BS EN 13795:2011+A1:2013 BS EN 13795:2011 BSI Standards Publication Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment — General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels BS EN 13795:2011+A1:2013 BRITISH STANDARD National foreword This British Standard is the UK implementation of EN 13795:2011+A1:2013 It supersedes BS EN 13795:2011, which will be withdrawn on 31 August 2013 The start and finish of text introduced or altered by amendment is indicated in the text by tags Tags indicating changes to CEN text carry the number of the CEN amendment For example, text altered by CEN amendment A1 is indicated by 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 this subcommittee 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 © The British Standards Institution 2013 Published by BSI Standards Limited 2013 ISBN 978 580 82249 ICS 11.140 Compliance with a British Standard cannot confer immunity from legal obligations This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 March 2011 Amendments/corrigenda issued since publication Date Text affected 30 April 2013 Implementation of CEN amendment A1:2013 EUROPEAN STANDARD EN 13795:2011+A1 NORME EUROPÉENNE EUROPÄISCHE NORM February 2013 ICS 11.140 Supersedes EN 13795:2011 English Version Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, 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 - Exigences générales pour les fabricants, les prestataires et les produits, méthodes d'essai, exigences et niveaux de performance Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung zur Verwendung als Medizinprodukte für Patienten, Klinikpersonal und Geräte - Allgemeine Anforderungen für Hersteller, Wiederaufbereiter und Produkte, Prüfverfahren und Gebrauchsanforderungen This European Standard was approved by CEN on February 2011 and includes Amendment approved by CEN on January 2013 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 CEN-CENELEC Management Centre 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 CEN-CENELEC Management Centre has the same status as the official versions CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels © 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members Ref No EN 13795:2011+A1:2013: E BS EN 13795:2011+A1:2013 EN 13795:2011+A1:2013 (E) EN 13795:2011+A1:2013 (E) Contents Page Foreword Introduction Scope Normative references Terms and definitions Performance requirements Testing 11 Manufacturing and processing requirements 11 Information to be supplied by the manufacturer or processor 11 Annex A (informative) Details of significant changes between this European Standard and the previous edition 13 Annex B (normative) Test methods 15 Annex C (informative) Prevention of infection in the operating room 17 Annex D (informative) Information on further characteristics 18 Annex ZA (informative) !Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices" 20 Bibliography 22 BS EN 13795:2011+A1:2013 EN 13795:2011+A1:2013 (E) EN 13795:2011+A1:2013 (E) Foreword This document (EN 13795:2011+A1:2013) has been prepared by Technical Committee CEN/TC 205 “Nonactive 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 August 2013, and conflicting national standards shall be withdrawn at the latest by August 2013 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights This document !supersedes EN 13795:2011" This document includes Amendment approved by CEN on 2013-01-08 The start and finish of text introduced or altered by amendment is indicated in the text by tags !" This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document Annex A provides details of significant changes between this European Standard and the previous edition represented by the three parts mentioned above According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom BS EN 13795:2011+A1:2013 EN 13795:2011+A1:2013 (E) EN 13795:2011+A1:2013 (E) Introduction The transmission of infective agents during invasive surgical procedures can occur in several ways (see informative Annex C) Surgical drapes, including the intended use as a sterile field, surgical gowns and clean air suits are used to minimize the spread of infective agents to and from patients’ operating wounds, thereby helping to prevent post-operative wound infections (see Annex C) The performance required of coverings for patients, clinical staff and equipment varies with, for example, the type and duration of the procedure, the degree of wetness of the operation field, the degree of mechanical stress on the materials and the susceptibility of the patient to infection The use of surgical gowns with resistance to the penetration of liquids can also diminish the risk to the operating staff from infective agents carried in blood or body fluids EN 13795 is intended to assist the communication between users, manufacturers and third parties with regard to material or product characteristics and performance requirements It focuses on Essential Requirements arising from the