EN 13795-2:2004/FprA1
(Amendment)Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods
Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods
Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung zur Verwendung als Medizinprodukte für Patienten, Klinikpersonal und Geräte - Teil 2: Prüfverfahren
Champs chirurgicaux, casaques et tenues de bloc, utilisés en tant que dispositifs médicaux pour les patients, le personnel et les équipements - Partie 2 : Méthodes d'essai
Operacijska pokrivala, pregrinjala in plašči ter čista oblačila, ki se uporabljajo kot medicinski pripomočki za paciente, zdravstveno osebje in opremo - 2. del: Preskusne metode
General Information
Relations
Overview
EN 13795-2:2004/FprA1 is the CEN draft amendment addressing test methods for surgical drapes, gowns and clean air suits used as medical devices for patients, clinical staff and equipment. Prepared by Technical Committee CEN/TC 205, this amendment updates Annex ZA to clarify the relationship between the standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices. Note: the document is issued as a final draft amendment and is distributed for review; it is not to be referred to as a final European Standard until formally adopted.
Key Topics
- Scope and purpose: Part 2 of the EN 13795 series focuses on specifying test methods to evaluate product performance relevant to clinical use and device classification.
- Test-method framework: Provides a harmonized approach for laboratory assessment to support product evaluation, regulatory submissions and quality assurance. The amendment confirms which clauses map to the Essential Requirements in Directive 93/42/EEC (Annex ZA).
- Regulatory alignment: When cited in the Official Journal and implemented nationally, compliance with the listed clauses confers a presumption of conformity with the corresponding Directive requirements, within the standard's scope.
- Standard development context: Produced in English, French and German official versions; national translations may be adopted under CEN rules. The draft is intended for unique acceptance procedure and national comment before formal amendment.
Applications
This document is directly relevant to stakeholders involved in the design, testing, procurement and regulatory compliance of surgical textile products:
- Manufacturers: Use the test-method framework to develop validated, consistent quality-control protocols and to demonstrate conformity during CE marking processes.
- Testing laboratories: Adopt harmonized test approaches for reproducible performance assessment and reporting.
- Healthcare procurement: Reference test-method results to specify products that meet required barrier and safety characteristics for operating-room use.
- Regulatory and clinical engineers: Interpret mapping to Directive 93/42/EEC to support conformity assessments and risk management.
Related Standards
- EN 13795-1 - (referenced for performance requirements and terminology; use in conjunction with Part 2)
- EN 13795-3 - (additional guidance on usage and clinical application within the series)
- Directive 93/42/EEC - Essential Requirements mapping via Annex ZA for medical-device conformity
This amendment emphasizes harmonization of test methods across CEN member states and supports consistent evaluation of barrier performance, safety and regulatory conformity for surgical drapes, gowns and clean air suits.
Frequently Asked Questions
EN 13795-2:2004/FprA1 is a draft published by the European Committee for Standardization (CEN). Its full title is "Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods". This standard covers: Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods
Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods
EN 13795-2:2004/FprA1 is classified under the following ICS (International Classification for Standards) categories: 11.140 - Hospital equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 13795-2:2004/FprA1 has the following relationships with other standards: It is inter standard links to EN 13795-2:2004+A1:2009, EN 13795-2:2004. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 13795-2:2004/FprA1 is associated with the following European legislation: EU Directives/Regulations: 2007/47/EC, 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 EN 13795-2:2004/FprA1 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 CEN standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2009
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Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical
staff and equipment - Part 2: Test methods
Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung zur Verwendung als
Medizinprodukte für Patienten, Klinikpersonal und Geräte - Teil 2: Prüfverfahren
Champs chirurgicaux, casaques et tenues de blocs, utilisés comme dispositifs médicaux,
pour les patients, le personnel médical et les équipements - Partie 2: Méthodes d'essai
Ta slovenski standard je istoveten z: EN 13795-2:2004/FprA1
ICS:
11.140 Oprema bolnišnic Hospital equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
FINAL DRAFT
EN 13795-2:2004
NORME EUROPÉENNE
EUROPÄISCHE NORM
FprA1
February 2009
ICS 11.140
English Version
Surgical drapes, gowns and clean air suits, used as medical
devices for patients, clinical staff and equipment - Part 2: Test
methods
Champs chirurgicaux, casaques et tenues de blocs, utilisés Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung
comme dispositifs médicaux, pour les patients, le zur Verwendung als Medizinprodukte für Patienten,
personnel médical et les équipements - Partie 2: Méthodes Klinikpersonal und Geräte - Teil 2: Prüfverfahren
d'essai
This draft amendment is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee
CEN/TC 205.
This draft amendment A1, if approved, will modify the European Standard EN 13795-2:2004. If this draft becomes an amendment, CEN
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment
into the relevant national standard without any alteration.
This draft amendment was established by CEN in three official versions (English, French, German). A version in any other language made
by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FO
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