oSIST prEN ISO 22610:2015
(Main)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)
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)
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/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)
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
Relations
Overview
oSIST prEN ISO 22610:2015 is a crucial international standard developed by CEN and ISO that specifies a test method to determine the resistance of surgical drapes, gowns, and clean air suits to wet bacterial penetration. These medical devices are essential for protecting patients, clinical staff, and medical equipment during surgical procedures. By assessing the resistance to bacterial penetration under wet conditions, this standard helps ensure infection control and safety in medical environments.
This standard applies to materials used in the manufacture of surgical drapes, gowns, and clean air suits, which are designed to act as barriers against bacterial contamination. It provides a scientifically validated procedure to simulate and measure the ability of these textiles to resist bacteria when exposed to moisture, a critical factor during surgery and other sterile procedures.
Key Topics
Scope and Application
Defines the test method for evaluating wet bacterial penetration resistance in surgical textiles used in hospitals and clinical settings.Terminology and Definitions
Clarifies terms such as agar plates, donor, test specimen, and resistance to wet bacterial penetration for consistent interpretation.Test Principles
Uses a bacterial inoculum, typically Bacillus atrophaeus, applied to one side of the test material to assess penetration through the textile onto agar plates under controlled wet conditions.Equipment and Materials
Specifies essential laboratory apparatus including biosafety cabinets, incubators, water baths, pipettes, nutrient media (TGEA agar, peptone water), and specialized testing devices like conical steel rings and dynamometers.Test Procedure
Details step-by-step methodology covering agar plate preparation, bacterial inoculum application, specimen assembly, exposure times, incubation, and controls for process validation.Result Evaluation and Reporting
Provides guidelines for quantitatively expressing bacterial penetration, data analysis, and documenting outcomes according to standardized format to ensure precise repeatability and reproducibility.Annexes and Normative Appendices
Include detailed descriptions of apparatus, nutrient media formulations, laboratory performance monitoring, and alignment with EU medical device regulatory directives (e.g., 93/42/EEC).
Applications
Medical Device Manufacturing
Manufacturers of surgical gowns, drapes, and clean air suits utilize this standard to validate the protective properties of their materials and products, ensuring compliance with international quality requirements.Healthcare Facilities
Hospitals and surgical centers benefit from quality-assured barrier garments and textiles tested per ISO 22610 to minimize cross-contamination risks during patient care and surgery.Regulatory Compliance
Supports conformity assessment against EU and international medical device directives by providing objective data on the barrier performance of protective clothing classified as non-active medical devices.Laboratory Testing and R&D
Testing laboratories apply this method for performance evaluation, quality control, and research into improved textile technologies offering enhanced resistance to microbial penetration.
Related Standards
- ISO 10993 Series - Biological evaluation of medical devices focusing on biocompatibility.
- ISO 13485 - Quality management systems for medical devices manufacturing and regulatory purposes.
- ISO 11737-1 - Sterilization of health care products and bioburden testing.
- EN 13795 - Surgical clothing and drapes - performance requirements and test methods for barrier properties.
- EU Directive 93/42/EEC - Medical device regulation outlining essential safety and performance criteria.
By following the standardized test method defined in oSIST prEN ISO 22610:2015, stakeholders can ensure surgical textiles provide reliable protection against bacterial contamination in wet environments, thereby promoting patient safety and supporting infection control protocols in healthcare settings.
Frequently Asked Questions
oSIST prEN ISO 22610:2015 is a draft published by the Slovenian Institute for Standardization (SIST). Its full title is "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)". This standard covers: DOW = DAV + 36 months
DOW = DAV + 36 months
oSIST prEN ISO 22610:2015 is classified under the following ICS (International Classification for Standards) categories: 11.140 - Hospital equipment; 13.340.10 - Protective clothing. The ICS classification helps identify the subject area and facilitates finding related standards.
oSIST prEN ISO 22610:2015 has the following relationships with other standards: It is inter standard links to SIST EN ISO 22610:2006, SIST EN ISO 22610:2006. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
oSIST prEN ISO 22610:2015 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/295. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase oSIST prEN ISO 22610:2015 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of SIST standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2015
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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
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
© ISO 2015, Published in Switzerland
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ii © ISO 2015 – All rights reserved
ISO/DIS 22610
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle.
...
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