【BS英国标准】BS EN 13795-3-2006 Surgical drapes, gowns and clean air suits, used as medical devices for.pdf

BRITISH STANDARD BS EN 13795-3:2006 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment Part 3: Performance requirements and performance levels The European Standard EN 13795-3:2006 has the status of a British Standard ICS 11.140 ? Licensed Copy: AUB User, na, Sat Aug 04 06:51:11 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS EN 13795-3:2006 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 January 2007 © BSI 2007 ISBN 978 0 580 50107 4 National foreword This British Standard was published by BSI. It is the UK implementation of EN 13795-3:2006. The UK participation in its preparation was entrusted by Technical Committee CH/205, Non-active medical devices, to Subcommittee CH/205/1, Medical textiles. A list of organizations represented on CH/205/1 can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments issued since publication Amd. No. DateComments Licensed Copy: AUB User, na, Sat Aug 04 06:51:11 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN 13795-3 June 2006 ICS 11.140 English Version Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels Champs chirurgicaux, casaques et tenues de bloc utilisés en tant que dispositifs médicaux pour les patients, le personnel et les équipements - Partie 3 : Exigences et seuil de performance Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung zur Verwendung als Medizinprodukte für Patienten, Klinikpersonal und Geräte - Teil 3: Gebrauchsanforderungen und Leistungsstufen This European Standard was approved by CEN on 27 April 2006. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists 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 Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, 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. EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels © 2006 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13795-3:2006: E Licensed Copy: AUB User, na, Sat Aug 04 06:51:11 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN 13795-3:2006 (E) 2 Contents Page Foreword3 Introduction.4 1 Scope5 2 Normative references5 3 Terms and definitions .5 4 Performance requirements.6 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC concerning medical devices 10 Bibliography11 Licensed Copy: AUB User, na, Sat Aug 04 06:51:11 GMT+00:00 2007, Uncontrolled Copy, (c) BSI w w w . b z f x w . c o m EN 13795-3:2006 (E) 3 Foreword This document (EN 13795-3:2006) has been prepared by Technical Committee CEN/TC 205 “Non-active medical devices”, the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by December 2006, and conflicting national standards shall be withdrawn at the latest by December 2006. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. EN 13795 consists of the following parts under the general title “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 Part 2: Test methods Part 3: Performance requirements and performance levels Attention is also drawn to the following: EN 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 22610:2006) EN ISO 22612 Clothing for protection against infectious agents Test method for resistance to dry microbial penetration (ISO 22612:2005) According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, 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. Licensed Copy: AUB User, na, Sat Aug 04 06:51:11 GMT+00:00 2007, Uncontrolled Copy, (c) BSI w w w . b z f x w . c o m EN 13795-3:2006 (E) 4 Introduction The series of EN 13795 specifies requirements for single-use and reusable coverings (i. e. surgical gowns, surgical drapes and clean air suits) used as medical devices for patients, clinical staff and equipment and intended to prevent the transmission of infective agents between patients and clinical staff during invasive surgical procedures. General requirements for surgical drapes, gowns and clean air suits, used as medical devices, for patients clinical staff and equipment are specified in EN 13795-1. In this respect EN 13795-1 specifies the relevant characteristics to be evaluated for products covered by this European Standard. EN 13795-2 specifies test methods for evaluating these characteristics. NOTE For more information on products contained within the scope of this European Standard it is recommended to refer to EN 13795-1. Licensed Copy: AUB User, na, Sat Aug 04 06:51:11 GMT+00:00 2007, Uncontrolled Copy, (c) BSI w w w . b z f x w . c o m EN 13795-3:2006 (E) 5 1 Scope This part of the series of EN 13795 specifies performance requirements for surgical drapes, gowns and clean air suits. NOTE General performance requirements are specified for various characteristics as per EN 13795-1:2002 Tables 1, 2 and 3 and should be evaluated according to EN 13795-2, EN ISO 22610 and EN ISO 22612. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 13795-1, 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 EN 13795-2, Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment Part 2: Test methods EN 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 22610:2006) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 less critical product area product area less likely to be involved in the transfer of infective agents to or from the wound NOTE 1 For the definition of critical product area please see EN 13795-1. NOTE 2 If the manufacturer differentiates between critical and less critical areas of the product, EN 13795-1 requires the manufacturer to identify these areas, and, if requested, to supply information on the rationale for this distinction. For more information see EN 13795-1. 3.2 performance level refers to products designated as “standard” or “high performance” according to Clause 4 of this standard NOTE With the introduction of two performance levels the EN 13795 series of standards acknowledges the fact that products are challenged to differing extents during surgical procedures, dependent upon the duration, mechanical stress and liquid challenge throughout the surgical procedure. 