BS EN 868 8 2009 ICS 11 080 30; 55 120 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BRITISH STANDARD Packaging materials for terminally sterilized medical devices Part 8 Re u[.]
BRITISH STANDARD Packaging materials for terminally sterilized medical devices Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 — Requirements and test methods ICS 11.080.30; 55.120 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BS EN 868-8:2009 BS EN 868-8:2009 National foreword This British Standard is the UK implementation of EN 868-8:2009 It supersedes BS EN 868-8:1999 which is withdrawn The UK participation in its preparation was entrusted to Technical Committee LBI/35, Sterilizers, autoclaves and disinfectors A list of organizations represented on this committee 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 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2009 © BSI 2009 ISBN 978 580 59167 Amendments/corrigenda issued since publication Date Comments BS EN 868-8:2009 EUROPEAN STANDARD EN 868-8 NORME EUROPÉENNE EUROPÄISCHE NORM May 2009 ICS 11.080.30 Supersedes EN 868-8:1999 English Version Packaging for terminally sterilized medical devices - Part 8: Reusable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods Matériaux d'emballage pour les dispositifs médicaux stérilisés au stade terminal - Partie 8: Conteneurs réutilisables de stérilisation pour stérilisateurs la vapeur d'eau conformes l'EN 285 - Exigences et méthodes d'essai Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 8: Wiederverwendbare Sterilisierbehälter für Dampf-Sterilisatoren nach EN 285 Anforderungen und Prüfverfahren This European Standard was approved by CEN on 23 April 2009 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 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 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 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 worldwide for CEN national Members Ref No EN 868-8:2009: E BS EN 868-8:2009 EN 868-8:2009 (E) Contents Page Foreword Introduction Scope Normative references Terms and definitions Requirements 5 Information to be supplied by the manufacturer Test methods Annex A (informative) Details of significant technical changes between this European Standard and the previous edition 10 Annex B (informative) Guidance on dimensions 11 Annex C (normative) Handle strength test 12 Annex D (normative) Stacking test 13 Annex E (normative) Stacking device capability test 14 Annex F (normative) Determination of sterilization performance 15 Annex G (normative) Load dryness tests 16 Annex H (informative) Guidance on determination of useful life 18 Bibliography 19 BS EN 868-8:2009 EN 868-8:2009 (E) Foreword This document (EN 868-8:2009) has been prepared by Technical Committee CEN/TC 102 “Sterilizers for medical purposes”, 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 November 2009, and conflicting national standards shall be withdrawn at the latest by November 2009 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 868-8:1999 Annex A provides details of significant technical changes between this European Standard and the previous edition EN 868 consists of the following parts, under the general title Packaging for terminally sterilized medical devices: Part 2: Sterilization wrap — Requirements and test methods; Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) — Requirements and test methods; Part 4: Paper bags — Requirements and test methods; Part 5: Sealable pouches and reels of porous materials and plastic film construction — Requirements and test methods; Part 6: Paper for low temperature sterilization processes — Requirements and test methods; Part 7: Adhesive coated paper for low temperature sterilization processes — Requirements and test methods; Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 — Requirements and test methods; Part 9: Uncoated nonwoven materials of polyolefines — Requirements and test methods; Part 10: Adhesive coated nonwoven materials of polyolefines — Requirements and test methods In addition, ISO/TC 198 "Sterilization of health care products" in collaboration with CEN/TC 102 "Sterilizers for medical purposes" has prepared the EN ISO 11607 series "Packaging for terminally sterilized medical devices" The EN ISO 11607 series specifies general requirements for materials, sterile barrier systems and packaging systems (Part 1) and validation requirements for forming, sealing and assembly processes (Part 2) 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, 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 the United Kingdom BS EN 868-8:2009 EN 868-8:2009 (E) Introduction The EN ISO 11607 series consists of two parts under the general title "Packaging for terminally sterilized medical devices" Part of this series specifies general requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use Part of this series specifies validation requirements for forming, sealing and assembly processes Every sterile barrier system shall fulfil the requirements of EN ISO 11607-1 The EN 868 series can be used to demonstrate compliance