Medical Device Directive 93/42/EEC which are applicable to surgical drapes, gowns and clean air suits The requirements and guidance in EN 13795 are expected to be of help to manufacturers and users when designing, processing, assessing and selecting products It is the intention of EN 13795 to ensure the same level of safety from single-use and reusable surgical clothing and drapes throughout their useful life BS EN 13795:2011+A1:2013 EN 13795:2011+A1:2013 (E) EN 13795:2011+A1:2013 (E) Scope This European Standard specifies information to be supplied to users and third party verifiers in addition to the usual labelling of medical devices (see EN 980 and EN 1041), concerning manufacturing and processing requirements This European Standard gives information on the characteristics of single-use and reusable surgical gowns, surgical drapes and clean air suits used as medical devices for patients, clinical staff and equipment, intended to prevent the transmission of infective agents between patients and clinical staff during surgical and other invasive procedures This European Standard specifies test methods for evaluating the identified characteristics of surgical drapes, gowns and clean air suits and sets performance requirements for these products EN 13795 does not cover requirements for flammability of products Suitable test methods for flammability and resistance to penetration by laser radiation, together with an appropriate classification system, are given in EN ISO 11810-1 and EN ISO 11810-2 Additional essential requirements that apply to surgical clothing and drapes are covered by other European Standards 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 20811, Textiles — Determination of resistance to water penetration — Hydrostatic pressure test EN 29073-3, Textiles — Test methods for nonwovens — Part 3: Determination of tensile strength and elongation EN ISO 139, Textiles — Standard atmospheres for conditioning and testing (ISO 139:2005) EN ISO 9073-10, Textiles — Test methods for nonwovens — Part 10: Lint and other particles generation in the dry state (ISO 9073-10:2003) EN ISO 11737-1:2006, Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006) EN ISO 13938-1, Textiles — Bursting properties of fabrics — Part 1: Hydraulic method for determination of bursting strength and bursting distension (ISO 13938-1:1999) 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) Terms and definitions For the purposes of this document, the following terms and definitions apply 3.1 cfu (colony forming unit) unit by which the culturable number of microorganisms is expressed NOTE The culturable number is the number of microorganisms, single cells or aggregates, able to form colonies on a solid nutrient medium BS EN 13795:2011+A1:2013 EN 13795:2011+A1:2013 (E) EN 13795:2011+A1:2013 (E) 3.2 clean air suit suit intended and shown to minimize contamination of the operating wound by the wearer's skin scales carrying infective agents via the operating room air thereby reducing the risk of wound infection NOTE Unlike the suit usually worn in the operating room, the clean air suit is designed to reduce the operating room air contamination by personnel 3.3 cleanliness freedom from unwanted foreign matter NOTE Such matter can be micro-organisms, organic residues or particulate matter 3.3.1 cleanliness — microbial freedom from population of viable micro-organisms on a product and/or a package NOTE In practical use, microbial cleanliness is often referred to as ‘bioburden’ 3.3.2 cleanliness — particulate matter freedom from particles that are contaminating a material and can be released but are not generated by mechanical impact 3.4 critical product area product area with a greater probability to be involved in the transfer of infective agents to or from the wound, e.g front and sleeves of surgical gowns 3.5 fabric cloth made from yarn or fibres by weaving, knitting and/or other types of binding or manufacture 3.6 infective agent micro-organism that has been shown to cause wound infections or that might cause infection in a member of the surgical team or the patient 3.7 less critical product area product area less likely to be involved in the transfer of infective agents to or from the wound 3.8 linting release of fibre fragments and other particles during handling and use NOTE These fragments and particles are originally from the fabric itself 3.9 manufacturer natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party NOTE For more details refer to the Medical Device Directive 93/42/EEC BS EN 13795:2011+A1:2013 EN 13795:2011+A1:2013 (E) EN 13795:2011+A1:2013 (E) 3.10 performance level discrete standard defined to classify products according to the performance requirements of this standard NOTE With the introduction of two performance levels EN 13795 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 3.10.1 standard performance classification addressing minimum performance requirements for various characteristics of