VDI 2083 Blatt 9.2:2017-01
Current
The latest, up-to-date edition.
Cleanroom technology - Consumables in the cleanroom
Hardcopy , PDF
German - English
01-01-2017
Preliminary note
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviations
5 Basic requirements
6 Differentiation between cleanroom compatibility
And compatibility with the required
cleanliness and basic considerations
7 Gloves
8 Multiple-use clothing
9 Single-use clothing
10 Single-use face masks
process-specific requirements
11 Shoes
12 Wipes
13 Swabs
14 Mop systems
15 Papers and notebooks
16 Packaging materials (bags, films)
Annex A - Measurement methods
A1 - Gloves
A2 - Multiple-use cleanroom clothing
A3 - Single-use face mask
A4 - Cleanroom shoes/overshoes
A5 - Wipes
A6 - Paper
A7 - Packaging materials
Annex B - Parameters of consumables -Recommendations
B1 - Single-use gloves
B2 - Outer cleanroom garments
B3 - Face masks
B4 - Wipes
B5 - Swabs
B6 - Paper
Annex C - Criteria for selection of
cleanroom textiles
C1 - Retention efficiency for
airborne particles
C2 - Air permeability
C3 - Migration behaviour (with respect to
intermediate garments)
C4 - Test method to determine the resistance
to dry and wet bacterial penetration
C5 - Wearing comfort
C6 - Electrostatic behaviour
C7 - Abrasion resistance and roughening
tendency
C8 - Style of cleanrm clothing
C9 - Recommendations for specifying
cleanrm clothing for a desired
particulate air cleanliness class
Annex D - Cleanroom-compatible decontamination
of multiple-use cleanroom
clothing and monitoring of
decontamination, sterilisation
D1 - General
D2 - Design and dimensioning of the
decontamination process
D3 - Requirements to be met by detergents
for multiple-use cleanrm clothing
D4 - Sterilisation
Annex E - Barrier properties of
single-use clothing
Bibliography
Specifies the basic properties of the Product types mentioned in terms of their use in a controlled environment as well as the cleanliness-related properties and how to test them.
DevelopmentNote |
Supersedes VDI 2083-5-2. (01/2017)
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DocumentType |
Standard
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Pages |
116
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PublisherName |
Verlag des Vereins Deutscher Ingenieure
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Status |
Current
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Supersedes |
SEMI E78 : 2012 | GUIDE TO ASSESS AND CONTROL ELECTROSTATIC DISCHARGE (ESD) AND ELECTROSTATIC ATTRACTION (ESA) FOR EQUIPMENT |
ISO 13934-1:2013 | Textiles — Tensile properties of fabrics — Part 1: Determination of maximum force and elongation at maximum force using the strip method |
DIN EN ISO 4628-1:2016-07 | PAINTS AND VARNISHES - EVALUATION OF DEGRADATION OF COATINGS - DESIGNATION OF QUANTITY AND SIZE OF DEFECTS, AND OF INTENSITY OF UNIFORM CHANGES IN APPEARANCE - PART 1: GENERAL INTRODUCTION AND DESIGNATION SYSTEM (ISO 4628-1:2016) |
EN ISO 4628-2:2016 | Paints and varnishes - Evaluation of degradation of coatings - Designation of quantity and size of defects, and of intensity of uniform changes in appearance - Part 2: Assessment of degree of blistering (ISO 4628-2:2016) |
ISO 11137-1:2006 | Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
EN ISO 22610:2006 | Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration (ISO 22610:2006) |
DIN EN ISO 14644-1:2016-06 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 1: CLASSIFICATION OF AIR CLEANLINESS BY PARTICLE CONCENTRATION (ISO 14644-1:2015) |
