
- 2017-03-01
- 实施
Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
- ICS
- 11.080.01
- CCS
- C10
- 发布
- 2017-03-01
- 实施
This document specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent. NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by the NOTE 2 National or regional regulations can provide requirements for work place safety.
Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2017-03-00
- 实施
Sterilization of health care products - Biological indicators - Part 1: General requirements
- ICS
- 11.080.01
- CCS
- C10
- 发布
- 2017-03-00
- 实施
Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods
- ICS
- 11.080.01
- CCS
- 发布
- 2017-00-00
- 实施
- 2018-09-01
Chemical disinfectants. Chlorine-containing disinfectants for the disinfection individual water supplies. General requirements
- ICS
- 11.080.01
- CCS
- 发布
- 2017-00-00
- 实施
- 2018-07-01
Chemical disinfectants. Pediculicide means for impregnation of fabrics and products from them. Methods of research of toxicity and danger indicators
- ICS
- 11.080.01
- CCS
- 发布
- 2017
- 实施
- 2018-01-01
Disinfectology and disinfection activities. Rules for testing disinfectants on volunteers
- ICS
- 11.080.01
- CCS
- 发布
- 2017
- 实施
- 2018-01-01