products used as medical devices in invasive surgical procedures 3.10.2 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 3.11 processor natural or legal person who processes products so that their performance complies with the requirements of this European Standard NOTE A processor who places a product on the market is a manufacturer in the sense of this European Standard NOTE A processor of reusable products is often referred to as a ‘reprocessor’ and processing reusable products is often referred to as ‘reprocessing’ (as e.g in Medical Device Directive 93/42/EEC) References in EN 13795 to ‘processors’ include ‘reprocessors’ and to ‘processing’ include ‘reprocessing’ 3.12 product surgical gown, surgical drape including equipment covering and clean air suit NOTE In cases of surgical packs, each gown or drape is regarded as a product 3.13 resistance to liquid penetration ability of material to withstand the penetration of liquid(s) from one side of the material through to the other 3.14 resistance to microbial penetration ability of material(s) to withstand penetration of micro-organisms from one side of the material through to the other 3.14.1 dry penetration effect of a combination of air movement and mechanical action by vibration on microbial penetration in dry condition 3.14.2 wet penetration effect of combination of wetness, pressure and rubbing on microbial penetration 3.15 reusable product product intended by the manufacturer to be reprocessed and reused BS EN 13795:2011+A1:2013 EN 13795:2011+A1:2013 (E) EN 13795:2011+A1:2013 (E) 3.16 single-use product product intended to be used once only for a single patient NOTE According to Medical Device Directive 93/42/EEC 3.17 sterile field area created by sterile surgical drape material where aseptic technique is practised NOTE A sterile field can be practised e.g on a back table 3.18 surgical drape drape covering the patient or equipment to prevent transfer of infective agents 3.19 surgical gown gown worn by a member of a surgical team to prevent transfer of infective agents 3.20 surgical procedure surgical intervention performed by a surgical team 3.20.1 invasive surgical procedure surgical procedure penetrating skin or mucosa Performance requirements To comply with EN 13795, products shall meet all the requirements specified in either Tables 1, or (as appropriate to the product), when tested according to this European Standard throughout their useful life If the intended purpose of a medical device specifies the use as a sterile field the requirements for surgical drapes and equipment covers apply as per Table NOTE 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 NOTE General information on testing is given in Clause For details on the test methods given in Tables 1, and and their application for the purpose of this European Standard, see Annex B NOTE Information on characteristics, which cannot be properly evaluated (as ‘adhesion for fixation for the purpose of wound isolation’ or ‘liquid control’) or which are not regarded normative (as ‘comfort’) is given in Annex D BS EN 13795:2011+A1:2013 EN 13795:2011+A1:2013 (E) EN 13795:2011+A1:2013 (E) Table — Characteristics to be evaluated and performance requirements for surgical drapes Requirement Test method (for references, see Clause 2) Unit Resistance to microbial penetration — Dry EN ISO 22612 Resistance to microbial penetration — Wet Characteristic Standard performance High performance Critical product area Less critical product area Critical product area Less critical product area CFU Not required ≤ 300 a Not required ≤ 300 a EN ISO 22610 IB ≥ 2,8b Not required 6,0 b c Not required Cleanliness — Microbial EN ISO 11737-1 CFU/ 100 cm2 ≤ 300 ≤ 300 ≤ 300 ≤ 300 Cleanliness — Particulate matter EN ISO 9073-10 IPM ≤ 3,5 ≤ 3,5 ≤ 3,5 ≤ 3,5 Linting EN ISO 9073-10 log10 (lint count) ≤ 4,0 ≤ 4,0 ≤ 4,0 ≤ 4,0 EN 20811 cm H2O ≥ 30 ≥ 10 ≥ 100 ≥ 10 Bursting strength — Dry EN ISO 13938-1 kPa ≥ 40 ≥ 40 ≥ 40 ≥ 40 Bursting strength — Wet EN ISO 13938-1 kPa ≥ 40 Not required ≥ 40 Not required Tensile strength — Dry EN 29073-3 N ≥ 15 ≥ 15 ≥ 20 ≥ 20 Tensile strength — Wet EN 29073-3 N ≥ 15 Not required ≥ 20 Not required Resistance to liquid penetration a Test conditions: challenge concentration 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 IB = 6,0 for the purpose of this European Standard means: no penetration IB = 6,0 is the maximum achievable value 108 CFU/g talc and 30 vibration time Table — Characteristics to be evaluated and performance requirements for clean air suits Test method (for references, see Clause 2) Unit Requirement b EN ISO 22612 CFU ≤ 300 a Cleanliness — Microbial EN ISO 11737-1 CFU/ 100 cm2 ≤ 300 Cleanliness — Particulate matter EN ISO 9073-10 IPM ≤ 3,5 Linting EN ISO 9073-10 log10 (lint count) ≤ 4,0 Bursting strength — Dry EN ISO 13938-1 kPa ≥ 40 Tensile strength — Dry EN 29073-3 N ≥ 20 Characteristic Resistance to microbial penetration — Dry a Test conditions: challenge concentration 