prEN ISO 22610

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/AWI 22610:2008)

DOW = DAV + 36 months

Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung zur Verwendung als Medizinprodukte für Patienten, Klinikpersonal und Geräte - Prüfverfahren für die Widerstandsfähigkeit gegen Keimdurchtritt im feuchten Zustand (ISO/AWI 22610:2008)

Champs chirurgicaux, casaques et tenues de bloc, utilisés en tant que dispositifs médicaux, pour les patients, le personnel et les équipements - Méthode d'essai de résistance à la pénétration de la barrière bactérienne à l'état humide

Operacijska pokrivala, pregrinjala in plašči ter čista oblačila, ki se uporabljajo kot medicinski pripomočki za paciente, zdravstveno osebje in opremo - Preskusne metode za določanje odpornosti proti prodiranju vlažnih bakterij (ISO/DIS 22610:2015)

General Information

• Status: Not Published
• ICS: 11.140 - Hospital equipment
• ICS: 13.340.10 - Protective clothing
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205/WG 14 - Surgical clothing and drapes used as medical devices in health care facilities - Performance requirements and test methods
• Current Stage: 3098 - Decision to reject - Consensus building
• Start Date: 11-Sep-2009
• Completion Date: 11-Sep-2009
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: oSIST prEN ISO 22610:2015 - 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/DIS 22610:2015)

Relations

• Revises: 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)
• Effective Date: 19-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 22610:2015
01-december-2015
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PHGLFLQVNLSULSRPRþNL]DSDFLHQWH]GUDYVWYHQRRVHEMHLQRSUHPR3UHVNXVQH
PHWRGH]DGRORþDQMHRGSRUQRVWLSURWLSURGLUDQMXYODåQLKEDNWHULM,62',6

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/DIS 22610:2015)
Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung zur Verwendung als
Medizinprodukte für Patienten, Klinikpersonal und Geräte - Prüfverfahren für die
Widerstandsfähigkeit gegen Keimdurchtritt im feuchten Zustand (ISO/DIS 22610:2015)
Champs chirurgicaux, casaques et tenues de bloc, utilisés en tant que dispositifs
médicaux, pour les patients, le personnel et les équipements - Méthode d'essai de
résistance à la pénétration de la barrière bactérienne à l'état humide (ISO/DIS
22610:2015)
Ta slovenski standard je istoveten z: prEN ISO 22610
ICS:
11.140 Oprema bolnišnic Hospital equipment
13.340.10 Varovalna obleka Protective clothing
oSIST prEN ISO 22610:2015 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 22610:2015

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oSIST prEN ISO 22610:2015
DRAFT INTERNATIONAL STANDARD
ISO/DIS 22610
ISO/TC 94/SC 13 Secretariat: SNV
Voting begins on: Voting terminates on:
2015-10-22 2016-01-22
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
Champs chirurgicaux, casaques et tenues de bloc, utilisés en tant que dispositifs médicaux, pour les
patients, le personnel et les équipements — Méthode d’essai de résistance à la pénétration de la barrière
bactérienne à l’état humide
ICS: 13.340.10
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for
Standardization (ISO), and processed under the ISO lead mode of collaboration
as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member
bodies for a parallel five month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments
received, will be submitted to a parallel two-month approval vote in ISO and
THIS DOCUMENT IS A DRAFT CIRCULATED
formal vote in CEN.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
To expedite distribution, this document is circulated as received from the
IN ADDITION TO THEIR EVALUATION AS
committee secretariat. ISO Central Secretariat work of editing and text
BEING ACCEPTABLE FOR INDUSTRIAL,
composition will be undertaken at publication stage.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 22610:2015(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2015

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oSIST prEN ISO 22610:2015
ISO/DIS 22610:2015(E) ISO/DIS 22610

Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle. 2
5 Equipment, reagents and materials . 3
6 Apparatus . 4
7 Preparation of the Agar Plates . 4
8 Bacterial inoculum . 5
9 Procedure . 5
10 Evaluation. 10
11 Expression of the results. 10
12 Report . 10
Annex A (normative)  Apparatus for testing resistance to wet bacterial penetration . 11
Annex B (normative)  Nutrient media . 14
Annex C (normative)  Equipment and laboratory performance monitoring . 15
Annex ZA (informative)  Relationship between this  European  Standard and the Essential
Requirements  of EU Directive (Add the reference and title of the Directive) . 16
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ii © ISO 2015 – All rights reserved

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oSIST prEN ISO 22610:2015
ISO/DIS 22610
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle.
...