EN ISO 14644

	DIN EN ISO 14644
Area	Air purity
title	Clean rooms and associated clean room areas
Brief description:	8 parts
Latest edition	various
ISO	14644

The EN ISO 14644 is a standard for clean rooms and associated clean room areas. Parts 1 and 2 of the standard replaced the old US Federal Standard 209E. This has been used in previous years to determine a clean room classification. For this reason, EN ISO 14644 builds on it, and the cleanroom classifications are comparable to those of the Federal Standard.

In Germany the standard is published as DIN standard DIN EN ISO 14644.

Clean room classes according to ISO 14644-1   Particles per m 3 ; class 0.1 µm 0.2 µm 0.3 µm 0.5 µm 1.0 µm 5.0 µm ISO 1 10           ISO 2 100 24 10       ISO 3 1,000 237 102 35     ISO 4 10,000 2,370 1,020 352 83   ISO 5 100,000 23,700 10,200 3,520 832   ISO 6 1,000,000 237,000 102,000 35,200 8,320 293 ISO 7       352,000 83,200 2,930 ISO 8       3,520,000 832,000 29,300 ISO 9       35,200,000 8,320,000 293,000

Clean room classes according to US FED STD 209E   Particles per m 3 ; class 0.1 µm 0.2 µm 0.3 µm 0.5 µm 5.0 µm - - 1 1,236 247 106 35   10 12,360 2,649 1,059 353   100   26,486 10,594 3,531   1,000       35,315 247 10,000       353.147 2,472 100,000       3,531,470 24,720 - Note: US FED STD 209E is no longer valid as of November 29, 2001. The values ​​of the US standard were in ft 3 and are shown here in m 3 for better comparison . The particle class 1 µm was not defined.

The standard deals with the topic of clean rooms for the semiconductor sector (protection of the product from humans and environmental conditions), as well as for biological hazardous substances (protection of humans and the environment from the product), but is also binding for the pharmaceutical industry , since parenterals (injection drugs ) must also be produced under strict clean room conditions.

List of parts of the standard:

• Part 1 Classification of air purity based on particle concentration
• Part 2 Specifications for testing and monitoring to prove continuous compliance with ISO 14644-1
• Part 3 test method
• Part 4 planning, execution and initial commissioning
• Part 5 operation
• Part 6 terms
• Part 7 SD modules ( clean air hoods , glove boxes, isolators and mini environments)
• Part 8 Classification of airborne molecular contamination
• Part 9 Classification of the particulate surface cleanliness (currently draft, status 2.2010)
• Part 10 Classification of chemical surface cleanliness (ISO 14644-10: 2013)

Measurement regulations

With the revision of the standard in December 2015, the measurement regulations (measurement conditions) were also revised:

1. The determination of the number of measuring points per room has been redefined. Previously defined as the root of the area as the minimum number of measurements, in the December 2015 version a minimum number of measuring points per area is specified in a table.
2. At the same time the statistical confidence interval fell away; instead, each measuring point should be considered individually: if the mean value of each measuring point is below the limit values, the measured room meets the requirements.
3. When taking a sample, the length of the hose between the measuring device and the point at which the sample was taken should be shorter than one meter.

Individual evidence

1. ↑ ^{a b c d e f} Changes with the new version from December 2015 (Part 1): Jürgen Blattner: Innovations in DIN EN ISO 14644-1: 2015 ( Memento of the original from January 18, 2017 in the Internet Archive ) Info: Der Archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. , gmp Verlag, accessed on January 18, 2017 
2. ↑ Committee ISO / TC 209 "Cleanrooms and associated controlled environments" , isotc.iso.org