with one or more of the requirements specified in EN ISO 11607-1 During the revision of EN 868 parts to 10 CEN/TC 102/WG recognized Resolution CEN/BT 21/2003 relating to the implementation of the uncertainty of measurement concept in standards Following this Resolution and the corresponding guidance, CEN/TC 102/WG has initiated a review of the test methods needed to show compliance with the requirements specified in EN 868 parts to 10 with the intention that the information required by CEN/BT 21/2003 be available for inclusion in EN 868 parts to 10 during one of their next revisions CEN/TC 102/WG also appreciates the initiatives of CEN with regard to the minimization of adverse environmental impacts by standards It was agreed that this subject should be given priority during the next edition of the EN ISO 11607 series that is the basic reference for all parts of the EN 868 series BS EN 868-8:2009 EN 868-8:2009 (E) Scope This part of EN 868 provides test methods and values for re-usable containers used as sterile barrier systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use These containers are intended to be used in steam sterilizers conforming to EN 285 NOTE The need for a packaging material inside the container is determined by the manufactures and users This part of EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part of EN 868 but does not add nor modify the general requirements specified in EN ISO 11607-1 As such, the particular requirements in 4.2 to 4.5 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1 NOTE When it is intended to use the containers in a steam sterilizer not conforming to EN 285 the sterilization performance of the container in the specific sterilization cycle to be used is validated by the user Other attributes of the container are also reviewed for compatibility with the sterilizer cycle e.g operating temperature NOTE When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g inner wrap, container filter, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities, may apply 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 285:2006, Sterilization — Steam sterilizers — Large sterilizers EN 10088-1, Stainless steels — Part 1: List of stainless steels EN ISO 4017, Hexagon head screws — Product grades A and B (ISO 4017:1999) EN ISO 11607-1:2006, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) ISO 4582, Plastics — Determination of changes in colour and variations in properties after exposure to daylight under glass, natural weathering or laboratory light sources Terms and definitions For the purposes of this document, the terms and definitions given in EN ISO 11607-1:2006 and EN 285:2006 apply 4.1 Requirements General The requirements of EN ISO 11607-1 apply NOTE EN ISO 11607-1, 5.1.10 specifies additional requirements for reusable containers BS EN 868-8:2009 EN 868-8:2009 (E) NOTE EN ISO 11607-1:2006, 5.1.4 refers to conditions during production and handling with respect to their impact on the product (e.g electrostatic conductivity, bioburden if applicable) NOTE 4.2 For validation requirements for forming, sealing and assembly processes, see EN ISO 11607-2 Requirements for construction and design 4.2.1 Shape and dimension 4.2.1.1 The container shall be in the general form of a parallelepipedal box NOTE Slight curvature or camber of the flat surfaces can be acceptable Rounding of the corners is desirable 4.2.1.2 The container including all connected parts e.g handles shall fit within one sterilization module (see EN 285) NOTE If the container does not fit within one sterilization module, but complies with all other requirements of this part of the standard, the manufacturer can claim compliance with EN ISO 11607-1, but not with EN 868-8 NOTE For guidance on dimensions see informative Annex B 4.2.1.3 4.2.2 For ease of cleaning all internal corners shall be radiused Lids and lid-latching devices 4.2.2.1 Access to the interior of the container shall be provided by a lid 4.2.2.2 The lid shall be secured to the base during use by locking devices The closure shall comply with the requirements in EN ISO 11607-1:2006, 5.1.10 c) 4.2.3 Tamper evident closure system 4.2.3.1 available A tamper evident closure system complying with EN ISO 11607-1:2006, 5.1.10 a) shall be 4.2.3.2 If the 'tamper evident' closure system is not a single-use disposable item, i.e does not irrevocably break when opened, then a special tool, key, code or treatment shall be required to re-set the closure system 4.2.4 Gasket 4.2.4.1 The interface between the lid and base shall be provided with a closure gasket The closure formed by the gasket with the lid latched in position shall provide microbial barrier properties as specified in EN ISO 11607-1:2006, 5.2 and 5.1.10 c) 4.2.4.2 The gasket shall be accessible for cleaning Frequency and method of maintenance shall be specified by the manufacturer (see Clause 5) 4.2.5 4.2.5.1 Handles Each container shall be provided with a suitable carrying device 4.2.5.2 The carrying devices, the means of their attachment to the container, and the container itself