DIN EN ISO 4628-7:2016-07 | PAINTS AND VARNISHES - EVALUATION OF DEGRADATION OF COATINGS - DESIGNATION OF QUANTITY AND SIZE OF DEFECTS, AND OF INTENSITY OF UNIFORM CHANGES IN APPEARANCE - PART 7: ASSESSMENT OF DEGREE OF CHALKING BY VELVET METHOD (ISO 4628-7:2016) |
ISO 14644-6:2007 | Cleanrooms and associated controlled environments Part 6: Vocabulary |
ISO 14644-8:2013 | Cleanrooms and associated controlled environments Part 8: Classification of air cleanliness by chemical concentration (ACC) |
ASTM F 1215 : 1989 | Test Method for Determining the Initial Efficiency of a Flatsheet Filter Medium in an Airflow Using Latex Spheres (Withdrawn 1998) |
DIN EN ISO 22612:2005-05 | Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration (ISO 22612:2005); German version EN ISO 22612:2005 |
DIN EN ISO 4628-6:2011-12 | Paints and varnishes - Evaluation of degradation of coatings - Designation of quantity and size of defects, and of intensity of uniform changes in appearance - Part 6: Assessment of degree of chalking by tape method (ISO 4628-6:2011) |
EN ISO 13934-1:2013 | Textiles - Tensile properties of fabrics - Part 1: Determination of maximum force and elongation at maximum force using the strip method (ISO 13934-1:2013) |
DIN IEC 60093 : 1993 | METHODS OF TEST FOR INSULATING MATERIALS FOR ELECTRICAL PURPOSES; VOLUME RESISTIVITY AND SURFACE RESISTIVITY OF SOLID ELECTRICAL INSULATING MATERIALS |
EN ISO 4628-1:2016 | Paints and varnishes - Evaluation of degradation of coatings - Designation of quantity and size of defects, and of intensity of uniform changes in appearance - Part 1: General introduction and designation system (ISO 4628-1:2016) |
EN 285:2015 | Sterilization - Steam sterilizers - Large sterilizers |
EN 149:2001+A1:2009 | Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking |
DIN EN ISO 14644-10:2013-06 | Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration (ISO 14644-10:2013) |
ISO 9237:1995 | Textiles — Determination of the permeability of fabrics to air |
ISO 9073-3:1989 | Textiles — Test methods for nonwovens — Part 3: Determination of tensile strength and elongation |
VDI 2083 Blatt 1:2013-01 | Cleanroom technology - Particulate air cleanliness classes |
EN ISO 20344:2011 | Personal protective equipment - Test methods for footwear (ISO 20344:2011) |
DIN EN 14683:2014-07 | MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS |
ISO 11737-1:2006 | Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
DIN EN 285:2016-05 | Sterilization - Steam sterilizers - Large sterilizers |
DIN EN ISO 9073-6:2003-05 | Textiles - Test methods for nonwovens - Part 6: Absorption (ISO 9073-6:2000); German version EN ISO 9073-6:2003 |
VDI 4700-1 : 2015 COR 1 2015 | Terminology of civil engineering and building services - Corrigendum concerning guideline VDI 4700 Part 1:2015-10 |
EN 26591-1:1992 | Packaging - Sacks - Description and method of measurement - Part 1: Empty paper sacks (ISO 6591-1:1984) |
EN ISO 9237:1995 | Textiles - Determination of permeability of fabrics to air (ISO 9237:1995) |
DIN EN ISO 8871-3:2004-09 | ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 3: DETERMINATION OF RELEASED-PARTICLE COUNT |
EN 16523-1:2015 | Determination of material resistance to permeation by chemicals - Part 1: Permeation by liquid chemical under conditions of continuous contact |
DIN EN 16523-1:2015-04 | DETERMINATION OF MATERIAL RESISTANCE TO PERMEATION BY CHEMICALS - PART 1: PERMEATION BY LIQUID CHEMICAL UNDER CONDITIONS OF CONTINUOUS CONTACT |
ISO 8871-3:2003 | Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 3: Determination of released-particle count |
