EN 13795-1:2002/FprA1
(Amendment)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
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
2009-02-25 EMA: Work item 00205206 was deleted because its content is included into work item 00205203.
Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung zur Verwendung als Medizinprodukte für Patienten, Klinikpersonal und Geräte - Teil 1: Allgemeine Anforderungen für Hersteller, Aufbereiter und Produkte
Champs chirurgicaux, casaques et tenues de bloc, utilisés en tant que dispositifs médicaux pour les patients, le personnel et les équipements - Partie 1: Exigences générales pour les fabricants, les prestataires et les produits
Operacijska pokrivala, pregrinjala in plašči ter čista oblačila, ki se uporabljajo kot medicinski pripomočki za paciente, zdravstveno osebje in opremo - 1. del: Splošne zahteve za proizvajalce, predelovalce in izdelke
General Information
Relations
Overview
EN 13795-1:2002/FprA1 is a European standard established by CEN that defines general requirements for surgical drapes, gowns, and clean air suits used as medical devices. These products are designed for patients, clinical staff, and equipment to minimize the risk of infection during surgical procedures. The standard is vital for manufacturers and processors, ensuring the production of safe, reliable, and effective medical textiles that contribute to infection control in healthcare settings.
This standard focuses on the essential criteria for quality, sterility, and performance, supporting compliance with relevant European medical device regulations, including Directive 93/42/EEC. It sets the foundation for preventing postoperative wound infections by controlling the spread of infectious agents via surgical barriers.
Key Topics
Scope and Definitions
- Covers surgical drapes, gowns, and clean air suits as classified medical devices.
- Defines the concept of a sterile field, emphasizing the area created by sterile surgical drapes where aseptic technique is practiced.
General Requirements
- Specifies manufacturing and processing conditions to meet safety and performance standards.
- Requires medical devices intended as sterile fields to comply with stricter surgical drape and equipment requirements.
Infection Prevention
- Stress on minimizing spread of infective agents between patients and clinical staff during operations.
- Requirements ensure materials contribute to effective aseptic techniques in operating rooms.
Compliance and Conformity
- Supports manufacturers in meeting the Essential Requirements outlined in EU Directive 93/42/EEC on Medical Devices.
- Details the relationship between this standard and other related standards (e.g., EN 13795-2 and EN 13795-3) for comprehensive coverage.
Applications
Healthcare Facilities
- Used by hospitals and surgical centers to select suitable surgical drapes, gowns, and clean air suits that comply with recognized quality and safety norms.
Medical Device Manufacturers
- Guides manufacturers and processors in developing products that fulfill hygiene and safety demands to reduce infection risks.
- Assists in regulatory submissions and standard compliance for market access across Europe.
Sterile Environments
- Applies to the creation and maintenance of sterile fields within operating rooms and other clinical environments.
- Ensures protective clothing and drapes maintain sterility and barrier protection during medical procedures.
Related Standards
EN 13795-2 and EN 13795-3
- Detail test methods and performance requirements complementing Part 1’s general requirements.
EU Medical Device Directive 93/42/EEC
- EN 13795-1 facilitates conformity to the essential requirements of this directive, critical for CE marking surgical drapes and gowns.
Directive 89/686/EEC on Personal Protective Equipment (PPE)
- For products intended for dual use as medical devices and PPE, this standard partially addresses necessary health and safety requirements.
Keywords: EN 13795-1, surgical drapes standard, gowns medical devices, clean air suits, infection control, sterile field, European medical device regulation, CEN standards, hospital equipment, surgical textiles compliance, medical device manufacturing, aseptic technique, healthcare infection prevention
Frequently Asked Questions
EN 13795-1:2002/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 1: General requirements for manufacturers, processors and products". This standard covers: 2009-02-25 EMA: Work item 00205206 was deleted because its content is included into work item 00205203.
2009-02-25 EMA: Work item 00205206 was deleted because its content is included into work item 00205203.
EN 13795-1:2002/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 13795-1:2002/FprA1 has the following relationships with other standards: It is inter standard links to EN 13795-1:2002+A1:2009, EN 13795-1:2002. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 13795-1:2002/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 13795-1:2002/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 1: General requirements for manufacturers, processors and
products
Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung zur Verwendung als
Medizinprodukte für Patienten, Klinikpersonal und Geräte - Teil 1: Allgemeine
Anforderungen für Hersteller, Aufbereiter und Produkte
Champs chirurgicaux, casaques et tenues de bloc, utilisés en tant que dispositifs
médicaux, pour les patients, le personnel et les équipements - Partie 1: Exigences
générales pour les fabricants, les prestataires et les produits
Ta slovenski standard je istoveten z: EN 13795-1:2002/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 13795-1:2002
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 1:
General requirements for manufacturers, processors and
products
Champs chirurgicaux, casaques et tenues de bloc, utilisés Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung
en tant que dispositifs médicaux, pour les patients, le zur Verwendung als Medizinprodukte für Patienten,
personnel et les équipements - Partie 1: Exigences Klinikpersonal und Geräte - Teil 1: Allgemeine
générales pour les fabricants, les prestataires et les Anforderungen für Hersteller, Aufbereiter und Produkte
produits
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 13795-1:2002. 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 FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13795-1:2002/FprA1:2009: E
worldwide for CEN national Members.
Foreword
This document (EN 13795-1:2002/FprA1:2009) has been prepared by Technical Committee CEN/TC 205
“Non-active medical devices”, the secretariat of which is held by DIN.
This document is
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