Cleanrooms and associated controlled environments — Biocontamination control —
Part 2: Evaluation and interpretation of biocontamination data

洁净室和相关控制环境 -
生物污染控制 -
第2部分：生物污染数据的评价与解释

以下摘录第1章节 范围；第2章节 参照标准；以及第3章节 术语与定义部分。

Cleanrooms and associated controlled environments —Biocontamination control —
Part 2:Evaluation and interpretation of biocontamination data

1 Scope

    This part of ISO 14698 gives guidance on methods for the evaluation of microbiological data and the estimation of
results obtained from sampling for viable particles in risk zones for biocontamination control. It should be used,
where appropriate, in conjunction with ISO 14698-1.

2 Normative references

    The following referenced documents are indispensable for the application of this document. For dated references,
only the edition cited applies. For undated references, the latest edition of the referenced document (including any
amendments) applies.

    ISO 14698-1:2003, Cleanrooms and associated controlled environments — Biocontamination control — Part 1:
General principles and methods

3 Terms and definitions

    For the purposes of this document, the following terms and definitions apply.

3.1
action level

    microbiological level set by the user in the context of controlled environments, which, when exceeded, requires
immediate intervention, including investigation of cause, and corrective action

3.2
alert level

    microbiological level set by the user for controlled environments, giving early warning of a potential drift from
normal conditions

    NOTE When alert levels are exceeded, this should result in increased attention to the process.

3.3
audit trail

chain of related documents, or entries within records, that allows related information to be traced

3.4
biocontamination

    contamination of materials, devices, individuals, surfaces, liquids, gases or air with viable particles

3.5
cleanroom

    room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner
to minimize the introduction, generation, and retention of particles inside the room, and in which other relevant
parameters, e.g. temperature, humidity and pressure, are controlled as necessary
[ISO 14644-1:1999, 2.1.1] [1]

3.6
data stratification

    regrouping of data so that important trends and deviations can be more easily seen and understood

3.7
estimate

    value of an estimator obtained as a result of an estimation
[ISO 3534-1:1993, 2.51] [2]

3.8
estimation

    operation of assigning, from the observations in a sample, numerical values to the parameters of a distribution
chosen as the statistical model for the population from which this sample is taken [ISO 3534-1:1993, 2.49] [2]

3.9
estimator

     statistic used to estimate a population parameter [ISO 3534-1:1993, 2.50] [2]

3.10
hazard

    biological, chemical or physical element or factor that adversely affects individuals, the environment, process or
product

3.11
risk
   
    combination of the probability of the occurrence of harm and the severity of that harm [ISO/IEC Guide 51:1999, 3.2] [8]

3.12
risk zone

    defined and delimited space where individuals, products or materials (or any combination of the above) are
particularly vulnerable to biocontamination

3.13
target level

    defined microbiological level set by the user, for its own purpose

3.14
validation

    confirmation, through the provision of objective evidence, that the requirements for a specific intended use or
application have been fulfilled [ISO 9000:2000, 3.8.5] [3]

3.15
viable particle

    particle that consists of, or supports, one or more live microorganisms

3.16
viable unit
VU

    one or more viable particles that are enumerated as a single unit
    NOTE  When VU are enumerated as colonies on agar media, it is common usage to name them colony-forming units
(CFU).