BS EN 868-3-2009 灭菌医疗装置的包装.生产纸袋(EN 868-4规定)和生产盒和卷筒用纸(EN 868-5规定)要求和试验方法.pdf

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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of an identical text or by endorsement, at the latest by November 2009, and conflicting national standards shall be withdrawn at the latest by November 2009.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 868-3:1999. 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. ÞÍ ÛÒ èêèóíæîððç EN 868-3:2009 (E) 4 Introduction The EN ISO 11607 series consists of two parts under the general title “Packaging for terminally sterilized medical devices“. Part 1 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 2 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 2 to 10 CEN/TC 102/WG 4 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 4 has initiated a review of the test methods needed to show compliance with the requirements specified in EN 868 parts 2 to 10 with the intention that the information required by CEN/BT 21/2003 be available for inclusion in EN 868 parts 2 to 10 during one of their next revisions. CEN/TC 102/WG 4 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. ÞÍ ÛÒ èêèóíæîððç EN 868-3:2009 (E) 5 1 Scope This part of EN 868 provides test methods and values for paper, used in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. NOTE 1 The need for a protective packaging may be determined by the manufacturer and the user. 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 or modify the general requirements specified in EN ISO 11607-1. As such, the particular requirements in 4.2 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. NOTE 2 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. The materials specified in this part of EN 868 are intended for single use only. NOTE 3 Applicable sterilization methods are specified by the manufacturer. 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 20187, Paper, board and pulps Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples (ISO 187:1990) EN 20535, Paper and board Determination of water absorptiveness Cobb method (ISO 535:1991) EN 21974, Paper Determination of tearing resistance (Elmendorf method) (ISO 1974:1990) EN ISO 536, Paper and board Determination of grammage (ISO 536:1995) EN ISO 1924-2, Paper and board Determination of tensile properties Part 2: Constant rate of elongation method (ISO 1924-2:1994) EN ISO 2758, Paper Determination of bursting strength (ISO 2758:2001) 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 3689, Paper and board Determination of bursting strength after immersion in water ISO 3781, Paper and board Determination of tensile strength after immersion in water ISO 5636-3, Paper and board Determination of air permeance (medium range) Part 3: Bendtsen method ISO 6588-2:2005, Paper, board and pulps Determination of pH of aqueous extracts Part 2: Hot extraction ÞÍ ÛÒ èêèóíæîððç EN 868-3:2009 (E) 6 ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times ISO 9197, Paper, board and pulps Determination of water-soluble chlorides ISO 9198, Paper, board and pulp Determination of water-soluble sulfates 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN ISO 11607-1:2006 apply. 4 Requirements 4.1 General The requirements of EN ISO 11607-1 apply. 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). 4.2 Performance requirements and test methods 4.2.1 The requirements of 4.2.11 and 4.2.15 do not apply to materials solely used in irradiation sterilization packaging. 4.2.2 No colour shall leach out of the paper. Compliance shall be tested by visual examination of a hot aqueous extract prepared in accordance with the method given in ISO 6588-2. 4.2.3 The average mass of 1 m² of the conditioned paper when tested in accordance with EN ISO 536 shall be within ± 5 % of the nominal value stated by the manufacturer. 4.2.4 The pH of an aqueous extract of the paper shall be not less than 5 nor greater than 8 when tested in accordance with ISO 6588-2. 4.2.5 The chloride content of the paper, calculated as sodium chloride, shall not exceed 0,05 % when tested in accordance with ISO 9197 using a hot extract prepared in accordance with ISO 6588-2:2005, 7.2 except that 2 ml of potassium chloride solution is not added. 4.2.6 The sulphate content of the paper, calculated as sodium sulphate, shall not exceed 0,25 % when tested in accordance with ISO 9198, using a hot extract prepared in accordance with ISO 6588-2:2005, 7.2 except that 2 ml of potassium chloride solution is not added. 4.2.7 When tested in accordance with Annex B the paper shall neither exhibit an increase in brightness due to the optical brightener of more than 1 % nor have more than five fluorescent spots, each having an axis greater than 1 mm per 0,01 m². 4.2.8 The internal tearing resistance of the conditioned paper shall be not less than 550 mN in both machine and cross direction when tested in accordance with EN 21974. 4.2.9 The air permeance of the conditioned paper shall be not less than 3,4 km/Pa s at an air pressure of 1,47 kPa when tested in accordance with ISO 5636-3. 4.2.10 The bursting strength of the conditioned paper shall be not less than 230 kPa when tested in accordance with EN ISO 2758. ÞÍ ÛÒ èêèóíæîððç EN 868-3:2009 (E) 7 4.2.11 The wet bursting strength of the paper shall be not less than 35 kPa when tested in accordance with ISO 3689 using an immersion time of 10 min. 4.2.12 The water repellency of the paper shall be such that the penetration time is not less than 20 s when tested in accordance with Annex C. 4.2.13 When tested in accordance with Annex D, the average of the pore diameters of the ten test pieces shall be lower than or equal to 35 km. No value shall be greater than 50 µm. 4.2.14 The tensile strength of the conditioned paper shall be not less than 4,40 kN/m in machine direction and not less than 2,20 kN/m in cross direction when tested in accordance with EN ISO 1924-2. 4.2.15 The wet tensile strength of the paper shall be not less than 0,90 kN/m in machine direction and not less than 0,45 kN/m in cross direction when tested in accordance with ISO 3781. 4.2.16 The surface absorbency of each side of the paper shall be not more than 20 g/m² when tested in accordance with EN 20535 using a 60 s exposure time (COBB method). 4.3 Marking 4.3.1 Protective packaging The protective packaging shall be legibly and durably marked with the following information: a) reference, stock or catalogue number; b) quantity; c) the manufacturer's or supplier's name or trade name, and address; d) date of manufacture in accordance with ISO 8601; e) lot number1; f) nominal mass in grams per square metre; g) nominal sheet size or nominal width of rolls in millimetres and length in metres; h) the recommended storage conditions. 4.3.2 Inner package The inner package or inner label with reel material shall be legibly and durably marked with the information a), b), c), e) and f) according to 4.3.1. 5 Information to be supplied by the manufacturer 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. 1 A reference number in order to trace the manufacturing history of the product ÞÍ ÛÒ èêèóíæîððç EN 868-3:2009 (E) 8 Annex A (informative) Details of significant technical changes between this European Standard and the previous edition Changes between this European Standard and EN 868-3:1999 are the following: a) changes in order to align this European Standard with the EN ISO 11607 series, in particular by: