ГОСТ Р ИСО 14644-7-2007 Чистые помещения и связанные с ними контролируемые среды. Часть 7. Изолирующие устройства (укрытия с чистым воздухом, боксы перчаточные, изоляторы и мини-окружения)

[1] ISO 10648-1:1997

Containment enclosures - Part 1: Design principles

[2] ISO 13408-1:1998

Aseptic processing of health care products - Part 1: General requirements

[3] ISO 13408-5:2006

Aseptic processing of health care products - Part 5: Aseptic processing of solid medical devices

[4] ISO 13408-6:2005

Aseptic processing of health care products - Part 6: Isolator/barrier technologies

[5] ISO 14644-5:2004

Cleanrooms and associated controlled environments - Part 5: Operations

[6] EN 12296:1998

Biotechnology - Equipment - Guidance on testing procedures for cleanability

[7] EN 12298:1998

Biotechnology - Equipment - Guidance on testing procedures for leaktightness

[8] EN 12307:1998

Biotechnology - Large-scale process and production - Guidance for good practice, procedures, training and control for personnel

[9] EN 12469:2000

Biotechnology - Performance criteria for microbiological safety cabinets

[10] ENV 1631:1997

Cleanroom technology - Design, construction and operation of cleanrooms and clean air devices

[11] AECP 59

Shielded and unshielded glove boxes for "hands on" operation. United Kingdom Atomic Energy Authority (UKAEA) Harwell Laboratory, Oxfordshire, UK

[12] AECP 1062

The Parjo method of leak rate testing low pressure containers. United Kingdom Atomic Energy Authority (UKAEA) Harwell Laboratory, Oxfordshire, UK

[13] BS 3636:1963

Methods for proving the gas tightness of vacuum for pressurized plants

[14] IEST-RP-CC0028:2002

Minienvironments. Institute of Environmental Sciences and Technology, Rolling Meadows, Illinois, USA

[15] NF 0137/1

Leak testing, Code of practice for test requirements for low working pressure containers. British Nuclear Fuels, plс, Technical Standards Group, Risley, UK

[16] SEMI E19-0697:1997

Standard mechanical interface (SMIF). SEMI, San Jose, California, USA

[17] SEMI E47.1-0303:2001

Provisional mechanical standard for boxes and pods used to transport and store 300-mm wafers. SEMI, San Jose, California, USA

[18] SEMI E45-1101:2001

Test method for the determination of inorganic contamination from mini-environments using vapor phase decomposition/total reflection X-ray fluorescence spectroscopy (VPD-TXRF), VPD/inductively coupled plasma-mass spectrometry (VPD/ICP-MS). SEMI, San Jose, California, USA

[19] SEMI E46-95:1995

Specification for the determination of organic contamination from mini-environments. SEMI, San Jose, California, USA To be published

[20] SEMI E62-0701:2001

Provisional specification for 300-mm front-opening interface mechanical standard (FIMS). SEMl, San Jose, California, USA

[21] SEMI S11-1296:1996

Environmental, safety and health guidelines for semiconductor manufacturing equipment minienvironments. SEMI, San Jose, California, USA

[22] TC 233/N229 DS:1995

Safe biotechnology - Performance criteria for safety cabinets. CEN, Brussels, Belgium

[23]

A guide to hazard and operability studies. Chemical Industry and Health Council of the Chemical Industry Association, Publications Department, 1977, London, UK

[24]

COLES T. Isolation technology: A practical guide. Interpharm Press, 1998, Buffalo Grove, Illinois, USA

[25]

FULTON S., BASS E. and CHRISTAL L. I300I Factory Guideline Compliance: Factory Integration Maturity Assessment for 300 mm Production Equipment: Version 4.0. International Sematech Technology Transfer # 98023468B-TR, March 31, 1999, Appendix G, Minienvironment Parametric Test Methods. International Sematech, 1999, Austin, Texas, USA

[26]

Isolators for pharmaceutical applications, ISBN 0 11 701829 5. HMSO, 1994, London, UK

[27]

SHERWOOD E., HOPE D., WHITMORE J., OTTESEN C. and DAVIS C. Integrated Minienvironment Design Best Practices. International Sematech Technology Transfer #99033693A, March 31, 1999, International Sematech, 1999, Austin, Texas, USA

[28]

SIRCH E.C. Isolatortechnik in der pharmazeutischen Industrie, in: Reinraumtechnik, Gail, L. and Hortag H.P. (eds.), pp.168-211, Springer Verlag, 2001, Berlin-Heidelberg-New York

[29]

SIRCH Е.С. User requirements and design specifications of isolator containment for pharmaceutical production, in: 1998 Proceedings of the 44th Annual Technical Meeting of the IEST concurrent with the ICCCS 14th International Symposium on Contamination Control, p.343, Institute of Environmental Sciences and Technology, Phoenix, Arizona, USA

[30]

TOLLIVER D.L. (ed.). Handbook of contamination control in microelectronics: principles, applications and technology. Noyes Publications, 1988, Park Ridge, New Jersey, USA

[31]

WAGNER C.M. and AKERS J.E. (eds.). Isolator technology: applications in the pharmaceutical and biotechnology industries. Interpharm Press, 1995, Buffalo Grove, Illinois, USA