Clean Air and Containment Review
The journal to enhance your knowledge of cleanroom, clean air and containment technology
Editor: John Neiger
Publisher: Euromed Communications
Site design:
forwestmedia

Standards

This page has a comprehensive list of standards relevant to clean air and containment technology, with convenient ordering links.

Standards issued after 1st January 2009 are at the head of this list.

Safety requirements for electrical equipment for measurement, control and laboratory use

BS EN 61010-1:2001, IEC 61010-1:2010 NEW
General requirements

CEN Biorisk management standards

CWA 15793:2008
Laboratory biorisk management standard
CEN Workshop 55 NEW
Guidance Document for CWA 15793:2008 'Laboratory Biorisk Management Standard'
CEN Workshop 53 NEW
Biosafety Professional Competence (BSP)

Safety in laboratories

AS/NZ 2243.3-2010 NEW
Part 3: Microbiological safety and containment

Biosafety Cabinetry

NSF/ANSI 49-2010A NEW
Design, Construction, Performance, and Field Certification

Energy management systems

BS EN 16001:2009 NEW
Requirements with guidance for use

High efficiency air filters (EPA, HEPA and ULPA)

BS EN 1822-1:2009 NEW
Classification, performance testing, marking
BS EN 1822-2:2009 NEW
Aerosol production, measuring equipment, particle counting statistics
BS EN 1822-3:2009 NEW
Testing flat sheet filter media
BS EN 1822-4:2009 NEW
Determining leakage of filter element (scan method)
BS EN 1822-5:2009 NEW
Determining the efficiency of filter element

Air filters for general air cleaning

BS EN 14799:2007
Air filters for general air cleaning. Terminology

Cleanrooms and associated controlled environments

BS EN ISO 14644-1:1999
Classification of air cleanliness
BS EN ISO 14644-2:2000
Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
BS EN ISO 14644-3:2005
Test methods
BS EN ISO 14644-4:2001
Design, construction and start-up
BS EN ISO 14644-5:2004
Operations
BS EN ISO 14644-6:2007
Vocabulary
BS EN ISO 14644-7:2004
Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
BS EN ISO 14644-8:2006
Classification of airborne molecular contamination
ISO 14644-9/DIS
Classification of surface particle cleanliness (under development)
ISO 14644-10/CD
Classification of surface chemical cleanliness (under development)
BS EN ISO 14698-1:2003
Biocontamination control. General principles and methods
BS EN ISO 14698-2:2003
Biocontamination control. Evaluation and interpretation of biocontamination data

Containment enclosures

ISO 10648-1:1997
Design principles
ISO 10648-1:1994
Classification according to leak tightness and associated checking methods

Environmental cleanliness in enclosed spaces

PD 6609:2007
Guide to in situ high efficiency filter leak testing

Calibration of particle counters

BS ISO 21501-4:2007
Determination of particle size distribution. Single particle light interaction methods. Light scattering airborne particle counter for clean spaces

Testing and calibration

BS EN ISO/IEC 17025:2005
General requirements for the competence of testing and calibration laboratories

Sterilization of medical devices

BS EN 13824:2004
Aseptic processing of liquid medical devices. Requirements

Sterilization of healthcare products

BS EN ISO 14937:2001
General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

(HEPA filter test)

BS 3928:1969
Method for sodium flame test for air filters (other than for air supply to I.C. engines and compressors)

Biotechnology

BS EN 12469:2000
Performance criteria for microbiological safety cabinets
BS EN 12296:1998
Equipment. Guidance on testing procedures for cleanability
BS EN 12297:1998
Equipment. Guidance on testing procedures for sterilizability
BS EN 12298:1998
Equipment. Guidance on testing procedures for leaktightness
BS EN 13091:2000
Performance criteria for filter elements and filtration assemblies
BS EN 12128:1998
Laboratories for research, development and analysis. Containment levels of microbiology laboratories, areas of risk, localities and physical safety requirements

Microbiological safety cabinets

BS 5726:2005
Information to be supplied by the purchaser to the vendor and to the installer, and siting and use of cabinets. Recommendations and guidance

Workplace atmospheres

BS EN 14583:2004
Volumetric bioaerosol sampling devices. Requirements and test methods

Functional safety. Safety instrumented systems for the process industry sector (IEC 61511)

BS EN 61511-1:2004
Framework, definitions, system, hardware and software requirements
BS EN 61511-2:2004
Guidelines for the application of IEC 61511-1
BS EN 61511-3:2004
Guidance for the determination of the required safety integrity levels

Health Technical Memorandum 03-01: Specialised Ventilation for Healthcare Premises

HTM 03-01- Part A, 2007
Design and Validation Heating and Ventilation Systems
HTM 03-01- Part B, 2007
Operational Management and Performance Verification