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DIN EN ISO 14644-4:2003-06

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Cleanrooms and associated controlled environments - Part 4: Design, construction and start up (ISO 14644-4:2001)
Available format(s)

Hardcopy , PDF

Superseded date

04-02-2023

Language(s)

English, German

Published date

06-01-2003

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Planning and design
  5.1 Planning procedure
  5.2 Design
6 Construction and start-up
7 Testing and approval
  7.1 General
  7.2 Construction approval
  7.3 Functional approval
  7.4 Operational approval
8 Documentation
  8.1 General
  8.2 Record of an installation
  8.3 Operational instructions
  8.4 Instructions for performance monitoring
  8.5 Maintenance instructions
  8.6 Maintenance record
  8.7 Record of operation and maintenance training
Annex A (informative) Control and segregation concepts
Annex B (informative) Classification examples
Annex C (informative) Approval of an installation
Annex D (informative) Layout of an installation
Annex E (informative) Construction and materials
Annex F (informative) Environmental control of cleanrooms
Annex G (informative) Control of air cleanliness
Annex H (informative) Additional specification of
        requirements to be agreed upon between
        purchaser/user and designer/supplier
Bibliography

This standard is included in DIN Handbook 406. Describes requirements for the design and construction of cleanroom installations but does not prescribe specific technological or contractual means to meet these requirements.

DocumentType
Standard
Pages
57
ProductNote
THIS STANDARD REFERS TO : ISO 14698-3
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded
SupersededBy
Supersedes

DIN HDBK 406 : 2ED 2016
DIN EN ISO 13408-1:2015-12 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013)
VDI 2083 Blatt 18:2012-01 Cleanroom technology - Biocontamination control
VDI 2083 Blatt 17:2013-06 Cleanroom technology - Compatibility of materials with the required cleanliness
VDI 2083 Blatt 15:2007-04 Cleanroom technology - Personnel at the clean work place
VDI 2083 Blatt 8.1:2014-10 Cleanroom technology - Air cleanliness chemical concentration (ACC)
VDI 2083 Blatt 1:2013-01 Cleanroom technology - Particulate air cleanliness classes
VDI 2083 Blatt 9.1:2006-12 Clean room technology - Compatibility with required cleanliness and surface cleanliness
VDI 2083 Blatt 3:2005-07 Cleanroom technology - Metrology and test methods
VDI 2083 Blatt 12:2000-01 Cleanroom technology - Safety and environmental aspects
DIN EN ISO 14644-3:2006-03 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS
DIN EN ISO 11737-2:2010-04 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS

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