108 CFU/g talc and 30 vibration time b Performance requirements apply for all products areas of clean air suits 10 BS EN 13795:2011+A1:2013 EN 13795:2011+A1:2013 (E) EN 13795:2011+A1:2013 (E) Testing 5.1 Testing for evaluation of the performance of products shall be done according to the test methods specified in Annex B All test results and test conditions shall be recorded and retained 5.2 Testing shall be performed on the finished product If the product is to be used after sterilisation, testing shall be performed on products after sterilisation with the exception of microbial cleanliness Testing shall include potential weak spots NOTE Performance requirements can vary in relation to the areas of the product and the risk of involvement in the transfer of infective agents to or from the wound NOTE To ensure product performance, combinations of materials or products in systems can be used 5.3 During manufacture and processing, testing shall be conducted according to the requirements of the manufacturer's and processor's quality system 5.4 Alternative test methods for monitoring may be used provided that they are validated and address the same characteristic and that the results have been shown to correlate with the test methods given in this European Standard Manufacturing and processing requirements 6.1 The manufacturer and processor shall document that the requirements set down in this European Standard are met and that the fitness for the intended purpose has been established for each use, both for single-use and reusable medical devices NOTE A quality system such as EN ISO 13485 is recommended, in case of processing of reusable products applied in accordance with EN 14065 6.2 Validated manufacturing and processing procedures shall be used 6.2.1 A manufacturing and processing specification shall be designed and validated for the product, including visual and hygienic cleanliness 6.2.2 The validation shall include all steps of manufacture and processing 6.2.3 The frequency of revalidation shall be determined during validation and shall be reassessed after any change of manufacturing or processing that could materially affect the product 6.2.4 The key manufacturing and processing variables shall be identified, monitored and recorded The type and frequency of routine monitoring shall be documented 6.2.5 NOTE The results of the validation and routine monitoring shall be recorded and retained For validation and monitoring processes quantitative biological, chemical and/or physical tests are preferred 6.3 During manufacturing and processing, the control of decontamination and disinfecting procedures and the traceability of sterilisation shall be maintained Information to be supplied by the manufacturer or processor 7.1 In addition to the information to be supplied according to the Medical Device Directive 93/42/EEC, if the manufacturer or processor differentiates between critical and less critical areas of the product, he/she shall supply information to identify them 11 BS EN 13795:2011+A1:2013 EN 13795:2011+A1:2013 (E) EN 13795:2011+A1:2013 (E) 7.2 The following additional information shall be supplied on request: a) the identity or information on the test methods used; b) the results of testing and test conditions for the characteristics given in Tables 1, and in Clause 12 BS EN 13795:2011+A1:2013 EN 13795:2011+A1:2013 (E) EN 13795:2011+A1:2013 (E) Annex A (informative) Details of significant changes between this European Standard and the previous edition A.1 General This European Standard does not include any technical changes The general requirements, test methods and performance requirements are the same as per EN 13795-1:2002+A1:2009, EN 13795-2:2004+A1:2009 and EN 13795-3:2006+A1:2009 Outdated contents and redundant information, which was needed to link the three separate parts or navigate between them, were deleted Outdated references (as e.g to standards that have been revised in the meantime) were updated In general references to test method standards are given now as dated references Whilst valid contents have been kept together in their respective clauses, the clauses themselves have been rearranged to achieve better readability Figure A.1 shows how the contents have been rearranged A.2 New structure of merged EN 13795:2011 After standard sections like Table of contents, Foreword, Introduction, Scope (Clause 1), Normative references (Clause 2) and Terms and definitions (Clause 3), this European Standard moves right into performance requirements In Clause characteristics, test methods and performance requirements are merged in one table for each product type General information on testing is then given in Clause 5, referring to the normative Annex B for all technical details of the test methods Manufacturing and processing requirements have been retained in Clause Information to be supplied by the manufacturer or processor has been tidied up and set as Clause Informative Annex C gives