DIN EN ISO 4628-2:2016-07 | PAINTS AND VARNISHES - EVALUATION OF DEGRADATION OF COATINGS - DESIGNATION OF QUANTITY AND SIZE OF DEFECTS, AND OF INTENSITY OF UNIFORM CHANGES IN APPEARANCE - PART 2: ASSESSMENT OF DEGREE OF BLISTERING (ISO 4628-2:2016) |
DIN EN ISO 22610:2015-12 (Draft) | SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - TEST METHOD TO DETERMINE THE RESISTANCE TO WET BACTERIAL PENETRATION |
IEST RP CC003.4 : 2011 | GARMENT SYSTEM CONSIDERATIONS IN CLEANROOMS AND OTHER CONTROLLED ENVIRONMENTS |
DIN EN ISO 2812-1:2007-05 | PAINTS AND VARNISHES - DETERMINATION OF RESISTANCE TO LIQUIDS - PART 1: IMMERSION IN LIQUIDS OTHER THAN WATER (ISO 2812-1:2017) |
VDI 3926 Blatt 1:2004-10 | Testing of cleanable filter media - Standard test for the evaluation of cleanable filter media |
DIN EN ISO 20345:2012-04 | Personal protective equipment - Safety footwear (ISO 20345:2011); German version EN ISO 20345:2011 |
DIN EN ISO 11137-1:2015-11 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, INCLUDING AMD 1:2013) |
DIN EN 455-3:2015-07 | Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
DIN EN ISO 11137-3:2015-08 (Draft) | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL (ISO 11137-3:2017) |
EN ISO 12947-2:2016 | Textiles - Determination of the abrasion resistance of fabrics by the Martindale method - Part 2: Determination of specimen breakdown (ISO 12947-2:2016) |
DIN EN ISO 4628-4:2016-07 | PAINTS AND VARNISHES - EVALUATION OF DEGRADATION OF COATINGS - DESIGNATION OF QUANTITY AND SIZE OF DEFECTS, AND OF INTENSITY OF UNIFORM CHANGES IN APPEARANCE - PART 4: ASSESSMENT OF DEGREE OF CRACKING (ISO 4628-4:2016) |
EN ISO 8871-3:2004 | Elastomeric parts for parenterals and for devices for pharmaceuticals use - Part 3: Determination of released-particle count (ISO 8871-3:2003) |
VDI 2083 Blatt 4.1:2006-10 | Cleanroom technology - Planning, construction and start-up of cleanrooms |
DIN EN ISO 20347:2012-05 | Personal protective equipment - Occupational footwear (ISO 20347:2012) |
EN ISO 4628-4:2016 | Paints and varnishes - Evaluation of degradation of coatings - Designation of quantity and size of defects, and of intensity of uniform changes in appearance - Part 4: Assessment of degree of cracking (ISO 4628-4:2016) |
VDI 2083 Blatt 8.1:2014-10 | Cleanroom technology - Air cleanliness chemical concentration (ACC) |
DIN EN ISO 14644-6:2007-10 | CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 6: VOCABULARY |
ISO 4628-4:2016 | Paints and varnishes Evaluation of degradation of coatings Designation of quantity and size of defects, and of intensity of uniform changes in appearance Part 4: Assessment of degree of cracking |
ISO 4628-3:2016 | Paints and varnishes — Evaluation of degradation of coatings — Designation of quantity and size of defects, and of intensity of uniform changes in appearance — Part 3: Assessment of degree of rusting |
ISO 216:2007 | Writing paper and certain classes of printed matter Trimmed sizes A and B series, and indication of machine direction |
ISO 20347:2012 | Personal protective equipment Occupational footwear |
EN ISO 4628-3:2016 | Paints and varnishes - Evaluation of degradation of coatings - Designation of quantity and size of defects, and of intensity of uniform changes in appearance - Part 3: Assessment of degree of rusting (ISO 4628-3:2016) |
VDI 1000:2017-02 | VDI Standardisation Work - Principles and procedures |
DIN EN 13795:2013-10 | SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS, TEST METHODS, PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS |
