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DIN EN ISO 22610:2015-12 (Draft)

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Available format(s)

Hardcopy , PDF

Superseded date

07-03-2021

Language(s)

German

Published date

01-01-2015

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Superseded

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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