3.2.1 standard performance classification addressing minimum performance requirements for various characteristics of products (see Clause 4) used as medical devices in invasive surgical procedures 3.2.2 high performance classification addressing elevated performance requirements for various characteristics of products used as medical devices in invasive surgical procedures NOTE Examples of surgical procedures where elevated performance level should be considered are those where extensive exposure to liquid, mechanical stresses or longer surgical procedures can be expected Licensed Copy: AUB User, na, Sat Aug 04 06:51:11 GMT+00:00 2007, Uncontrolled Copy, (c) BSI w w w . b z f x w . c o m EN 13795-3:2006 (E) 6 3.3 product surgical gown, surgical drape including equipment coverings and clean air suit 4 Performance requirements To comply with the EN 13795 series of standards, products shall meet all the requirements specified in either Tables 1, 2 or 3 (as appropriate to the product),when tested according to EN 13795-2 throughout their useful life. NOTE 1 General requirements and guidance for manufactures, processors and products, on the information to be supplied, for manufacturing, processing and testing are given in EN 13795-1. NOTE 2 Test methods for evaluation of all characteristics are specified in EN 13795-2, EN ISO 22610 and EN ISO 22612. NOTE 3 Performance requirements are specified depending on product area and performance level. However for some characteristics the performance requirement will apply for all performance levels and product areas of the medical device. Licensed Copy: AUB User, na, Sat Aug 04 06:51:11 GMT+00:00 2007, Uncontrolled Copy, (c) BSI w w w . b z f x w . c o m EN 13795-3:2006 (E) 7 Table 1 Performance requirements for surgical gowns Requirement Standard performance High performance Characteristic Unit Critical product area Less critical product area Critical product area Less critical product area Resistance to microbial penetration Dry Log10 (CFU) Not required 2 a, c Not required 2 a, c Resistance to microbial penetration Wet IB 2,8 b Not required 6,0 b, d Not required Cleanliness Microbial Log10 (CFU/dm2) 2 c 2 c 2 c 2 c Cleanliness Particulate matter IPM 3,5 3,5 3,5 3,5 Linting Log10 (lint count) 4,0 4,0 4,0 4,0 Resistance to liquid penetration cm H2O 20 10 100 10 Bursting strength Dry kPa 40 40 40 40 Bursting strength Wet kPa 40 Not required 40 Not required Tensile strength Dry N 20 20 20 20 Tensile strength Wet N 20 Not required 20 Not required a Test conditions: challenge concentration 108 CFU/g talc. and 30 min vibration time. b The Least Significant Difference (LSD) for IB when estimated using EN ISO 22610, was found to be 0,98 at the 95% confidence level. This is the minimum difference needed to distinguish between two materials thought to be different. Thus materials varying by up to 0,98 IB are probably not different; materials varying by more than 0,98 IB probably are different. (The 95% confidence levels means that an observer would be correct 19 times out of 20 to accept these alternatives). c For the purpose of this standard, log10 CFU 2 means maximum 300 CFU. d IB = 6,0 for the purpose of this standard means: no penetration. IB = 6,0 is the maximum achievable value. Licensed Copy: AUB User, na, Sat Aug 04 06:51:11 GMT+00:00 2007, Uncontrolled Copy, (c) BSI w w w . b z f x w . c o m EN 13795-3:2006 (E) 8 Table 2 Performance requirements for surgical drapes Requirement Standard performance High performance Characteristic Unit Critical product area Less critical product area Critical product area Less critical product area Resistance to microbial penetration Dry Log10 (CFU) Not required 2 a, c Not required 2 a, c Resistance to microbial penetration Wet IB 2,8 b Not required 6,0 b, d Not required Cleanliness Microbial Log10 (CFU/dm2) 2 c 2 c 2 c 2 c Cleanliness Particulate matter IPM 3,5 3,5 3,5 3,5 Linting Log10 (lint count) 4,0 4,0 4,0 4,0 Resistance to liquid penetration cm H2O 30 10 100 10 Bursting strength Dry kPa 40 40 40 40 Bursting strength Wet kPa 40 Not required 40 Not required Tensile strength Dry N 15 15 20 20 Tensile strength Wet N 15 Not required 20 Not required a Test conditions: challenge concentration 108 CFU/g talc. and 30 min vibration time. b The Least Significant Difference (LSD) for IB when estimated using EN ISO 22610, was found to be 0,98 at the 95% confidence level. This is the minimum difference needed to distinguish between two materials thought to be different. Thus materials varying by up to 0,98 IB are probably not different; materials varying by more than 0,98 IB probably are different. (The 95% confidence levels means that an observer would be correct 19 times out of 20 to accept these alternatives). c For the purpose of this standard, log10 CFU 2 means maximum 300 CFU. d IB = 6,0 for the purpose of this standard means: no penetration. IB = 6,0 is the maximum achievable value. Licensed Copy: AUB User, na, Sat Aug 04 06:51:11 GMT+00:00 2007, Uncontrolled Copy, (c) BSI w w w . b z f x w . c o m EN 13795-3:2006 (E) 9 Table 3 Performance requirements for clean air suits Characteristic Unit Requirement b Resistance to microbial penetration Dry Log10 (CFU) 2 a, c Cleanliness Microbial Log10 (CFU/dm2) 2 c Cleanliness Particulate matter IPM 3,5 Linting Log10 (lint count) 4,0 Bursting strength Dry kPa 40 Tensile strength Dry N 20 a Test conditions: challenge concentration 108 CFU/g talc and 30 minutes vibration time. b Performance requirements apply for all products areas of clean air suits, as clean air suits should be used in addition to surgical gowns and not as a substitute. c For the purpose of this standard, log10 CFU 2 means maximum 300 CFU Licensed Copy: AUB User, na, S