shall be sufficiently robust to support the weight of the filled container without permanent deformation > mm when tested in accordance with Annex C If a permanent deformation is measured, performance characteristics of the container (in particular sterile barrier properties) shall be demonstrated to remain unchanged BS EN 868-8:2009 EN 868-8:2009 (E) 4.2.6 Stacking capability 4.2.6.1 The top and base of each container shall be sufficiently strong to allow stacking and shall be fitted with means to ensure that all containers of the same nominal size and of the same provenance shall stack securely After the test in accordance with Annex D, the container shall show no permanent deformation > mm and shall have unchanged performance characteristics When tested in accordance with Annex E, the tested container shall remain stacked 4.2.6.2 The containers shall be designed and constructed so that when stacked and loaded into the sterilizer in the manner specified by the manufacturer they will allow free passage of steam and/or air between containers Compliance shall be tested by the performance tests carried out as described in Annex C to F 4.2.7 Sterilant Port 4.2.7.1 Each container shall be provided with a sterilant port in one or more of its principle surfaces 4.2.7.2 The sterilant port shall be designed to meet the following requirements: a) It shall permit the attainment of the specified sterilization conditions Compliance shall be tested in accordance with Annex F b) It shall permit adequate drying when processed in a sterilizer conforming to EN 285 Compliance shall be tested in accordance with Annex G c) It shall permit microbial barrier properties during removal, transport and subsequent storage as specified in EN ISO 11607-1:2006, 5.1.10 b) Compliance shall be tested in accordance with applicable barrier tests (see EN ISO 11607-1:2006) NOTE 4.2.8 A condensate drain is considered to be a sterilant port Load A full size container, i.e of one sterilization module size, shall be designed and constructed to allow a total load of up to 10 kg to be sterilized in a sterilizer conforming to EN 285 Fractional sizes shall accommodate proportionally smaller loads NOTE National or regional legislation on occupational health and work safety may require a limitation or restriction of the acceptable weight to handle 4.3 Service life The sterilization container and its components shall, when processed in accordance with the provided instructions for use, meet all requirements during its useful life as it is stated by the manufacturer NOTE The manufacturers instructions include also important information on service, cleaning procedures, the manner of inspection and acceptance criteria, maintenance and replacement of components (see e.g ISO 11607-1:2006, 5.1.10) BS EN 868-8:2009 EN 868-8:2009 (E) NOTE 500 cycles are considered a minimum as a useful life for containers and 100 cycles as a minimum for specific components like gaskets For demonstration of compliance, using accelerated aging protocols shall be regarded as sufficient challenge until data from real-time aging studies are available NOTE 4.4 For guidance on determination of useful life, see Annex H Material requirements 4.4.1 The container and its components shall be able to withstand (both chemical and physical) steam sterilization in a sterilizer conforming to EN 285 without any adverse effects on the container or its components Compliance with EN ISO 11607-1:2006, 5.3 shall be tested: a) in a container which has been subjected to the stated number of use cycles; and b) on a container which has been subjected to use-cycles, stored under ambient conditions with the lid closed for months and then subjected to further use-cycles 4.4.2 The container and its reusable components shall be able to withstand proper cleaning procedures as indicated by the manufacturer without adverse effect to the container or its components Compliance with EN ISO 11607-1 shall be tested: a) in a container which has been subjected to the stated number of cleaning procedures as indicated by the manufacturer; and b) on a container which has been subjected to use-cycles, stored under ambient conditions with the lid closed for months and then subjected to further use-cycles 4.4.3 The container and its components shall be made of materials which are lightstable under the conditions of use Compliance shall be tested in accordance with ISO 4582 4.4.4 If the container and/or its components are made from different materials, there shall be no negative interaction (e.g contact-corrosion) between the materials Compliance shall be deemed to be met if the performance test according to 4.4.1 and 4.4.2 has been carried out successfully 4.4.5 When the container is used as intended, the materials used for the container or its components shall not build up any electrostatic charge 4.4.6 The material, design, construction and surface finish shall facilitate easy internal and external disinfection and cleaning 4.5 Marking Containers shall be marked with the manufacturer's or supplier's name or trademark Information