DIN EN ISO 20344:2013-02 | Personal protective equipment - Test methods for footwear (ISO 20344:2011) |
IEC 60093:1980 | Methods of test for volume resistivity and surface resistivity of solid electrical insulating materials |
EN ISO 11137-2:2015 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013) |
ISO 4628-5:2016 | Paints and varnishes — Evaluation of degradation of coatings — Designation of quantity and size of defects, and of intensity of uniform changes in appearance — Part 5: Assessment of degree of flaking |
EN ISO 9001:2015 | Quality management systems - Requirements (ISO 9001:2015) |
ISO 4628-1:2016 | Paints and varnishes Evaluation of degradation of coatings Designation of quantity and size of defects, and of intensity of uniform changes in appearance Part 1: General introduction and designation system |
ISO 11137-3:2017 | Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control |
ISO 22612:2005 | Clothing for protection against infectious agents Test method for resistance to dry microbial penetration |
DIN EN ISO 12947-1:2007-04 | Textiles - Determination of the abrasion resistance of fabrics by the Martindale method - Part 1: Martindale abrasion testing apparatus (ISO 12947-1:1998 + Cor. 1:2002) (includes Corrigendum AC:2006) |
DIN EN ISO 15378:2016-03 | PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) (ISO 15378:2017) |
EN ISO 20345:2011 | Personal protective equipment - Safety footwear (ISO 20345:2011) |
EN ISO 7730:2005 | Ergonomics of the thermal environment - Analytical determination and interpretation of thermal comfort using calculation of the PMV and PPD indices and local thermal comfort criteria (ISO 7730:2005) |
EN ISO 4628-6:2011 | Paints and varnishes - Evaluation of degradation of coatings - Designation of quantity and size of defects, and of intensity of uniform changes in appearance - Part 6: Assessment of degree of chalking by tape method (ISO 4628-6:2011) |
ISO 16604:2004 | Clothing for protection against contact with blood and body fluids Determination of resistance of protective clothing materials to penetration by blood-borne pathogens Test method using Phi-X 174 bacteriophage |
ISO 15378:2017 | Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) |
EN 14683:2014 | Medical face masks - Requirements and test methods |
ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
ISO 22610:2006 | Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment Test method to determine the resistance to wet bacterial penetration |
EN ISO 14644-8:2013 | Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC) (ISO 14644-8:2013) |
DIN EN ISO 14644-9:2012-12 | Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration (ISO 14644-9:2012) |
EN 13795:2011+A1:2013 | Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels |
ISO 12947-4:1998 | Textiles — Determination of the abrasion resistance of fabrics by the Martindale method — Part 4: Assessment of appearance change |
ASTM F 2101 : 2014 : REDLINE | TEST METHOD FOR EVALUATING THE BACTERIAL FILTRATION EFFICIENCY (BFE) OF MEDICAL FACE MASK MATERIALS, USING A BIOLOGICAL AEROSOL OF STAPHYLOCOCCUS AUREUS |
VDI 2083 Blatt 5.1:2007-09 | Cleanroom technology - Cleanroom operation |
ISO 11092:2014 | Textiles — Physiological effects — Measurement of thermal and water-vapour resistance under steady-state conditions (sweating guarded-hotplate test) |
ISO 14644-1:2015 | Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration |
EN ISO 20347:2012 | Personal protective equipment - Occupational footwear (ISO 20347:2012) |
ISO 9001:2015 | Quality management systems — Requirements |
