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มาตรฐานและหน่วยงานที่เกี่ยวข้องกับห้องปลอดเชื้อ (Cleanroom) มีดังนี้


Federal Standard 209E


This is the very first international standard relating cleanrooms. Although ISO 14644-1 supersedes this standard, it is still in use throughout the world. Hereunder is a notice of cancellation for FED-STD-209E released by the U.S. General Services Administration (GSA).


NOTICE OF CANCELLATION FED-STD-209 NOTICE 1 
November 29, 2001 

FEDERAL STANDARD 

AIRBORNE PARTICULATE CLEANLINESS CLASSES 
IN CLEANROOMS AND CLEAN ZONES


Federal Standard 209E dated September 11, 1992 is hereby canceled and superseded by International Organization for Standardization (ISO) Standards. International Standards for Cleanrooms and associated controlled environments, ISO 14644-1 Part 1: Classification of air cleanliness; and ISO 14644-2 Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1. Application for copies of ISO Standards 14644-1 Part 1, and 14644-2 Part 2; may be addressed to the Institute of Environmental Sciences and Technology (IEST), 940 East Northwest Highway, Mount Prospect, IL 60056-3444. Phone: 847-255-1561, Fax: 847-255-1699, Web site: www.iest.org, E-mail:publicationsales@iest.org.

Preparing Activity: GSA-FSS 
FSC 3694 

 

ISO 14644 cleanroom standard

 

This standard is a substitute for obsolete Federal Standard 209E. This consists of the following parts, under the general title "Cleanrooms and Associated Controlled Environments":


ISO 14644-1: Classification of air cleanliness


This give the airborne particle limits for different standards of cleanrooms. It also gives the methods that should be used to measure the airborne particles when testing a cleanroom to determine its class.


ISO 14644-2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1


This gives information, including time intervals, for testing a cleanroom to show that it still complies with ISO 14644-1 standard.


ISO 14644-3: Metrology and test methods


This gives a description of the test methods that should be used to test the clean room to show that it is working correctly.


ISO 14644-4: Design, construction, and startup


This gives general guidance as to how a cleanroom should be designed, constructed and made ready for handling over to the user.


ISO 14644-5: Operation


This gives genera advice on how to run a cleanroom.


ISO 14644-6: Terms and definitions


This is a collection of all the definitions of terms used in the ISO cleanroom standards.


ISO 14644-7: Separative enclosures (clean air hoods, gloveboxes, isolator, mini-environments)


This gives information on clean air devices such as isolators and minienvironments.


ISO 14644-8: Molecular contamination


This gives information on gaseous contamination in cleanrooms.


ISO 14644-9: Classification of surface particle cleanliness (DRAFT)


This describes the classification of the particle contamination levels on solid surfaces in cleanrooms and associated controlled environments applications.


Pharmaceutical standards : The European Union Guide to Good Manufacturing Practice (EU GGMP)


The most recent pharmaceutical standard that is used in Europe came into operation on January 1997. This is called The rules governing medicinal products in the European Union. Volume 4. Good manufacturing practices : Medicinal products for human and veterinary use. This document can be downloaded free from the internet at http://gsfcc.org


IEST Recommended Practices (RPs)


These practices are produced by the IEST in the United States. The following RPs are available:


IEST-RP-CC001: HEPA and ULPA filters

 

This covers the basic provisions for HEPA and ULPA filter units. Six levels of performance and six grades of construction are included.


IEST-RP-CC002: Laminar flow clean-air devices


Cover definitions, procedures for evaluation performance, and major requirements of unidirectional flow clean air devices.

 

IEST-RP-CC003: Garments required in cleanrooms and controlled environments


Provides guidance for the specification, testing, selection and maintenance of garments use in cleanrooms.


IEST-RP-CC004: Evaluating wiping materials used in cleanrooms and other controlled environments


Describes methods for testing wiper used in cleanrooms for characteristics related to cleanliness and function


IEST-RP-CC005: Cleanroom gloves and finger cots


Describes parameters and tests that apply to gloves and finger cots.


IEST-RP-CC006: Testing cleanrooms


Describes tests to evaluate and characterize the overall performance of the cleanroom and clean zone system.


IEST-RP-CC007: Testing ULPA filters


Describes a test procedure for production testing of ULPA filters for particle penetration and pressure drop.


IEST-RP-CC021: Tesing HEPA and ULPA filter media

 

Discusses test methods for physical and filtration properties of high efficiency particulate air and ultra low penetration air filtration media.


IEST-RP-CC034: HEPA and ULPA filter leak tests


Covers definitions, equipment and procedures for leak testing filters in the factory and in the cleanroom.