to be supplied by the manufacturer The following information should be supplied in addition to EN ISO 11607-1:2006, Clause 7: a) the manufacturer's or supplier's name or trade name, and address; BS EN 868-8:2009 EN 868-8:2009 (E) b) specification of the essential parts; c) manner of inspection and maintenance and/or replacement; d) service-life of the container (use cycles); e) service-life of gasket; f) service and cleaning procedures; g) description on how thermocouples can be inserted into the container (for validation purposes) without being damaged and without altering performance; h) maximum load of the container to be used for the determination of the sterilization performance and load dryness tests NOTE For requirements on information to be provided by the manufacturer national or regional legislation may apply, see in particular Directive 93/42/EEC, Annex I, Section 13 Test methods NOTE If the specific test procedures not specify otherwise, tests can be carried out concurrently NOTE With regard to the verification of the material requirements no test is needed if historical evidence can be documented or if there are bibliographic references for materials which have been previously used satisfactorily NOTE Determinations of useful life (see Annex H) can be used prior to longevity testing BS EN 868-8:2009 EN 868-8:2009 (E) Annex A (informative) Details of significant technical changes between this European Standard and the previous edition Changes between this European Standard and EN 868-8:1999 are the following: a) changes in order to align this European Standard with the EN ISO 11607 series, in particular by 1) amending the main element of the title, the scope and the terminology; 2) using EN ISO 11607-1 as normative reference regarding the general requirements for materials, sterile barrier systems and packaging systems; 3) amending the requirements on lid and lid-latching devices, the tamper evident closure system, the gasket, the microbial barrier properties of the sterilant port and materials; b) in addition to a) first dash, the scope has been modified to explain that other requirements might be of relevance for additional materials being used inside a sterile barrier system; c) an explanatory note has been inserted to refer the user of this European Standard to the general requirements on conditions during production and handling with respect to their impact on the product in EN ISO 11607; d) requirements on the design of handles have been amended to be more general; e) requirements on robustness (forming) and stacking capability have been amended in order to improve verifiability; f) requirements on service life have been amended; g) test methods on sterilization performance and load dryness have been amended on the basis of EN 285:2006 (second edition); h) requirements on information to be provided by the manufacturer have been amended; i) text has been revised editorially (e.g by updating normative and informative references) NOTE 10 This list is not exhaustive BS EN 868-8:2009 EN 868-8:2009 (E) Annex B (informative) Guidance on dimensions Historical evidence demonstrates the dimensions shown in Figure B.1 allow adequate space for loading and unloading of the sterilizer Containers with fractional sizes (e.g 1/2 sterilization unit (STU), 1/4 STU, etc.) should have the same width as given in Figure B.1 Dimensions in millimetres Key Loadable space 1) Maximum outer height hmax = 270 mm Heights < 270 mm are recommended to be 210 mm, 160 mm, 140 mm and 110 mm The internal loadable height h1 should be minimum: hmax - 50 mm in case of sterilant ports in lid and bottom; hmax - 30 mm in case of sterilant ports in lid or bottom or neither lid nor bottom 2) These dimensions are given by the definition of a sterilization module (STU) Figure B.1 — Dimensions 11 BS EN 868-8:2009 EN 868-8:2009 (E) Annex C (normative) Handle strength test C.1 Procedure Distribute the weight of the test load equally inside the container, close the lid and suspend the container at both handles without horizontal force for at least 10 C.2 Result Calculate the mass of the test load as follows: m = 10 kg + (h x 0,1 kg/mm) where h is the loadable height in millimetres; and m is the mass of the test load EXAMPLE For a container with 10 kg + (210 mm x 0,1 kg/mm) = 31 kg 12 a loadable height of 210 mm the mass of the test load is BS EN 868-8:2009 EN 868-8:2009 (E) Annex D (normative) Stacking test D.1 Procedure Stress the upper of two stacked containers with the force F, which shall be introduced with a load-distributing device This force F depends on the projected planar surface area of the container and shall be 500 mN/cm², with a minimum of 100 N NOTE The lower container is the test-container The top-most one is used only to introduce the test force through the stacking device into the test-container 13 BS EN 868-8:2009 EN 868-8:2009 (E) Annex E (normative) Stacking device capability test E.1 Apparatus The test container shall be prepared with an equally distributed load of 10 kg and stacked on top of a bottom fixed container