general explanations and information on prevention of infection in the operating theatre Informative Annex D accommodates information on characteristics, which we either don't regard as normative (like comfort) or for which standardised means of evaluation couldn’t be identified (e.g liquid control and adhesion for fixation for the purpose of wound isolation) Finally standard sections follow again (Annex ZA and Bibliography) 13 BS EN 13795:2011+A1:2013 EN 13795:2011+A1:2013 (E) EN 13795:2011+A1:2013 (E) Figure A.1 — Re-ordering of the contents of the previous edition (represented by the former parts) and this European Standard 14 BS EN 13795:2011+A1:2013 EN 13795:2011+A1:2013 (E) EN 13795:2011+A1:2013 (E) Annex B (normative) Test methods B.1 General Where the standard test methods not specify the atmosphere for pre-conditioning, conditioning and testing, the specifications of EN ISO 139 shall be applied Prior to testing, the samples shall be conditioned in the relaxed state B.2 Test method for evaluation of cleanliness — microbial For evaluation of cleanliness — microbial, product shall be tested according to EN ISO 11737-1 A stomaching method shall be used NOTE EN ISO 11737-1 does not provide a fixed test method but specifies requirements for test methods and test mechanisms The requirements of EN ISO 11737-1 are such that different test methods developed in accordance with it provide comparable results Information on the stomacher method is given in EN ISO 11737-1:2006, B.2.2.1 The result shall be expressed as cfu/100 cm2 B.3 Test method for evaluation of cleanliness – particulate matter For estimation of cleanliness — particulate matter, product shall be tested according to EN ISO 9073-10 NOTE EN ISO 9073-10 allows for the test method to be conducted in a laminar flow hood It is important to validate that laminar flow is occurring if equipment required for the test is located in the hood The following specific amendments apply for the purpose of this document for estimation of cleanliness – particulate matter: a) Particle counts for the size range µm to 25 µm shall be calculated NOTE b) Particles of this size range are considered to be capable of carrying microorganisms Particle counts from time steps 30 s, 60 s and 90 s shall be added together for the calculation of particulate matter PM: PM = C30 + C60 + C90 The result of the test shall be reported as the index for particulate matter (IPM) expressed as log10 of particulate matter: IPM = log10PM NOTE This procedure cannot distinguish between particulate matter and linting for this time period and includes both B.4 Test method for evaluation of linting For evaluation of linting product shall be tested according to EN ISO 9073-10 15 BS EN 13795:2011+A1:2013 EN 13795:2011+A1:2013 (E) EN 13795:2011+A1:2013 (E) NOTE EN ISO 9073-10 allows for the test method to be conducted in a laminar flow hood It is important to validate that laminar flow is occurring if equipment required for the test is located in the hood The result of the test, i.e the coefficient of linting, shall be calculated for particles in the size range µm to 25 µm and reported as log10 of the count value NOTE Particles of this size range are considered to be capable of carrying microorganisms B.5 Test method for evaluation of resistance to liquid penetration For evaluation of resistance to liquid penetration product shall be tested according to EN 20811 The following specific amendments to the procedure in EN 20811 apply for the purpose of EN 13795: a) the test area shall be 100 cm2; b) the rate of increase of water pressure shall be (10 ± 0,5) cm/min; c) the side of the product in contact with the test liquid shall be the outer side B.6 Test method for evaluation of bursting strength in dry and wet state For evaluation of bursting strength, product shall be tested according to EN ISO 13938-1 The preparation of samples for wet state testing shall be performed according to EN 29073-3 NOTE The test conditions should be specified in the test report NOTE If there are differences in the test results of both sides of material, both sides should be tested and the results should be recorded B.7 Test method for evaluation of tensile strength in dry and wet state For evaluation of tensile strength, product shall be tested according to EN 29073-3 in the wet and dry states both in longitudinal and in lateral directions B.8 Test method for evaluation of resistance to dry microbial penetration For evaluation of resistance to dry microbial penetration the product shall be tested according to EN ISO 22612 B.9 Test method for evaluation of resistance to wet microbial penetration For evaluation of resistance to wet microbial penetration the product shall be tested according to EN ISO 22610 16 BS EN 13795:2011+A1:2013 EN 13795:2011+A1:2013 (E) EN 13795:2011+A1:2013 (E) Annex C (informative) Prevention of infection in the operating room The majority of post-operative surgical site infections are acquired at the