13.040.35 清洁室（无菌室）及相关受控环境 标准查询与下载
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Cleanrooms and associated controlled environments -- Part 17: Particle deposition rate applications (ISO 14644-17:2021)
- ICS
- 13.040.35
- CCS
- 发布
- 2021-07-20
- 实施
- 2021-07-20
Cleanrooms and associated controlled environments - Part 17: Particle deposition rate applications (ISO 14644-17:2021)
- ICS
- 13.040.35
- CCS
- 发布
- 2021-07-01
- 实施
- 2021-07-01
ISO 14644-14:2016 specifies a methodology to assess the suitability of equipment (e.g. machinery, measuring equipment, process equipment, components and tools) for use in cleanrooms and associated controlled environments, with respect to airborne particle cleanliness as specified in ISO 14644‑1. Particle sizes range from 0,1 µm to equal to or larger than 5 µm (given in ISO 14644‑1). NOTE Where regulatory agencies impose supplementary guidelines or restrictions, appropriate adaptation of the assessment methodology can be required. The following items are not covered by this ISO 14644-14:2016: - assessment of suitability with respect to biocontamination; - testing for suitability of decontamination agents and techniques; - cleanability of equipment and materials; - requirements on design of equipment and selection of materials; - physical properties of materials (e.g. electrostatic, thermal properties); - optimizing performance of equipment for specific process applications; - selection and use of statistical methods for testing; - protocols and requirements for local safety regulations.
Cleanrooms and associated controlled environments — Part 14: Assessment of suitability for use of equipment by airborne particle concentration
- ICS
- 13.040.35
- CCS
- 发布
- 2021-07-01
- 实施
ISO 14644-15:2017 provides requirements and guidelines for assessing the chemical airborne cleanliness of equipment and materials which are foreseen to be used in cleanrooms and associated controlled environments which are linked to the ISO standard for cleanliness classes by chemical concentration (see ISO 14644‑8). The following are outside the scope of ISO 14644-15:2017: - health and safety requirements; - compatibility with cleaning agents and techniques; - cleanability; - biocontamination; - specific requirements of equipment and materials for processes and products; - design details of equipment.
Cleanrooms and associated controlled environments — Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration
- ICS
- 13.040.35
- CCS
- 发布
- 2021-07-01
- 实施
This document gives direction on the interpretation and application of the results of the measurement of particle deposition rate on one or more vulnerable surfaces in a cleanroom as part of a contamination control programme. It provides some instructions on how to influence the
Cleanrooms and associated controlled environments - Part 17: Particle deposition rate applications (ISO 14644-17:2021); German version EN ISO 14644-17:2021
- ICS
- 13.040.35
- CCS
- 发布
- 2021-06-00
- 实施
Cleanrooms and associated controlled environments - Part 17: Particle deposition rate applications (ISO 14644-17:2021)
- ICS
- 13.040.35
- CCS
- 发布
- 2021-06-00
- 实施
- 2021-06-01
Cleanrooms and associated controlled environments - Part 17: Particle deposition rate applications (ISO 14644-17:2021)
- ICS
- 13.040.35
- CCS
- 发布
- 2021-05-14
- 实施
- 2021-05-14
Cleanrooms and associated controlled environments - Biocontamination control
- ICS
- 13.040.35
- CCS
- 发布
- 2021-04-01
- 实施
- 2021-04-01
Cleanrooms and associated controlled environments – Part 17: Particle deposition rate applications (ISO 14644-17:2021)
- ICS
- 13.040.35
- CCS
- 发布
- 2021-03-19
- 实施
- 2021-03-19
Cleanrooms and associated controlled environments – Part 17: Particle deposition rate applications
- ICS
- 13.040.35
- CCS
- 发布
- 2021-03-19
- 实施
- 2021-03-19
Cleanrooms and associated controlled environments. Particle deposition rate applications
- ICS
- 13.040.35
- CCS
- 发布
- 2021-03-02
- 实施
- 2021-03-02
Cleanrooms and associated controlled environments - Part 17 : particle deposition rate applications
- ICS
- 13.040.35
- CCS
- 发布
- 2021-02-24
- 实施
- 2021-06-12
Cleanrooms and associated controlled environments -- Biocontamination control
- ICS
- 13.040.35
- CCS
- 发布
- 2021-02-03
- 实施
- 2021-02-03
Cleanrooms and associated controlled environments - Biocontamination control
- ICS
- 13.040.35
- CCS
- 发布
- 2021-02-01
- 实施
- 2021-02-01
This document gives direction on the interpretation and application of the results of the measurement of particle deposition rate on one or more vulnerable surfaces in a cleanroom as part of a contamination control programme. It provides some instructions on how to influence the particle deposition rate and reduce the risk of particle contamination on vulnerable surfaces. This document gives information on how a cleanroom user can use the particle deposition rate measurements to determine limits that can be set for macroparticles on vulnerable surfaces. It also gives a risk assessment method by which an acceptable risk of deposition of particles onto vulnerable surfaces in a cleanroom can be established and, when this is not achieved, methods that can be used to reduce the particle deposition rate. An alternative to the particle deposition rate is the particle obscuration rate which determines the rate of increase of coverage of particles onto an area of surface over time. The particle obscuration rate can be used in an analogous way to the particle deposition rate and the required particle obscuration rate for a specified surface can be calculated and the risk from deposited particles reduced. This document does not: — provide a method to classify a cleanroom with respect to particle deposition rate or particle obscuration rate; — directly consider the deposition of microbe-carrying particles, although they can be treated as particles; — give any consideration to surface deposition by contact as, for example, when personnel touch a product and contamination is transferred.
Cleanrooms and associated controlled environments - Part 17: Particle deposition rate applications
- ICS
- 13.040.35
- CCS
- 发布
- 2021-02-00
- 实施
Cleanrooms and associated controlled environments - Part 17: Particle deposition rate applications (ISO 14644-17:2021)
- ICS
- 13.040.35
- CCS
- 发布
- 2021-02-00
- 实施
This document establishes the requirements, recommendations and methodology for microbiological contamination control in clean controlled environments. It also sets out the requirements for establishing and demonstrating microbiological control in clean controlled environments. T
Cleanrooms and associated controlled environments - Biocontamination control; German version EN 17141:2020
- ICS
- 13.040.35
- CCS
- N61
- 发布
- 2021-02-00
- 实施
Cleanrooms and associated controlled environments - Biocontamination control
- ICS
- 13.040.35
- CCS
- 发布
- 2021-01-00
- 实施
- 2021-01-01
This Standard provides requirements and guidelines for assessing the chemical airborne cleanliness of equipment and materials which are foreseen to be used in cleanrooms and associated controlled environments which are linked to the ISO standard for cleanliness classes by chemica
Cleanrooms and associated controlled environments - Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration
- ICS
- 13.040.35
- CCS
- C65/74
- 发布
- 2021
- 实施
Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration
- ICS
- 13.040.35
- CCS
- C70
- 发布
- 2021
- 实施