of the same design E.2 Procedure Stess the test-container with a force of 40 N in the horizontal directions as shown in Figure E.1 Figure E.1 — Directions of force to be supplied 14 BS EN 868-8:2009 EN 868-8:2009 (E) Annex F (normative) Determination of sterilization performance F.1 Apparatus F.1.1 Sterilizer conforming to EN 285 with the operating cycle adjusted to the limits specified in EN 285 F.1.2 Thermometric recording instrument as described in 24.5 of EN 285:2006 and temperature sensors according to 24.4 of EN 285:2006 F.1.3 Test load of fabric as specified in EN 285:2006, 24.1, sufficient to completely fill the container F.1.4 Tested container modified to provide a gastight port for the insertion of two temperature sensors F.2 Procedure F.2.1 Fully load the container according to the manufacturer's instructions with sheets of the fabric test load (F.1.3) F.2.2 Place one temperature sensor in the approximate geometric centre of the load and a second sensor between the lid and the wall of the container in the region of the sterilant port F.2.3 Secure the lid on the container and place the container in the steam sterilizer F.2.4 Place the third temperature sensor in the sterilizer chamber approximately 50 mm above the geometric centre of the upper surface of the container and locate the fourth sensor in the sterilizer chamber drain F.2.5 Carry out the operating cycle on the sterilizer and record the temperatures attained at all four sensing locations throughout the cycle F.2.6 Repeat the above procedure twice more F.3 Results F.3.1 Report the differences in temperature during the plateau period between the centre of the test load and the active drain F.3.2 The equilibration time shall not exceed 15 s for sterilizer chambers up to 800 l and 30 s for larger sterilizer chambers F.3.3 During the plateau period the temperature measured between the load and the container wall shall not exceed the temperature measured in the sterilizer chamber by more than K for the first 60 s and K for the remaining period F.3.4 Throughout the holding time the temperature measured in the sterilizer chamber and at the nominal geometric centre of the loaded container shall: a) be within the sterilization temperature band (see 8.3.1.1 of EN 285:2006); b) not differ from one another by more than K 15 BS EN 868-8:2009 EN 868-8:2009 (E) Annex G (normative) Load dryness tests G.1 Apparatus G.1.1 Sterilizer conforming to EN 285 with the operating cycle adjusted to the limits specified in EN 285 G.1.2 Balance capable of weighing a load up to 15 kg with an accuracy of ± g or better G.2 Loads G.2.1 Metal The container shall be loaded to the maximum mass ± 0,1 kg as specified by the manufacturer with metal screws which shall: a) be austenitic stainless steel according to EN 10088-1; b) be hexagon head screws ISO 4017-M12 x 100; c) be cleaned, degreased and dried G.2.2 Textile The container shall be fully loaded with textile material which consists of reusable items that may be used for testing repeatedly if the requirements in this annex are met The environmental aspects regarding cleaning intervals of these materials as well as means used for cleaning and conditioning should be considered The material shall be a) as described in 24.7.3 of EN 285:2006; b) washed when new and when soiled and not subjected to any fabric conditioning agent; c) dried and aired according to 24.7.4 of EN 285:2006 G.3 Procedure G.3.1 Metal Load Carry out the test procedure described in 20.3 of EN 285:2006 with a container loaded according to G.2.1 as the “testpack” 16 BS EN 868-8:2009 EN 868-8:2009 (E) G.3.2 Textile load G.3.2.1 Weigh the empty container (and its components) (m1) G.3.2.2 Load the container as indicated by the manufacturer G.3.2.3 Weigh the loaded container (m2) G.3.2.4 Load the container into the sterilizer according to the manufacturer's instructions G.3.2.5 Carry out a sterilization cycle Start the sterilization cycle within 60 s of placing the test load in the sterilizer chamber G.3.2.6 At completion of the cycle and within min, weigh the container (m3) G.4 Results G.4.1 Metal load The calculated change in moisture value (see 20.3.3.9 in EN 285:2006) shall not exceed 0,2 % G.4.2 Textile load Calculate the change in moisture content as a percentage of the dry load mass by using the formula: m3 − m × 100 % m − m1 where m1 is the weight of the empty container, in grams; m2 is the weight of the loaded container before the cycle, in grams; m3 is the weight of the loaded container at completion of the cycle, in grams The calculated value shall not exceed % 17 BS EN 868-8:2009 EN 868-8:2009 (E) Annex H (informative) Guidance on determination of useful life H.1 Test specimen Container which fits within one sterilization module (see EN 285) H.2 Apparatus Steam sterilizer with a test cycle according to Figure H.1 NOTE The number of test cycles is regarded as equivalent to "real" sterilization cycles, i.e 100 test cycles correspond to 100 "real" sterilization cycles Key p1 < 100 mbar absolute p2 > 000 mbar absolute t1 > t2 > Figure H.1 — Test cycle 18