EN ISO 22610:2006
Current
The latest, up-to-date edition.
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)
01-07-2006
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principle
5 Reagents and materials
6 Apparatus
7 Preparation of test samples and pieces
7.1 Agar plates
7.2 Carrier material
7.3 Test specimen
8 Procedure
8.1 Preparation of donor
8.2 Conditioning
8.3 Test set-up
8.4 Application of materials
8.5 Test
9 Test report
10 Performance monitoring
10.1 General
10.2 With carbon paper
10.3 With reference material
Annex A (normative) Apparatus for testing resistance to wet
bacterial penetration
Annex B (normative) Nutrient media
Annex C (informative) Examples of how to use the test results
to characterize a barrier material
ANNEX ZA (informative) Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC
Bibliography
ISO 22610:2006 specifies a test method, with associated test apparatus, which is used to determine the resistance of a material to the penetration of bacteria, carried by a liquid, when subjected to mechanical rubbing.
| Committee |
CEN/TC 205
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| ISO 22610:2018 | Identical |
| NEN EN ISO 22610 : 2006 | Identical |
| NBN EN ISO 22610 : 2006 | Identical |
| NS EN ISO 22610 : 1ED 2006 | Identical |
| UNE-EN ISO 22610:2007 | Identical |
| SN EN ISO 22610 : 2006 | Identical |
| I.S. EN ISO 22610:2006 | Identical |
| BS EN ISO 22610:2006 | Identical |
| DIN EN ISO 22610:2015-12 (Draft) | Identical |
| PN EN ISO 22610 : 2007 | Identical |
| ISO 22610:2006 | Identical |
| UNI EN ISO 22610 : 2006 | Identical |
| NF EN ISO 22610 : 2006 | Identical |
| DIN EN ISO 22610:2006-10 | Identical |
| I.S. EN 13795:2011 | 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 |
| I.S. EN 13795-3:2006 | SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 3: PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS |
| BS 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 |
| VDI 2083 Blatt 18:2012-01 | Cleanroom technology - Biocontamination control |
| VDI 2083 Blatt 9.2:2017-01 | Cleanroom technology - Consumables in the cleanroom |
| UNI EN 13795 : 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 |
| UNI EN 13795-3 : 2009 | SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 3: PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS |
| 09/30190221 DC : 0 | BS EN 13795 - 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 |
| UNE-EN 13795:2011 | 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 |
| 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 |
| EN 13795-3:2006+A1:2009 | Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels |
| 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 |
| BS EN 13795-3 : 2006 | SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 3: PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS |
| DIN EN 13795-3:2009-12 | SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 3: PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS |
| EN 13795-3:2006+A1:2009 | Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels |
| EN 13795-1:2002+A1:2009 | Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products |
| 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 6330:2012 | Textiles Domestic washing and drying procedures for textile testing |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 11607:2003 | Packaging for terminally sterilized medical devices |
| EN 13795-2:2004+A1:2009 | Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods |
| ISO 139:2005 | Textiles — Standard atmospheres for conditioning and testing |
| ISO 15797:2002 | Textiles Industrial washing and finishing procedures for testing of workwear |
| ISO 13683:1997 | Sterilization of health care products Requirements for validation and routine control of moist heat sterilization in health care facilities |
| EN 554 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT |
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