ISO 2812-1:2017 | Paints and varnishes — Determination of resistance to liquids — Part 1: Immersion in liquids other than water |
EN ISO 11137-1:2015 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) |
IEST RP CC004.3 : 2004 | EVALUATING WIPING MATERIALS USED IN CLEANROOMS AND OTHER CONTROLLED ENVIRONMENTS |
EN 455-2:2015 | Medical gloves for single use - Part 2: Requirements and testing for physical properties |
ISO 7730:2005 | Ergonomics of the thermal environment — Analytical determination and interpretation of thermal comfort using calculation of the PMV and PPD indices and local thermal comfort criteria |
ISO 9073-10:2003 | Textiles — Test methods for nonwovens — Part 10: Lint and other particles generation in the dry state |
ASTM F 51/F51M : 2000 | TEST METHOD FOR SIZING AND COUNTING PARTICULATE CONTAMINANT IN AND ON CLEAN ROOM GARMENTS |
EN ISO 11092:2014 | Textiles - Physiological effects - Measurement of thermal and water-vapour resistance under steady-state conditions (sweating guarded-hotplate test) (ISO 11092:2014) |
DIN EN 455-2:2015-07 | Medical gloves for single use - Part 2: Requirements and testing for physical properties |
DIN EN ISO 13934-1:2013-08 | TEXTILES - TENSILE PROPERTIES OF FABRICS - PART 1: DETERMINATION OF MAXIMUM FORCE AND ELONGATION AT MAXIMUM FORCE USING THE STRIP METHOD (ISO 13934-1:2013) |
ISO 20346:2014 | Personal protective equipment Protective footwear |
EN ISO 20346:2014 | Personal protective equipment - Protective footwear (ISO 20346:2014) |
EN ISO 9073-6:2003 | Textiles - Test methods for nonwovens - Part 6: Absorption (ISO 9073-6:2000) |
ISO 4628-6:2011 | Paints and varnishes — Evaluation of degradation of coatings — Designation of quantity and size of defects, and of intensity of uniform changes in appearance — Part 6: Assessment of degree of chalking by tape method |
DIN EN ISO 9001:2015-11 | QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015) |
EN ISO 9073-10:2004 | Textiles - Test methods for nonwovens - Part 10: Lint and other particles generation in the dry state (ISO 9073-10:2003) |
DIN EN ISO 12947-4:2007-04 | Textiles - Determination of abrasion resistance of fabrics by the Martindale method - Part 4: Assessment of appearance change (ISO 12947-4:1998 + Cor. 1:2002) (includes Corrigendum AC:2006) |
ISO 20345:2011 | Personal protective equipment Safety footwear |
EN ISO 4628-7:2016 | Paints and varnishes - Evaluation of degradation of coatings - Designation of quantity and size of defects, and of intensity of uniform changes in appearance - Part 7: Assessment of degree of chalking by velvet method (ISO 4628-7:2016) |
EN ISO 14644-10:2013 | Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration (ISO 14644-10:2013) |
VDI 2083 Blatt 17:2013-06 | Cleanroom technology - Compatibility of materials with the required cleanliness |
DIN EN 31092:2013-01 | TEXTILES - PHYSIOLOGICAL EFFECTS - MEASUREMENT OF THERMAL AND WATER-VAPOUR RESISTANCE UNDER STEADY-STATE CONDITIONS (SWEATING GUARDED-HOTPLATE TEST) (ISO 11092:1993 + AMD.1:2012) |
DIN EN ISO 4628-3:2016-07 | Paints and varnishes - Evaluation of degradation of coatings - Designation of quantity and size of defects, and of intensity of uniform changes in appearance - Part 3: Assessment of degree of rusting (ISO 4628-3:2016); German version EN ISO 4628-3:2016 |
EN ISO 868:2003 | Plastics and ebonite - Determination of indentation hardness by means of a durometer (Shore hardness) (ISO 868:2003) |
EN ISO 4628-5:2016 | Paints and varnishes - Evaluation of degradation of coatings - Designation of quantity and size of defects, and of intensity of uniform changes in appearance - Part 5: Assessment of degree of flaking (ISO 4628-5:2016) |