time of operation when there is a possibility for micro-organisms to reach the open wound The source of micro-organisms is either exogenous, i.e staff, inanimate objects, fellow patients or endogenous, i.e the patient In clean operations, i.e operations in sterile tissue and where hollow viscous is not entered, the skin of operating room personnel and of the patient are the most important sources of micro-organisms In infection-prone operations, e.g orthopaedic and vascular implant surgery, the normal microbial skin flora is of significance as a cause of surgical site infection Routes of infection are contact or airborne In the latter case, dispersed human skin scales are often the carriers of infection Some of the types of barrier used to reduce surgical site infection are addressed in this European Standard A healthy individual can disperse to the air approximately 000 bacteria-carrying skin scales per minute during walking The particles are µm to 60 µm in size and the average number of aerobic and anaerobic bacteria carried is estimated to be about five per skin scale The airborne particles contaminate the wound directly by sedimentation or indirectly by first settling on instruments or other items that are then brought into contact with the wound Fabrics with interstices larger than 80 µm little to prevent the dispersal of skin scales Clean air suits can support the reduction of the dispersal of bacteria-carrying skin scales from the human body into the operating room air Clean air suits should be used in addition to surgical gowns and not as a substitute Surgical gowns are used to prevent direct contact transfer of infective agents from the surgical team to the operating wound and vice versa Surgical gowns prevent dispersal of skin scales to the operating room air only if they are made of a suitable material and used in combination with ultra-clean air systems Drapes are used to provide a microbiologically clean working area around the wound If they enclose the wound tightly and are fixed to the skin, they also reduce transfer of the patient's skin flora into the wound Drapes and/or collective devices are also used to control the spread of potentially contaminated body fluids from the wound area 17 BS EN 13795:2011+A1:2013 EN 13795:2011+A1:2013 (E) EN 13795:2011+A1:2013 (E) Annex D (informative) Information on further characteristics D.1 Comfort D.1.1 General The concept of comfort is based on several different factors, such as physiological comfort, ease of movement or factors that will influence and/or affect the individual's satisfaction with the product Combinations of materials and design of clothing, notably scrub suits and operating theatre gowns that will minimize the physiological stress during work are to be encouraged The thermophysiological comfort of a garment depends on such properties as its thermal resistance, air permeability, water-vapour resistance and drapeability NOTE Drapeability addresses the ability of a material to conform to a given shape or object NOTE Water-vapour resistance is defined as the water-vapour pressure difference between the two faces of a material divided by the resultant evaporative heat flux per unit area in the direction of the gradient The evaporative heat flux can consist of both diffusive and convective components Tactile comfort is highly dependent on properties of the fabric such as stretchability, drapeability and the surface structure of the fabric, and also on garment weight, size, fit and manufacture Other properties, such as rustling tendency, softness and skin irritation are difficult to measure Evaluation should be based on trials of the products or practical experience D.1.2 Surgical gowns and clean air suits The overall comfort of surgical gowns and clean air suits can be influenced by a number of factors: design, fit, breathability, weight, surface thickness, electrostatic properties, colour, light reflectance, odour and skin sensitivity Other important variables that can influence comfort include undergarments, health and physical conditions, work load, mental stress and environmental conditions, such as temperature, relative humidity, and air changes in operating room Comfort is subjective and can be influenced by one or a combination of the aforementioned factors D.1.3 Surgical drapes Surgical drapes should be flexible so that they will cover the patient closely and smoothly, allowing placement and manipulation of instruments and draping of other related equipment, such as ring stands, back tables, and Mayo stands Surgical drapes should provide reasonable physiological comfort to support the physical condition of the patient 18 BS EN 13795:2011+A1:2013 EN 13795:2011+A1:2013 (E) EN 13795:2011+A1:2013 (E) D.2 Adhesion for fixation for the purpose of wound isolation Adhesives are used to attach fabrics during the preparation for an operation and to attach drapes to a patient on the operating table Different adhesives are chosen for