DIN EN ISO 22610:2015-12 (Draft)
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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
Hardcopy , PDF
03-07-2021
German
01-01-2015
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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
This standard is included in DIN Handbook 475. Specifies a test method, with associated test, which is used to determine the resistance of a material to the penetration of bacteria, carried by a liquid, when subjected to mechanical rubbing.
| DevelopmentNote |
DRAFT 2017 issued in May 2017. (05/2017)
|
| DocumentType |
Draft
|
| Pages |
44
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| Standards | Relationship |
| NEN EN ISO 22610 : 2006 | Identical |
| NBN EN ISO 22610 : 2006 | Identical |
| 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 |
| ISO 22610:2006 | Identical |
| UNI EN ISO 22610 : 2006 | Identical |
| NF EN ISO 22610 : 2006 | Identical |
| DIN HDBK 475 : 2ED 2013 | |
| VDI 2083 Blatt 18:2012-01 | Cleanroom technology - Biocontamination control |
| VDI 2083 Blatt 9.2:2017-01 | Cleanroom technology - Consumables in the cleanroom |
| 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 |
| DIN EN ISO 13485:2016-08 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) |
| ISO 6330:2012 | Textiles Domestic washing and drying procedures for textile testing |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| DIN EN ISO 15797:2004-06 | TEXTILES - INDUSTRIAL WASHING AND FINISHING PROCEDURES FOR TESTING OF WORKWEAR |
| ISO 11607:2003 | Packaging for terminally sterilized medical devices |
| 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) |
| 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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