DIN EN ISO 11737-1:2009-09 | STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS |
ISO 12947-2:2016 | Textiles — Determination of the abrasion resistance of fabrics by the Martindale method — Part 2: Determination of specimen breakdown |
VDI 2083 Blatt 9.1:2006-12 | Clean room technology - Compatibility with required cleanliness and surface cleanliness |
DIN EN ISO 20346:2014-09 | Personal protective equipment - Protective footwear (ISO 20346:2014); German version EN ISO 20346:2014 |
IEST RP CC003.3 : 2003 ERRATA 2008 | GARMENTS SYSTEMS CONSIDERATIONS FOR CLEANROOMS AND OTHER CONTROLLED ENVIRONMENTS |
EN ISO 216:2007 | Writing paper and certain classes of printed matter - Trimmed sizes - A and B series, and indication of machine direction (ISO 216:2007) |
EN ISO 14644-6:2007 | Cleanrooms and associated controlled environments - Part 6: Vocabulary (ISO 14644-6:2007) |
DIN EN ISO 4628-5:2016-07 | Paints and varnishes - Evaluation of degradation of coatings - Designation of quantity and size of defects, and of intensity of uniform changes in appearance - Part 5: Assessment of degree of flaking (ISO 4628-5:2016) |
ISO 178:2010 | Plastics Determination of flexural properties |
VDE 0303-30 : 1993 | METHODS OF TEST FOR INSULATING MATERIALS FOR ELECTRICAL PURPOSES; VOLUME RESISTIVITY AND SURFACE RESISTIVITY OF SOLID ELECTRICAL INSULATING MATERIALS |
EN ISO 14644-1:2015 | Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015) |
TRGS 727 : 2016 COR 2016 | VERMEIDUNG VON ZUENDGEFAHREN INFOLGE ELEKTROSTATISCHER AUFLADUNGEN |
ISO 9073-6:2000 | Textiles — Test methods for nonwovens — Part 6: Absorption |
EN ISO 14644-9:2012 | Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration (ISO 14644-9:2012) |
DIN EN 149:2009-08 | RESPIRATORY PROTECTIVE DEVICES - FILTERING HALF MASKS TO PROTECT AGAINST PARTICLES - REQUIREMENTS, TESTING, MARKING |
EN ISO 11137-3:2017 | Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017) |
IEST RP CC005.4 : 2013 | GLOVES AND FINGER COTS USED IN CLEANROOMS AND OTHER CONTROLLED ENVIRONMENTS |
VDA PART 19-1 : 2015 | INSPECTION OF TECHNICAL CLEANLINESS - PARTICULATE CONTAMINATION OF FUNCTIONALLY RELEVANT AUTOMOTIVE COMPONENTS |
EN ISO 15378:2017 | Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017) |
ISO 20344:2011 | Personal protective equipment Test methods for footwear |
ISO 4628-2:2016 | Paints and varnishes Evaluation of degradation of coatings Designation of quantity and size of defects, and of intensity of uniform changes in appearance Part 2: Assessment of degree of blistering |
ISO 4628-7:2016 | Paints and varnishes Evaluation of degradation of coatings Designation of quantity and size of defects, and of intensity of uniform changes in appearance Part 7: Assessment of degree of chalking by velvet method |
CLC/TR 50404:2003 | Electrostatics - Code of practice for the avoidance of hazards due to static electricity |
EN ISO 22612:2005 | Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration (ISO 22612:2005) |
ISO 14644-9:2012 | Cleanrooms and associated controlled environments Part 9: Classification of surface cleanliness by particle concentration |
ISO 868:2003 | Plastics and ebonite — Determination of indentation hardness by means of a durometer (Shore hardness) |
DIN EN ISO 12947-2:2015-09 (Draft) | TEXTILES - DETERMINATION OF THE ABRASION RESISTANCE OF FABRICS BY THE MARTINDALE METHOD - PART 2: DETERMINATION OF SPECIMEN BREAKDOWN (ISO 12947-2:2016) |
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