different materials, e.g material to material and material to the skin In choosing an adhesive, the following considerations should be taken into account: a) adhesives should not cause damage to the skin; b) when used on reusable materials, the adhesives should be removable during processing without damaging the fabric D.3 Liquid control Liquid control is regarded relevant to reduce the risk of transfer of infective agents by liquids used or generated close to the surgical wound Liquid control can be achieved by several mechanisms Examples of test methods are given in the bibliography but it is regarded as technically impossible to specify a single test method, which addresses all aspects of liquid control and provides comparable results If absorption is a factor claimed by the manufacturer in order to have liquid control then evaluation is recommended according to EN ISO 9073-11 with the following specifications: a) Distilled or deionised water shall be used as test liquid b) Results shall be reported in %RO (run off) and in retention percentages given as follows: 1) %Retention = 100 − %RO 2) “%Retention” is thus the amount of liquid retained by the material 19 BS EN 13795:2011+A1:2013 EN 13795:2011+A1:2013 (E) EN 13795:2011+A1:2013 (E) Annex ZA (informative) !Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on Medical Devices Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on Medical Devices Clause(s)/subclause(s) of this European Standard Corresponding Essential Requirements of Directive 93/42/EEC Qualifying remarks/Notes 7.2 (Tables 1, and 3), 5, 6, B.3, 8.1 B.4, B.5, B.6, B.7, B.8, B.9 8.4 (Tables 1, and 3), 8.5 13.3 j) If special operating instructions according to 7.1 of this European Standard are given, they are not necessarily submitted on the label Additional information supplied according to 7.2 is usually neither part of the label nor of the regular instructions for use For devices intended by the manufacturer to be for dual use in accordance with Article 1(6) of Directive 93/42/EEC, the following Table ZA.2 details the relevant Essential Requirements of Directive 89/686/EC on Personal Protective Equipment and their corresponding clauses of this European Standard Table ZA.2, however, does not imply any citation in the OJEU under the PPE Directive and thus does not provide presumption of conformity for the PPE Directive 20 BS EN 13795:2011+A1:2013 EN 13795:2011+A1:2013 (E) EN 13795:2011+A1:2013 (E) Table ZA.2 — Relevant Essential Requirements from Directive 89/686/EEC on Personal Protective Equipment that are addressed by this European Standard (according to Article 1(6) of amended Directive 93/42/EEC) Clause(s)/subclause(s) of this European Standard 4, 5, 6, 7, Annex B Essential Requirements (ERs) of Directive 89/686/EEC 3.10.2 Qualifying remarks/Notes Other basic health and safety requirements are not specifically addressed WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard." 21 BS EN 13795:2011+A1:2013 EN 13795:2011+A1:2013 (E) EN 13795:2011+A1:2013 (E) Bibliography [1] EN 980, Symbols for use in the labelling of medical devices [2] EN 1041, Information supplied by the manufacturer of medical devices [3] EN 14065, Textiles — Laundry processed textiles — Biocontamination control system [4] EN 31092, Textiles — Determination of physiological properties — Measurement of thermal and water-vapour resistance under steady-state conditions (sweating guarded - hotplate test) (ISO 11092:1993) [5] EN ISO 9073-11, Textiles — Test methods for nonwovens — Part 11: Run-off (ISO 9073-11:2002) [6] EN ISO 9073-12, Textiles — Test methods for nonwovens — Part 12: Demand absorbency (ISO 9073-12:2002) [7] EN ISO 9237, Textiles — Determination of permeability of fabrics to air (ISO 9237:1995) [8] EN ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) [9] EN ISO 11607-2, Packaging for terminally sterilized medical devices — requirements for forming, sealing and assembly processes (ISO 11607-2:2006) [10] EN ISO 11810-1, Lasers and laser-related equipment — Test method and classification for the laser resistance of surgical drapes and/or patient protective covers — Part 1: Primary ignition and penetration (ISO 11810-1:2005) [11] EN ISO 11810-2, Lasers and laser-related equipment — Test method and classification for the laserresistance of surgical drapes and/or patient-protective covers — Part 2: Secondary ignition (ISO 11810-2:2007) [12] EN ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003) [13] Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ L 169, 12.7.1993, p 1– 43 22 Part 2: Validation This page deliberately left blank NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW British Standards Institution (BSI) BSI is the national body responsible for preparing British Standards and other standards-related publications, information and services BSI is incorporated by Royal Charter British Standards and other standardization products 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